Mary Ann Moon

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomized to receive 10 mg oral escitalopram or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts.

However, Dr. Freeman found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

Significant improvement in hot flash frequency and severity was shown within 1 week of starting escitalopram.

Source DR. FREEMAN

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomized to receive 10 mg oral escitalopram or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts.

However, Dr. Freeman found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

Significant improvement in hot flash frequency and severity was shown within 1 week of starting escitalopram.

Source DR. FREEMAN

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomized to receive 10 mg oral escitalopram or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts.

However, Dr. Freeman found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

Significant improvement in hot flash frequency and severity was shown within 1 week of starting escitalopram.

Source DR. FREEMAN

The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the journal.

Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates.

To date, “only a few” studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. To study the bidirectional relationship, the investigators analyzed data in a large prospective cohort – the Nurses' Health Study.

The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50–75 years in 1996 and were followed until 2006.

Depressive symptoms were categorized according to the women's scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemics, or insulin therapy.

During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not. This rise in diabetes risk showed a “dose-response relationship” with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.

This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted for BMI and lifestyle factors, particularly physical activity.

In a separate analysis of the same data, 7,415 subjects developed incident clinical depression during follow-up. Compared with women without diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).

Controlling for hypertension and coronary heart disease attenuated this association, but it remained significant.

The risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36 for developing clinical depression; in those taking oral agents, RR was 1.42; and in those taking insulin, RR was 1.78.

These findings show that depression and diabetes “are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors,” Dr. Pan and his associates said.

Since both depression and diabetes are highly prevalent in the middle-aged and elderly populations, particularly among women, “proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions,” they noted.

The reasons for the bidirectional association are not yet clear. It is possible that antidepressants, which exert some clinical effects on glucose homeostasis and are known to cause weight gain, contribute to diabetes risk. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants investigation, the researchers said.

This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de la Recherche en Santé du Québec. No financial conflicts of interest were reported.

The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the journal.

Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates.

To date, “only a few” studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. To study the bidirectional relationship, the investigators analyzed data in a large prospective cohort – the Nurses' Health Study.

The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50–75 years in 1996 and were followed until 2006.

Depressive symptoms were categorized according to the women's scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemics, or insulin therapy.

During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not. This rise in diabetes risk showed a “dose-response relationship” with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.

This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted for BMI and lifestyle factors, particularly physical activity.

In a separate analysis of the same data, 7,415 subjects developed incident clinical depression during follow-up. Compared with women without diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).

Controlling for hypertension and coronary heart disease attenuated this association, but it remained significant.

The risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36 for developing clinical depression; in those taking oral agents, RR was 1.42; and in those taking insulin, RR was 1.78.

These findings show that depression and diabetes “are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors,” Dr. Pan and his associates said.

Since both depression and diabetes are highly prevalent in the middle-aged and elderly populations, particularly among women, “proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions,” they noted.

The reasons for the bidirectional association are not yet clear. It is possible that antidepressants, which exert some clinical effects on glucose homeostasis and are known to cause weight gain, contribute to diabetes risk. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants investigation, the researchers said.

This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de la Recherche en Santé du Québec. No financial conflicts of interest were reported.

The association between diabetes and depression is bidirectional in middle-age women, with the presence of either disease significantly raising the risk that the other also will develop, according to a report in the journal.

Moreover, diabetes raises the risk of depression, and depression raises the risk of diabetes, independently of other known risk factors such as adiposity that are common to both diseases, said An Pan, Ph.D., of the Harvard School of Public Health, Boston, and his associates.

To date, “only a few” studies have examined the association between diabetes and depression simultaneously, and their results have been inconsistent. To study the bidirectional relationship, the investigators analyzed data in a large prospective cohort – the Nurses' Health Study.

The NHS involved female registered nurses residing in 11 states who were followed every 2 years via health questionnaires. Dr. Pan and his colleagues assessed a subset of 65,381 NHS participants who were aged 50–75 years in 1996 and were followed until 2006.

Depressive symptoms were categorized according to the women's scores on the Mental Health Index 5, whether depression had been diagnosed by a physician and whether they used antidepressants. Diabetes was categorized as requiring no medications, only oral hypoglycemics, or insulin therapy.

During follow-up, 2,844 incident cases of diabetes were documented. The risk of developing diabetes was significantly higher in women who had depressive symptoms than in those who did not. This rise in diabetes risk showed a “dose-response relationship” with worsening depressive symptoms, such that diabetes risk increased significantly as scores on the MHI-5 rose.

This association between depression and diabetes remained significant, although it was markedly attenuated, when the data were adjusted for BMI and lifestyle factors, particularly physical activity.

In a separate analysis of the same data, 7,415 subjects developed incident clinical depression during follow-up. Compared with women without diabetes, women with diabetes had a relative risk of developing clinical depression of 1.44, the investigators said (Arch. Intern. Med. 2010;170:1884-91).

Controlling for hypertension and coronary heart disease attenuated this association, but it remained significant.

The risk of developing clinical depression also showed a dose-response relationship with worsening diabetes symptoms. Women with diabetes who were not taking any medication had a relative risk of 1.36 for developing clinical depression; in those taking oral agents, RR was 1.42; and in those taking insulin, RR was 1.78.

These findings show that depression and diabetes “are closely related to each other, and this reciprocal association also depends on the severity and treatment of each condition. All the associations were independent of sociodemographic, diet, and lifestyle factors,” Dr. Pan and his associates said.

Since both depression and diabetes are highly prevalent in the middle-aged and elderly populations, particularly among women, “proper lifestyle interventions including adequate weight management and regular physical activity are recommended to lower the risk of both conditions,” they noted.

The reasons for the bidirectional association are not yet clear. It is possible that antidepressants, which exert some clinical effects on glucose homeostasis and are known to cause weight gain, contribute to diabetes risk. However, the link between depression and diabetes was significant independent of BMI, so the possibility that antidepressants might exert some other metabolic effect warrants investigation, the researchers said.

This study was supported by the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, and the Fonds de la Recherche en Santé du Québec. No financial conflicts of interest were reported.

Major Finding: Patients with major depression and concomitant poorly controlled diabetes and/or CHD who received an intervention targeting all such conditions showed greater improvements in HbA_1c, LDL cholesterol levels, systolic blood pressure, and depression scores than did patients who received usual care.

Data Source: A 1-year randomized controlled trial involving 214 patients.

Disclosures: This study was supported by the National Institute of Mental Health and the Group Health Cooperative. The researchers reported ties to Wyeth, Eli Lilly, Forest, Pfizer, Prescott Medical, HealthSTAR Communications, the World Psychiatry Association, John A. Hartford Foundation, Johnson & Johnson, Samepage, and Roche Diagnostics.

A primary care–based intervention significantly improved glycated hemoglobin, LDL cholesterol, blood pressure, and depression outcomes in patients who had concomitant coronary heart disease, diabetes, and depression, according to a randomized, controlled trial.

The intervention also improved quality of life and patient satisfaction with their health care, said Dr. Wayne J. Katon of the departments of psychiatry and behavioral sciences, University of Washington, Seattle, and his associates.

The investigators designed the intervention in part because “the care of patients with multiple chronic diseases accounts for the majority of health care costs, [and] effective approaches to managing such complex care in primary [practice] are needed, particularly when psychological and physical disorders coexist.”

The intervention targeted patients with major depression and poorly controlled diabetes, coronary heart disease (CHD), or both. It included structured patient visits every 2–3 weeks to 14 clinics comprising 151 primary care physicians.

In each clinic, three part-time nurses promoted patient self-care, provided educational materials, and monitored control of depression, hyperglycemia, hypertension, and hyperlipidemia. The nurses received weekly supervision with a psychiatrist, a primary care physician, and a psychologist to review patient progress and adjust treatment as necessary.

The estimated cost of the intervention was $1,224 per patient.

To assess the effectiveness of the intervention, Dr. Katon and his colleagues randomly assigned 106 patients to receive the intervention and 108 to receive usual care for 1 year.

At the conclusion of the study, patients in the intervention group showed significantly greater overall improvement than did controls in hemoglobin A_1c (mean decrease 0.58%), LDL cholesterol (a mean decrease of 6.9 mg/dL), and systolic blood pressure (mean decrease 5.1 mm Hg), as well as significantly improved scores on the SCL-20 measure of depression (mean decrease 0.40 points).

These differences are greater than those reported in the literature for trials of single CHD and diabetes medications, the investigators noted.

A higher proportion of patients in the intervention group (37%) than in the control group (22%) attained values on all three medical risk factors that met levels recommended in clinical guidelines, and a higher proportion also showed reductions of 50% or more in SCL-20 scores.

