Heidi Splete

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

WASHINGTON — As long as they're healthy, adults of any age should be encouraged to exercise, because studies show that it's a safe way to improve their cardiovascular health.

“It turns out that healthy older adults are able to make the necessary cardiovascular adjustments—and physiological homeostasis is preserved—and they are able to exercise effectively,” said Douglas Seals, Ph.D., a physiologist who studies aging and exercise at the University of Colorado, Boulder. He spoke at the annual meeting of the Society of Geriatric Cardiology.

“Aging will limit the absolute intensity and duration of submaximal aerobic exercise that can be performed by older adults…. However, performance of sustained submaximal exercise is not impaired by advancing age,” said Dr. Seals.

Dr. Seals cited a study that compared measurements during and after submaximal physical exertion in sedentary and trained groups of both healthy young men (aged 20–32 years) and healthy older men (aged 60–70 years). The volunteers walked on a treadmill for 60 minutes with enough effort to reach 70% of their maximum oxygen uptake, or VO₂ max. Both groups of older men had smaller increases in heart rate and lower rates of perceived exertion than did the younger men. Plasma lactate responses, which can be used to indicate metabolic stress in muscles, were also smaller in the older men. Plasma catecholamine responses, which can show a physiological stress response to exercise, barely increased in any of the men (J. Appl. Physiol. 1988;65:900-8).

“One could reasonably interpret these data to mean that older adults undergo a smaller increase in physiological stress from the resting state, compared with young adults in submaximal exercise conditions,” said Dr. Seals.

He and his colleagues reinforced these findings in a similar study of young and elderly men during a 45-minute treadmill walk (Clin. Physiol. 1995;15:169-81). The older men had lesser increases in heart rate, internal body temperature, and plasma norepinephrine concentrations than did the younger group.

The take-home message is that older adults make the necessary cardiovascular adjustments to handle submaximal exercise, he said.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028]).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted.

“We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” the investigators wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

SAN DIEGO — Several preoperative factors—a longer bypass limb length, low vitamin D levels, and African American ethnicity—were significant predictors of postoperative vitamin D deficiency in a study of 145 patients undergoing gastric bypass surgery.

Vitamin D deficiency can place such patients at increased risk for calcium and parathyroid hormone (PTH) abnormalities, and identifying the deficiency prior to surgery allows clinicians to intervene, Dr. Judy Jin wrote in a poster presented at the annual Digestive Disease Week.

Dr. Jin, of the department of surgery at Case Western Reserve University in Cleveland, and her colleagues reviewed data from 145 patients who underwent Roux-en-Y gastric bypass surgery between January 2005 and October 2006. The average age of the patients was 44 years, and the average BMI was 49 kg/m

The researchers tracked patient demographics and the laboratory values of calcium, vitamin D, and parathyroid hormone at 3-month intervals for 1 year. Overall, 42% of the patients had vitamin D deficiency (defined as vitamin D levels less than 20 ng/mL) either before surgery or during the 1-year follow-up period.

In a multivariate analysis, patients with postoperative vitamin D deficiency had significantly lower preoperative vitamin D levels than did those who didn't have postoperative deficiency (19.9 ng/mL vs. 30.0 ng/mL). Patients with postoperative vitamin D deficiency also were significantly more likely to have had a longer limb bypass (165 cm) vs. a short limb bypass (75 cm) and to be African American vs. another ethnicity. Preoperative PTH levels, age, sex, or reduction in BMI had no apparent effect on postoperative vitamin D.

Dr. Jin reported that she had no conflicts to disclose.

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Older age was the strongest predictor of early mortality in adults with gastrointestinal bleeding after investigators controlled for medications and comorbidities, according to data from more than 1,000 adults treated at a single medical center.

More clinicians have turned to low-dose aspirin and antithrombotic agents for cardiovascular disease prevention, but the interaction of these products with other risk factors for GI bleeding has not been studied thoroughly.

“We aimed to assess the 30-day mortality after upper gastrointestinal bleeding in association with the use of NSAIDs, low-dose aspirin, and other antithrombotic drugs,” Dr. Ali S. Taha of Crosshouse Hospital and the University of Glasgow, Scotland, and associates wrote in a poster presented at the annual Digestive Disease Week.

The investigators analyzed data from 1,014 adults who presented with a first episode of upper GI bleeding. A total of 45% of the patients were aged 65 years and older, and 8.1% of these patients died within 30 days of bleeding, compared with 1.3% of the younger patients.

After adjustment for multiple variables, patients aged 65 years and older had a significantly greater risk of 30-day mortality compared with their younger counterparts. In a univariate analysis, cerebrovascular disease, cardiovascular disease, and the use of diuretics, digoxin, and either low-dose aspirin or other antithrombotic drugs were significantly associated with an increased risk of 30-day mortality. Low-dose aspirin was defined as 75 mg/day, and the antithrombotic drugs included clopidogrel, dipyridamole, and warfarin.

Use of NSAIDs had no significant impact on 30-day mortality, and the specific withdrawal of rofecoxib (Vioxx) had no apparent effect on 30-day mortality rates in this population. The Blatchford score (an accepted measure of risk in patients with upper GI bleeding) was calculated using both clinical and laboratory data at each patient's presentation. Patients scoring higher than 10 on this measure had five times the risk of early death, compared with patients scoring 0-2.

