Nephrology

Men with prostate cancer are twice as likely to have had male pattern baldness starting at age 20, according to results of a study that found no increased risk among men who began balding in their 30s or 40s.

The findings, published Feb. 16 in Annals of Oncology (doi:10.1093/annonc/mdq695), suggest that men with early baldness may benefit from routine prostate cancer screening or preventive measures that could include the systematic use of 5-alpha reductase inhibitors, the researchers wrote.

For their research, Dr. Michael Yassa, who was a radiation oncology fellow at the European Georges Pompidou Hospital in Paris at the time of the study, and his associates studied 388 men with a diagnosis of prostate cancer, recruited from radiation oncology clinics in three French institutions. The study also included 281 matched controls with no history of cancer or hormonal pathologies, but with family histories similar to those of the cases. The mean age of the subjects was 67.2, and the controls, 66.4.

All study participants were asked to report any personal history of prostate cancer and their fathers’ histories of the same, and to describe their balding pattern at ages 20, 30, and 40 along with their fathers’, using a set of four images adapted from the Hamilton–Norwood scale of male pattern baldness. Case subjects’ age at diagnosis, stage of disease at diagnosis, treatment, and other information were recorded.

The men with prostate cancer were twice as likely to have had male pattern baldness at age 20 (odds ratio [OR] 2.01). "This trend was lost at ages 30 or 40," the researchers wrote. No specific pattern of hair loss appeared to be a predictive factor for the development of prostate cancer.

Any balding present at age 20 was associated with an increased incidence of prostate cancer later in life. Cancer patients with early balding did not develop cancers younger – those with any pattern of balding by age 20 and 40 had a mean age of diagnosis of 64.4 and 64.5 years, respectively, compared with 64.3 years for patients with no balding by age 40. The researchers also found no associations between early balding and more aggressive types of tumors.

Dr. Yassa, now with the University of Montreal, and colleagues cited a number of earlier studies with conflicting evidence on the links between baldness and cancer. One Duke University study (Cancer Epidemiol. Biomarkers Prev. 2000;9:325-8) showed that men who developed vertex baldness by age 30 had nearly a twofold increase in risk of developing prostate cancer, but a more recent population-based study (Cancer Epidemiol. [doi:10.1016/j.canep.2010.02.003]) showed baldness at age 30 to be associated with 29% relative risk reduction for prostate cancer.

The investigators in the current study speculated that androgens might be implicated in any link between early balding and cancer. "Finasteride blocks the conversion of testosterone to dihydrotestosterone, the active metabolite of testosterone, slowing the progression of androgenic alopecia and decreasing the incidence of prostate cancer," they wrote.

They also acknowledged that their own study was limited by its small size and a case-control design involving self-reporting, that could allow for recall and selective recall bias, and a lack of controlling for factors including African heritage and dietary differences. Neither Dr. Hassa nor his coauthors declared conflicts of interest.

Men with prostate cancer are twice as likely to have had male pattern baldness starting at age 20, according to results of a study that found no increased risk among men who began balding in their 30s or 40s.

The findings, published Feb. 16 in Annals of Oncology (doi:10.1093/annonc/mdq695), suggest that men with early baldness may benefit from routine prostate cancer screening or preventive measures that could include the systematic use of 5-alpha reductase inhibitors, the researchers wrote.

For their research, Dr. Michael Yassa, who was a radiation oncology fellow at the European Georges Pompidou Hospital in Paris at the time of the study, and his associates studied 388 men with a diagnosis of prostate cancer, recruited from radiation oncology clinics in three French institutions. The study also included 281 matched controls with no history of cancer or hormonal pathologies, but with family histories similar to those of the cases. The mean age of the subjects was 67.2, and the controls, 66.4.

All study participants were asked to report any personal history of prostate cancer and their fathers’ histories of the same, and to describe their balding pattern at ages 20, 30, and 40 along with their fathers’, using a set of four images adapted from the Hamilton–Norwood scale of male pattern baldness. Case subjects’ age at diagnosis, stage of disease at diagnosis, treatment, and other information were recorded.

The men with prostate cancer were twice as likely to have had male pattern baldness at age 20 (odds ratio [OR] 2.01). "This trend was lost at ages 30 or 40," the researchers wrote. No specific pattern of hair loss appeared to be a predictive factor for the development of prostate cancer.