The study was not adequately powered to detect between-group differences in rates of hospitalization or cardiovascular events.

“Although effects on the glycated hemoglobin level, LDL cholesterol level, and systolic blood pressure were modest, on a population level they may meaningfully decrease the risks of macrovascular and microvascular disease,” Dr. Katon and his associates said (N. Engl. J. Med. 2010;363:2611-20).

Patients in the intervention group also were significantly more likely than were those in the control group to have made changes in their doses of insulin, antihypertensive drugs, and antidepressants during the study period.

In self-reports, patients in the intervention group showed greater improvements in quality of life and said they were more satisfied with their health care than did patients in the usual-care group.

“Our results suggest that an intervention involving coordinated efforts of physicians and nurses may facilitate the care of patients with multiple conditions within a primary care medical home,” the researchers said.

'The care of patients with multiple chronic diseases accounts for the majority of health care costs.'

Source DR. KATON

Major Finding: Patients with major depression and concomitant poorly controlled diabetes and/or CHD who received an intervention targeting all such conditions showed greater improvements in HbA_1c, LDL cholesterol levels, systolic blood pressure, and depression scores than did patients who received usual care.

Data Source: A 1-year randomized controlled trial involving 214 patients.

Disclosures: This study was supported by the National Institute of Mental Health and the Group Health Cooperative. The researchers reported ties to Wyeth, Eli Lilly, Forest, Pfizer, Prescott Medical, HealthSTAR Communications, the World Psychiatry Association, John A. Hartford Foundation, Johnson & Johnson, Samepage, and Roche Diagnostics.

A primary care–based intervention significantly improved glycated hemoglobin, LDL cholesterol, blood pressure, and depression outcomes in patients who had concomitant coronary heart disease, diabetes, and depression, according to a randomized, controlled trial.

The intervention also improved quality of life and patient satisfaction with their health care, said Dr. Wayne J. Katon of the departments of psychiatry and behavioral sciences, University of Washington, Seattle, and his associates.

The investigators designed the intervention in part because “the care of patients with multiple chronic diseases accounts for the majority of health care costs, [and] effective approaches to managing such complex care in primary [practice] are needed, particularly when psychological and physical disorders coexist.”

The intervention targeted patients with major depression and poorly controlled diabetes, coronary heart disease (CHD), or both. It included structured patient visits every 2–3 weeks to 14 clinics comprising 151 primary care physicians.

In each clinic, three part-time nurses promoted patient self-care, provided educational materials, and monitored control of depression, hyperglycemia, hypertension, and hyperlipidemia. The nurses received weekly supervision with a psychiatrist, a primary care physician, and a psychologist to review patient progress and adjust treatment as necessary.

The estimated cost of the intervention was $1,224 per patient.

To assess the effectiveness of the intervention, Dr. Katon and his colleagues randomly assigned 106 patients to receive the intervention and 108 to receive usual care for 1 year.

At the conclusion of the study, patients in the intervention group showed significantly greater overall improvement than did controls in hemoglobin A_1c (mean decrease 0.58%), LDL cholesterol (a mean decrease of 6.9 mg/dL), and systolic blood pressure (mean decrease 5.1 mm Hg), as well as significantly improved scores on the SCL-20 measure of depression (mean decrease 0.40 points).

These differences are greater than those reported in the literature for trials of single CHD and diabetes medications, the investigators noted.

A higher proportion of patients in the intervention group (37%) than in the control group (22%) attained values on all three medical risk factors that met levels recommended in clinical guidelines, and a higher proportion also showed reductions of 50% or more in SCL-20 scores.

The study was not adequately powered to detect between-group differences in rates of hospitalization or cardiovascular events.

“Although effects on the glycated hemoglobin level, LDL cholesterol level, and systolic blood pressure were modest, on a population level they may meaningfully decrease the risks of macrovascular and microvascular disease,” Dr. Katon and his associates said (N. Engl. J. Med. 2010;363:2611-20).

Patients in the intervention group also were significantly more likely than were those in the control group to have made changes in their doses of insulin, antihypertensive drugs, and antidepressants during the study period.

In self-reports, patients in the intervention group showed greater improvements in quality of life and said they were more satisfied with their health care than did patients in the usual-care group.

“Our results suggest that an intervention involving coordinated efforts of physicians and nurses may facilitate the care of patients with multiple conditions within a primary care medical home,” the researchers said.

'The care of patients with multiple chronic diseases accounts for the majority of health care costs.'

Source DR. KATON

Major Finding: Patients with major depression and concomitant poorly controlled diabetes and/or CHD who received an intervention targeting all such conditions showed greater improvements in HbA_1c, LDL cholesterol levels, systolic blood pressure, and depression scores than did patients who received usual care.

Data Source: A 1-year randomized controlled trial involving 214 patients.

Disclosures: This study was supported by the National Institute of Mental Health and the Group Health Cooperative. The researchers reported ties to Wyeth, Eli Lilly, Forest, Pfizer, Prescott Medical, HealthSTAR Communications, the World Psychiatry Association, John A. Hartford Foundation, Johnson & Johnson, Samepage, and Roche Diagnostics.

A primary care–based intervention significantly improved glycated hemoglobin, LDL cholesterol, blood pressure, and depression outcomes in patients who had concomitant coronary heart disease, diabetes, and depression, according to a randomized, controlled trial.

The intervention also improved quality of life and patient satisfaction with their health care, said Dr. Wayne J. Katon of the departments of psychiatry and behavioral sciences, University of Washington, Seattle, and his associates.

The investigators designed the intervention in part because “the care of patients with multiple chronic diseases accounts for the majority of health care costs, [and] effective approaches to managing such complex care in primary [practice] are needed, particularly when psychological and physical disorders coexist.”

The intervention targeted patients with major depression and poorly controlled diabetes, coronary heart disease (CHD), or both. It included structured patient visits every 2–3 weeks to 14 clinics comprising 151 primary care physicians.

In each clinic, three part-time nurses promoted patient self-care, provided educational materials, and monitored control of depression, hyperglycemia, hypertension, and hyperlipidemia. The nurses received weekly supervision with a psychiatrist, a primary care physician, and a psychologist to review patient progress and adjust treatment as necessary.

The estimated cost of the intervention was $1,224 per patient.

To assess the effectiveness of the intervention, Dr. Katon and his colleagues randomly assigned 106 patients to receive the intervention and 108 to receive usual care for 1 year.

At the conclusion of the study, patients in the intervention group showed significantly greater overall improvement than did controls in hemoglobin A_1c (mean decrease 0.58%), LDL cholesterol (a mean decrease of 6.9 mg/dL), and systolic blood pressure (mean decrease 5.1 mm Hg), as well as significantly improved scores on the SCL-20 measure of depression (mean decrease 0.40 points).

These differences are greater than those reported in the literature for trials of single CHD and diabetes medications, the investigators noted.

A higher proportion of patients in the intervention group (37%) than in the control group (22%) attained values on all three medical risk factors that met levels recommended in clinical guidelines, and a higher proportion also showed reductions of 50% or more in SCL-20 scores.

The study was not adequately powered to detect between-group differences in rates of hospitalization or cardiovascular events.

“Although effects on the glycated hemoglobin level, LDL cholesterol level, and systolic blood pressure were modest, on a population level they may meaningfully decrease the risks of macrovascular and microvascular disease,” Dr. Katon and his associates said (N. Engl. J. Med. 2010;363:2611-20).

Patients in the intervention group also were significantly more likely than were those in the control group to have made changes in their doses of insulin, antihypertensive drugs, and antidepressants during the study period.

In self-reports, patients in the intervention group showed greater improvements in quality of life and said they were more satisfied with their health care than did patients in the usual-care group.

“Our results suggest that an intervention involving coordinated efforts of physicians and nurses may facilitate the care of patients with multiple conditions within a primary care medical home,” the researchers said.

'The care of patients with multiple chronic diseases accounts for the majority of health care costs.'

Source DR. KATON

Forty percent of patients with psoriasis were found to have the metabolic syndrome in a study of a nationally representative sample of more than 6,500 adults.

The prevalence of the metabolic syndrome was about twice as high in psoriasis patients as in adults without psoriasis, even after adjustment for potential confounders such as age, sex, race/ethnicity, smoking status, and CRP levels, reported Dr. Thorvardur Jon Love of Brigham and Women's Hospital, Boston, and his associates.

“Based on these data, it is estimated that of the 6.6 million adults (age range 20–59 years) with psoriasis in the United States, 2.7 million have the metabolic syndrome, or nearly a million more individuals than would be expected from individuals without psoriasis,” they noted.

