Nephrology

CHICAGO — Maintaining a lower hemoglobin level may help prevent morbidity and mortality in patients with chronic kidney disease, according to a study of 1,432 patients randomized to two different hemoglobin goals.

Almost half of patients with stage 3–5 chronic kidney disease (CKD) have anemia, and nephrologists know that treating anemia with erythropoietin and iron “improves quality of life, well-being, exercise tolerance, and lowers the risk of transfusions,” said Dr. Ajay Singh, who presented late-breaking results of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study at a meeting on clinical nephrology sponsored by the National Kidney Foundation.

A deficiency of erythropoietin, which is produced by the kidneys, is known to contribute to anemia. Iron deficiency also plays a role, noted Dr. Singh, director of the dialysis unit at Brigham and Women's Hospital, Boston.

But researchers have not yet elucidated the optimal target hemoglobin level for CKD patients. Dr. Singh and his associates conducted a randomized, controlled trial of 1,432 patients with CKD. The patients were randomized to one of two groups, with a target hemoglobin of either 13.5 g/dL or 11.3 g/dL. The groups had similar baseline characteristics: About half of those in each group had diabetes, and about one-third had hypertension.

Patients were followed weekly, for a median of 16 months, to assess how many in each group reached a primary composite end point of death, MI, stroke, or severe heart failure requiring hospital admission. Patients in both groups received an average dose of 8,000 U of erythropoietin subcutaneously every week. To achieve the hemoglobin levels specified in the trial, some patients were switched to every-other-week dosing.

Patients also received iron supplementation, as indicated, according to the standard of care.

The patients randomized to the lower hemoglobin level were significantly less likely to reach the primary composite end point, compared with those randomized to the higher hemoglobin level.

Further analysis of the data showed that death and heart failure were driving the composite end point, rather than an increased incidence of stroke or MI. No difference was seen between the groups in reaching the secondary composite end point: all-cause mortality, change in hemoglobin level or hematocrit, or development of heart failure.

The physiologic mechanisms underlying the findings have not yet been worked out. “The biologic mechanisms are unclear,” Dr. Singh said in an interview.

It is not yet known whether the poorer outcomes seen in the high-hemoglobin group were the result of the higher level of hemoglobin itself, the use of erythropoietin to achieve this higher hemoglobin level, or other factors. “It seems to be a phenomenon related to kidney disease,” he added.

CHICAGO — Maintaining a lower hemoglobin level may help prevent morbidity and mortality in patients with chronic kidney disease, according to a study of 1,432 patients randomized to two different hemoglobin goals.

Almost half of patients with stage 3–5 chronic kidney disease (CKD) have anemia, and nephrologists know that treating anemia with erythropoietin and iron “improves quality of life, well-being, exercise tolerance, and lowers the risk of transfusions,” said Dr. Ajay Singh, who presented late-breaking results of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study at a meeting on clinical nephrology sponsored by the National Kidney Foundation.

A deficiency of erythropoietin, which is produced by the kidneys, is known to contribute to anemia. Iron deficiency also plays a role, noted Dr. Singh, director of the dialysis unit at Brigham and Women's Hospital, Boston.

But researchers have not yet elucidated the optimal target hemoglobin level for CKD patients. Dr. Singh and his associates conducted a randomized, controlled trial of 1,432 patients with CKD. The patients were randomized to one of two groups, with a target hemoglobin of either 13.5 g/dL or 11.3 g/dL. The groups had similar baseline characteristics: About half of those in each group had diabetes, and about one-third had hypertension.

Patients were followed weekly, for a median of 16 months, to assess how many in each group reached a primary composite end point of death, MI, stroke, or severe heart failure requiring hospital admission. Patients in both groups received an average dose of 8,000 U of erythropoietin subcutaneously every week. To achieve the hemoglobin levels specified in the trial, some patients were switched to every-other-week dosing.

Patients also received iron supplementation, as indicated, according to the standard of care.

The patients randomized to the lower hemoglobin level were significantly less likely to reach the primary composite end point, compared with those randomized to the higher hemoglobin level.

Further analysis of the data showed that death and heart failure were driving the composite end point, rather than an increased incidence of stroke or MI. No difference was seen between the groups in reaching the secondary composite end point: all-cause mortality, change in hemoglobin level or hematocrit, or development of heart failure.

The physiologic mechanisms underlying the findings have not yet been worked out. “The biologic mechanisms are unclear,” Dr. Singh said in an interview.

It is not yet known whether the poorer outcomes seen in the high-hemoglobin group were the result of the higher level of hemoglobin itself, the use of erythropoietin to achieve this higher hemoglobin level, or other factors. “It seems to be a phenomenon related to kidney disease,” he added.

CHICAGO — Maintaining a lower hemoglobin level may help prevent morbidity and mortality in patients with chronic kidney disease, according to a study of 1,432 patients randomized to two different hemoglobin goals.

Almost half of patients with stage 3–5 chronic kidney disease (CKD) have anemia, and nephrologists know that treating anemia with erythropoietin and iron “improves quality of life, well-being, exercise tolerance, and lowers the risk of transfusions,” said Dr. Ajay Singh, who presented late-breaking results of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study at a meeting on clinical nephrology sponsored by the National Kidney Foundation.

A deficiency of erythropoietin, which is produced by the kidneys, is known to contribute to anemia. Iron deficiency also plays a role, noted Dr. Singh, director of the dialysis unit at Brigham and Women's Hospital, Boston.

But researchers have not yet elucidated the optimal target hemoglobin level for CKD patients. Dr. Singh and his associates conducted a randomized, controlled trial of 1,432 patients with CKD. The patients were randomized to one of two groups, with a target hemoglobin of either 13.5 g/dL or 11.3 g/dL. The groups had similar baseline characteristics: About half of those in each group had diabetes, and about one-third had hypertension.

Patients were followed weekly, for a median of 16 months, to assess how many in each group reached a primary composite end point of death, MI, stroke, or severe heart failure requiring hospital admission. Patients in both groups received an average dose of 8,000 U of erythropoietin subcutaneously every week. To achieve the hemoglobin levels specified in the trial, some patients were switched to every-other-week dosing.

Patients also received iron supplementation, as indicated, according to the standard of care.

The patients randomized to the lower hemoglobin level were significantly less likely to reach the primary composite end point, compared with those randomized to the higher hemoglobin level.

Further analysis of the data showed that death and heart failure were driving the composite end point, rather than an increased incidence of stroke or MI. No difference was seen between the groups in reaching the secondary composite end point: all-cause mortality, change in hemoglobin level or hematocrit, or development of heart failure.

The physiologic mechanisms underlying the findings have not yet been worked out. “The biologic mechanisms are unclear,” Dr. Singh said in an interview.

It is not yet known whether the poorer outcomes seen in the high-hemoglobin group were the result of the higher level of hemoglobin itself, the use of erythropoietin to achieve this higher hemoglobin level, or other factors. “It seems to be a phenomenon related to kidney disease,” he added.

SAN FRANCISCO — Adjustment of threshold values of prostate-specific antigen velocity for age can substantially improve prostate cancer detection among men younger than 70 years, Dr. Judd W. Moul said at a prostate cancer symposium sponsored by the American Society of Clinical Oncology.

In a review of data from more than 11,000 men who underwent PSA testing during a 7-year period, Dr. Moul and colleagues at Duke University Medical Center in Durham, N.C., tested the hypothesis that lowering the threshold for what's considered the “normal” PSA velocity for younger age groups would help detect disease sooner than current thresholds allow.

The investigators calculated PSA velocities from patients' PSA measures over time and correlated them to prostate biopsy status. They then normalized velocity percentiles to three different age categories (40–59 years, 60–69 years, and 70 years and older).