Any balding present at age 20 was associated with an increased incidence of prostate cancer later in life. Cancer patients with early balding did not develop cancers younger – those with any pattern of balding by age 20 and 40 had a mean age of diagnosis of 64.4 and 64.5 years, respectively, compared with 64.3 years for patients with no balding by age 40. The researchers also found no associations between early balding and more aggressive types of tumors.

Dr. Yassa, now with the University of Montreal, and colleagues cited a number of earlier studies with conflicting evidence on the links between baldness and cancer. One Duke University study (Cancer Epidemiol. Biomarkers Prev. 2000;9:325-8) showed that men who developed vertex baldness by age 30 had nearly a twofold increase in risk of developing prostate cancer, but a more recent population-based study (Cancer Epidemiol. [doi:10.1016/j.canep.2010.02.003]) showed baldness at age 30 to be associated with 29% relative risk reduction for prostate cancer.

The investigators in the current study speculated that androgens might be implicated in any link between early balding and cancer. "Finasteride blocks the conversion of testosterone to dihydrotestosterone, the active metabolite of testosterone, slowing the progression of androgenic alopecia and decreasing the incidence of prostate cancer," they wrote.

They also acknowledged that their own study was limited by its small size and a case-control design involving self-reporting, that could allow for recall and selective recall bias, and a lack of controlling for factors including African heritage and dietary differences. Neither Dr. Hassa nor his coauthors declared conflicts of interest.

Men with prostate cancer are twice as likely to have had male pattern baldness starting at age 20, according to results of a study that found no increased risk among men who began balding in their 30s or 40s.

The findings, published Feb. 16 in Annals of Oncology (doi:10.1093/annonc/mdq695), suggest that men with early baldness may benefit from routine prostate cancer screening or preventive measures that could include the systematic use of 5-alpha reductase inhibitors, the researchers wrote.

For their research, Dr. Michael Yassa, who was a radiation oncology fellow at the European Georges Pompidou Hospital in Paris at the time of the study, and his associates studied 388 men with a diagnosis of prostate cancer, recruited from radiation oncology clinics in three French institutions. The study also included 281 matched controls with no history of cancer or hormonal pathologies, but with family histories similar to those of the cases. The mean age of the subjects was 67.2, and the controls, 66.4.

All study participants were asked to report any personal history of prostate cancer and their fathers’ histories of the same, and to describe their balding pattern at ages 20, 30, and 40 along with their fathers’, using a set of four images adapted from the Hamilton–Norwood scale of male pattern baldness. Case subjects’ age at diagnosis, stage of disease at diagnosis, treatment, and other information were recorded.

The men with prostate cancer were twice as likely to have had male pattern baldness at age 20 (odds ratio [OR] 2.01). "This trend was lost at ages 30 or 40," the researchers wrote. No specific pattern of hair loss appeared to be a predictive factor for the development of prostate cancer.

Any balding present at age 20 was associated with an increased incidence of prostate cancer later in life. Cancer patients with early balding did not develop cancers younger – those with any pattern of balding by age 20 and 40 had a mean age of diagnosis of 64.4 and 64.5 years, respectively, compared with 64.3 years for patients with no balding by age 40. The researchers also found no associations between early balding and more aggressive types of tumors.

Dr. Yassa, now with the University of Montreal, and colleagues cited a number of earlier studies with conflicting evidence on the links between baldness and cancer. One Duke University study (Cancer Epidemiol. Biomarkers Prev. 2000;9:325-8) showed that men who developed vertex baldness by age 30 had nearly a twofold increase in risk of developing prostate cancer, but a more recent population-based study (Cancer Epidemiol. [doi:10.1016/j.canep.2010.02.003]) showed baldness at age 30 to be associated with 29% relative risk reduction for prostate cancer.

The investigators in the current study speculated that androgens might be implicated in any link between early balding and cancer. "Finasteride blocks the conversion of testosterone to dihydrotestosterone, the active metabolite of testosterone, slowing the progression of androgenic alopecia and decreasing the incidence of prostate cancer," they wrote.

They also acknowledged that their own study was limited by its small size and a case-control design involving self-reporting, that could allow for recall and selective recall bias, and a lack of controlling for factors including African heritage and dietary differences. Neither Dr. Hassa nor his coauthors declared conflicts of interest.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

DENVER – The risk of death for patients with hepatitis C is higher than that of patients with chronic kidney disease, but when both conditions are present, chronic kidney disease does not significantly increase mortality beyond the risk associated with hepatitis C alone.

