Mary Ann Moon

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

Patients who take warfarin are at higher risk of death if they sustain trauma than are those not on warfarin, regardless of type of injury, indication for anticoagulation, or comorbidities, according to a report published online Jan. 17 in Archives of Surgery.

This finding is particularly troubling because warfarin use is quite common, particularly among people over age 65, and is steadily increasing, said Dr. Lesly A. Dossett of Vanderbilt University, Nashville, Tenn., and her associates.

Noting that "no large multicenter trial has previously documented the prevalence of warfarin use among injured patients or its impact on mortality," the researchers assessed its use by analyzing data from the American College of Surgeons’ National Trauma Data Bank, a registry that compiles medical records from more than 770 participating trauma centers across the United States and Puerto Rico.

Dr. Dossett and her colleagues assessed 1,230,422 patients treated for injuries at 402 trauma centers between 2002 and 2007. Overall, 3% of patients in this cohort were taking warfarin when they were injured.

The use of warfarin doubled from a 2% prevalence in 2002 to a 4% prevalence by the end of the study.

For the subgroup of patients over age 65, 9% were taking warfarin when they were injured, and the prevalence of warfarin use rose from 7% in 2002 to 13% by the end of the study.

A total of 9.3% of warfarin users died from their injuries, compared with only 4.8% of nonusers. When mortality data were broken down by patient age, the unadjusted odds ratio for death was 1.51 in warfarin users younger than 65 and 1.41 in users older than 65.

"These unadjusted mortality odds suggest that whether or not warfarin use has a mechanistic link to increased trauma mortality, its use indicates a constellation of demographic and clinical characteristics that collectively increases the odds of death in all patients taking warfarin," the investigators said (Arch. Surg. 2011 Jan. 17 [doi:10.1001/archsurg.2010.313]).

Among the nearly 35,000 study subjects who sustained head injuries with intracranial hemorrhage, warfarin users had significantly higher mortality (22%) than did nonusers (18%). However, when the data were assessed by patient age, only the patients younger than age 65 were at increased risk. Their mortality was 50% higher if they were taking warfarin than if they were not.

Even after the data were adjusted to account for injury pattern and patient comorbidities, warfarin use remained "a significant independent risk factor for death from injury," Dr. Dossett and her associates said.

This study was not designed to determine whether warfarin plays a causal role in mortality or simply serves as a marker for other factors that lead to worse outcomes, they added.

The study was limited in that it was unable to account for the use of other anticoagulant and antiplatelet agents. "Since the presumed mechanistic impact of warfarin on trauma outcome is coagulopathy, patients not classified as warfarin users may use antiplatelet agents that introduce this same mechanism, thereby underestimating the effect of warfarin," the researchers said.

They were unable to assess the degree of anticoagulation achieved with warfarin therapy, or even the degree of patient compliance with recommended treatment. However, they said, "For trauma centers treating patients who present as warfarin users, these data should highlight the importance of seeking an accurate history of warfarin use and its indication, as well as the immediate initiation of its reversal."

No financial conflicts of interest were reported.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

HDL cholesterol’s efflux capacity, a measure of its ability to promote cholesterol efflux from lipid-laden macrophages, was strongly inversely correlated with atherosclerotic burden in a study of two independent groups of subjects reported in the Jan. 13 issue of the New England Journal of Medicine.

In a study assessing HDL cholesterol efflux capacity in two independent populations, this key measure of HDL function was a stronger predictor of both subclinical atherosclerosis disease (as assessed by carotid intima media thickness) and coronary artery disease than was HDL level itself.

"These results could be important in the assessment of new therapies targeting HDL metabolism and reverse cholesterol transport," and may even guide the development of new treatments, said Dr. Amit V. Khera of the cardiovascular institute at the University of Pennsylvania, Philadelphia, and his associates.

They first tested efflux capacity in serum samples from a cohort of 203 healthy white adults participating in a study of HDL-related biomarkers and atherosclerosis. These subjects underwent measurement of carotid artery intima-media thickness as part of that study.