Conventional screening protocols consider a PSA velocity increase of 0.75 ng/mL or more per year to be an indicator of increased prostate cancer risk regardless of patient age.

After adjustment of the data for patient age, the threshold PSA velocity for men aged 40–59 years was lowered to 0.25 ng/mL per year.

For men aged 60–69 years, it was lowered to 0.50 ng/mL per year. The threshold for men older than 69 remained 0.75 ng/mL, Dr. Moul said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

In a comparison of the screening accuracy of the age-adjusted threshold with the traditional standard, the prostate cancer detection rate in the study cohort increased from 19% to 35% among men in the youngest category and from 25% to 57% among men in the middle age group.

“The sensitivity of the age-adjusted PSA velocity for the younger group was 0.519, compared to 0.265 for the standard,” Dr. Moul said. “For the middle age group, the sensitivity with the lower threshold was 0.398, compared to 0.306.”

Specificity values in these two groups were only slightly and nonsignificantly diminished from those associated with the conventional threshold values, he said.

Based on the findings, “it's clear that age-adjusted PSA velocity could significantly improve our ability to detect early prostate cancer,” he said.

SAN FRANCISCO — Adjustment of threshold values of prostate-specific antigen velocity for age can substantially improve prostate cancer detection among men younger than 70 years, Dr. Judd W. Moul said at a prostate cancer symposium sponsored by the American Society of Clinical Oncology.

In a review of data from more than 11,000 men who underwent PSA testing during a 7-year period, Dr. Moul and colleagues at Duke University Medical Center in Durham, N.C., tested the hypothesis that lowering the threshold for what's considered the “normal” PSA velocity for younger age groups would help detect disease sooner than current thresholds allow.

The investigators calculated PSA velocities from patients' PSA measures over time and correlated them to prostate biopsy status. They then normalized velocity percentiles to three different age categories (40–59 years, 60–69 years, and 70 years and older).

Conventional screening protocols consider a PSA velocity increase of 0.75 ng/mL or more per year to be an indicator of increased prostate cancer risk regardless of patient age.

After adjustment of the data for patient age, the threshold PSA velocity for men aged 40–59 years was lowered to 0.25 ng/mL per year.

For men aged 60–69 years, it was lowered to 0.50 ng/mL per year. The threshold for men older than 69 remained 0.75 ng/mL, Dr. Moul said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

In a comparison of the screening accuracy of the age-adjusted threshold with the traditional standard, the prostate cancer detection rate in the study cohort increased from 19% to 35% among men in the youngest category and from 25% to 57% among men in the middle age group.

“The sensitivity of the age-adjusted PSA velocity for the younger group was 0.519, compared to 0.265 for the standard,” Dr. Moul said. “For the middle age group, the sensitivity with the lower threshold was 0.398, compared to 0.306.”

Specificity values in these two groups were only slightly and nonsignificantly diminished from those associated with the conventional threshold values, he said.

Based on the findings, “it's clear that age-adjusted PSA velocity could significantly improve our ability to detect early prostate cancer,” he said.

SAN FRANCISCO — Adjustment of threshold values of prostate-specific antigen velocity for age can substantially improve prostate cancer detection among men younger than 70 years, Dr. Judd W. Moul said at a prostate cancer symposium sponsored by the American Society of Clinical Oncology.

In a review of data from more than 11,000 men who underwent PSA testing during a 7-year period, Dr. Moul and colleagues at Duke University Medical Center in Durham, N.C., tested the hypothesis that lowering the threshold for what's considered the “normal” PSA velocity for younger age groups would help detect disease sooner than current thresholds allow.

The investigators calculated PSA velocities from patients' PSA measures over time and correlated them to prostate biopsy status. They then normalized velocity percentiles to three different age categories (40–59 years, 60–69 years, and 70 years and older).

Conventional screening protocols consider a PSA velocity increase of 0.75 ng/mL or more per year to be an indicator of increased prostate cancer risk regardless of patient age.

After adjustment of the data for patient age, the threshold PSA velocity for men aged 40–59 years was lowered to 0.25 ng/mL per year.

For men aged 60–69 years, it was lowered to 0.50 ng/mL per year. The threshold for men older than 69 remained 0.75 ng/mL, Dr. Moul said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

In a comparison of the screening accuracy of the age-adjusted threshold with the traditional standard, the prostate cancer detection rate in the study cohort increased from 19% to 35% among men in the youngest category and from 25% to 57% among men in the middle age group.

“The sensitivity of the age-adjusted PSA velocity for the younger group was 0.519, compared to 0.265 for the standard,” Dr. Moul said. “For the middle age group, the sensitivity with the lower threshold was 0.398, compared to 0.306.”

Specificity values in these two groups were only slightly and nonsignificantly diminished from those associated with the conventional threshold values, he said.

Based on the findings, “it's clear that age-adjusted PSA velocity could significantly improve our ability to detect early prostate cancer,” he said.

SAN FRANCISCO — Among men with early-stage prostate cancer who choose watchful waiting as their primary treatment strategy, the rate of rise in their prostate-specific antigen level is more predictive of survival than any single PSA value, Dr. Jennifer Cullen said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

In a retrospective study of nearly 1,400 men with early prostate cancer being followed with watchful waiting rather than active intervention, those men with a PSA velocity (the rate of increase in PSA value) of less than 2 ng/mL per year during a mean follow-up time of nearly 5 years had a significantly better overall survival rate than did men whose PSA velocity was at least 2 ng/mL per year, said Dr. Cullen of the Department of Defense Center for Prostate Disease Research (CPDR) in Rockville, Md.

The study sample consisted of military-care beneficiaries from the CPDR database who were diagnosed with biopsy-proven, clinically localized prostate cancer between January 1989 and December 2003 and who did not receive any clinical intervention for their cancer for at least 6 months after diagnosis. Of the 1,369 men who met these criteria, the survival analysis was limited to 830 men who had a record of at least one follow-up appointment in the first 3 years following diagnosis, “to be sure that no other therapy was chosen at some time point after their care in the [CPDR] database program,” she said.

All of the subjects had at least three PSA values after diagnosis but not spaced within 3 months of each other, to minimize the potential for noise-related inaccuracies that could occur at shorter intervals. The mean age was 69 years, and the mean follow-up time was nearly 5 years.

The investigators generated survival analyses for men with PSA velocities below 2 ng/mL versus 2 ng/mL or more—a distinction that is literature driven, according to Dr. Cullen.

After controlling for comorbidities, secondary treatment, and time to secondary treatment, “we observed significantly poorer survival for those men in the higher PSA velocity group, independent of PSA value at diagnosis,” she said. “Only 56% of men in the higher-velocity category were alive at follow-up, compared with 87% of those with lower velocity values.”

On the heels of the recent report by the Scandinavian Prostate Cancer Group Study No. 4, a long-term trial showing small but significant overall and disease-specific survival differences between watchful waiting and radical prostatectomy (N. Engl. J. Med. 2005;352:1977–84), the findings of this study shed light on how best to evaluate the survival potential of watchful waiting for a given patient, Dr. Cullen noted at the meeting, cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

The Scandinavian study “did not specifically investigate factors that might impact survival in men who choose watchful waiting,” she said. “Our goal was to look for characteristics that might be predictive of better or worse outcomes.”

Although limited by its retrospective design, “our database is so large that we have the ability to do robust subset analyses such as this one,” Dr. Cullen said. The findings, though promising, still need to be replicated in a nonmilitary population. In addition, she said, “we want to look at the relative impact of other survival predictors, including patient age, specific tumor characteristics, and Gleason scores, as well as the optimal frequency of PSA testing.”