"Both patients with hepatitis C and [those with] chronic kidney disease die of similar causes," Dr. Rajiv J. Gandhi said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Overall, many of them die from heart disease. Albuminuria has been linked to cardiovascular risk and cardiovascular disease. Hepatitis C patients have more albuminuria than those without hepatitis. This might be a target for intervention to decrease cardiovascular risk."

Dr. Gandhi of the University of Minnesota, Minneapolis, and his associate Dr. Robert N. Foley studied 15,540 people aged 20 years and older in the National Health and Nutrition Examination Survey 1988-1994 who completed examination and laboratory testing for HCV antibody and serum creatinine, and were included in the mortality file linking them to the National Death Index.

The researchers performed descriptive analysis comparing participants on demographic, examination, laboratory, and questionnaire variables grouped by HCV antibody status and went on to compare mortality based on HCV and chronic kidney disease status, with follow-up through 2006.

The mean age of study participants was 43 years, and 57% were white. Overall, 388 of the study participants (2.5%) were HCV positive. Compared with HCV-negative patients, those who were HCV positive tended to have higher albumin-to-creatinine ratios, lower blood urea nitrogen levels, and higher estimated glomerular filtration rates.

At the end of follow-up, a higher proportion of HCV-positive individuals had died, compared with HCV-negative individuals (22.2% vs. 17.2%, respectively), but this difference did not reach statistical significance.

An analysis adjusted for age, sex, and race revealed that the hazard ratio for all-cause mortality was 2.5 for participants with chronic kidney disease alone, 3.9 for those with HCV alone and 4.2 when both conditions were present.

The researchers also found that albuminuria was associated with similarly increased mortality in HCV-negative and HCV-positive study participants (hazard ratio, 5.6 and 5.1, respectively). In addition, a glomerular filtration rate of less than 60 mL/min per1.73 m2 was associated with increased mortality in HCV-negative individuals (HR, 10.3), and mortality was markedly higher in HCV-positive individuals (HR, 54.3).

"Overall, HCV-positive participants have higher mean estimated glomerular filtration rates and albumin to creatinine ratios, which likely indicates early stages of kidney disease characterized by hyperfiltration and increased albuminuria," the researchers wrote in their poster. "Screening for early markers of kidney disease such as albuminuria among HCV-positive individuals may allow early intervention and could potentially decrease the mortality observed in this group."

Dr. Gandhi acknowledged certain limitations of the study, including its cross-sectional design and the fact that lab measurements were taken at one point in time.

Dr. Gandhi said that he had no relevant financial disclosures to make.

To the Editor: Thank you for the thorough review of gout and chronic kidney disease in the December 2010 issue of Cleveland Clinic Journal of Medicine.

Table 2 displays results from the Febuxostat Versus Allopurinol Controlled Trial (FACT), in which we see that 76% of patients treated with febuxostat 80 mg per day achieved a serum uric acid level of less than 6 mg/dL at week 28. With a dose of febuxostat 240 mg per day, 94% of patients were able to reduce their serum uric acid below 6 mg/dL, the threshold needed to prevent precipitation of uric acid crystals. However, the maximum daily dose recommended in the product information for Uloric (febuxostat) is 80 mg, at which approximately 24% of patients failed to lower their serum uric acid levels to less than 6 mg/dL.

When encountering such patients in clinical practice, would the authors advise pushing the daily dose of febuxostat up to 240 mg, if needed? Alternatively, is there any role for combination therapy with both febuxostat and allopurinol for gout patients with severe resistant hyperuricemia?

To the Editor: Thank you for the thorough review of gout and chronic kidney disease in the December 2010 issue of Cleveland Clinic Journal of Medicine.

Table 2 displays results from the Febuxostat Versus Allopurinol Controlled Trial (FACT), in which we see that 76% of patients treated with febuxostat 80 mg per day achieved a serum uric acid level of less than 6 mg/dL at week 28. With a dose of febuxostat 240 mg per day, 94% of patients were able to reduce their serum uric acid below 6 mg/dL, the threshold needed to prevent precipitation of uric acid crystals. However, the maximum daily dose recommended in the product information for Uloric (febuxostat) is 80 mg, at which approximately 24% of patients failed to lower their serum uric acid levels to less than 6 mg/dL.