There was no association between HDL level and subclinical CAD. In contrast, there was a significant inverse correlation between HDL cholesterol efflux capacity and subclinical CAD, which remained robust after the data were adjusted for HDL and apolipoprotein A-1 levels.

The investigators then assessed efflux capacity using serum samples from 793 white participants in a case-control cohort who underwent cardiac catheterization. The 442 patients found to have CAD showed significantly lower efflux capacity than did the 351 control subjects who were free of CAD.

Moreover, in a further analysis of the data, the proportion of patients with CAD decreased consistently with increasing efflux capacity. When the cohort was divided into quartiles of efflux capacity, the quartile with the highest efflux capacity showed a distinct decrease in CAD compared with the quartile with the lowest efflux capacity.

All of these correlations remained robust through several adjustments of the data to account for subject age, sex, and traditional cardiovascular disease risk factors, Dr. Khera and his colleagues said (N. Engl. J. Med. 2010;364:127-35).

"Although cholesterol efflux from macrophages represents only a small fraction of overall flux through the reverse-cholesterol-transport pathway, it is probably the component that is most relevant to atheroprotection," they noted.

"These findings reinforce the concept that assessment of HDL function" – not just HDL levels –"may prove informative in refining our understanding of HDL-mediated atheroprotection," the researchers added.

This study was supported by the National Heart, Lung, and Blood Institute; the National Center for Research Resources; the Doris Duke Charitable Foundation; and the Howard Hughes Medical Institute. Dr. Khera’s associates reported ties to Kinemed, Vascular Strategies, and GlaxoSmithKline, as well as involvement with a patent on cell culture systems for determining cholesterol efflux potential in serum.

Consumers who typically pay $400-$2,000 to obtain their genetic risk profiles via the Internet appear to change very little after reading the results, at least in the short term, according to a Jan. 12 report in the New England Journal of Medicine.

In a prospective study involving 3,639 participants who chose to obtain direct-to-consumer, genomewide risk profiling with a commercially available test, there were no measurable changes in anxiety level, dietary fat intake, or exercise level – markers of change in health behavior – or in the use of screening tests for health disorders in the 3 months after they received their results.

In addition, only 10% of the subjects consulted with a genetic counselor, even though there was active outreach from the counselor and services were provided free of charge. A total of 26% reported sharing their results with their physician, according to Cinnamon S. Bloss, Ph.D., of Scripps Genomic Medicine and Scripps Health in La Jolla, Calif., and her associates.

The study participants are still being followed to track their longer-term psychological and behavioral responses during the next year. Meanwhile, "generally speaking, our findings support the null hypothesis (that provision of the results of a direct-to-consumer genomic risk test does not affect health-related behavior), but the potential effects on the population at large are still unknown," the investigators noted.

The clinical validity and utility of genomewide profiling have never been demonstrated. Proponents have argued that consumers who purchase the test may become more compliant with health-screening practices and adopt more healthful lifestyles. Opponents have argued that instead, such testing may raise consumers’ anxiety and boost their use of unnecessary and expensive medical screening and procedures.

To examine this issue, Dr. Bloss and her colleagues performed an ongoing, longitudinal, cohort study in which subjects were assessed at baseline and at 3 months to measure changes in their anxiety symptoms and behavior after profiling. All subjects purchased the genomewide risk profiles at a subsidized cost and were offered free genetic counseling in exchange for their participation.

Only 2,037 subjects completed the 3-month follow-up. A total of 55 completed the baseline health assessment but withdrew from the study, 223 never submitted a sample for genetic testing or never viewed their results, and 1,310 viewed their results but were lost to follow-up. "The failure of a large percentage of subjects (44%) to complete the study is notable," the researchers said.

"We found no evidence that learning the results of genomic risk testing had any short-term psychological, behavioral, or clinical effects on the study subjects," they said (N. Engl. J. Med. 2011 Jan. 12 [doi:10.1056/NEJMoa1011893]).

Overall, the participants showed no discernible change in anxiety level, according to measurements on the Impact of Events Scale–Revised or the Avoidance and Intrusion subscales of this anxiety-screening tool. More than 90% of subjects had low scores indicating no test-related distress, and more than 97% had low scores indicating no clinically significant test-related distress.