SAN FRANCISCO — Among men with early-stage prostate cancer who choose watchful waiting as their primary treatment strategy, the rate of rise in their prostate-specific antigen level is more predictive of survival than any single PSA value, Dr. Jennifer Cullen said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

In a retrospective study of nearly 1,400 men with early prostate cancer being followed with watchful waiting rather than active intervention, those men with a PSA velocity (the rate of increase in PSA value) of less than 2 ng/mL per year during a mean follow-up time of nearly 5 years had a significantly better overall survival rate than did men whose PSA velocity was at least 2 ng/mL per year, said Dr. Cullen of the Department of Defense Center for Prostate Disease Research (CPDR) in Rockville, Md.

The study sample consisted of military-care beneficiaries from the CPDR database who were diagnosed with biopsy-proven, clinically localized prostate cancer between January 1989 and December 2003 and who did not receive any clinical intervention for their cancer for at least 6 months after diagnosis. Of the 1,369 men who met these criteria, the survival analysis was limited to 830 men who had a record of at least one follow-up appointment in the first 3 years following diagnosis, “to be sure that no other therapy was chosen at some time point after their care in the [CPDR] database program,” she said.

All of the subjects had at least three PSA values after diagnosis but not spaced within 3 months of each other, to minimize the potential for noise-related inaccuracies that could occur at shorter intervals. The mean age was 69 years, and the mean follow-up time was nearly 5 years.

The investigators generated survival analyses for men with PSA velocities below 2 ng/mL versus 2 ng/mL or more—a distinction that is literature driven, according to Dr. Cullen.

After controlling for comorbidities, secondary treatment, and time to secondary treatment, “we observed significantly poorer survival for those men in the higher PSA velocity group, independent of PSA value at diagnosis,” she said. “Only 56% of men in the higher-velocity category were alive at follow-up, compared with 87% of those with lower velocity values.”

On the heels of the recent report by the Scandinavian Prostate Cancer Group Study No. 4, a long-term trial showing small but significant overall and disease-specific survival differences between watchful waiting and radical prostatectomy (N. Engl. J. Med. 2005;352:1977–84), the findings of this study shed light on how best to evaluate the survival potential of watchful waiting for a given patient, Dr. Cullen noted at the meeting, cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

The Scandinavian study “did not specifically investigate factors that might impact survival in men who choose watchful waiting,” she said. “Our goal was to look for characteristics that might be predictive of better or worse outcomes.”

Although limited by its retrospective design, “our database is so large that we have the ability to do robust subset analyses such as this one,” Dr. Cullen said. The findings, though promising, still need to be replicated in a nonmilitary population. In addition, she said, “we want to look at the relative impact of other survival predictors, including patient age, specific tumor characteristics, and Gleason scores, as well as the optimal frequency of PSA testing.”

SAN FRANCISCO — Among men with early-stage prostate cancer who choose watchful waiting as their primary treatment strategy, the rate of rise in their prostate-specific antigen level is more predictive of survival than any single PSA value, Dr. Jennifer Cullen said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

In a retrospective study of nearly 1,400 men with early prostate cancer being followed with watchful waiting rather than active intervention, those men with a PSA velocity (the rate of increase in PSA value) of less than 2 ng/mL per year during a mean follow-up time of nearly 5 years had a significantly better overall survival rate than did men whose PSA velocity was at least 2 ng/mL per year, said Dr. Cullen of the Department of Defense Center for Prostate Disease Research (CPDR) in Rockville, Md.

The study sample consisted of military-care beneficiaries from the CPDR database who were diagnosed with biopsy-proven, clinically localized prostate cancer between January 1989 and December 2003 and who did not receive any clinical intervention for their cancer for at least 6 months after diagnosis. Of the 1,369 men who met these criteria, the survival analysis was limited to 830 men who had a record of at least one follow-up appointment in the first 3 years following diagnosis, “to be sure that no other therapy was chosen at some time point after their care in the [CPDR] database program,” she said.

All of the subjects had at least three PSA values after diagnosis but not spaced within 3 months of each other, to minimize the potential for noise-related inaccuracies that could occur at shorter intervals. The mean age was 69 years, and the mean follow-up time was nearly 5 years.

The investigators generated survival analyses for men with PSA velocities below 2 ng/mL versus 2 ng/mL or more—a distinction that is literature driven, according to Dr. Cullen.

After controlling for comorbidities, secondary treatment, and time to secondary treatment, “we observed significantly poorer survival for those men in the higher PSA velocity group, independent of PSA value at diagnosis,” she said. “Only 56% of men in the higher-velocity category were alive at follow-up, compared with 87% of those with lower velocity values.”

On the heels of the recent report by the Scandinavian Prostate Cancer Group Study No. 4, a long-term trial showing small but significant overall and disease-specific survival differences between watchful waiting and radical prostatectomy (N. Engl. J. Med. 2005;352:1977–84), the findings of this study shed light on how best to evaluate the survival potential of watchful waiting for a given patient, Dr. Cullen noted at the meeting, cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

The Scandinavian study “did not specifically investigate factors that might impact survival in men who choose watchful waiting,” she said. “Our goal was to look for characteristics that might be predictive of better or worse outcomes.”

Although limited by its retrospective design, “our database is so large that we have the ability to do robust subset analyses such as this one,” Dr. Cullen said. The findings, though promising, still need to be replicated in a nonmilitary population. In addition, she said, “we want to look at the relative impact of other survival predictors, including patient age, specific tumor characteristics, and Gleason scores, as well as the optimal frequency of PSA testing.”

SAN FRANCISCO — Prostatitis can quickly lead to surges in prostate-specific antigen levels, potentially undermining the use of the biomarker's rate of change to help detect cancer, Dr. Scott Eggener said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

Previous studies have shown that prostate-specific antigen (PSA) velocity can be a valuable tool for assessing prostate cancer risk. Specifically, PSA velocity elevations of 2.0 ng/mL per year or higher have been identified as significant with respect to the risk of dying of prostate cancer, said Dr. Eggener of Memorial Sloan-Kettering Cancer Center in New York. It has also been suggested, however, that certain conditions, such as prostatitis and benign prostatic hyperplasia, could be confounding variables for rising PSA velocities.

Dr. Eggener and his colleagues analyzed records from 1,851 men enrolled in a community-based prostate cancer screening trial. At the time of their first biopsy, 468 men were diagnosed with prostate cancer, and 135 were diagnosed with prostatitis.

All of the men had a normal digital rectal exam and a calculable PSA velocity for the year prior to biopsy.

“What we found, relative to rising PSA velocity, was a general trend for decreasing cancer detection rate and a corresponding trend for increasing prostatitis,” Dr. Eggener said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

Specifically, 30% of the men with a PSA velocity of 0–1.99 ng/mL in the year before biopsy had prostate cancer, and 5% had prostatitis. In comparison, among men with a PSA velocity of 2.0–3.99 ng/mL, 22% had cancer on first biopsy, and 8% had prostatitis.

Men whose PSA velocities were greater than 4.0 ng/mL were equally likely to have prostatitis or prostate cancer, with 13% being diagnosed with each condition.

The risk of cancer diagnosis peaked relative to PSA velocity increases of 0.3–0.5 ng/mL per year, and the risk of prostatitis diagnosis rose substantially with PSA velocity increases of more than 2.0 ng/mL per year, Dr. Eggener said.

“Men with prostatitis often have dramatic rises in PSA prompting biopsy, but subsequently have a significant drop in PSA in the year or two following biopsy,” he said.

Men with a normal digital rectal exam, elevated PSA, and a high PSA velocity should therefore undergo repeat PSA testing. “If any symptoms or laboratory findings suggest prostatitis, they should undergo appropriate evaluation and treatment,” he said.

Dr. Eggener stressed that PSA velocity continues to be “very useful in assessing prostate cancer risk,” but that dramatic increases over short periods of time should raise suspicion of prostatitis, in addition to prostate cancer.