The study findings may partially explain why previous research has found increased risks of cardiovascular and metabolic morbidity and mortality in psoriasis patients. In particular, patients with severe psoriasis have been reported to be at an increased risk for MI, stroke, and cardiovascular mortality, and have been reported to die 3–4 years earlier than people without psoriasis, the investigators added.

The metabolic syndrome is characterized by abdominal obesity, hypertriglyceridemia, low HDL cholesterol levels, hypertension, and high fasting glucose levels. Recent research has pegged the incidence of the disorder at 15%–24% in the general U.S. population.

Noting that there has been only one previous study examining the relationship between psoriasis and the metabolic syndrome, and that until now there have been no population-based data on the issue, Dr. Love and his colleagues used data from the National Health and Nutrition Examination Survey (NHANES) 2003–2006 to assess the prevalence of the metabolic syndrome and its components in psoriasis.

The study included 2,456 adults (mean age 39 years) who did not have preexisting diabetes; 71 had psoriasis.

The prevalence of the metabolic syndrome was 40% among psoriasis patients, compared with 23% among patients without psoriasis. The odds ratio for patients with psoriasis to have the metabolic syndrome was 2.16 on univariate analysis and 1.96 after the data were adjusted to account for potential confounding factors.

When CRP levels were removed from the analysis to cancel out the potentially confounding effect of inflammation, odds ratios did not change materially, Dr. Love and his associates reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.370]).

“When we applied these data to the 2008 U.S. census population estimate, 6.6 million (95% CI, 4.8-8.3) individuals aged 20–59 years were estimated to have psoriasis in the United States, and 2.7 million (95% CI, 1.6-3.6) of these individuals with psoriasis were estimated to have the metabolic syndrome, an excess of 1 million patients compared with the expected value among individuals without psoriasis,” they noted.

The most common feature of the metabolic syndrome to be found among psoriasis patients was abdominal obesity, present in 63%. Hypertriglyceridemia and low HDL levels also were common.

These findings indicate that “a diagnosis of psoriasis should trigger a high clinical suspicion [of] and investigation for a potential coexistence of the metabolic syndrome. If present, the syndrome needs to be recognized as a potentially more life-threatening factor than psoriasis given the serious associated complications,” Dr. Love and his colleagues wrote.

This association also should be considered when choosing therapy for psoriasis. “For example, tumor necrosis factor blockers may decrease insulin resistance,” they added.

This study was supported in part by the National Institutes of Health, the Psoriasis Foundation, and the National Heart, Lung, and Blood Institute. One of Dr. Love's associates reported ties to Amgen, Abbott, Celgene, Centocor, Pfizer, and Novartis.

Forty percent of patients with psoriasis were found to have the metabolic syndrome in a study of a nationally representative sample of more than 6,500 adults.

The prevalence of the metabolic syndrome was about twice as high in psoriasis patients as in adults without psoriasis, even after adjustment for potential confounders such as age, sex, race/ethnicity, smoking status, and CRP levels, reported Dr. Thorvardur Jon Love of Brigham and Women's Hospital, Boston, and his associates.

“Based on these data, it is estimated that of the 6.6 million adults (age range 20–59 years) with psoriasis in the United States, 2.7 million have the metabolic syndrome, or nearly a million more individuals than would be expected from individuals without psoriasis,” they noted.

The study findings may partially explain why previous research has found increased risks of cardiovascular and metabolic morbidity and mortality in psoriasis patients. In particular, patients with severe psoriasis have been reported to be at an increased risk for MI, stroke, and cardiovascular mortality, and have been reported to die 3–4 years earlier than people without psoriasis, the investigators added.

The metabolic syndrome is characterized by abdominal obesity, hypertriglyceridemia, low HDL cholesterol levels, hypertension, and high fasting glucose levels. Recent research has pegged the incidence of the disorder at 15%–24% in the general U.S. population.

Noting that there has been only one previous study examining the relationship between psoriasis and the metabolic syndrome, and that until now there have been no population-based data on the issue, Dr. Love and his colleagues used data from the National Health and Nutrition Examination Survey (NHANES) 2003–2006 to assess the prevalence of the metabolic syndrome and its components in psoriasis.

The study included 2,456 adults (mean age 39 years) who did not have preexisting diabetes; 71 had psoriasis.

The prevalence of the metabolic syndrome was 40% among psoriasis patients, compared with 23% among patients without psoriasis. The odds ratio for patients with psoriasis to have the metabolic syndrome was 2.16 on univariate analysis and 1.96 after the data were adjusted to account for potential confounding factors.

When CRP levels were removed from the analysis to cancel out the potentially confounding effect of inflammation, odds ratios did not change materially, Dr. Love and his associates reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.370]).

“When we applied these data to the 2008 U.S. census population estimate, 6.6 million (95% CI, 4.8-8.3) individuals aged 20–59 years were estimated to have psoriasis in the United States, and 2.7 million (95% CI, 1.6-3.6) of these individuals with psoriasis were estimated to have the metabolic syndrome, an excess of 1 million patients compared with the expected value among individuals without psoriasis,” they noted.

The most common feature of the metabolic syndrome to be found among psoriasis patients was abdominal obesity, present in 63%. Hypertriglyceridemia and low HDL levels also were common.

These findings indicate that “a diagnosis of psoriasis should trigger a high clinical suspicion [of] and investigation for a potential coexistence of the metabolic syndrome. If present, the syndrome needs to be recognized as a potentially more life-threatening factor than psoriasis given the serious associated complications,” Dr. Love and his colleagues wrote.

This association also should be considered when choosing therapy for psoriasis. “For example, tumor necrosis factor blockers may decrease insulin resistance,” they added.

This study was supported in part by the National Institutes of Health, the Psoriasis Foundation, and the National Heart, Lung, and Blood Institute. One of Dr. Love's associates reported ties to Amgen, Abbott, Celgene, Centocor, Pfizer, and Novartis.

Forty percent of patients with psoriasis were found to have the metabolic syndrome in a study of a nationally representative sample of more than 6,500 adults.

The prevalence of the metabolic syndrome was about twice as high in psoriasis patients as in adults without psoriasis, even after adjustment for potential confounders such as age, sex, race/ethnicity, smoking status, and CRP levels, reported Dr. Thorvardur Jon Love of Brigham and Women's Hospital, Boston, and his associates.

“Based on these data, it is estimated that of the 6.6 million adults (age range 20–59 years) with psoriasis in the United States, 2.7 million have the metabolic syndrome, or nearly a million more individuals than would be expected from individuals without psoriasis,” they noted.

The study findings may partially explain why previous research has found increased risks of cardiovascular and metabolic morbidity and mortality in psoriasis patients. In particular, patients with severe psoriasis have been reported to be at an increased risk for MI, stroke, and cardiovascular mortality, and have been reported to die 3–4 years earlier than people without psoriasis, the investigators added.

The metabolic syndrome is characterized by abdominal obesity, hypertriglyceridemia, low HDL cholesterol levels, hypertension, and high fasting glucose levels. Recent research has pegged the incidence of the disorder at 15%–24% in the general U.S. population.

Noting that there has been only one previous study examining the relationship between psoriasis and the metabolic syndrome, and that until now there have been no population-based data on the issue, Dr. Love and his colleagues used data from the National Health and Nutrition Examination Survey (NHANES) 2003–2006 to assess the prevalence of the metabolic syndrome and its components in psoriasis.

The study included 2,456 adults (mean age 39 years) who did not have preexisting diabetes; 71 had psoriasis.

The prevalence of the metabolic syndrome was 40% among psoriasis patients, compared with 23% among patients without psoriasis. The odds ratio for patients with psoriasis to have the metabolic syndrome was 2.16 on univariate analysis and 1.96 after the data were adjusted to account for potential confounding factors.

When CRP levels were removed from the analysis to cancel out the potentially confounding effect of inflammation, odds ratios did not change materially, Dr. Love and his associates reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.370]).

“When we applied these data to the 2008 U.S. census population estimate, 6.6 million (95% CI, 4.8-8.3) individuals aged 20–59 years were estimated to have psoriasis in the United States, and 2.7 million (95% CI, 1.6-3.6) of these individuals with psoriasis were estimated to have the metabolic syndrome, an excess of 1 million patients compared with the expected value among individuals without psoriasis,” they noted.

The most common feature of the metabolic syndrome to be found among psoriasis patients was abdominal obesity, present in 63%. Hypertriglyceridemia and low HDL levels also were common.

These findings indicate that “a diagnosis of psoriasis should trigger a high clinical suspicion [of] and investigation for a potential coexistence of the metabolic syndrome. If present, the syndrome needs to be recognized as a potentially more life-threatening factor than psoriasis given the serious associated complications,” Dr. Love and his colleagues wrote.