Despite the importance of comorbidities and medication use, the results suggest that age is a strong and independent predictor of early mortality in patients with upper GI bleeding. More studies are needed to determine the clinical implications for treatment, Dr. Taha said in an interview. “Ulcer prevention should be considered seriously in elderly patients, particularly in the presence of other comorbid conditions and use of ulcerogenic drugs. And once bleeding has taken place, such patients should be targeted for intensive management.”

Dr. Taha said he has received grants and research support from Astellas Pharma Inc., AstraZeneca Pharmaceuticals, Merck & Co., and Yamanouchi Pharmaceutical Co.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

SAN DIEGO — Treatment with natalizumab significantly reduced the rates of overall hospitalization and disease-specific hospitalization for adults with Crohn's disease, according to data from 1,373 adults presented at the annual Digestive Disease Week.

Hospitalization is one of the greatest expenses associated with Crohn's disease (CD), and preventing hospitalization remains a major goal of treatment, said Dr. Bruce E. Sands, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, both in Boston.

To investigate the impact of natalizumab on all-cause and CD-specific hospitalizations, Dr. Sands and his colleagues analyzed pooled data from two previous randomized, controlled trials—ENCORE (Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy)—which included a total intent-to-treat population of 1,414 persons.

The two patient groups had an average age of 38 years and similar demographic characteristics at baseline. The patients had been randomly assigned to receive an intravenous dose of 300 mg natalizumab or a placebo every 4 weeks for a 12-week induction period. The hospitalization rate was calculated as hospital admissions per 100 courses (per 100 patients). The study involved an additional analysis of a subgroup of 346 patients who had failed prior anti-TNF therapy and had active inflammation, as shown by elevated C-reactive protein levels. “We observed a total of 136 all-cause hospitalizations in the entire cohort, and of these, 109 were Crohn's related,” Dr. Sands said.

In a multivariate analysis, natalizumab was associated with a significant reduction of 35% in the all-cause hospitalization rate. Natalizumab use also was associated with a comparable 30% reduction in the CD-related hospitalization rate, but the difference was not statistically significant.

In the multivariate model, the effect size was even more dramatic for the subset of anti-TNF-resistant patients. The all-cause hospitalization rate in this group was significantly lower for patients who received natalizumab, compared with placebo (9.7/100 patients vs. 20.8/100 patients). The CD-related hospitalization rates also were significantly lower for natalizumab patients vs. placebo patients (6.3/100 patients vs. 12.8/100 patients). “Both anti-TNF experience and elevated C-reactive protein were associated with greater risk of hospitalization,” he added.

In both univariate and multivariate analysis, the other independent predictors of hospitalization were low body mass index, baseline C-reactive protein level, prior anti-TNF experience, and elevation of baseline Crohn's Disease Activity Index (CDAI). Age, gender, and baseline steroid and immunosuppressant use were not associated with risk of hospitalization.

Dr. Sands has received consulting fees, grants, and research support from companies including Abbott Laboratories, Centocor Inc., Genentech Inc., Procter & Gamble Pharmaceuticals Inc., Otsuka America Pharmaceutical Inc., Shire PLC, and UCB BioPharma.

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS

BALTIMORE – Moderate to severe sleep apnea significantly increased the risk of all-cause mortality, according to 14 years of follow-up data from a large community sample.

“Sleep apnea is a disease of public health significance,” said Nathaniel Marshall, Ph.D., of the University of Sydney, who presented results from the Busselton Health Study at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have suggested that obstructive sleep apnea (OSA) increases the risk of death from cardiovascular disease, Dr. Marshall said. Until recently, however, the role of sleep apnea as an independent predictor of all-cause mortality has not been well studied, he added.

The Busselton Health Study is an ongoing community-based study in Busselton, Western Australia.

For the study, the researchers analyzed data from 400 community-dwelling adults aged 45-60 years. All of the participants were tested for OSA using a home sleep apnea monitoring device. Sleep apnea was quantified using the respiratory disturbance index (RDI), and moderate to severe apnea was defined as an RDI score of 15 or more respiratory disruptions per hour of sleep.

Complete data were available from 380 participants (278 men and 102 women) after an average of 13.4 years. The mortality rate was significantly higher (33.3%) among the 18 participants who had moderate to severe apnea (six deaths), compared with 6.5% among the 77 participants with mild OSA (five deaths) and 7.7% among the 285 participants without OSA (22 deaths).

Compared with people who did not have sleep apnea, the mortality hazard ratio was 6.24 for people with moderate to severe sleep apnea, after the researchers controlled for risk factors including age, gender, body mass index, mean arterial pressure (as a measure of blood pressure), smoking status, total cholesterol, HDL cholesterol, diabetes status, and physician-diagnosed angina.

“I was suspicious of the size of this effect,” Dr. Marshall said. “If you put this same model into an odds ratio, you get an odds ratio of about 10.” To put it another way, “sleep apnea has about the same effect on mortality as getting 18 years older,” he said.

But the results reflect similar recent findings from two studies in the United States–the multicenter Sleep Heart Health Study and the Wisconsin Sleep Study–that also show significant independent associations between OSA and all-cause mortality.