SAN FRANCISCO — Prostatitis can quickly lead to surges in prostate-specific antigen levels, potentially undermining the use of the biomarker's rate of change to help detect cancer, Dr. Scott Eggener said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

Previous studies have shown that prostate-specific antigen (PSA) velocity can be a valuable tool for assessing prostate cancer risk. Specifically, PSA velocity elevations of 2.0 ng/mL per year or higher have been identified as significant with respect to the risk of dying of prostate cancer, said Dr. Eggener of Memorial Sloan-Kettering Cancer Center in New York. It has also been suggested, however, that certain conditions, such as prostatitis and benign prostatic hyperplasia, could be confounding variables for rising PSA velocities.

Dr. Eggener and his colleagues analyzed records from 1,851 men enrolled in a community-based prostate cancer screening trial. At the time of their first biopsy, 468 men were diagnosed with prostate cancer, and 135 were diagnosed with prostatitis.

All of the men had a normal digital rectal exam and a calculable PSA velocity for the year prior to biopsy.

“What we found, relative to rising PSA velocity, was a general trend for decreasing cancer detection rate and a corresponding trend for increasing prostatitis,” Dr. Eggener said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

Specifically, 30% of the men with a PSA velocity of 0–1.99 ng/mL in the year before biopsy had prostate cancer, and 5% had prostatitis. In comparison, among men with a PSA velocity of 2.0–3.99 ng/mL, 22% had cancer on first biopsy, and 8% had prostatitis.

Men whose PSA velocities were greater than 4.0 ng/mL were equally likely to have prostatitis or prostate cancer, with 13% being diagnosed with each condition.

The risk of cancer diagnosis peaked relative to PSA velocity increases of 0.3–0.5 ng/mL per year, and the risk of prostatitis diagnosis rose substantially with PSA velocity increases of more than 2.0 ng/mL per year, Dr. Eggener said.

“Men with prostatitis often have dramatic rises in PSA prompting biopsy, but subsequently have a significant drop in PSA in the year or two following biopsy,” he said.

Men with a normal digital rectal exam, elevated PSA, and a high PSA velocity should therefore undergo repeat PSA testing. “If any symptoms or laboratory findings suggest prostatitis, they should undergo appropriate evaluation and treatment,” he said.

Dr. Eggener stressed that PSA velocity continues to be “very useful in assessing prostate cancer risk,” but that dramatic increases over short periods of time should raise suspicion of prostatitis, in addition to prostate cancer.

SAN FRANCISCO — Prostatitis can quickly lead to surges in prostate-specific antigen levels, potentially undermining the use of the biomarker's rate of change to help detect cancer, Dr. Scott Eggener said at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.

Previous studies have shown that prostate-specific antigen (PSA) velocity can be a valuable tool for assessing prostate cancer risk. Specifically, PSA velocity elevations of 2.0 ng/mL per year or higher have been identified as significant with respect to the risk of dying of prostate cancer, said Dr. Eggener of Memorial Sloan-Kettering Cancer Center in New York. It has also been suggested, however, that certain conditions, such as prostatitis and benign prostatic hyperplasia, could be confounding variables for rising PSA velocities.

Dr. Eggener and his colleagues analyzed records from 1,851 men enrolled in a community-based prostate cancer screening trial. At the time of their first biopsy, 468 men were diagnosed with prostate cancer, and 135 were diagnosed with prostatitis.

All of the men had a normal digital rectal exam and a calculable PSA velocity for the year prior to biopsy.

“What we found, relative to rising PSA velocity, was a general trend for decreasing cancer detection rate and a corresponding trend for increasing prostatitis,” Dr. Eggener said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.

Specifically, 30% of the men with a PSA velocity of 0–1.99 ng/mL in the year before biopsy had prostate cancer, and 5% had prostatitis. In comparison, among men with a PSA velocity of 2.0–3.99 ng/mL, 22% had cancer on first biopsy, and 8% had prostatitis.

Men whose PSA velocities were greater than 4.0 ng/mL were equally likely to have prostatitis or prostate cancer, with 13% being diagnosed with each condition.

The risk of cancer diagnosis peaked relative to PSA velocity increases of 0.3–0.5 ng/mL per year, and the risk of prostatitis diagnosis rose substantially with PSA velocity increases of more than 2.0 ng/mL per year, Dr. Eggener said.

“Men with prostatitis often have dramatic rises in PSA prompting biopsy, but subsequently have a significant drop in PSA in the year or two following biopsy,” he said.

Men with a normal digital rectal exam, elevated PSA, and a high PSA velocity should therefore undergo repeat PSA testing. “If any symptoms or laboratory findings suggest prostatitis, they should undergo appropriate evaluation and treatment,” he said.

Dr. Eggener stressed that PSA velocity continues to be “very useful in assessing prostate cancer risk,” but that dramatic increases over short periods of time should raise suspicion of prostatitis, in addition to prostate cancer.

PARIS — The noninvasive NMP22 BladderChek assay gives general practitioners a way to screen asymptomatic patients with hematuria for bladder cancer during office visits, Dr. H. Barton Grossman said at the annual congress of the European Association of Urology.

“At least in the United States, most of these patients are not being tested at all, not being referred to urologists, until they have several episodes of significant blood in their urine,” said Dr. Grossman, professor and chairman of urology at the M.D. Anderson Cancer Center in Houston.

“I think the best use of this test is actually going to be in the initial diagnosis of people with hematuria in general practice offices,” he told European urologists who questioned whether the NMP22 protein assay yields too many false-positive results for urologists to find it clinically useful.

Dr. Grossman presented updated results from a large study that found that the NMP22 protein assay can increase the accuracy of screening when used in combination with cystoscopy (JAMA 2005;293:810–6).

The investigators compared the NMP22 test results with cytology results, with cystoscopy as the reference standard. Patients provided a voided urine sample before undergoing cystoscopy. The urine sample was divided into two parts: One portion was tested for NMP22 in the office, and the other was sent for routine cytology.

If a tumor was found and removed during cystoscopy, diagnosis was based on pathology of the tumor.

A total of 23 academic, private practice, and veterans' facilities in 10 states recruited high-risk patients from September 2001 to February 2002. Of 1,331 patients enrolled, 79 patients (6%) were found to have bladder cancers.

In the data Dr. Grossman reported at the meeting, the NMP22 test was significantly more sensitive than cytology for detecting every stage of bladder cancer, including low-, mid-, and high-grade tumors. Overall, its sensitivity was 57%, compared with 18% for cytology.

Dr. Grossman said the NMP22 test picked up six bladder cancers that were missed by cystoscopy. Used together, the noninvasive protein assay and the endoscopic procedure detected 94% of cancers (74/79) in the study population. Only 86% (68/79) were found by cystoscopy alone.

Eleven patients had muscle invasive cancers. Dr. Grossman said 10 (91%) were identified by the combination of cystoscopy and NMP22, compared with six (55%) found with cystoscopy alone.

Though less sensitive, cytology was more specific than the NMP22 assay: 99% vs. 86% in patients who did not have cancer.

Taking questions from the audience at the conclusion of his talk, Dr. Grossman debated estimates of the protein test's false-positive rate with European urologists who have argued that it is as high as 80%.

Dr. Grossman rejected the critics' estimates as too high, and said that in any case the test was not considered an alternative to cystoscopy.

“The more tumors you pick up, the fewer tumors you are going to miss, and that results in a greater negative predictive value,” he said.

In an interview, he said the NMP22 test is ideal for general practitioners because they can pretty well rule out bladder cancer if it is negative. If it is positive, he said, they should refer the patient to a urologist for further screening.