This association also should be considered when choosing therapy for psoriasis. “For example, tumor necrosis factor blockers may decrease insulin resistance,” they added.

This study was supported in part by the National Institutes of Health, the Psoriasis Foundation, and the National Heart, Lung, and Blood Institute. One of Dr. Love's associates reported ties to Amgen, Abbott, Celgene, Centocor, Pfizer, and Novartis.

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomly assigned to receive oral escitalopram (10 mg) or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts. However, they found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

'It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram.'

Source DR. FREEMAN

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomly assigned to receive oral escitalopram (10 mg) or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts. However, they found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

'It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram.'

Source DR. FREEMAN

Major Finding: Escitalopram decreased the frequency of hot flashes by nearly half, from 9.78 per day to 5.26 per day.

Data Source: An 8-week multicenter, randomized, double-blind clinical trial involving 205 women.

Disclosures: This study was supported by the National Institute of Aging, the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research on Women's Health, the Indiana Clinical and Translational Sciences Institute, and the National Center for Research Resources. Forest Laboratories provided the escitalopram and placebo pills. Dr. Freeman reported ties to Forest Laboratories, Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals, and Bayer Health Care, and her associates also reported ties to numerous drug companies.

The selective serotonin reuptake inhibitor escitalopram rapidly reduces the frequency and severity of hot flashes in menopausal women, according to a report.

In a multicenter, randomized clinical trial comparing 10 or 20 mg per day of escitalopram with placebo, the drug's benefit “was only modestly less than that reported in a meta-analysis of estrogen therapy,” said Ellen W. Freeman, Ph.D., of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and her associates.

“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well tolerated in the management of menopausal hot flashes,” they said.

The double-blind trial involved 205 women who were in the menopausal transition, were postmenopausal, or had undergone hysterectomy with one or both ovaries intact. Ninety-five of the women self-reported as African American, 102 as white, and 8 as other. These subjects recorded at least 28 hot flashes or night sweats per week in a daily diary for 3 weeks before enrollment, or hot flashes or night sweats rated as bothersome or severe 4 or more days per week.

The women were randomly assigned to receive oral escitalopram (10 mg) or a matching placebo for 8 weeks. If they did not show a reduction in hot flash frequency or at least a 50% reduction in hot flash severity at 4 weeks, the dose was escalated to 20 mg of active drug or placebo.

At baseline, the mean frequency of hot flashes was 9.78 per day. After 8 weeks, that decreased by nearly half, to 5.26 per day in women taking escitalopram. This reduction was significantly greater than the 33% decrease to 6.43 hot flashes per day in the placebo group.

A total of 55% of women receiving active drug showed a decline of at least 50% in hot flash frequency, compared with 36% of women receiving placebo. Similarly, 19% of the escitalopram group showed a decline of at least 75% in hot flash frequency, compared with only 9% of the placebo group.

Data from the study subjects' daily diaries showed that every week for the duration of the study, the frequency of hot flashes was significantly decreased in the escitalopram group compared with the placebo group, Dr. Freeman and her colleagues said (JAMA 2010;305:267-74).

Escitalopram also diminished the severity of hot flashes by 24%, compared with a decrease of 14% with placebo. Seventy percent of women taking the active drug reported satisfaction with treatment, compared with 43% of those taking placebo.

These benefits were consistent across all subgroups of subjects, regardless of the women's race, menopausal status, depression scores, or anxiety scores.

Treatment response was rapid, with women in the escitalopram group showing significant improvement in hot flash frequency and severity within 1 week of starting treatment, the investigators noted.

The study subjects were followed up about 3 weeks after discontinuing their study medication. Hot flash frequency had rebounded by a significantly greater amount in the escitalopram group (7.18 hot flashes per day) than in the placebo group (6.65 hot flashes per day), as had the severity of hot flashes.

Sixty-four percent of the women taking escitalopram said they wanted to continue taking their assigned medication, compared with only 42% of those in the placebo group.

“It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram,” which suggests that the mechanism underlying the drug's effect on hot flashes may differ from that underlying its effect in psychiatric conditions. This finding also supports the hypothesis that serotonin receptors play a role in the pathogenesis of hot flashes, Dr. Freeman and her associates said.

Overall, 53% of women taking escitalopram and 63% taking placebo reported newly emergent adverse effects, none of which were serious. Nine women in the escitalopram group and two in the placebo group discontinued treatment because of adverse events, including dizziness, vivid dreams, nausea, and excessive sweating.

Dr. Freeman and her colleagues reported that to their knowledge, their clinical trial is the first to examine whether racial differences exist in response to SSRI treatment for hot flashes. Previous studies have shown that African American women are more likely to report hot flashes than their white counterparts. However, they found that “race did not significantly affect the response to escitalopram in the present study.”

Additional studies are needed to compare the efficacy of SSRIs and selective serotonin norepinephrine inhibitors in treating hot flashes related to menopause, they reported.

'It is noteworthy that women who were not clinically anxious or depressed responded to escitalopram.'

Source DR. FREEMAN

The risks of opioid use for elderly patients with nonmalignant pain vary considerably by different agents and by different durations of use, according to an analysis of Medicare databases.

Patients taking codeine for more than 180 days are at increased risk for cardiovascular events, and those taking oxycodone or codeine for only 30 days are at increased risk for any-cause mortality, said Dr. Daniel H. Solomon and his associates in the rheumatology department and the pharmacoepidemiology division at Brigham and Women's Hospital, Boston.

“This study's findings do not agree with a commonly held belief that all opioids are associated with similar risk,” the investigators noted.

They compared the safety profiles of different opioids for the treatment of nonmalignant pain in elderly patients because “relatively little attention has been paid” to this issue even though the use of these drugs has risen by 50%-100% in recent years. In contrast, patients and physicians are relatively well informed about the toxicities of NSAIDs used for the same indications.

Dr. Solomon and his colleagues analyzed information in two states' Medicare databases of pharmaceutical coverage for low-income patients (mean age, 79 years) between 1995 and 2005. They matched 6,275 subjects who took five of the most commonly prescribed opioids for a variety of baseline factors using propensity scores.

Hydrocodone was used as the reference exposure, to which codeine, oxycodone, propoxyphene, and tramadol were compared.

The risk of cardiovascular events including MI, stroke, heart failure, revascularization, and cardiac death was similar across the five opioid groups after 30 days of use. However, by 180 days the cardiovascular risk with codeine was significantly higher (risk ratio 1.62) than with the other four opioids.

This finding is surprising and requires validation in other study populations, the investigators said (Arch. Intern. Med. 2010;170:1979-86).

All-cause mortality was elevated after only 30 days of use for patients taking oxycodone (RR 2.43) or codeine (RR 2.05), but not for those taking other opioids.

In contrast, the risk of fracture of the hip, pelvis, wrist, or humerus was significantly reduced after 30 days of treatment for patients taking tramadol (RR 0.21) or propoxyphene (RR 0.54)

The risk of gastrointestinal adverse events – including upper GI bleeding, lower GI bleeding, and bowel obstruction – did not differ across opioid groups.

These risks remained consistent through a range of sensitivity analyses either 30 days or 180 days and regardless of whether patients were taking low, medium, high, or very high doses of the drugs.

View on the News

Opioids Are Not 'Interchangeable'

The findings by Dr. Solomon and his associates “challenge the conventional notion that the safety profiles of opioids are generally interchangeable” and carry two important clinical implications, said Dr. William C. Becker and Dr. Patrick G. O'Connor.

The first and most crucial implication is that the frequent use of codeine must be reexamined. “The untested but widespread assumption that codeine is safer from an addiction standpoint because of its lower potency may need to give way to these data demonstrating increased risk of cardiovascular events and all-cause mortality. If codeine is of middling efficacy for pain and is more risky than other opioids, there would be little reason to use it,” they noted.

Secondly, the elevated risk of fractures with opioid use “has solid biological plausibility” by two mechanisms of action: Opioids raise the rate of falls, and they suppress the production of androgen and estradiol, imperiling bone health. The study findings suggest that basic safety measures to counterbalance these effects are not being implemented.

“Efforts to improve patients' understanding of safe medication-taking practices, providers' understanding of safe prescribing practices, and standardization of safety-oriented follow-up are sorely needed,” said Dr. Becker and Dr. O'Connor.

DR. BECKER and DR. O'CONNOR are internists at Yale University, New Haven, Conn. They reported no relevant financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010; 170:1986-8).

The risks of opioid use for elderly patients with nonmalignant pain vary considerably by different agents and by different durations of use, according to an analysis of Medicare databases.

Patients taking codeine for more than 180 days are at increased risk for cardiovascular events, and those taking oxycodone or codeine for only 30 days are at increased risk for any-cause mortality, said Dr. Daniel H. Solomon and his associates in the rheumatology department and the pharmacoepidemiology division at Brigham and Women's Hospital, Boston.