However, it is possible that subjects who may have been harmed psychologically by the testing are the ones who declined to participate in the first place, or who dropped out, Dr. Bloss and her associates noted.

The study subjects also showed no change in dietary fat intake or exercise level.

Subjects also did not pursue screening for a variety of disorders that their genetic profiles may have prompted, including thyroid testing, colonoscopy, cholesterol screening, cardiac stress testing, mammography, prostate-specific antigen testing, eye exams, or blood tests for numerous diseases that have a genetic component.

"This may be a good thing, given that the majority of the screening tests we assessed are considered inappropriate for asymptomatic persons. In most instances, the use of such tests would probably result in a waste of health care resources," the researchers said.

This study was limited in that it involved selected subjects and was of longitudinal design so it did not include a control group. Moreover, "the subjects in our study are clearly not representative of the broader U.S. population, and we therefore cannot draw conclusions about the effect of genomewide testing on the population at large," Dr. Bloss and her colleagues said.

The study was funded by the National Institutes of Health’s National Human Genome Research Institute and National Center for Research Resources, as well as by the Scripps Genomic Medicine division of Scripps Health. No financial conflicts of interest were reported.

Consumers who typically pay $400-$2,000 to obtain their genetic risk profiles via the Internet appear to change very little after reading the results, at least in the short term, according to a Jan. 12 report in the New England Journal of Medicine.

In a prospective study involving 3,639 participants who chose to obtain direct-to-consumer, genomewide risk profiling with a commercially available test, there were no measurable changes in anxiety level, dietary fat intake, or exercise level – markers of change in health behavior – or in the use of screening tests for health disorders in the 3 months after they received their results.

In addition, only 10% of the subjects consulted with a genetic counselor, even though there was active outreach from the counselor and services were provided free of charge. A total of 26% reported sharing their results with their physician, according to Cinnamon S. Bloss, Ph.D., of Scripps Genomic Medicine and Scripps Health in La Jolla, Calif., and her associates.

The study participants are still being followed to track their longer-term psychological and behavioral responses during the next year. Meanwhile, "generally speaking, our findings support the null hypothesis (that provision of the results of a direct-to-consumer genomic risk test does not affect health-related behavior), but the potential effects on the population at large are still unknown," the investigators noted.

The clinical validity and utility of genomewide profiling have never been demonstrated. Proponents have argued that consumers who purchase the test may become more compliant with health-screening practices and adopt more healthful lifestyles. Opponents have argued that instead, such testing may raise consumers’ anxiety and boost their use of unnecessary and expensive medical screening and procedures.

To examine this issue, Dr. Bloss and her colleagues performed an ongoing, longitudinal, cohort study in which subjects were assessed at baseline and at 3 months to measure changes in their anxiety symptoms and behavior after profiling. All subjects purchased the genomewide risk profiles at a subsidized cost and were offered free genetic counseling in exchange for their participation.

Only 2,037 subjects completed the 3-month follow-up. A total of 55 completed the baseline health assessment but withdrew from the study, 223 never submitted a sample for genetic testing or never viewed their results, and 1,310 viewed their results but were lost to follow-up. "The failure of a large percentage of subjects (44%) to complete the study is notable," the researchers said.

"We found no evidence that learning the results of genomic risk testing had any short-term psychological, behavioral, or clinical effects on the study subjects," they said (N. Engl. J. Med. 2011 Jan. 12 [doi:10.1056/NEJMoa1011893]).

Overall, the participants showed no discernible change in anxiety level, according to measurements on the Impact of Events Scale–Revised or the Avoidance and Intrusion subscales of this anxiety-screening tool. More than 90% of subjects had low scores indicating no test-related distress, and more than 97% had low scores indicating no clinically significant test-related distress.

However, it is possible that subjects who may have been harmed psychologically by the testing are the ones who declined to participate in the first place, or who dropped out, Dr. Bloss and her associates noted.

The study subjects also showed no change in dietary fat intake or exercise level.