“It is fast, and it is cheap,” he said. “We have a lot of patients we follow with a history of bladder cancer. If you do this test and it is negative … you can stop right there because it has very good negative prediction. But the positive prediction is not so high, and we would follow that up.”

The test uses four drops of urine and gives results in 30 minutes at a cost of $25-$50 per patient, according to Dr. Grossman. A positive finding is based on an NMP22 antigen level of 10 U/mL or greater.

Malignant cancer cells have been found with concentrations up to 80 times greater than those found in normal cells, he said.

The assay is approved for use in the United States and Europe. Its manufacturer, Matritech Inc., financed the study. Dr. Grossman said that he has no financial disclosures.

PARIS — The noninvasive NMP22 BladderChek assay gives general practitioners a way to screen asymptomatic patients with hematuria for bladder cancer during office visits, Dr. H. Barton Grossman said at the annual congress of the European Association of Urology.

“At least in the United States, most of these patients are not being tested at all, not being referred to urologists, until they have several episodes of significant blood in their urine,” said Dr. Grossman, professor and chairman of urology at the M.D. Anderson Cancer Center in Houston.

“I think the best use of this test is actually going to be in the initial diagnosis of people with hematuria in general practice offices,” he told European urologists who questioned whether the NMP22 protein assay yields too many false-positive results for urologists to find it clinically useful.

Dr. Grossman presented updated results from a large study that found that the NMP22 protein assay can increase the accuracy of screening when used in combination with cystoscopy (JAMA 2005;293:810–6).

The investigators compared the NMP22 test results with cytology results, with cystoscopy as the reference standard. Patients provided a voided urine sample before undergoing cystoscopy. The urine sample was divided into two parts: One portion was tested for NMP22 in the office, and the other was sent for routine cytology.

If a tumor was found and removed during cystoscopy, diagnosis was based on pathology of the tumor.

A total of 23 academic, private practice, and veterans' facilities in 10 states recruited high-risk patients from September 2001 to February 2002. Of 1,331 patients enrolled, 79 patients (6%) were found to have bladder cancers.

In the data Dr. Grossman reported at the meeting, the NMP22 test was significantly more sensitive than cytology for detecting every stage of bladder cancer, including low-, mid-, and high-grade tumors. Overall, its sensitivity was 57%, compared with 18% for cytology.

Dr. Grossman said the NMP22 test picked up six bladder cancers that were missed by cystoscopy. Used together, the noninvasive protein assay and the endoscopic procedure detected 94% of cancers (74/79) in the study population. Only 86% (68/79) were found by cystoscopy alone.

Eleven patients had muscle invasive cancers. Dr. Grossman said 10 (91%) were identified by the combination of cystoscopy and NMP22, compared with six (55%) found with cystoscopy alone.

Though less sensitive, cytology was more specific than the NMP22 assay: 99% vs. 86% in patients who did not have cancer.

Taking questions from the audience at the conclusion of his talk, Dr. Grossman debated estimates of the protein test's false-positive rate with European urologists who have argued that it is as high as 80%.

Dr. Grossman rejected the critics' estimates as too high, and said that in any case the test was not considered an alternative to cystoscopy.

“The more tumors you pick up, the fewer tumors you are going to miss, and that results in a greater negative predictive value,” he said.

In an interview, he said the NMP22 test is ideal for general practitioners because they can pretty well rule out bladder cancer if it is negative. If it is positive, he said, they should refer the patient to a urologist for further screening.

“It is fast, and it is cheap,” he said. “We have a lot of patients we follow with a history of bladder cancer. If you do this test and it is negative … you can stop right there because it has very good negative prediction. But the positive prediction is not so high, and we would follow that up.”

The test uses four drops of urine and gives results in 30 minutes at a cost of $25-$50 per patient, according to Dr. Grossman. A positive finding is based on an NMP22 antigen level of 10 U/mL or greater.

Malignant cancer cells have been found with concentrations up to 80 times greater than those found in normal cells, he said.

The assay is approved for use in the United States and Europe. Its manufacturer, Matritech Inc., financed the study. Dr. Grossman said that he has no financial disclosures.

PARIS — The noninvasive NMP22 BladderChek assay gives general practitioners a way to screen asymptomatic patients with hematuria for bladder cancer during office visits, Dr. H. Barton Grossman said at the annual congress of the European Association of Urology.

“At least in the United States, most of these patients are not being tested at all, not being referred to urologists, until they have several episodes of significant blood in their urine,” said Dr. Grossman, professor and chairman of urology at the M.D. Anderson Cancer Center in Houston.

“I think the best use of this test is actually going to be in the initial diagnosis of people with hematuria in general practice offices,” he told European urologists who questioned whether the NMP22 protein assay yields too many false-positive results for urologists to find it clinically useful.

Dr. Grossman presented updated results from a large study that found that the NMP22 protein assay can increase the accuracy of screening when used in combination with cystoscopy (JAMA 2005;293:810–6).

The investigators compared the NMP22 test results with cytology results, with cystoscopy as the reference standard. Patients provided a voided urine sample before undergoing cystoscopy. The urine sample was divided into two parts: One portion was tested for NMP22 in the office, and the other was sent for routine cytology.

If a tumor was found and removed during cystoscopy, diagnosis was based on pathology of the tumor.

A total of 23 academic, private practice, and veterans' facilities in 10 states recruited high-risk patients from September 2001 to February 2002. Of 1,331 patients enrolled, 79 patients (6%) were found to have bladder cancers.

In the data Dr. Grossman reported at the meeting, the NMP22 test was significantly more sensitive than cytology for detecting every stage of bladder cancer, including low-, mid-, and high-grade tumors. Overall, its sensitivity was 57%, compared with 18% for cytology.

Dr. Grossman said the NMP22 test picked up six bladder cancers that were missed by cystoscopy. Used together, the noninvasive protein assay and the endoscopic procedure detected 94% of cancers (74/79) in the study population. Only 86% (68/79) were found by cystoscopy alone.

Eleven patients had muscle invasive cancers. Dr. Grossman said 10 (91%) were identified by the combination of cystoscopy and NMP22, compared with six (55%) found with cystoscopy alone.

Though less sensitive, cytology was more specific than the NMP22 assay: 99% vs. 86% in patients who did not have cancer.

Taking questions from the audience at the conclusion of his talk, Dr. Grossman debated estimates of the protein test's false-positive rate with European urologists who have argued that it is as high as 80%.

Dr. Grossman rejected the critics' estimates as too high, and said that in any case the test was not considered an alternative to cystoscopy.

“The more tumors you pick up, the fewer tumors you are going to miss, and that results in a greater negative predictive value,” he said.

In an interview, he said the NMP22 test is ideal for general practitioners because they can pretty well rule out bladder cancer if it is negative. If it is positive, he said, they should refer the patient to a urologist for further screening.

“It is fast, and it is cheap,” he said. “We have a lot of patients we follow with a history of bladder cancer. If you do this test and it is negative … you can stop right there because it has very good negative prediction. But the positive prediction is not so high, and we would follow that up.”

The test uses four drops of urine and gives results in 30 minutes at a cost of $25-$50 per patient, according to Dr. Grossman. A positive finding is based on an NMP22 antigen level of 10 U/mL or greater.

Malignant cancer cells have been found with concentrations up to 80 times greater than those found in normal cells, he said.

The assay is approved for use in the United States and Europe. Its manufacturer, Matritech Inc., financed the study. Dr. Grossman said that he has no financial disclosures.

PARIS — New indications for phosphodiesterase-5 inhibitors will likely go beyond as-needed treatment of erectile dysfunction to regular care and treatments for a range of vascular disorders, Dr. Peter Hedlund said at the annual congress of the European Association of Urology.