The association between moderate to severe OSA and all-cause mortality in the Busselton Health Study persisted even in a partly adjusted model that did not control for blood pressure. That model was used for comparison because OSA is a known cause of hypertension, Dr. Marshall noted. However, the researchers found no significant association between mild sleep apnea and an increased risk of death, which is good news, he said.

The study was limited by a lack of information about any treatment of sleep apnea in the study group, but the community-based format of the study kept it free of clinical referral bias, Dr. Marshall explained.

The results suggest that sleep apnea could be added to the list of standard mortality risk factors. But the findings also emphasize the need for randomized controlled trials of sleep apnea treatments that are designed to identify reductions in mortality risk, Dr. Marshall noted.

Dr. Marshall reported that he had no financial conflicts to disclose.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON – Type 2 diabetes did not increase the risk of onset or progression of Alzheimer's disease in older adults, according to results from a study of more than 700 individuals presented in a poster at the annual meeting of the American Geriatrics Society.

The prevalences of Alzheimer's disease (AD) and type 2 diabetes are rising, and data from previous studies suggest an association between the two conditions.

In this prospective study, Youngjee Choi of the Alzheimer's Disease Research Center and a medical student at Washington University in St. Louis, and colleagues examined the frequency of type 2 diabetes in 506 adults (196 men and 310 women) with dementia and 318 adults (127 men and 191 women) without dementia.

The study participants, who were enrolled in a longitudinal study of aging and dementia, had an average age of 77 years. The mental status of the participants was determined using the Clinical Dementia Rating, which is sensitive to individual cognitive decline. The study excluded individuals with diabetes who used insulin.

Significantly more of the participants with dementia had type 2 diabetes at baseline than did the nondemented participants (10.7% vs. 5.7%).

But a Cox regression analysis showed no association between type 2 diabetes and the onset or progression of AD during a 12-year follow-up period, although AD and type 2 diabetes were significantly associated at baseline in this sample.

Independent of type 2 diabetes, dementia progression was significantly higher among the participants who were demented at baseline, compared with those who were not. Older age and the presence of the APOE ?4 allele significantly increased the risk of AD onset in nondemented individuals. Older age, the presence of the APOE ?4 allele, and being female and having less education were significantly associated with dementia progression in those who met criteria for AD at baseline.

The study did not use a community-based sample, which may have caused selection bias, and the duration of disease and level of glucose control for the participants with type 2 diabetes were unknown, the researchers noted.

The study was supported in part by grants from the National Institutes of Health and the Summer Training on Aging Research Topics-Mental Health program. None of the researchers disclosed any financial conflicts.

WASHINGTON – Type 2 diabetes did not increase the risk of onset or progression of Alzheimer's disease in older adults, according to results from a study of more than 700 individuals presented in a poster at the annual meeting of the American Geriatrics Society.

The prevalences of Alzheimer's disease (AD) and type 2 diabetes are rising, and data from previous studies suggest an association between the two conditions.

In this prospective study, Youngjee Choi of the Alzheimer's Disease Research Center and a medical student at Washington University in St. Louis, and colleagues examined the frequency of type 2 diabetes in 506 adults (196 men and 310 women) with dementia and 318 adults (127 men and 191 women) without dementia.

The study participants, who were enrolled in a longitudinal study of aging and dementia, had an average age of 77 years. The mental status of the participants was determined using the Clinical Dementia Rating, which is sensitive to individual cognitive decline. The study excluded individuals with diabetes who used insulin.

Significantly more of the participants with dementia had type 2 diabetes at baseline than did the nondemented participants (10.7% vs. 5.7%).

But a Cox regression analysis showed no association between type 2 diabetes and the onset or progression of AD during a 12-year follow-up period, although AD and type 2 diabetes were significantly associated at baseline in this sample.

Independent of type 2 diabetes, dementia progression was significantly higher among the participants who were demented at baseline, compared with those who were not. Older age and the presence of the APOE ?4 allele significantly increased the risk of AD onset in nondemented individuals. Older age, the presence of the APOE ?4 allele, and being female and having less education were significantly associated with dementia progression in those who met criteria for AD at baseline.

The study did not use a community-based sample, which may have caused selection bias, and the duration of disease and level of glucose control for the participants with type 2 diabetes were unknown, the researchers noted.

The study was supported in part by grants from the National Institutes of Health and the Summer Training on Aging Research Topics-Mental Health program. None of the researchers disclosed any financial conflicts.

WASHINGTON – Type 2 diabetes did not increase the risk of onset or progression of Alzheimer's disease in older adults, according to results from a study of more than 700 individuals presented in a poster at the annual meeting of the American Geriatrics Society.

The prevalences of Alzheimer's disease (AD) and type 2 diabetes are rising, and data from previous studies suggest an association between the two conditions.

In this prospective study, Youngjee Choi of the Alzheimer's Disease Research Center and a medical student at Washington University in St. Louis, and colleagues examined the frequency of type 2 diabetes in 506 adults (196 men and 310 women) with dementia and 318 adults (127 men and 191 women) without dementia.

The study participants, who were enrolled in a longitudinal study of aging and dementia, had an average age of 77 years. The mental status of the participants was determined using the Clinical Dementia Rating, which is sensitive to individual cognitive decline. The study excluded individuals with diabetes who used insulin.

Significantly more of the participants with dementia had type 2 diabetes at baseline than did the nondemented participants (10.7% vs. 5.7%).