Subjects also did not pursue screening for a variety of disorders that their genetic profiles may have prompted, including thyroid testing, colonoscopy, cholesterol screening, cardiac stress testing, mammography, prostate-specific antigen testing, eye exams, or blood tests for numerous diseases that have a genetic component.

"This may be a good thing, given that the majority of the screening tests we assessed are considered inappropriate for asymptomatic persons. In most instances, the use of such tests would probably result in a waste of health care resources," the researchers said.

This study was limited in that it involved selected subjects and was of longitudinal design so it did not include a control group. Moreover, "the subjects in our study are clearly not representative of the broader U.S. population, and we therefore cannot draw conclusions about the effect of genomewide testing on the population at large," Dr. Bloss and her colleagues said.

The study was funded by the National Institutes of Health’s National Human Genome Research Institute and National Center for Research Resources, as well as by the Scripps Genomic Medicine division of Scripps Health. No financial conflicts of interest were reported.

Consumers who typically pay $400-$2,000 to obtain their genetic risk profiles via the Internet appear to change very little after reading the results, at least in the short term, according to a Jan. 12 report in the New England Journal of Medicine.

In a prospective study involving 3,639 participants who chose to obtain direct-to-consumer, genomewide risk profiling with a commercially available test, there were no measurable changes in anxiety level, dietary fat intake, or exercise level – markers of change in health behavior – or in the use of screening tests for health disorders in the 3 months after they received their results.

In addition, only 10% of the subjects consulted with a genetic counselor, even though there was active outreach from the counselor and services were provided free of charge. A total of 26% reported sharing their results with their physician, according to Cinnamon S. Bloss, Ph.D., of Scripps Genomic Medicine and Scripps Health in La Jolla, Calif., and her associates.

The study participants are still being followed to track their longer-term psychological and behavioral responses during the next year. Meanwhile, "generally speaking, our findings support the null hypothesis (that provision of the results of a direct-to-consumer genomic risk test does not affect health-related behavior), but the potential effects on the population at large are still unknown," the investigators noted.

The clinical validity and utility of genomewide profiling have never been demonstrated. Proponents have argued that consumers who purchase the test may become more compliant with health-screening practices and adopt more healthful lifestyles. Opponents have argued that instead, such testing may raise consumers’ anxiety and boost their use of unnecessary and expensive medical screening and procedures.

To examine this issue, Dr. Bloss and her colleagues performed an ongoing, longitudinal, cohort study in which subjects were assessed at baseline and at 3 months to measure changes in their anxiety symptoms and behavior after profiling. All subjects purchased the genomewide risk profiles at a subsidized cost and were offered free genetic counseling in exchange for their participation.

Only 2,037 subjects completed the 3-month follow-up. A total of 55 completed the baseline health assessment but withdrew from the study, 223 never submitted a sample for genetic testing or never viewed their results, and 1,310 viewed their results but were lost to follow-up. "The failure of a large percentage of subjects (44%) to complete the study is notable," the researchers said.

"We found no evidence that learning the results of genomic risk testing had any short-term psychological, behavioral, or clinical effects on the study subjects," they said (N. Engl. J. Med. 2011 Jan. 12 [doi:10.1056/NEJMoa1011893]).

Overall, the participants showed no discernible change in anxiety level, according to measurements on the Impact of Events Scale–Revised or the Avoidance and Intrusion subscales of this anxiety-screening tool. More than 90% of subjects had low scores indicating no test-related distress, and more than 97% had low scores indicating no clinically significant test-related distress.

However, it is possible that subjects who may have been harmed psychologically by the testing are the ones who declined to participate in the first place, or who dropped out, Dr. Bloss and her associates noted.

The study subjects also showed no change in dietary fat intake or exercise level.

Subjects also did not pursue screening for a variety of disorders that their genetic profiles may have prompted, including thyroid testing, colonoscopy, cholesterol screening, cardiac stress testing, mammography, prostate-specific antigen testing, eye exams, or blood tests for numerous diseases that have a genetic component.

"This may be a good thing, given that the majority of the screening tests we assessed are considered inappropriate for asymptomatic persons. In most instances, the use of such tests would probably result in a waste of health care resources," the researchers said.