Promising uses include treatment of pulmonary hypertension, digital ischemia, lower urinary tract symptoms in benign prostatic hyperplasia, and female sexual response, according to Dr. Hedlund of the department of clinical and experimental pharmacology at Lund University Hospital in Sweden.

For erectile dysfunction patients, he cited studies showing better outcomes when tadalafil and sildenafil citrate are taken daily as opposed to as needed. Prophylactic treatment with phosphodiesterase-5 (PDE-5) inhibitors may also improve erectile function after nerve-sparing procedures, Dr. Hedlund added. He emphasized that larger randomized controlled trials are necessary before definitive statements can be made about postprostatectomy patients.

“Endothelial dysfunction is probably the common denominator between erectile dysfunction and vascular disease,” Dr. Hedlund said. He noted that endothelial dysfunction is linked to vascular disease and risk factors for vascular disease, such as hypercholesterolemia, diabetes, and hypertension.

All three PDE-5 inhibitors—tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra)—caused pulmonary vasorelaxation in a small study, he noted, but sildenafil was the only one to improve arterial oxygenation. It is the only PDE-5 inhibitor approved for treatment of pulmonary hypertension in the United States and in Europe.

In another presentation at the congress, Dr. Piero Montorsi cited growing evidence that erectile dysfunction is a vascular disorder. Dr. Montorsi of the Institute of Cardiology at the University of Milan spoke at a symposium sponsored by Lilly ICOS LLC, maker of tadalafil. Outlining the “reconditioning endothelium concept,” he suggested that PDE-5 inhibitors may be effective in treating erectile dysfunction because they improve endothelial function.

“The goal of chronic therapy should be to achieve a sustained improvement of both erectile function and systemic vascular function through an improvement of endothelial function,” Dr. Montorsi said, adding, “Beneficial effect of concomitant treatment of risk factors is a crucial step and should always be a part of the ED treatment strategy.”

Among possible new indications for PDE-5 inhibitors, Dr. Montorsi included coronary artery disease and peripheral arterial disease along with many of the potential uses cited by Dr. Hedlund.

PARIS — New indications for phosphodiesterase-5 inhibitors will likely go beyond as-needed treatment of erectile dysfunction to regular care and treatments for a range of vascular disorders, Dr. Peter Hedlund said at the annual congress of the European Association of Urology.

Promising uses include treatment of pulmonary hypertension, digital ischemia, lower urinary tract symptoms in benign prostatic hyperplasia, and female sexual response, according to Dr. Hedlund of the department of clinical and experimental pharmacology at Lund University Hospital in Sweden.

For erectile dysfunction patients, he cited studies showing better outcomes when tadalafil and sildenafil citrate are taken daily as opposed to as needed. Prophylactic treatment with phosphodiesterase-5 (PDE-5) inhibitors may also improve erectile function after nerve-sparing procedures, Dr. Hedlund added. He emphasized that larger randomized controlled trials are necessary before definitive statements can be made about postprostatectomy patients.

“Endothelial dysfunction is probably the common denominator between erectile dysfunction and vascular disease,” Dr. Hedlund said. He noted that endothelial dysfunction is linked to vascular disease and risk factors for vascular disease, such as hypercholesterolemia, diabetes, and hypertension.

All three PDE-5 inhibitors—tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra)—caused pulmonary vasorelaxation in a small study, he noted, but sildenafil was the only one to improve arterial oxygenation. It is the only PDE-5 inhibitor approved for treatment of pulmonary hypertension in the United States and in Europe.

In another presentation at the congress, Dr. Piero Montorsi cited growing evidence that erectile dysfunction is a vascular disorder. Dr. Montorsi of the Institute of Cardiology at the University of Milan spoke at a symposium sponsored by Lilly ICOS LLC, maker of tadalafil. Outlining the “reconditioning endothelium concept,” he suggested that PDE-5 inhibitors may be effective in treating erectile dysfunction because they improve endothelial function.

“The goal of chronic therapy should be to achieve a sustained improvement of both erectile function and systemic vascular function through an improvement of endothelial function,” Dr. Montorsi said, adding, “Beneficial effect of concomitant treatment of risk factors is a crucial step and should always be a part of the ED treatment strategy.”

Among possible new indications for PDE-5 inhibitors, Dr. Montorsi included coronary artery disease and peripheral arterial disease along with many of the potential uses cited by Dr. Hedlund.

PARIS — New indications for phosphodiesterase-5 inhibitors will likely go beyond as-needed treatment of erectile dysfunction to regular care and treatments for a range of vascular disorders, Dr. Peter Hedlund said at the annual congress of the European Association of Urology.

Promising uses include treatment of pulmonary hypertension, digital ischemia, lower urinary tract symptoms in benign prostatic hyperplasia, and female sexual response, according to Dr. Hedlund of the department of clinical and experimental pharmacology at Lund University Hospital in Sweden.

For erectile dysfunction patients, he cited studies showing better outcomes when tadalafil and sildenafil citrate are taken daily as opposed to as needed. Prophylactic treatment with phosphodiesterase-5 (PDE-5) inhibitors may also improve erectile function after nerve-sparing procedures, Dr. Hedlund added. He emphasized that larger randomized controlled trials are necessary before definitive statements can be made about postprostatectomy patients.

“Endothelial dysfunction is probably the common denominator between erectile dysfunction and vascular disease,” Dr. Hedlund said. He noted that endothelial dysfunction is linked to vascular disease and risk factors for vascular disease, such as hypercholesterolemia, diabetes, and hypertension.

All three PDE-5 inhibitors—tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra)—caused pulmonary vasorelaxation in a small study, he noted, but sildenafil was the only one to improve arterial oxygenation. It is the only PDE-5 inhibitor approved for treatment of pulmonary hypertension in the United States and in Europe.

In another presentation at the congress, Dr. Piero Montorsi cited growing evidence that erectile dysfunction is a vascular disorder. Dr. Montorsi of the Institute of Cardiology at the University of Milan spoke at a symposium sponsored by Lilly ICOS LLC, maker of tadalafil. Outlining the “reconditioning endothelium concept,” he suggested that PDE-5 inhibitors may be effective in treating erectile dysfunction because they improve endothelial function.

“The goal of chronic therapy should be to achieve a sustained improvement of both erectile function and systemic vascular function through an improvement of endothelial function,” Dr. Montorsi said, adding, “Beneficial effect of concomitant treatment of risk factors is a crucial step and should always be a part of the ED treatment strategy.”

Among possible new indications for PDE-5 inhibitors, Dr. Montorsi included coronary artery disease and peripheral arterial disease along with many of the potential uses cited by Dr. Hedlund.

PARIS — How a physician responds when a male patient brings up erectile dysfunction can determine whether the patient will stay on medical treatment, investigators reported at the annual congress of the European Association of Urology.

In an eight-country study of nearly 3,000 men with erectile dysfunction, those who were dissatisfied or extremely dissatisfied with their physician-patient interactions were about half as likely to use a phosphodiesterase-5 (PDE-5) inhibitor more than once, compared with men who were extremely satisfied with their doctors' responses. Men who felt neutral about the discussion were most apt to stop treatment (odds ratio 0.20 for continued use).

Patients also were less likely to stay on a PDE-5 inhibitor in three other circumstances: if they felt the doctor was not positive (OR 0.24), if they discussed the problem only once (OR 0.33), or if the doctor recommended something else instead of prescribing treatment (OR 0.53).

“Clearly the perception that you [the physician] are taking me [the patient] seriously, that you are interested in this problem, will make an impact on my continuing with therapy,” coinvestigator Michael Sand, R.N., said in an interview after Dr. Raymond C. Rosen reported on the multinational Men's Attitudes to Life Events and Sexuality (MALES) phase II study.