When encountering such patients in clinical practice, would the authors advise pushing the daily dose of febuxostat up to 240 mg, if needed? Alternatively, is there any role for combination therapy with both febuxostat and allopurinol for gout patients with severe resistant hyperuricemia?

To the Editor: Thank you for the thorough review of gout and chronic kidney disease in the December 2010 issue of Cleveland Clinic Journal of Medicine.

Table 2 displays results from the Febuxostat Versus Allopurinol Controlled Trial (FACT), in which we see that 76% of patients treated with febuxostat 80 mg per day achieved a serum uric acid level of less than 6 mg/dL at week 28. With a dose of febuxostat 240 mg per day, 94% of patients were able to reduce their serum uric acid below 6 mg/dL, the threshold needed to prevent precipitation of uric acid crystals. However, the maximum daily dose recommended in the product information for Uloric (febuxostat) is 80 mg, at which approximately 24% of patients failed to lower their serum uric acid levels to less than 6 mg/dL.

When encountering such patients in clinical practice, would the authors advise pushing the daily dose of febuxostat up to 240 mg, if needed? Alternatively, is there any role for combination therapy with both febuxostat and allopurinol for gout patients with severe resistant hyperuricemia?

In Reply: The clinical dilemma Dr. Keller describes is the inability to lower the serum urate to a consensually accepted target level of less than 6.0 mg/dL in patients with significant gouty arthritis, when using doses of febuxostat (or for that matter allopurinol) recommended by the US Food and Drug Administration (FDA). This problem is not limited to the management of the gouty patient with renal insufficiency, and we will describe our approach.

In patients failing to meet target serum urate levels, patient adherence to the prescribed dosing should be considered first, since as many as 50% of patients do not adhere to their prescribed hypouricemic medication regimen.¹

As Dr. Keller notes, staying below the FDA-approved daily dosage (in the absence of renal insufficiency) of febuxostat (80 mg) or allopurinol (800 mg) will result in some patients not achieving adequate urate-lowering to ameliorate their gout. With clinical and laboratory monitoring for intolerance, we have increased the dose of allopurinol to above 800 mg when necessary; we have explained to patients that this was above the normally recommended dosage of the drug. Of those patients who have been truly intolerant to allopurinol whom we have needed to switch to febuxostat, there have been a few who have required greater than 80 mg daily, and we have increased the dosage, again with extra vigilance in monitoring (liver tests in particular) and after discussion with the patient. Thus far, we have been fortunate in not having had significant side effects, but we do not assume that all patients will tolerate more than 80 mg daily.

Since both febuxostat and allopurinol inhibit the same enzyme (xanthine oxidase) as their mechanism of action, we do not anticipate an advantage to using combined drug therapy, as opposed to increasing the dose of one or the other of the medications. There might even be some loss of efficacy due to inhibitor competition at the enzyme’s active site. Alternatively, in the patient with normal renal function, there might be an advantage to adding probenecid, a uricosuric drug, to either allopurinol or febuxostat, in order to gain some additional hypouricemic effect.

Finally, it is worth reemphasizing that in clinical trials, although febuxostat 80 mg may have outperformed allopurinol at a dose of 300 mg (or less), in clinical practice it is quite reasonable to significantly increase the dosage of allopurinol to at least 800 mg daily as long as it is tolerated, before switching to the very effective but much more expensive alternative. The goal of therapy is, after all, to safely lower the serum urate level to well below its saturation point. Surveys of prescribing habits indicate that physicians have been very reluctant to increase the dose of allopurinol to above 300 mg daily and, unfortunately, do not adequately monitor the efficacy of the therapy in lowering the serum urate level.

In Reply: The clinical dilemma Dr. Keller describes is the inability to lower the serum urate to a consensually accepted target level of less than 6.0 mg/dL in patients with significant gouty arthritis, when using doses of febuxostat (or for that matter allopurinol) recommended by the US Food and Drug Administration (FDA). This problem is not limited to the management of the gouty patient with renal insufficiency, and we will describe our approach.