But a Cox regression analysis showed no association between type 2 diabetes and the onset or progression of AD during a 12-year follow-up period, although AD and type 2 diabetes were significantly associated at baseline in this sample.

Independent of type 2 diabetes, dementia progression was significantly higher among the participants who were demented at baseline, compared with those who were not. Older age and the presence of the APOE ?4 allele significantly increased the risk of AD onset in nondemented individuals. Older age, the presence of the APOE ?4 allele, and being female and having less education were significantly associated with dementia progression in those who met criteria for AD at baseline.

The study did not use a community-based sample, which may have caused selection bias, and the duration of disease and level of glucose control for the participants with type 2 diabetes were unknown, the researchers noted.

The study was supported in part by grants from the National Institutes of Health and the Summer Training on Aging Research Topics-Mental Health program. None of the researchers disclosed any financial conflicts.

BALTIMORE – Both increased weight and sleep problems were associated with children's reports of poor quality of life, based on results from a study of 100 children aged 8-12 years.

Previous studies have linked poor quality of life to overweight and to sleep problems in children but this study is one of the few to investigate the joint contribution of weight and sleep to quality of life, said Kelly Ann Davis, who presented the results in a poster at the annual meeting of the Associated Professional Sleep Societies.

Ms. Davis and her colleagues used several types of statistical analysis to determine whether there were significant differences in sleep patterns for children in three different weight categories as defined by the Centers for Disease Control and Prevention–healthy, overweight, or obese.

Parents and children completed the Children's Sleep Habits Questionnaire, the Pediatric Sleep Questionnaire, and the Pediatric Quality of Life 4.0. Each child's height and weight was measured by a health care professional.

“I also ran a logistic regression analysis to determine how much variance in children's quality of life scores [reported by both parents and children] was predicted by weight and sleep problems,” Ms. Davis, a research technician at the Children's Hospital of Philadelphia, said in an interview.

Sleep and weight each contributed to poor quality of life scores reported by the children.

Both sleep and weight were significant predictors of poor scores on the child-reported measures of psychosocial function and total quality of life, accounting for 48% and 33% of the variance, respectively. In addition, weight, but not sleep, was a significant predictor of low scores on child-reported physical function tests, accounting for 23% of the variance.

In a breakdown of the children's sleep patterns, obese children had significantly more symptoms of sleep-disordered breathing, compared with both overweight and healthy weight children, and both obese and overweight children had significantly more symptoms of excessive daytime sleepiness, compared with healthy weight children. In addition, overweight children had significantly longer sleep duration and significantly longer sleep onset latency, compared with healthy weight children.

Sleep was not a significant predictor of low scores on parent-reported measures of the child's quality of life.

Increased weight was the only significant predictor of low scores, and it accounted for 11% of the variance in physical function scores and 12% of the variance in both psychological function scores and total quality of life scores.

“It is important for health care professionals to be aware of the association between weight and sleep and ask parents of overweight children about their child's sleep,” Ms. Davis wrote. The results support findings from previous studies that show a high prevalence of sleep problems among obese children.

Ms. Davis had no financial conflicts to disclose.

BALTIMORE – Both increased weight and sleep problems were associated with children's reports of poor quality of life, based on results from a study of 100 children aged 8-12 years.

Previous studies have linked poor quality of life to overweight and to sleep problems in children but this study is one of the few to investigate the joint contribution of weight and sleep to quality of life, said Kelly Ann Davis, who presented the results in a poster at the annual meeting of the Associated Professional Sleep Societies.

Ms. Davis and her colleagues used several types of statistical analysis to determine whether there were significant differences in sleep patterns for children in three different weight categories as defined by the Centers for Disease Control and Prevention–healthy, overweight, or obese.

Parents and children completed the Children's Sleep Habits Questionnaire, the Pediatric Sleep Questionnaire, and the Pediatric Quality of Life 4.0. Each child's height and weight was measured by a health care professional.

“I also ran a logistic regression analysis to determine how much variance in children's quality of life scores [reported by both parents and children] was predicted by weight and sleep problems,” Ms. Davis, a research technician at the Children's Hospital of Philadelphia, said in an interview.

Sleep and weight each contributed to poor quality of life scores reported by the children.

Both sleep and weight were significant predictors of poor scores on the child-reported measures of psychosocial function and total quality of life, accounting for 48% and 33% of the variance, respectively. In addition, weight, but not sleep, was a significant predictor of low scores on child-reported physical function tests, accounting for 23% of the variance.

In a breakdown of the children's sleep patterns, obese children had significantly more symptoms of sleep-disordered breathing, compared with both overweight and healthy weight children, and both obese and overweight children had significantly more symptoms of excessive daytime sleepiness, compared with healthy weight children. In addition, overweight children had significantly longer sleep duration and significantly longer sleep onset latency, compared with healthy weight children.

Sleep was not a significant predictor of low scores on parent-reported measures of the child's quality of life.

Increased weight was the only significant predictor of low scores, and it accounted for 11% of the variance in physical function scores and 12% of the variance in both psychological function scores and total quality of life scores.

“It is important for health care professionals to be aware of the association between weight and sleep and ask parents of overweight children about their child's sleep,” Ms. Davis wrote. The results support findings from previous studies that show a high prevalence of sleep problems among obese children.