“I am sure part of this is because men are uncomfortable to begin with,” Mr. Sand said. “The other key is men are recognizing that their physicians know more about this problem than they do, so they are looking for some signal from what they consider a knowledgeable source that this is a good idea.”

Mr. Sand, a sexologist, is based in Germany with the Bayer Corporation, maker of vardenafil (Levitra). Dr. Rosen is a psychologist at Robert Wood Johnson Medical School in Piscataway, N.J. Their coauthors were based in Canada and the United Kingdom. The MALES study recruited 2,912 men, aged 20–75 years, who self-reported erectile dysfunction. This analysis was based on follow-up questions that were posed to 1,907 men who reported discussing erectile dysfunction with their physicians.

Patients were most likely to continue therapy if the doctor prescribed a PDE-5 inhibitor (OR 4.67), but referral to another physician also favored staying on a drug (OR 1.75). All of the differences were statistically significant.

The same investigators also reported on interviews with 293 female partners of men in the MALES study. They reported that men were more likely to seek treatment if their female partners were concerned about the impact of erectile dysfunction on their sex lives, if they believed that it was caused by a medical condition, and if they believed that the condition could be treated medically.

“If she believes this is a medical problem, [that] it is related to an organic disease, that it is not going away, he is more likely to seek therapy,” Mr. Sand said. “She plays a big role in his seeking treatment.”

PARIS — How a physician responds when a male patient brings up erectile dysfunction can determine whether the patient will stay on medical treatment, investigators reported at the annual congress of the European Association of Urology.

In an eight-country study of nearly 3,000 men with erectile dysfunction, those who were dissatisfied or extremely dissatisfied with their physician-patient interactions were about half as likely to use a phosphodiesterase-5 (PDE-5) inhibitor more than once, compared with men who were extremely satisfied with their doctors' responses. Men who felt neutral about the discussion were most apt to stop treatment (odds ratio 0.20 for continued use).

Patients also were less likely to stay on a PDE-5 inhibitor in three other circumstances: if they felt the doctor was not positive (OR 0.24), if they discussed the problem only once (OR 0.33), or if the doctor recommended something else instead of prescribing treatment (OR 0.53).

“Clearly the perception that you [the physician] are taking me [the patient] seriously, that you are interested in this problem, will make an impact on my continuing with therapy,” coinvestigator Michael Sand, R.N., said in an interview after Dr. Raymond C. Rosen reported on the multinational Men's Attitudes to Life Events and Sexuality (MALES) phase II study.

“I am sure part of this is because men are uncomfortable to begin with,” Mr. Sand said. “The other key is men are recognizing that their physicians know more about this problem than they do, so they are looking for some signal from what they consider a knowledgeable source that this is a good idea.”

Mr. Sand, a sexologist, is based in Germany with the Bayer Corporation, maker of vardenafil (Levitra). Dr. Rosen is a psychologist at Robert Wood Johnson Medical School in Piscataway, N.J. Their coauthors were based in Canada and the United Kingdom. The MALES study recruited 2,912 men, aged 20–75 years, who self-reported erectile dysfunction. This analysis was based on follow-up questions that were posed to 1,907 men who reported discussing erectile dysfunction with their physicians.

Patients were most likely to continue therapy if the doctor prescribed a PDE-5 inhibitor (OR 4.67), but referral to another physician also favored staying on a drug (OR 1.75). All of the differences were statistically significant.

The same investigators also reported on interviews with 293 female partners of men in the MALES study. They reported that men were more likely to seek treatment if their female partners were concerned about the impact of erectile dysfunction on their sex lives, if they believed that it was caused by a medical condition, and if they believed that the condition could be treated medically.

“If she believes this is a medical problem, [that] it is related to an organic disease, that it is not going away, he is more likely to seek therapy,” Mr. Sand said. “She plays a big role in his seeking treatment.”

PARIS — How a physician responds when a male patient brings up erectile dysfunction can determine whether the patient will stay on medical treatment, investigators reported at the annual congress of the European Association of Urology.

In an eight-country study of nearly 3,000 men with erectile dysfunction, those who were dissatisfied or extremely dissatisfied with their physician-patient interactions were about half as likely to use a phosphodiesterase-5 (PDE-5) inhibitor more than once, compared with men who were extremely satisfied with their doctors' responses. Men who felt neutral about the discussion were most apt to stop treatment (odds ratio 0.20 for continued use).

Patients also were less likely to stay on a PDE-5 inhibitor in three other circumstances: if they felt the doctor was not positive (OR 0.24), if they discussed the problem only once (OR 0.33), or if the doctor recommended something else instead of prescribing treatment (OR 0.53).

“Clearly the perception that you [the physician] are taking me [the patient] seriously, that you are interested in this problem, will make an impact on my continuing with therapy,” coinvestigator Michael Sand, R.N., said in an interview after Dr. Raymond C. Rosen reported on the multinational Men's Attitudes to Life Events and Sexuality (MALES) phase II study.

“I am sure part of this is because men are uncomfortable to begin with,” Mr. Sand said. “The other key is men are recognizing that their physicians know more about this problem than they do, so they are looking for some signal from what they consider a knowledgeable source that this is a good idea.”

Mr. Sand, a sexologist, is based in Germany with the Bayer Corporation, maker of vardenafil (Levitra). Dr. Rosen is a psychologist at Robert Wood Johnson Medical School in Piscataway, N.J. Their coauthors were based in Canada and the United Kingdom. The MALES study recruited 2,912 men, aged 20–75 years, who self-reported erectile dysfunction. This analysis was based on follow-up questions that were posed to 1,907 men who reported discussing erectile dysfunction with their physicians.

Patients were most likely to continue therapy if the doctor prescribed a PDE-5 inhibitor (OR 4.67), but referral to another physician also favored staying on a drug (OR 1.75). All of the differences were statistically significant.

The same investigators also reported on interviews with 293 female partners of men in the MALES study. They reported that men were more likely to seek treatment if their female partners were concerned about the impact of erectile dysfunction on their sex lives, if they believed that it was caused by a medical condition, and if they believed that the condition could be treated medically.

“If she believes this is a medical problem, [that] it is related to an organic disease, that it is not going away, he is more likely to seek therapy,” Mr. Sand said. “She plays a big role in his seeking treatment.”

PARIS — Erectile dysfunction may be an independent risk factor for heart disease, according to investigators from two studies who gave poster presentations at the annual meeting of the European Association of Urology.

Dr. Francis Dubosq reported that myocardial scintography revealed coronary artery disease in 9 (29%) of 31 men who sought treatment for erectile dysfunction (ED) from urologists at Hôpital Foch in Suresnes, France. The investigators excluded patients with known coronary artery disease or two or more cardiovascular risk factors from the population referred to cardiology for screening.

Dr. Arthur Bohnen reported that ED was an independent risk factor for acute myocardial infarction and stroke in a longitudinal, population-based study that followed 1,248 men for an average of 6.5 years in Krimpen, Netherlands.

His group found that older men with severe ED were 2.5 times more likely to have a cardiovascular event than men with no ED; the odds were 1.5 times higher for those with moderate ED. Both investigators said the results from the ongoing studies were preliminary. Although they stopped short of drawing definitive conclusions, each saw immediate implications for physicians.

Dr. Dubosq, a urologist at Hôpital Foch, said physicians should view men with ED as being at high risk for coronary artery disease. “You have to be very careful because these patients are going to be candidates for artery involvements,” he said, emphasizing that the patients screened had no symptoms of coronary artery disease.

Dr. Bohnen, a general practitioner at Erasmus Medical Center, Rotterdam, Netherlands, said physicians should consider ED when estimating a patient's cardiovascular risk. “They should ask a question about ED and not only ask about smoking,” he said. “It shows here [ED] is an independent risk factor, independent of the other risk factors.”