In patients failing to meet target serum urate levels, patient adherence to the prescribed dosing should be considered first, since as many as 50% of patients do not adhere to their prescribed hypouricemic medication regimen.¹

As Dr. Keller notes, staying below the FDA-approved daily dosage (in the absence of renal insufficiency) of febuxostat (80 mg) or allopurinol (800 mg) will result in some patients not achieving adequate urate-lowering to ameliorate their gout. With clinical and laboratory monitoring for intolerance, we have increased the dose of allopurinol to above 800 mg when necessary; we have explained to patients that this was above the normally recommended dosage of the drug. Of those patients who have been truly intolerant to allopurinol whom we have needed to switch to febuxostat, there have been a few who have required greater than 80 mg daily, and we have increased the dosage, again with extra vigilance in monitoring (liver tests in particular) and after discussion with the patient. Thus far, we have been fortunate in not having had significant side effects, but we do not assume that all patients will tolerate more than 80 mg daily.

Since both febuxostat and allopurinol inhibit the same enzyme (xanthine oxidase) as their mechanism of action, we do not anticipate an advantage to using combined drug therapy, as opposed to increasing the dose of one or the other of the medications. There might even be some loss of efficacy due to inhibitor competition at the enzyme’s active site. Alternatively, in the patient with normal renal function, there might be an advantage to adding probenecid, a uricosuric drug, to either allopurinol or febuxostat, in order to gain some additional hypouricemic effect.

Finally, it is worth reemphasizing that in clinical trials, although febuxostat 80 mg may have outperformed allopurinol at a dose of 300 mg (or less), in clinical practice it is quite reasonable to significantly increase the dosage of allopurinol to at least 800 mg daily as long as it is tolerated, before switching to the very effective but much more expensive alternative. The goal of therapy is, after all, to safely lower the serum urate level to well below its saturation point. Surveys of prescribing habits indicate that physicians have been very reluctant to increase the dose of allopurinol to above 300 mg daily and, unfortunately, do not adequately monitor the efficacy of the therapy in lowering the serum urate level.

In Reply: The clinical dilemma Dr. Keller describes is the inability to lower the serum urate to a consensually accepted target level of less than 6.0 mg/dL in patients with significant gouty arthritis, when using doses of febuxostat (or for that matter allopurinol) recommended by the US Food and Drug Administration (FDA). This problem is not limited to the management of the gouty patient with renal insufficiency, and we will describe our approach.

In patients failing to meet target serum urate levels, patient adherence to the prescribed dosing should be considered first, since as many as 50% of patients do not adhere to their prescribed hypouricemic medication regimen.¹

As Dr. Keller notes, staying below the FDA-approved daily dosage (in the absence of renal insufficiency) of febuxostat (80 mg) or allopurinol (800 mg) will result in some patients not achieving adequate urate-lowering to ameliorate their gout. With clinical and laboratory monitoring for intolerance, we have increased the dose of allopurinol to above 800 mg when necessary; we have explained to patients that this was above the normally recommended dosage of the drug. Of those patients who have been truly intolerant to allopurinol whom we have needed to switch to febuxostat, there have been a few who have required greater than 80 mg daily, and we have increased the dosage, again with extra vigilance in monitoring (liver tests in particular) and after discussion with the patient. Thus far, we have been fortunate in not having had significant side effects, but we do not assume that all patients will tolerate more than 80 mg daily.

Since both febuxostat and allopurinol inhibit the same enzyme (xanthine oxidase) as their mechanism of action, we do not anticipate an advantage to using combined drug therapy, as opposed to increasing the dose of one or the other of the medications. There might even be some loss of efficacy due to inhibitor competition at the enzyme’s active site. Alternatively, in the patient with normal renal function, there might be an advantage to adding probenecid, a uricosuric drug, to either allopurinol or febuxostat, in order to gain some additional hypouricemic effect.

Finally, it is worth reemphasizing that in clinical trials, although febuxostat 80 mg may have outperformed allopurinol at a dose of 300 mg (or less), in clinical practice it is quite reasonable to significantly increase the dosage of allopurinol to at least 800 mg daily as long as it is tolerated, before switching to the very effective but much more expensive alternative. The goal of therapy is, after all, to safely lower the serum urate level to well below its saturation point. Surveys of prescribing habits indicate that physicians have been very reluctant to increase the dose of allopurinol to above 300 mg daily and, unfortunately, do not adequately monitor the efficacy of the therapy in lowering the serum urate level.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

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.

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.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.