This study was limited in that it involved selected subjects and was of longitudinal design so it did not include a control group. Moreover, "the subjects in our study are clearly not representative of the broader U.S. population, and we therefore cannot draw conclusions about the effect of genomewide testing on the population at large," Dr. Bloss and her colleagues said.

The study was funded by the National Institutes of Health’s National Human Genome Research Institute and National Center for Research Resources, as well as by the Scripps Genomic Medicine division of Scripps Health. No financial conflicts of interest were reported.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

Behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring using bladder diaries decreases episodes of postprostatectomy incontinence by half, according to a Jan. 12 report in JAMA.

In what researchers described as the first randomized, controlled trial of behavioral therapy involving men with incontinence persisting more than 1 year after radical prostatectomy, the intervention also improved symptoms of frequency, urgency, and nocturia; lessened the impact of incontinence on daily activities; and improved incontinence-specific quality of life, compared with a control condition, said Dr. Patricia S. Goode of the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center, and her associates.

Adding biofeedback training and pelvic floor electrical stimulation did not improve on the results compared with the behavioral intervention alone, they noted.

In the multicenter trial, 70 patients were randomly assigned to receive the behavioral intervention alone, 70 to receive the behavioral intervention plus biofeedback and pelvic floor electrical stimulation, and 68 were assigned to a control group. A total of 176 subjects completed the 8-week intervention and were followed-up at 6 months and 1 year.

The behavioral therapy entailed four office visits at 2-week intervals with a physician or nurse practitioner. Patients were instructed in using anal palpation and in pelvic floor muscle exercises that they were to practice in three daily sessions at home. They were given a handout to guide management of fluid intake, with attention to distributing fluid consumption throughout the day.

Patients with stress incontinence were taught to contract the pelvic floor muscles just before and after activities that caused leakage, such as coughing or lifting. Patients with urge incontinence were taught to stay still rather than rushing to a toilet when urinary urgency occurred and to contract the pelvic floor muscles repeatedly until the urgency abated, when they could then walk to a bathroom at a normal pace.

All the intervention patients kept daily bladder diaries and exercise logs through the 8-week therapy, which they discussed with caregivers at office visits.

Patients in the "behavior plus" group received this intervention plus in-office biofeedback to help them isolate the pelvic floor muscles. They also were instructed in daily home use of electrical stimulation of the pelvic floor muscles using an anal probe for 15-minute sessions.

Patients in the control group kept daily bladder diaries and discussed urinary incontinence at office visits every 2 weeks, to control for the effects of self-monitoring, clinic visits, and attention from clinic staff.

The primary outcome measure was the reduction in the number of incontinence episodes cited in the patient diaries at 8 weeks. Patients who received behavioral therapy alone showed a mean reduction of 55%, from 28 episodes to 13 per week. Those in the "behavior plus" group showed a similar 51% reduction, from 26 to 12 episodes per week.

This reflects a significantly greater decrease than the 24% reduction, from 25 to 20 episodes per week, reported in the control group, Dr. Goode and her colleagues said (JAMA 2011;305:151-9).

About 16% of the men who received behavioral therapy and 17% of those who received behavioral therapy plus biofeedback and electrical stimulation achieved complete urinary continence, compared with less than 6% of the control group.

Similarly, men in both active-treatment groups showed significant improvement on measures of quality of life and impact of incontinence on daily activities, while those in the control group did not. Men in both active-treatment groups also reported decreases in urinary frequency, urgency, and nocturia, while those in the control group did not.

Ninety percent of men in both active-treatment groups described their urinary leakage as "better" or "much better," compared with only 10% of the control group. Similarly, 47% of the men in both treatment groups said they were completely satisfied with their improvements. Episodes of urinary leakage were "extremely disturbing" to only 4% of the men who received active treatment, compared with 18% of the control group.

The men in both active treatment groups also were more likely to report that they needed fewer pads or diapers than before therapy (42%-55%), compared with only 5% of the control group.

The improvements in both active treatment groups largely persisted throughout the 1-year follow-up period.