Ms. Davis had no financial conflicts to disclose.

BALTIMORE – Both increased weight and sleep problems were associated with children's reports of poor quality of life, based on results from a study of 100 children aged 8-12 years.

Previous studies have linked poor quality of life to overweight and to sleep problems in children but this study is one of the few to investigate the joint contribution of weight and sleep to quality of life, said Kelly Ann Davis, who presented the results in a poster at the annual meeting of the Associated Professional Sleep Societies.

Ms. Davis and her colleagues used several types of statistical analysis to determine whether there were significant differences in sleep patterns for children in three different weight categories as defined by the Centers for Disease Control and Prevention–healthy, overweight, or obese.

Parents and children completed the Children's Sleep Habits Questionnaire, the Pediatric Sleep Questionnaire, and the Pediatric Quality of Life 4.0. Each child's height and weight was measured by a health care professional.

“I also ran a logistic regression analysis to determine how much variance in children's quality of life scores [reported by both parents and children] was predicted by weight and sleep problems,” Ms. Davis, a research technician at the Children's Hospital of Philadelphia, said in an interview.

Sleep and weight each contributed to poor quality of life scores reported by the children.

Both sleep and weight were significant predictors of poor scores on the child-reported measures of psychosocial function and total quality of life, accounting for 48% and 33% of the variance, respectively. In addition, weight, but not sleep, was a significant predictor of low scores on child-reported physical function tests, accounting for 23% of the variance.

In a breakdown of the children's sleep patterns, obese children had significantly more symptoms of sleep-disordered breathing, compared with both overweight and healthy weight children, and both obese and overweight children had significantly more symptoms of excessive daytime sleepiness, compared with healthy weight children. In addition, overweight children had significantly longer sleep duration and significantly longer sleep onset latency, compared with healthy weight children.

Sleep was not a significant predictor of low scores on parent-reported measures of the child's quality of life.

Increased weight was the only significant predictor of low scores, and it accounted for 11% of the variance in physical function scores and 12% of the variance in both psychological function scores and total quality of life scores.

“It is important for health care professionals to be aware of the association between weight and sleep and ask parents of overweight children about their child's sleep,” Ms. Davis wrote. The results support findings from previous studies that show a high prevalence of sleep problems among obese children.

Ms. Davis had no financial conflicts to disclose.

WASHINGTON — As more clinicians practice computed tomographic colonography, they will learn the language in which to report their findings, Dr. Michael Zalis said at a meeting on CT colonography sponsored by the AGA (American Gastoenterological Association) Institute.

“We need to organize our reporting in response to the growth of CTC,” said Dr. Zalis, a radiologist specializing in abdominal imaging and intervention at Massachusetts General Hospital, Boston.

The American Cancer Society and a task force representing several other medical societies have endorsed CTC as a co-lorectal screening method, which means that Medicare coverage of CTC will likely increase, he added.

There are many benefits to using a standard set of terms to report CTC findings, Dr. Zalis said. Standard language can make patient management easier. For example, as CTC becomes more common, a patient may have an exam performed by one practitioner in one location and a follow-up visit with someone else in another location—even another state.

Common terms not only facilitate comparisons across sites, they also facilitate large-scale analysis of CTC by the government and by insurance carriers, Dr. Zalis noted. But standard CTC reporting terms also help physicians track their personal quality metrics on items such as false-positive rates and call back rates, he said.

The CT Colonography Reporting and Data System (C-RADS) project was a collaborative effort that developed terms and guidelines for CTC with categories for describing colonic and extracolonic findings.

Whether CTC will be regulated in the same way as mammography remains to be seen, but the establishment of C-RADS may prepare clinicians to handle similar regulation if it develops.

“For CT colonography, the target of detection is a precursor to colon cancer, the advanced adenoma, usually defined as a lesion greater than 1 cm in size,” Dr. Zalis said.

“The vast majority of even the intermediate-size lesions that we observe are not the advanced adenomas,” he said. And only about 5% of polyps between 0.6 cm and 1 cm are advanced adenomas, according to findings from large surgical series, he said.

The C-RADS characterization of polyps uses a scale from 0 (inadequate prep) to 4 (colonic mass, likely malignant). For example, a C1 means no visible abnormalities of the colon and no polyps of 6 mm or larger. (See box.)

The C-RADS criteria recommend not reporting diminutive lesions that are less than 6 mm in size.

“Hyperplastic polyps per se are not the target for screening in colorectal carcinoma,” Dr. Zalis said. “We are not being cavalier, but we are going to recognize that the clinical significance of these lesions is very small.”

When a clinician finds intermediate polyps (6–9 mm), the C-RADS criteria recommend reporting the polyps and opting for short-interval surveillance if there are one to two; the criteria recommend considering optical colonoscopy for patients with three or more midsized polyps.

“Polyps grow slowly, and any intermediate polyps tend to be stable and may even regress over time,” Dr. Zalis explained.

Patients with polyps that are 10 mm or larger should be referred for a follow-up colonoscopy, as should patients with three or more polyps in the 6- to 9- mm category, he said.

And a patient with a potentially malignant colonic mass should be sent for a surgical consultation.

The screening interval for optical colonoscopy is 10 years. CTC might approach that at some point, but for now the recommended interval is 5 years, Dr. Zalis said.