“This study's findings do not agree with a commonly held belief that all opioids are associated with similar risk,” the investigators noted.

They compared the safety profiles of different opioids for the treatment of nonmalignant pain in elderly patients because “relatively little attention has been paid” to this issue even though the use of these drugs has risen by 50%-100% in recent years. In contrast, patients and physicians are relatively well informed about the toxicities of NSAIDs used for the same indications.

Dr. Solomon and his colleagues analyzed information in two states' Medicare databases of pharmaceutical coverage for low-income patients (mean age, 79 years) between 1995 and 2005. They matched 6,275 subjects who took five of the most commonly prescribed opioids for a variety of baseline factors using propensity scores.

Hydrocodone was used as the reference exposure, to which codeine, oxycodone, propoxyphene, and tramadol were compared.

The risk of cardiovascular events including MI, stroke, heart failure, revascularization, and cardiac death was similar across the five opioid groups after 30 days of use. However, by 180 days the cardiovascular risk with codeine was significantly higher (risk ratio 1.62) than with the other four opioids.

This finding is surprising and requires validation in other study populations, the investigators said (Arch. Intern. Med. 2010;170:1979-86).

All-cause mortality was elevated after only 30 days of use for patients taking oxycodone (RR 2.43) or codeine (RR 2.05), but not for those taking other opioids.

In contrast, the risk of fracture of the hip, pelvis, wrist, or humerus was significantly reduced after 30 days of treatment for patients taking tramadol (RR 0.21) or propoxyphene (RR 0.54)

The risk of gastrointestinal adverse events – including upper GI bleeding, lower GI bleeding, and bowel obstruction – did not differ across opioid groups.

These risks remained consistent through a range of sensitivity analyses either 30 days or 180 days and regardless of whether patients were taking low, medium, high, or very high doses of the drugs.

View on the News

Opioids Are Not 'Interchangeable'

The findings by Dr. Solomon and his associates “challenge the conventional notion that the safety profiles of opioids are generally interchangeable” and carry two important clinical implications, said Dr. William C. Becker and Dr. Patrick G. O'Connor.

The first and most crucial implication is that the frequent use of codeine must be reexamined. “The untested but widespread assumption that codeine is safer from an addiction standpoint because of its lower potency may need to give way to these data demonstrating increased risk of cardiovascular events and all-cause mortality. If codeine is of middling efficacy for pain and is more risky than other opioids, there would be little reason to use it,” they noted.

Secondly, the elevated risk of fractures with opioid use “has solid biological plausibility” by two mechanisms of action: Opioids raise the rate of falls, and they suppress the production of androgen and estradiol, imperiling bone health. The study findings suggest that basic safety measures to counterbalance these effects are not being implemented.

“Efforts to improve patients' understanding of safe medication-taking practices, providers' understanding of safe prescribing practices, and standardization of safety-oriented follow-up are sorely needed,” said Dr. Becker and Dr. O'Connor.

DR. BECKER and DR. O'CONNOR are internists at Yale University, New Haven, Conn. They reported no relevant financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010; 170:1986-8).

The risks of opioid use for elderly patients with nonmalignant pain vary considerably by different agents and by different durations of use, according to an analysis of Medicare databases.

Patients taking codeine for more than 180 days are at increased risk for cardiovascular events, and those taking oxycodone or codeine for only 30 days are at increased risk for any-cause mortality, said Dr. Daniel H. Solomon and his associates in the rheumatology department and the pharmacoepidemiology division at Brigham and Women's Hospital, Boston.

“This study's findings do not agree with a commonly held belief that all opioids are associated with similar risk,” the investigators noted.

They compared the safety profiles of different opioids for the treatment of nonmalignant pain in elderly patients because “relatively little attention has been paid” to this issue even though the use of these drugs has risen by 50%-100% in recent years. In contrast, patients and physicians are relatively well informed about the toxicities of NSAIDs used for the same indications.

Dr. Solomon and his colleagues analyzed information in two states' Medicare databases of pharmaceutical coverage for low-income patients (mean age, 79 years) between 1995 and 2005. They matched 6,275 subjects who took five of the most commonly prescribed opioids for a variety of baseline factors using propensity scores.

Hydrocodone was used as the reference exposure, to which codeine, oxycodone, propoxyphene, and tramadol were compared.

The risk of cardiovascular events including MI, stroke, heart failure, revascularization, and cardiac death was similar across the five opioid groups after 30 days of use. However, by 180 days the cardiovascular risk with codeine was significantly higher (risk ratio 1.62) than with the other four opioids.

This finding is surprising and requires validation in other study populations, the investigators said (Arch. Intern. Med. 2010;170:1979-86).

All-cause mortality was elevated after only 30 days of use for patients taking oxycodone (RR 2.43) or codeine (RR 2.05), but not for those taking other opioids.

In contrast, the risk of fracture of the hip, pelvis, wrist, or humerus was significantly reduced after 30 days of treatment for patients taking tramadol (RR 0.21) or propoxyphene (RR 0.54)

The risk of gastrointestinal adverse events – including upper GI bleeding, lower GI bleeding, and bowel obstruction – did not differ across opioid groups.

These risks remained consistent through a range of sensitivity analyses either 30 days or 180 days and regardless of whether patients were taking low, medium, high, or very high doses of the drugs.

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Opioids Are Not 'Interchangeable'

The findings by Dr. Solomon and his associates “challenge the conventional notion that the safety profiles of opioids are generally interchangeable” and carry two important clinical implications, said Dr. William C. Becker and Dr. Patrick G. O'Connor.

The first and most crucial implication is that the frequent use of codeine must be reexamined. “The untested but widespread assumption that codeine is safer from an addiction standpoint because of its lower potency may need to give way to these data demonstrating increased risk of cardiovascular events and all-cause mortality. If codeine is of middling efficacy for pain and is more risky than other opioids, there would be little reason to use it,” they noted.

Secondly, the elevated risk of fractures with opioid use “has solid biological plausibility” by two mechanisms of action: Opioids raise the rate of falls, and they suppress the production of androgen and estradiol, imperiling bone health. The study findings suggest that basic safety measures to counterbalance these effects are not being implemented.

“Efforts to improve patients' understanding of safe medication-taking practices, providers' understanding of safe prescribing practices, and standardization of safety-oriented follow-up are sorely needed,” said Dr. Becker and Dr. O'Connor.

DR. BECKER and DR. O'CONNOR are internists at Yale University, New Haven, Conn. They reported no relevant financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010; 170:1986-8).

Major Finding: African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites.

Data Source: Single-center, observational cohort study of 1,024 white and 66 black patients with parkinsonism.

Disclosures: Dr. Hemming's associates reported ties to numerous manufacturers of drugs for Parkinson's disease.

African Americans with parkinsonism had more severe symptoms, more disability, and poorer symptom management than did whites during a 5-year assessment at a single center.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities “may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these,” wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi: 10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as “the first to show health disparities in disease severity and disability in parkinsonism.”

“Studies in different patient populations and geographic locations are necessary to confirm these findings,” they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university's movement disorders center between 2003 and 2008. A total of 66 patients were African American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a “striking difference that may influence mortality” because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) than they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemmings and his associates said. “We need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means,” they noted.

“Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention,” the investigators wrote.

In addition, they suggested that “physicians may be influenced by unconfirmed reports that Parkinson's disease is less common in African American populations.”

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Major Finding: African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites.

Data Source: Single-center, observational cohort study of 1,024 white and 66 black patients with parkinsonism.

Disclosures: Dr. Hemming's associates reported ties to numerous manufacturers of drugs for Parkinson's disease.

African Americans with parkinsonism had more severe symptoms, more disability, and poorer symptom management than did whites during a 5-year assessment at a single center.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities “may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these,” wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi: 10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as “the first to show health disparities in disease severity and disability in parkinsonism.”

“Studies in different patient populations and geographic locations are necessary to confirm these findings,” they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university's movement disorders center between 2003 and 2008. A total of 66 patients were African American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a “striking difference that may influence mortality” because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) than they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemmings and his associates said. “We need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means,” they noted.

“Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention,” the investigators wrote.

In addition, they suggested that “physicians may be influenced by unconfirmed reports that Parkinson's disease is less common in African American populations.”

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Major Finding: African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites.

Data Source: Single-center, observational cohort study of 1,024 white and 66 black patients with parkinsonism.

Disclosures: Dr. Hemming's associates reported ties to numerous manufacturers of drugs for Parkinson's disease.