Since biofeedback and electrical stimulation of the pelvic floor yielded no additive benefit, they don’t appear to be useful for postprostatectomy urinary incontinence. Dropping these techniques from the regimen will make behavioral therapy more practical and less costly, the investigators noted.

"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery, but had stopped when they failed to improve sufficiently." In contrast, more than 80% of the men in the active treatment groups continued to adhere to the exercise and bladder control strategies for months after this behavioral intervention, most likely because they perceived greater improvement.

The study findings clearly show that behavioral therapy should be offered to all men with persistent postprostatectomy urinary incontinence "because it can yield significant durable improvement in incontinence and quality of life, even years after radical prostatectomy," Dr. Goode and her associates noted.

They added that two good resources for locating qualified behavioral therapy in such patients are the National Association for Continence and the Wound, Ostomy, and Continence Nurses Society.

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs Birmingham-Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reported receiving a research grant from Pfizer. Her associates reported ties to Astellas, GlaxoSmithKline, Vantia, Boehringer-Ingelheim, Ferring, Johnson & Johnson, Allergan, Indevus, and Novartis.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Photo (c) Elsevier 2004. Habif: Clinical Dermatology 4E.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public's acceptance of the vaccine has been slow, and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine's effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Photo (c) Elsevier 2004. Habif: Clinical Dermatology 4E.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public's acceptance of the vaccine has been slow, and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine's effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Photo (c) Elsevier 2004. Habif: Clinical Dermatology 4E.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public's acceptance of the vaccine has been slow, and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine's effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.

The herpes zoster vaccine reduced the incidence of the disease by 55% in real-world clinical practice, according to a report in the Jan. 12 issue of JAMA.

Elsevier 2004. Habif: Clinical Dermatology 4E

This finding, from a retrospective cohort study involving more than 303,000 healthy, community-dwelling adults aged 60 and older from diverse backgrounds, confirms and extends the results of clinical trials that found the vaccine effective under idealized conditions. In addition, the cohort study found further benefits that had not been shown before: The herpes zoster vaccine also decreased the rate of ophthalmic herpes, and it was effective in patients with underlying chronic diseases that were feared to interfere with their immune function.

Thus, the benefits of the herpes zoster vaccine extend to the ophthalmic manifestation of the disease, to all races, both genders, and all ages over 60, as well as to patients with chronic illness, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, Pasadena, and associates.

These results are particularly important given that the public’s acceptance of the vaccine has been slow and it is not yet in widespread use. "This vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients.

"Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," Dr. Tseng and his colleagues wrote.

They assessed the vaccine's effectiveness in 75,761 California patients in the managed care plan who were immunized in 2007-2009, comparing outcomes with those of 227,283 age-matched control subjects who were not vaccinated. A total of 5,434 cases of herpes zoster developed during an average follow-up of 1-2 years.

The incidence of herpes zoster was 6.4 per 1,000 person-years in the vaccinated group, compared with 13 per 1,000 patient-years in the control group. This reflects a 55% reduction in incidence with the vaccine, the investigators wrote (JAMA 2011;305:160-6).

This result indicates that "1 episode of herpes zoster would be averted for every 71 patients receiving the vaccine," they wrote.

The vaccine benefit persisted across all subgroups of patients, particularly in the oldest subjects. "Our results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population," Dr. Tseng and his associates wrote.

"For the oldest group, this could translate into a very large absolute reduction in disease because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions," the researchers added.

The vaccine’s effectiveness against ophthalmic herpes is an important finding not reported previously. Ophthalmic involvement is common and can lead to serious vision-threatening sequelae, they noted.

The finding that the vaccine also was effective in patients with chronic underlying disease was "reassuring," because "these diseases might have interfered with functional immunity and vaccine effectiveness. Control of pain from herpes zoster and postherpetic neuralgia is complicated in these patients because of their underlying conditions and the medications they must take," Dr. Tseng and his colleagues said.

The study was limited in that it involved only fully insured patients in a single region of the country, so "the results need to be generalized carefully." In addition, with its short follow-up, the study "was not designed to capture any decline in protection that is likely to occur with time," they added.

Dr. Tseng and three associates reported receiving research funding from Merck for other vaccine studies.