The French study looked at a younger population, aged 45–70 years, chosen from 153 men seeking treatment for ED. The 20% sample selected for cardiology screening had a median age of 58 years.

Scores on the International Index of Erectile Dysfunction showed that 2 of the men had severe ED, 10 had moderate ED, and 19 had mild ED.

Blood tests showed no evidence of diabetes, dyslipidemia, or androgen deficiency, and Doppler ultrasound did not detect peripheral artery disease in any of the subjects screened for heart disease in the French study. Using Laurier scores, described as “an estimation adapted to [the] European population of the 10-year risk for 'hard' CAD,” the investigators found that the median score was significantly different from “the ideal index of people the same age without CAD risk factors”: 6.84 for the ED population vs. 5.32.

The Dutch study enrolled men aged 50–78 years at baseline without regard to whether they presented with ED.

Patients with a radical prostatectomy, prostate or bladder cancer, or neurogenic disease were excluded.

Of 1,248 men enrolled, 856 had no ED, 284 had moderate ED, and 108 had severe ED based on responses to the International Continence Society male sex questionnaire. During the follow-up period, 4.6% of the men had cardiovascular events. Within the population of men who had a cardiovascular event, 20% had severe ED and 31% had moderate ED.

The investigators defined cardiovascular disease as “acute myocardial infarction, stroke, or sudden death determined by an expert panel based on general practitioner data and hospital discharge letters.”

Risk associated with ED was independent of cardiovascular risk factors such as cholesterol, blood pressure, body mass index, Framingham risk scores, family history, and smoking status.

PARIS — Erectile dysfunction may be an independent risk factor for heart disease, according to investigators from two studies who gave poster presentations at the annual meeting of the European Association of Urology.

Dr. Francis Dubosq reported that myocardial scintography revealed coronary artery disease in 9 (29%) of 31 men who sought treatment for erectile dysfunction (ED) from urologists at Hôpital Foch in Suresnes, France. The investigators excluded patients with known coronary artery disease or two or more cardiovascular risk factors from the population referred to cardiology for screening.

Dr. Arthur Bohnen reported that ED was an independent risk factor for acute myocardial infarction and stroke in a longitudinal, population-based study that followed 1,248 men for an average of 6.5 years in Krimpen, Netherlands.

His group found that older men with severe ED were 2.5 times more likely to have a cardiovascular event than men with no ED; the odds were 1.5 times higher for those with moderate ED. Both investigators said the results from the ongoing studies were preliminary. Although they stopped short of drawing definitive conclusions, each saw immediate implications for physicians.

Dr. Dubosq, a urologist at Hôpital Foch, said physicians should view men with ED as being at high risk for coronary artery disease. “You have to be very careful because these patients are going to be candidates for artery involvements,” he said, emphasizing that the patients screened had no symptoms of coronary artery disease.

Dr. Bohnen, a general practitioner at Erasmus Medical Center, Rotterdam, Netherlands, said physicians should consider ED when estimating a patient's cardiovascular risk. “They should ask a question about ED and not only ask about smoking,” he said. “It shows here [ED] is an independent risk factor, independent of the other risk factors.”

The French study looked at a younger population, aged 45–70 years, chosen from 153 men seeking treatment for ED. The 20% sample selected for cardiology screening had a median age of 58 years.

Scores on the International Index of Erectile Dysfunction showed that 2 of the men had severe ED, 10 had moderate ED, and 19 had mild ED.

Blood tests showed no evidence of diabetes, dyslipidemia, or androgen deficiency, and Doppler ultrasound did not detect peripheral artery disease in any of the subjects screened for heart disease in the French study. Using Laurier scores, described as “an estimation adapted to [the] European population of the 10-year risk for 'hard' CAD,” the investigators found that the median score was significantly different from “the ideal index of people the same age without CAD risk factors”: 6.84 for the ED population vs. 5.32.

The Dutch study enrolled men aged 50–78 years at baseline without regard to whether they presented with ED.

Patients with a radical prostatectomy, prostate or bladder cancer, or neurogenic disease were excluded.

Of 1,248 men enrolled, 856 had no ED, 284 had moderate ED, and 108 had severe ED based on responses to the International Continence Society male sex questionnaire. During the follow-up period, 4.6% of the men had cardiovascular events. Within the population of men who had a cardiovascular event, 20% had severe ED and 31% had moderate ED.

The investigators defined cardiovascular disease as “acute myocardial infarction, stroke, or sudden death determined by an expert panel based on general practitioner data and hospital discharge letters.”

Risk associated with ED was independent of cardiovascular risk factors such as cholesterol, blood pressure, body mass index, Framingham risk scores, family history, and smoking status.

PARIS — Erectile dysfunction may be an independent risk factor for heart disease, according to investigators from two studies who gave poster presentations at the annual meeting of the European Association of Urology.

Dr. Francis Dubosq reported that myocardial scintography revealed coronary artery disease in 9 (29%) of 31 men who sought treatment for erectile dysfunction (ED) from urologists at Hôpital Foch in Suresnes, France. The investigators excluded patients with known coronary artery disease or two or more cardiovascular risk factors from the population referred to cardiology for screening.

Dr. Arthur Bohnen reported that ED was an independent risk factor for acute myocardial infarction and stroke in a longitudinal, population-based study that followed 1,248 men for an average of 6.5 years in Krimpen, Netherlands.

His group found that older men with severe ED were 2.5 times more likely to have a cardiovascular event than men with no ED; the odds were 1.5 times higher for those with moderate ED. Both investigators said the results from the ongoing studies were preliminary. Although they stopped short of drawing definitive conclusions, each saw immediate implications for physicians.

Dr. Dubosq, a urologist at Hôpital Foch, said physicians should view men with ED as being at high risk for coronary artery disease. “You have to be very careful because these patients are going to be candidates for artery involvements,” he said, emphasizing that the patients screened had no symptoms of coronary artery disease.

Dr. Bohnen, a general practitioner at Erasmus Medical Center, Rotterdam, Netherlands, said physicians should consider ED when estimating a patient's cardiovascular risk. “They should ask a question about ED and not only ask about smoking,” he said. “It shows here [ED] is an independent risk factor, independent of the other risk factors.”

The French study looked at a younger population, aged 45–70 years, chosen from 153 men seeking treatment for ED. The 20% sample selected for cardiology screening had a median age of 58 years.

Scores on the International Index of Erectile Dysfunction showed that 2 of the men had severe ED, 10 had moderate ED, and 19 had mild ED.

Blood tests showed no evidence of diabetes, dyslipidemia, or androgen deficiency, and Doppler ultrasound did not detect peripheral artery disease in any of the subjects screened for heart disease in the French study. Using Laurier scores, described as “an estimation adapted to [the] European population of the 10-year risk for 'hard' CAD,” the investigators found that the median score was significantly different from “the ideal index of people the same age without CAD risk factors”: 6.84 for the ED population vs. 5.32.

The Dutch study enrolled men aged 50–78 years at baseline without regard to whether they presented with ED.

Patients with a radical prostatectomy, prostate or bladder cancer, or neurogenic disease were excluded.

Of 1,248 men enrolled, 856 had no ED, 284 had moderate ED, and 108 had severe ED based on responses to the International Continence Society male sex questionnaire. During the follow-up period, 4.6% of the men had cardiovascular events. Within the population of men who had a cardiovascular event, 20% had severe ED and 31% had moderate ED.

The investigators defined cardiovascular disease as “acute myocardial infarction, stroke, or sudden death determined by an expert panel based on general practitioner data and hospital discharge letters.”

Risk associated with ED was independent of cardiovascular risk factors such as cholesterol, blood pressure, body mass index, Framingham risk scores, family history, and smoking status.