African Americans with parkinsonism had more severe symptoms, more disability, and poorer symptom management than did whites during a 5-year assessment at a single center.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities “may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these,” wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi: 10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as “the first to show health disparities in disease severity and disability in parkinsonism.”

“Studies in different patient populations and geographic locations are necessary to confirm these findings,” they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university's movement disorders center between 2003 and 2008. A total of 66 patients were African American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson's Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a “striking difference that may influence mortality” because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) than they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemmings and his associates said. “We need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means,” they noted.

“Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention,” the investigators wrote.

In addition, they suggested that “physicians may be influenced by unconfirmed reports that Parkinson's disease is less common in African American populations.”

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online.

The study findings “cast doubt on the argument that the use of electronic health records is a 'magic bullet' for health care quality improvement, as some advocates imply,” according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.

“Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve” quality, the authors wrote, adding that “the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.

“Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking,” as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.

They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.

To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.

Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.

When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 indicators (avoidance of unnecessary electrocardiography during routine examinations).

An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.

The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. “Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators,” they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).

Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems “should be monitored carefully and [their] impact and cost evaluated rigorously,” Mr. Romano and Dr. Stafford added.

This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.

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Surprising Results

The “dismal” results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.

“We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.

“The results of Romano and Stafford's study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data,” they wrote.

DR. MCDONALD and DR. ABHYANKAR are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed. 2010.518]).

Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online.

The study findings “cast doubt on the argument that the use of electronic health records is a 'magic bullet' for health care quality improvement, as some advocates imply,” according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.

“Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve” quality, the authors wrote, adding that “the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.

“Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking,” as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.

They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.

To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.

Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.

When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 indicators (avoidance of unnecessary electrocardiography during routine examinations).

An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.

The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. “Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators,” they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).

Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems “should be monitored carefully and [their] impact and cost evaluated rigorously,” Mr. Romano and Dr. Stafford added.

This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.

View on The News

Surprising Results

The “dismal” results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.

“We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.

“The results of Romano and Stafford's study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data,” they wrote.

DR. MCDONALD and DR. ABHYANKAR are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed. 2010.518]).

Electronic health records, either with or without features to aid clinical decision making, failed to improve the quality of outpatient care in a study of more than 240,000 physician visits across the country, according to a report published online.

The study findings “cast doubt on the argument that the use of electronic health records is a 'magic bullet' for health care quality improvement, as some advocates imply,” according to Max J. Romano and Dr. Randall S. Stafford of the prevention research center at Stanford (Calif.) University.

“Since 1991, the Institute of Medicine has repeatedly called for increasing electronic health record (EHR) use to improve” quality, the authors wrote, adding that “the American Reinvestment and Recovery Act stimulus bill set aside $19.2 billion to promote health information technology use in the United States, with the underlying assumption that more health IT is better.

“Nonetheless, evidence linking increased national use of outpatient EHRs to improved quality is lacking,” as are data supporting included clinical decision support tools, Mr. Romano and Dr. Stafford said.

They analyzed data from two nationally representative samples collected by the National Center for Health Statistics in 2005-2007, the most recent years available. This included 243,478 patient visits to office-based, emergency department, and outpatient department physicians in family medicine, internal medicine, geriatrics, pediatrics, and general practice.

To evaluate the quality of care provided during these visits, 20 quality indicators were assessed in five areas: pharmacologic management of chronic diseases (such as atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension); appropriate antibiotic use in urinary tract and viral upper respiratory tract infections; preventive counseling regarding diet, exercise, and smoking cessation; appropriate use of screening tests such as blood pressure measurement, urinalysis, and echocardiography; and inappropriate prescribing in the elderly.

Electronic health records were used in approximately 30% of all patient visits, and clinical decision support features were used in 17%. Neither EHR nor clinical decision support features were associated with higher-quality care.

When an EHR was used, care quality was better than when no EHR was used for only 1 of the 20 quality indicators (dietary counseling). Similarly, when a clinical decision support feature was used, care quality was better for only 1 of 20 indicators (avoidance of unnecessary electrocardiography during routine examinations).

An analysis of the office-based visits separately from the hospital-based visits showed similar results. The use of a clinical decision support feature was helpful only in avoiding inappropriate ECGs in office-based visits. And such features were helpful in promoting smoking cessation counseling in hospital-based visits, but actually were linked to poorer performance in the use of inhaled corticosteroids for asthma and the use of appropriate blood pressure monitoring.

The investigators found that EHRs were used much more frequently during visits in the Western United States than in other regions. A post-hoc analysis showed that this did not correlate with improved care in the Western United States. “Western visits had higher quality than other regions for 2 indicators (appropriate antibiotic use in respiratory infection and avoiding inappropriate ECG ordering), worse quality for 3 indicators (UTI antibiotic selection, diet counseling, and exercise counseling), and similar quality for the remaining 15 indicators,” they wrote (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed.2010.527]).

Since the use of EHRs and clinical decision support features is expected to increase because of federal incentives associated with their use, the real world performance of such systems “should be monitored carefully and [their] impact and cost evaluated rigorously,” Mr. Romano and Dr. Stafford added.

This study was supported by the National Heart, Lung, and Blood Institute and Stanford University.

View on The News

Surprising Results

The “dismal” results reported by Mr. Romano and Dr. Stafford were surprising, given that previously reported randomized controlled trials had found that the use of EHRs and clinical decision support features were strongly beneficial, said Dr. Clement McDonald and Dr. Swapna Abhyankar.

“We know from multiple randomized controlled trials that well-implemented clinical decision support systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level.

“The results of Romano and Stafford's study suggest not. However, we suspect that the EHR and clinical decision support systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data,” they wrote.

DR. MCDONALD and DR. ABHYANKAR are with the National Library of Medicine in Bethesda, Md. They reported no relevant financial disclosures. These comments were taken from their invited commentary that accompanied the report by Mr. Romano and Dr. Stafford (Arch. Intern. Med. 2011 Jan. 24 [doi:10.1001/archinternmed. 2010.518]).

Older adults without dementia who had a low ratio of beta-amyloid 42:40 in plasma showed faster cognitive decline in a 9-year study than did those with a higher ratio of the two beta-amyloid peptides, according to a report in JAMA.

This cognitive decline was more marked in subjects who had less cognitive reserve, as estimated by their lower educational attainment and lower literacy.

“These results are important, as the prevalence of cognitive impairment is increasing exponentially and prevention will be crucial. To identify those at risk of dementia, biomarkers like plasma beta-amyloid level that are relatively easy to obtain and minimally invasive could be useful,” wrote Dr. Kristine Yaffe of the University of California, San Francisco, and her associates.

The investigators assessed the relationship between beta-amyloid levels and cognitive decline using a cohort of 3,075 community-dwelling residents of Memphis and Pittsburgh who had been enrolled in an aging study in 1997-1998 when they were 70-79 years old. They studied 997 of the individuals who had undergone repeated cognitive assessments during follow-up through 2007.

The mean age at baseline was 74 years. Approximately 555 of the study subjects were women, and 54% were African American.

A low beta-amyloid 42:40 ratio at baseline was significantly associated with greater cognitive decline on the Modified Mini-Mental State Examination, which has a maximum score of 100. Mean scores on the Modified Mini-Mental State Examination after 9 years of follow-up declined 6.59 points among people in the lowest tertile of plasma beta-amyloid 42:40 ratio, 6.16 points among those in the middle tertile, and 3.60 points among those in the highest tertile.

The investigators also detected a significant, but less robust, association between tertiles of plasma beta-amyloid 42 levels and cognitive decline.

Both associations remained significant when the data were adjusted to account for subject age, race, education level, smoking status, diabetes status, and apolipoprotein E e4 status, according to Dr. Yaffe and her colleagues (JAMA 2011;305:261-6).

Moreover, the association between plasma beta-amyloid 42:40 ratio and cognitive decline was strongest among people with a low cognitive reserve (as measured by less than a high school diploma or 6th grade literacy) and weakest among people with higher cognitive reserve.

People who carried the apolipoprotein E e4 allele also showed a stronger association between plasma beta-amyloid 42:40 ratio and cognitive decline.

“Our results suggest that the plasma beta-amyloid 42:40 ratio appears to be a biomarker of cognitive decline,” the researchers noted.

The modifying effect of cognitive reserve on the association between cognitive decline and plasma beta-amyloid 42:40 ratio “suggests possible pathways, such as cognitive activity or ongoing education, for mitigating or preventing beta-amyloid effects on cognition,” they added.

The investigators did not measure cerebrospinal fluid levels of beta-amyloid 42 and 40 and so could not correlate them with plasma levels of the peptides, Dr. Yaffe and her associates said.

This study was supported by the National Institute on Aging. No relevant financial disclosures were reported.