“We are early in our experience with CTC and the data aren't there yet to support a longer interval,” but that interval may increase with more data,” he noted.

Extracolonic findings must be documented and classified in the interest of good patient care, although fewer than 10% of patients will have clinically significant extracolonic findings, Dr. Zalis said. “But the findings will be there, so they have to be handled in an appropriate way.

“We have to carefully balance the mandate to identify clinically significant findings with the costs of each false positive,” he said. “We don't want to be causing unnecessary work-ups for obviously benign lesions.”

Although CTC has limitations, an attentive clinician can do a reasonable characterization of extracolonic findings and can reduce the likelihood of extracolonic work-ups and the resulting costs.

The C-RADS classification of extracolonic findings ranges from 0 (technical failure) to 4 (a potentially significant finding, such as a renal mass or liposarcoma. (See box.)

Details of clinically significant findings classified as E4 should be communicated to referring physicians according to accepted practice guidelines, Dr. Zalis said.

There are limitations with C-RADS, and the intent was to come up with a practical reporting scheme based on the data that were available, Dr. Zalis said.

Surveillance and screening intervals, especially for small polyps, and more advanced decision models will be forthcoming. And additional reporting for CTC may include some sort of confidence indicator, he said.

A confidence indicator would allow an interpreting clinician to communicate a level of confidence to an endoscopist so he or she can decide how hard to look for something before declaring that it is a false positive.

“Of course there will be nuances that we can't capture on the first round, but we needed to start somewhere, and we expect the criteria will expand with experience,” he added.

Dr. Zalis disclosed that he has received grant and research support from GE Healthcare Inc.

Classification of CTC Findings

These 10 categories, provided by Dr. Zalis, represent the C-RADS classification of colonic and extracolonic findings on computed tomographic colonography, with a few examples (but not a comprehensive list) for each category:

Colonic Findings

▸ C0: Inadequate study/awaiting prior comparisons. Use this category in cases of inadequate prep or insufflation, or when the image can't be read because of excess fluid or feces.

▸ C1: Normal colon or benign lesion. Use this category for cases of no polyp greater than 6 mm, and continue routine screening.

▸ C2: Indeterminate lesion. Use this category for cases of fewer than three polyps 6–9 mm.

▸ C3: Polyp, possibly advanced adenoma. Use this category for cases of three or more polyps 6–9 mm or any polyp 10 mm or larger; a follow-up colonoscopy is recommended.

▸ C4: Colonic mass, likely malignant. Use this category when a lesion compromises the bowel lumen, or there is evidence of extracolonic invasion; surgical consultation is recommended.

Extracolonic Findings

▸ E0: Limited exam. Use this category when an exam is compromised by an artifact so that evaluation of extracolonic soft tissues is limited.

▸ E1: Normal exam or anatomic variant. Use this category when no extracolonic abnormalities are visible, or if there is an anatomic variant such as a retroaortic left renal vein.

▸ E2: Clinically insignificant finding. Use this category when no work-up is indicated, such as for simple cysts or a vertebral hemangioma.

▸ E3: Likely insignificant finding, incompletely characterized, such as a minimally complex renal cyst. Use this category when a work-up may be needed, based on practice and patient preference.

▸ E4: Potentially significant finding. Use this category for a solid renal mass or liposarcoma, and be sure to communicate the details to the referring physician.

WASHINGTON — As more clinicians practice computed tomographic colonography, they will learn the language in which to report their findings, Dr. Michael Zalis said at a meeting on CT colonography sponsored by the AGA (American Gastoenterological Association) Institute.

“We need to organize our reporting in response to the growth of CTC,” said Dr. Zalis, a radiologist specializing in abdominal imaging and intervention at Massachusetts General Hospital, Boston.

The American Cancer Society and a task force representing several other medical societies have endorsed CTC as a co-lorectal screening method, which means that Medicare coverage of CTC will likely increase, he added.

There are many benefits to using a standard set of terms to report CTC findings, Dr. Zalis said. Standard language can make patient management easier. For example, as CTC becomes more common, a patient may have an exam performed by one practitioner in one location and a follow-up visit with someone else in another location—even another state.

Common terms not only facilitate comparisons across sites, they also facilitate large-scale analysis of CTC by the government and by insurance carriers, Dr. Zalis noted. But standard CTC reporting terms also help physicians track their personal quality metrics on items such as false-positive rates and call back rates, he said.

The CT Colonography Reporting and Data System (C-RADS) project was a collaborative effort that developed terms and guidelines for CTC with categories for describing colonic and extracolonic findings.

Whether CTC will be regulated in the same way as mammography remains to be seen, but the establishment of C-RADS may prepare clinicians to handle similar regulation if it develops.

“For CT colonography, the target of detection is a precursor to colon cancer, the advanced adenoma, usually defined as a lesion greater than 1 cm in size,” Dr. Zalis said.

“The vast majority of even the intermediate-size lesions that we observe are not the advanced adenomas,” he said. And only about 5% of polyps between 0.6 cm and 1 cm are advanced adenomas, according to findings from large surgical series, he said.

The C-RADS characterization of polyps uses a scale from 0 (inadequate prep) to 4 (colonic mass, likely malignant). For example, a C1 means no visible abnormalities of the colon and no polyps of 6 mm or larger. (See box.)