Older adults without dementia who had a low ratio of beta-amyloid 42:40 in plasma showed faster cognitive decline in a 9-year study than did those with a higher ratio of the two beta-amyloid peptides, according to a report in JAMA.

This cognitive decline was more marked in subjects who had less cognitive reserve, as estimated by their lower educational attainment and lower literacy.

“These results are important, as the prevalence of cognitive impairment is increasing exponentially and prevention will be crucial. To identify those at risk of dementia, biomarkers like plasma beta-amyloid level that are relatively easy to obtain and minimally invasive could be useful,” wrote Dr. Kristine Yaffe of the University of California, San Francisco, and her associates.

The investigators assessed the relationship between beta-amyloid levels and cognitive decline using a cohort of 3,075 community-dwelling residents of Memphis and Pittsburgh who had been enrolled in an aging study in 1997-1998 when they were 70-79 years old. They studied 997 of the individuals who had undergone repeated cognitive assessments during follow-up through 2007.

The mean age at baseline was 74 years. Approximately 555 of the study subjects were women, and 54% were African American.

A low beta-amyloid 42:40 ratio at baseline was significantly associated with greater cognitive decline on the Modified Mini-Mental State Examination, which has a maximum score of 100. Mean scores on the Modified Mini-Mental State Examination after 9 years of follow-up declined 6.59 points among people in the lowest tertile of plasma beta-amyloid 42:40 ratio, 6.16 points among those in the middle tertile, and 3.60 points among those in the highest tertile.

The investigators also detected a significant, but less robust, association between tertiles of plasma beta-amyloid 42 levels and cognitive decline.

Both associations remained significant when the data were adjusted to account for subject age, race, education level, smoking status, diabetes status, and apolipoprotein E e4 status, according to Dr. Yaffe and her colleagues (JAMA 2011;305:261-6).

Moreover, the association between plasma beta-amyloid 42:40 ratio and cognitive decline was strongest among people with a low cognitive reserve (as measured by less than a high school diploma or 6th grade literacy) and weakest among people with higher cognitive reserve.

People who carried the apolipoprotein E e4 allele also showed a stronger association between plasma beta-amyloid 42:40 ratio and cognitive decline.

“Our results suggest that the plasma beta-amyloid 42:40 ratio appears to be a biomarker of cognitive decline,” the researchers noted.

The modifying effect of cognitive reserve on the association between cognitive decline and plasma beta-amyloid 42:40 ratio “suggests possible pathways, such as cognitive activity or ongoing education, for mitigating or preventing beta-amyloid effects on cognition,” they added.

The investigators did not measure cerebrospinal fluid levels of beta-amyloid 42 and 40 and so could not correlate them with plasma levels of the peptides, Dr. Yaffe and her associates said.

This study was supported by the National Institute on Aging. No relevant financial disclosures were reported.

Older adults without dementia who had a low ratio of beta-amyloid 42:40 in plasma showed faster cognitive decline in a 9-year study than did those with a higher ratio of the two beta-amyloid peptides, according to a report in JAMA.

This cognitive decline was more marked in subjects who had less cognitive reserve, as estimated by their lower educational attainment and lower literacy.

“These results are important, as the prevalence of cognitive impairment is increasing exponentially and prevention will be crucial. To identify those at risk of dementia, biomarkers like plasma beta-amyloid level that are relatively easy to obtain and minimally invasive could be useful,” wrote Dr. Kristine Yaffe of the University of California, San Francisco, and her associates.

The investigators assessed the relationship between beta-amyloid levels and cognitive decline using a cohort of 3,075 community-dwelling residents of Memphis and Pittsburgh who had been enrolled in an aging study in 1997-1998 when they were 70-79 years old. They studied 997 of the individuals who had undergone repeated cognitive assessments during follow-up through 2007.

The mean age at baseline was 74 years. Approximately 555 of the study subjects were women, and 54% were African American.

A low beta-amyloid 42:40 ratio at baseline was significantly associated with greater cognitive decline on the Modified Mini-Mental State Examination, which has a maximum score of 100. Mean scores on the Modified Mini-Mental State Examination after 9 years of follow-up declined 6.59 points among people in the lowest tertile of plasma beta-amyloid 42:40 ratio, 6.16 points among those in the middle tertile, and 3.60 points among those in the highest tertile.

The investigators also detected a significant, but less robust, association between tertiles of plasma beta-amyloid 42 levels and cognitive decline.

Both associations remained significant when the data were adjusted to account for subject age, race, education level, smoking status, diabetes status, and apolipoprotein E e4 status, according to Dr. Yaffe and her colleagues (JAMA 2011;305:261-6).

Moreover, the association between plasma beta-amyloid 42:40 ratio and cognitive decline was strongest among people with a low cognitive reserve (as measured by less than a high school diploma or 6th grade literacy) and weakest among people with higher cognitive reserve.

People who carried the apolipoprotein E e4 allele also showed a stronger association between plasma beta-amyloid 42:40 ratio and cognitive decline.

“Our results suggest that the plasma beta-amyloid 42:40 ratio appears to be a biomarker of cognitive decline,” the researchers noted.

The modifying effect of cognitive reserve on the association between cognitive decline and plasma beta-amyloid 42:40 ratio “suggests possible pathways, such as cognitive activity or ongoing education, for mitigating or preventing beta-amyloid effects on cognition,” they added.

The investigators did not measure cerebrospinal fluid levels of beta-amyloid 42 and 40 and so could not correlate them with plasma levels of the peptides, Dr. Yaffe and her associates said.

This study was supported by the National Institute on Aging. No relevant financial disclosures were reported.

Budesonide was found noninferior to, but not better than, mesalamine for inducing remission of mildly to moderately active Crohn's disease in an international phase III clinical trial, Dr. Andreas Tromm and his colleagues reported.

In addition, once-daily dosing with 9 mg of budesonide was as effective as was the standard regimen of 3-mg doses taken three times daily. “From a clinical practice perspective, it would seem justified to recommend the budesonide 9-mg once-daily regimen, since this would be expected to improve adherence,” said Dr. Tromm of Evangelisches Hospital Hattingen (Germany) and his associates (Gastroenterology 2011 February [doi:10.1053/j.gastro.2010.11.004]).

Recent guidelines from the European Crohn's and Colitis Organisation recommend budesonide as more effective than mesalamine for mildly active, localized ileocecal Crohn's disease, and also recommend that budesonide or systemic corticosteroids are preferable for treating moderately active localized ileocecal disease. Budesonide has a superior adverse effect profile and is better able to preserve adrenal function and bone mass, the authors wrote.

“However, only a single randomized study [involving only 182 subjects] a decade ago has directly compared the efficacy and safety of budesonide versus mesalamine for the management of active Crohn's disease,” they added. No studies have explored the use of different dosing regimens.

Dr. Tromm and his colleagues performed a double-blind phase III clinical trial in which adults with mildly to moderately active Crohn's disease were randomly assigned to receive eudragit-L-coated mesalamine tablets 4.5 g/day (153 patients), 3-mg budesonide capsules three times per day (79 patients), or one 9-mg oral budesonide capsule once daily (77 patients), for 8 weeks. The study subjects were followed every 2 weeks at 46 gastroenterology clinics.

The mean Crohn's Disease Activity Index (CDAI) score was higher in both budesonide groups than in the mesalamine group, and both budesonide groups had a higher proportion of patients with CDAI scores over 300. Also, both budesonide groups had more patients with extraintestinal manifestations of Crohn's disease. Otherwise there were no meaningful differences among the study groups in clinical characteristics.

The primary efficacy end point was clinical remission (a CDAI score of 150 or less) at the conclusion of the trial. Remission occurred in 70% of the patients taking budesonide, compared with 62% of those taking mesalamine. This difference was not statistically significant but did meet the criteria for noninferiority in effectiveness.

More physicians rated budesonide as achieving “therapeutic success” or “therapeutic benefit” than mesalamine, but this difference also did not reach statistical significance.

Remission rates did not differ significantly between the once-daily (67%) and thrice-daily (72%) budesonide groups, nor did any other efficacy end points. “Although tested in only an exploratory sense, these data suggest that once-daily or thrice-daily administration does not affect the efficacy of budesonide,” Dr. Tromm and his colleagues said.

The subgroup of female patients demonstrated a greater clinical response to budesonide (75% remission) than to mesalamine (57%). “Whether this finding reflects a genuine treatment effect remains uncertain, since other studies of budesonide for active Crohn's disease have observed no gender-specific effects,” they noted.

The greatest difference in treatment response was seen in the subgroups of patients who had high CDAI scores or high CRP levels at baseline, indicating greater severity of inflammation. Sixty-six percent of patients with high baseline CDAI scores remitted with budesonide, compared with only 49% of those with high CDAI scores who took mesalamine. The remission rate was 65% with budesonide for patients with high baseline CRP levels, compared with only 52% with mesalamine.

Median time to treatment response and median time to remission did not differ among the three treatment groups. Similarly, the median decrease in CDAI scores did not differ, and it was significant with all three of the drug regimens.

Adverse events occurred in 39% of patients taking t.i.d. budesonide, 47% of those taking once-daily budesonide, and 47% of those taking mesalamine. The corresponding rates of adverse events suspected to be drug related were 10%, 12%, and 7%.

The study was funded by Dr. Falk Pharma GmbH. Dr. Tromm disclosed receiving speakers' honoraria and travel funding from Dr. Falk Pharma, and several authors are employees of the company, whereas other authors had no conflicts of interest to disclose.

Budesonide was found noninferior to, but not better than, mesalamine for inducing remission of mildly to moderately active Crohn's disease in an international phase III clinical trial, Dr. Andreas Tromm and his colleagues reported.

In addition, once-daily dosing with 9 mg of budesonide was as effective as was the standard regimen of 3-mg doses taken three times daily. “From a clinical practice perspective, it would seem justified to recommend the budesonide 9-mg once-daily regimen, since this would be expected to improve adherence,” said Dr. Tromm of Evangelisches Hospital Hattingen (Germany) and his associates (Gastroenterology 2011 February [doi:10.1053/j.gastro.2010.11.004]).

Recent guidelines from the European Crohn's and Colitis Organisation recommend budesonide as more effective than mesalamine for mildly active, localized ileocecal Crohn's disease, and also recommend that budesonide or systemic corticosteroids are preferable for treating moderately active localized ileocecal disease. Budesonide has a superior adverse effect profile and is better able to preserve adrenal function and bone mass, the authors wrote.

“However, only a single randomized study [involving only 182 subjects] a decade ago has directly compared the efficacy and safety of budesonide versus mesalamine for the management of active Crohn's disease,” they added. No studies have explored the use of different dosing regimens.

Dr. Tromm and his colleagues performed a double-blind phase III clinical trial in which adults with mildly to moderately active Crohn's disease were randomly assigned to receive eudragit-L-coated mesalamine tablets 4.5 g/day (153 patients), 3-mg budesonide capsules three times per day (79 patients), or one 9-mg oral budesonide capsule once daily (77 patients), for 8 weeks. The study subjects were followed every 2 weeks at 46 gastroenterology clinics.

The mean Crohn's Disease Activity Index (CDAI) score was higher in both budesonide groups than in the mesalamine group, and both budesonide groups had a higher proportion of patients with CDAI scores over 300. Also, both budesonide groups had more patients with extraintestinal manifestations of Crohn's disease. Otherwise there were no meaningful differences among the study groups in clinical characteristics.

The primary efficacy end point was clinical remission (a CDAI score of 150 or less) at the conclusion of the trial. Remission occurred in 70% of the patients taking budesonide, compared with 62% of those taking mesalamine. This difference was not statistically significant but did meet the criteria for noninferiority in effectiveness.

More physicians rated budesonide as achieving “therapeutic success” or “therapeutic benefit” than mesalamine, but this difference also did not reach statistical significance.

Remission rates did not differ significantly between the once-daily (67%) and thrice-daily (72%) budesonide groups, nor did any other efficacy end points. “Although tested in only an exploratory sense, these data suggest that once-daily or thrice-daily administration does not affect the efficacy of budesonide,” Dr. Tromm and his colleagues said.

The subgroup of female patients demonstrated a greater clinical response to budesonide (75% remission) than to mesalamine (57%). “Whether this finding reflects a genuine treatment effect remains uncertain, since other studies of budesonide for active Crohn's disease have observed no gender-specific effects,” they noted.

The greatest difference in treatment response was seen in the subgroups of patients who had high CDAI scores or high CRP levels at baseline, indicating greater severity of inflammation. Sixty-six percent of patients with high baseline CDAI scores remitted with budesonide, compared with only 49% of those with high CDAI scores who took mesalamine. The remission rate was 65% with budesonide for patients with high baseline CRP levels, compared with only 52% with mesalamine.

Median time to treatment response and median time to remission did not differ among the three treatment groups. Similarly, the median decrease in CDAI scores did not differ, and it was significant with all three of the drug regimens.

Adverse events occurred in 39% of patients taking t.i.d. budesonide, 47% of those taking once-daily budesonide, and 47% of those taking mesalamine. The corresponding rates of adverse events suspected to be drug related were 10%, 12%, and 7%.

The study was funded by Dr. Falk Pharma GmbH. Dr. Tromm disclosed receiving speakers' honoraria and travel funding from Dr. Falk Pharma, and several authors are employees of the company, whereas other authors had no conflicts of interest to disclose.

Budesonide was found noninferior to, but not better than, mesalamine for inducing remission of mildly to moderately active Crohn's disease in an international phase III clinical trial, Dr. Andreas Tromm and his colleagues reported.

In addition, once-daily dosing with 9 mg of budesonide was as effective as was the standard regimen of 3-mg doses taken three times daily. “From a clinical practice perspective, it would seem justified to recommend the budesonide 9-mg once-daily regimen, since this would be expected to improve adherence,” said Dr. Tromm of Evangelisches Hospital Hattingen (Germany) and his associates (Gastroenterology 2011 February [doi:10.1053/j.gastro.2010.11.004]).

Recent guidelines from the European Crohn's and Colitis Organisation recommend budesonide as more effective than mesalamine for mildly active, localized ileocecal Crohn's disease, and also recommend that budesonide or systemic corticosteroids are preferable for treating moderately active localized ileocecal disease. Budesonide has a superior adverse effect profile and is better able to preserve adrenal function and bone mass, the authors wrote.

“However, only a single randomized study [involving only 182 subjects] a decade ago has directly compared the efficacy and safety of budesonide versus mesalamine for the management of active Crohn's disease,” they added. No studies have explored the use of different dosing regimens.

Dr. Tromm and his colleagues performed a double-blind phase III clinical trial in which adults with mildly to moderately active Crohn's disease were randomly assigned to receive eudragit-L-coated mesalamine tablets 4.5 g/day (153 patients), 3-mg budesonide capsules three times per day (79 patients), or one 9-mg oral budesonide capsule once daily (77 patients), for 8 weeks. The study subjects were followed every 2 weeks at 46 gastroenterology clinics.

The mean Crohn's Disease Activity Index (CDAI) score was higher in both budesonide groups than in the mesalamine group, and both budesonide groups had a higher proportion of patients with CDAI scores over 300. Also, both budesonide groups had more patients with extraintestinal manifestations of Crohn's disease. Otherwise there were no meaningful differences among the study groups in clinical characteristics.

The primary efficacy end point was clinical remission (a CDAI score of 150 or less) at the conclusion of the trial. Remission occurred in 70% of the patients taking budesonide, compared with 62% of those taking mesalamine. This difference was not statistically significant but did meet the criteria for noninferiority in effectiveness.

More physicians rated budesonide as achieving “therapeutic success” or “therapeutic benefit” than mesalamine, but this difference also did not reach statistical significance.

Remission rates did not differ significantly between the once-daily (67%) and thrice-daily (72%) budesonide groups, nor did any other efficacy end points. “Although tested in only an exploratory sense, these data suggest that once-daily or thrice-daily administration does not affect the efficacy of budesonide,” Dr. Tromm and his colleagues said.

The subgroup of female patients demonstrated a greater clinical response to budesonide (75% remission) than to mesalamine (57%). “Whether this finding reflects a genuine treatment effect remains uncertain, since other studies of budesonide for active Crohn's disease have observed no gender-specific effects,” they noted.

The greatest difference in treatment response was seen in the subgroups of patients who had high CDAI scores or high CRP levels at baseline, indicating greater severity of inflammation. Sixty-six percent of patients with high baseline CDAI scores remitted with budesonide, compared with only 49% of those with high CDAI scores who took mesalamine. The remission rate was 65% with budesonide for patients with high baseline CRP levels, compared with only 52% with mesalamine.

Median time to treatment response and median time to remission did not differ among the three treatment groups. Similarly, the median decrease in CDAI scores did not differ, and it was significant with all three of the drug regimens.

Adverse events occurred in 39% of patients taking t.i.d. budesonide, 47% of those taking once-daily budesonide, and 47% of those taking mesalamine. The corresponding rates of adverse events suspected to be drug related were 10%, 12%, and 7%.

The study was funded by Dr. Falk Pharma GmbH. Dr. Tromm disclosed receiving speakers' honoraria and travel funding from Dr. Falk Pharma, and several authors are employees of the company, whereas other authors had no conflicts of interest to disclose.