The C-RADS criteria recommend not reporting diminutive lesions that are less than 6 mm in size.

“Hyperplastic polyps per se are not the target for screening in colorectal carcinoma,” Dr. Zalis said. “We are not being cavalier, but we are going to recognize that the clinical significance of these lesions is very small.”

When a clinician finds intermediate polyps (6–9 mm), the C-RADS criteria recommend reporting the polyps and opting for short-interval surveillance if there are one to two; the criteria recommend considering optical colonoscopy for patients with three or more midsized polyps.

“Polyps grow slowly, and any intermediate polyps tend to be stable and may even regress over time,” Dr. Zalis explained.

Patients with polyps that are 10 mm or larger should be referred for a follow-up colonoscopy, as should patients with three or more polyps in the 6- to 9- mm category, he said.

And a patient with a potentially malignant colonic mass should be sent for a surgical consultation.

The screening interval for optical colonoscopy is 10 years. CTC might approach that at some point, but for now the recommended interval is 5 years, Dr. Zalis said.

“We are early in our experience with CTC and the data aren't there yet to support a longer interval,” but that interval may increase with more data,” he noted.

Extracolonic findings must be documented and classified in the interest of good patient care, although fewer than 10% of patients will have clinically significant extracolonic findings, Dr. Zalis said. “But the findings will be there, so they have to be handled in an appropriate way.

“We have to carefully balance the mandate to identify clinically significant findings with the costs of each false positive,” he said. “We don't want to be causing unnecessary work-ups for obviously benign lesions.”

Although CTC has limitations, an attentive clinician can do a reasonable characterization of extracolonic findings and can reduce the likelihood of extracolonic work-ups and the resulting costs.

The C-RADS classification of extracolonic findings ranges from 0 (technical failure) to 4 (a potentially significant finding, such as a renal mass or liposarcoma. (See box.)

Details of clinically significant findings classified as E4 should be communicated to referring physicians according to accepted practice guidelines, Dr. Zalis said.

There are limitations with C-RADS, and the intent was to come up with a practical reporting scheme based on the data that were available, Dr. Zalis said.

Surveillance and screening intervals, especially for small polyps, and more advanced decision models will be forthcoming. And additional reporting for CTC may include some sort of confidence indicator, he said.

A confidence indicator would allow an interpreting clinician to communicate a level of confidence to an endoscopist so he or she can decide how hard to look for something before declaring that it is a false positive.

“Of course there will be nuances that we can't capture on the first round, but we needed to start somewhere, and we expect the criteria will expand with experience,” he added.

Dr. Zalis disclosed that he has received grant and research support from GE Healthcare Inc.

Classification of CTC Findings

These 10 categories, provided by Dr. Zalis, represent the C-RADS classification of colonic and extracolonic findings on computed tomographic colonography, with a few examples (but not a comprehensive list) for each category:

Colonic Findings

▸ C0: Inadequate study/awaiting prior comparisons. Use this category in cases of inadequate prep or insufflation, or when the image can't be read because of excess fluid or feces.

▸ C1: Normal colon or benign lesion. Use this category for cases of no polyp greater than 6 mm, and continue routine screening.

▸ C2: Indeterminate lesion. Use this category for cases of fewer than three polyps 6–9 mm.

▸ C3: Polyp, possibly advanced adenoma. Use this category for cases of three or more polyps 6–9 mm or any polyp 10 mm or larger; a follow-up colonoscopy is recommended.

▸ C4: Colonic mass, likely malignant. Use this category when a lesion compromises the bowel lumen, or there is evidence of extracolonic invasion; surgical consultation is recommended.

Extracolonic Findings

▸ E0: Limited exam. Use this category when an exam is compromised by an artifact so that evaluation of extracolonic soft tissues is limited.

▸ E1: Normal exam or anatomic variant. Use this category when no extracolonic abnormalities are visible, or if there is an anatomic variant such as a retroaortic left renal vein.

▸ E2: Clinically insignificant finding. Use this category when no work-up is indicated, such as for simple cysts or a vertebral hemangioma.

▸ E3: Likely insignificant finding, incompletely characterized, such as a minimally complex renal cyst. Use this category when a work-up may be needed, based on practice and patient preference.

▸ E4: Potentially significant finding. Use this category for a solid renal mass or liposarcoma, and be sure to communicate the details to the referring physician.

WASHINGTON — As more clinicians practice computed tomographic colonography, they will learn the language in which to report their findings, Dr. Michael Zalis said at a meeting on CT colonography sponsored by the AGA (American Gastoenterological Association) Institute.

“We need to organize our reporting in response to the growth of CTC,” said Dr. Zalis, a radiologist specializing in abdominal imaging and intervention at Massachusetts General Hospital, Boston.

The American Cancer Society and a task force representing several other medical societies have endorsed CTC as a co-lorectal screening method, which means that Medicare coverage of CTC will likely increase, he added.

There are many benefits to using a standard set of terms to report CTC findings, Dr. Zalis said. Standard language can make patient management easier. For example, as CTC becomes more common, a patient may have an exam performed by one practitioner in one location and a follow-up visit with someone else in another location—even another state.

Common terms not only facilitate comparisons across sites, they also facilitate large-scale analysis of CTC by the government and by insurance carriers, Dr. Zalis noted. But standard CTC reporting terms also help physicians track their personal quality metrics on items such as false-positive rates and call back rates, he said.

The CT Colonography Reporting and Data System (C-RADS) project was a collaborative effort that developed terms and guidelines for CTC with categories for describing colonic and extracolonic findings.

Whether CTC will be regulated in the same way as mammography remains to be seen, but the establishment of C-RADS may prepare clinicians to handle similar regulation if it develops.

“For CT colonography, the target of detection is a precursor to colon cancer, the advanced adenoma, usually defined as a lesion greater than 1 cm in size,” Dr. Zalis said.

“The vast majority of even the intermediate-size lesions that we observe are not the advanced adenomas,” he said. And only about 5% of polyps between 0.6 cm and 1 cm are advanced adenomas, according to findings from large surgical series, he said.

The C-RADS characterization of polyps uses a scale from 0 (inadequate prep) to 4 (colonic mass, likely malignant). For example, a C1 means no visible abnormalities of the colon and no polyps of 6 mm or larger. (See box.)

The C-RADS criteria recommend not reporting diminutive lesions that are less than 6 mm in size.

“Hyperplastic polyps per se are not the target for screening in colorectal carcinoma,” Dr. Zalis said. “We are not being cavalier, but we are going to recognize that the clinical significance of these lesions is very small.”

When a clinician finds intermediate polyps (6–9 mm), the C-RADS criteria recommend reporting the polyps and opting for short-interval surveillance if there are one to two; the criteria recommend considering optical colonoscopy for patients with three or more midsized polyps.

“Polyps grow slowly, and any intermediate polyps tend to be stable and may even regress over time,” Dr. Zalis explained.

Patients with polyps that are 10 mm or larger should be referred for a follow-up colonoscopy, as should patients with three or more polyps in the 6- to 9- mm category, he said.

And a patient with a potentially malignant colonic mass should be sent for a surgical consultation.

The screening interval for optical colonoscopy is 10 years. CTC might approach that at some point, but for now the recommended interval is 5 years, Dr. Zalis said.

“We are early in our experience with CTC and the data aren't there yet to support a longer interval,” but that interval may increase with more data,” he noted.

Extracolonic findings must be documented and classified in the interest of good patient care, although fewer than 10% of patients will have clinically significant extracolonic findings, Dr. Zalis said. “But the findings will be there, so they have to be handled in an appropriate way.

“We have to carefully balance the mandate to identify clinically significant findings with the costs of each false positive,” he said. “We don't want to be causing unnecessary work-ups for obviously benign lesions.”

Although CTC has limitations, an attentive clinician can do a reasonable characterization of extracolonic findings and can reduce the likelihood of extracolonic work-ups and the resulting costs.

The C-RADS classification of extracolonic findings ranges from 0 (technical failure) to 4 (a potentially significant finding, such as a renal mass or liposarcoma. (See box.)

Details of clinically significant findings classified as E4 should be communicated to referring physicians according to accepted practice guidelines, Dr. Zalis said.

There are limitations with C-RADS, and the intent was to come up with a practical reporting scheme based on the data that were available, Dr. Zalis said.

Surveillance and screening intervals, especially for small polyps, and more advanced decision models will be forthcoming. And additional reporting for CTC may include some sort of confidence indicator, he said.

A confidence indicator would allow an interpreting clinician to communicate a level of confidence to an endoscopist so he or she can decide how hard to look for something before declaring that it is a false positive.

“Of course there will be nuances that we can't capture on the first round, but we needed to start somewhere, and we expect the criteria will expand with experience,” he added.

Dr. Zalis disclosed that he has received grant and research support from GE Healthcare Inc.

Classification of CTC Findings

These 10 categories, provided by Dr. Zalis, represent the C-RADS classification of colonic and extracolonic findings on computed tomographic colonography, with a few examples (but not a comprehensive list) for each category:

Colonic Findings

▸ C0: Inadequate study/awaiting prior comparisons. Use this category in cases of inadequate prep or insufflation, or when the image can't be read because of excess fluid or feces.

▸ C1: Normal colon or benign lesion. Use this category for cases of no polyp greater than 6 mm, and continue routine screening.

▸ C2: Indeterminate lesion. Use this category for cases of fewer than three polyps 6–9 mm.

▸ C3: Polyp, possibly advanced adenoma. Use this category for cases of three or more polyps 6–9 mm or any polyp 10 mm or larger; a follow-up colonoscopy is recommended.

▸ C4: Colonic mass, likely malignant. Use this category when a lesion compromises the bowel lumen, or there is evidence of extracolonic invasion; surgical consultation is recommended.

Extracolonic Findings

▸ E0: Limited exam. Use this category when an exam is compromised by an artifact so that evaluation of extracolonic soft tissues is limited.

▸ E1: Normal exam or anatomic variant. Use this category when no extracolonic abnormalities are visible, or if there is an anatomic variant such as a retroaortic left renal vein.

▸ E2: Clinically insignificant finding. Use this category when no work-up is indicated, such as for simple cysts or a vertebral hemangioma.

▸ E3: Likely insignificant finding, incompletely characterized, such as a minimally complex renal cyst. Use this category when a work-up may be needed, based on practice and patient preference.

▸ E4: Potentially significant finding. Use this category for a solid renal mass or liposarcoma, and be sure to communicate the details to the referring physician.