Nephrology

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

DENVER – Black children who receive kidney transplants appear more likely to lose their transplants sooner, compared with whites, results from a large analysis showed.

In addition, black pediatric patients living in high poverty neighborhoods face a more than twofold risk of transplant failure, compared with white patients.

"It has been reported that kidney transplants in blacks do not last as long as in whites, but we don’t really understand why this happens," Dr. Sandra Amaral said during a press briefing at the annual meeting of the American Society of Nephrology. "We think part of it is biologic; there are genetic differences between races, differences in diseases, and differences in our immune systems. But we also think that there may be socioeconomic differences. Based on our clinical practice, what we see is that if you’re poor it’s harder to get to your [medical] appointments. It may be harder to pay for your medicines. You may live in a household with a single care provider who’s really struggling to just feed you, much less make sure that your medicines are given on time every single day."

Dr. Amaral of the department of pediatrics at Emory University, Atlanta, and her associates studied 5,024 patients from the United States Renal Data System (USRDS) under age 21 years who received a kidney transplant between 2000 and 2006. The researchers followed the patients for transplant outcomes through September 2008 and linked their residential zip codes with poverty data from the 2000 United States Census.

Dr. Amaral reported that 18.3% of the patients experienced organ rejection during a mean follow-up of 3.6 years. Black patients were 2.3 times more likely than were white, non-Hispanic patients to experience organ rejection. In addition, Hispanic white patients were 24% less likely to experience organ rejection, compared with non-Hispanic white patients (hazard ratio = 0.76).

After the researchers adjusted for demographic, clinical, and socioeconomic factors, the researchers found that blacks were more likely to experience organ rejection, compared with non-Hispanic whites, and the degree of disparity varied by patient’s residential neighborhood.

Poverty also played a role in adverse outcomes in all patients. However, black patients fared worse. For example, black patients from neighborhoods in which more than 25% of residents lived below the federal poverty line were 2.46 times more likely to experience organ rejection, compared with their white counterparts. This relationship was also apparent in the wealthiest neighborhoods (those in which fewer than 5% lived below the federal poverty line), where black patients were 40% more likely to experience organ rejection at any given time during the follow-up, compared with non-Hispanic whites.

"It looks like poverty does make a difference," Dr. Amaral said. "It makes it harder for you to have a successful transplant."

She acknowledged certain limitations of the study, including the fact that the USRDS is unable to capture the specific barriers that get in the way of better transplant survival. "Is it because patients can’t pay for their medications, or is it because they can’t get to their appointments?" she asked. "Are there other things that get in the way of them being successful? This is an area for further study."

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

LAS VEGAS – Although women who had more severe stress urinary incontinence were more likely to require repeat injections, they were also more likely to respond to transurethral bulking agent injection therapy, results of a retrospective review of 124 cases showed.

"Clinical and urodynamic parameters may help predict treatment response and the likelihood of retreatment, such that patients with indicators of more severe incontinence have a significantly better treatment response, although they may require repeat injections to achieve this result," said Dr. Deborah R. Karp of the Cleveland Clinic Florida in Weston, who presented the results at the annual meeting of the AAGL.

The patients all underwent transurethral bulking with Uroplasty’s Macroplastique (MPQ) between July 2007 and September 2009. They had a mean age of 74 years and a mean body mass index of 28 kg/m2. Two-thirds had undergone previous anti-incontinence surgery, and 15% had previously received a different bulking agent.

A self-report incontinence severity scale was used, in which 0 was complete continence, 1 indicated one or two incontinent episodes per day, 2 indicated three or four episodes per day, and 3 indicated more than five episodes per day. Treatment response (defined as a decrease by at least 1 point on the incontinence severity score), was reported by 61% (76) of the women, whereas the other 39% (48) reported treatment failure (defined as either no change or an increase in the score).

Of the 76 responders, 66% (50) were treated with a single injection, whereas the rest (26) required multiple injections to achieve a response. The strongest variable associated with a positive treatment response was previous anterior colporrhaphy (odds ratio, 2.8). Other significant predictors included a maximum urethral closure pressure (MUCP) of less than or equal to 40 cm H2O (OR, 2.6), clinical reporting of mixed incontinence (OR, 2.4), use of three or more pads per day (OR, 2.1), five or more incontinent episodes per day (OR, 2.1), or a first leak of less than 50 mL on cystometrogram (OR, 2.0).

Factors found not to be associated with treatment response included urethral hypermobility, Valsalva leak point pressure (VLPP), previous sling, and the volume of MPQ injected, Dr. Karp reported.

A secondary analysis examined the combined group of 26 responders and 16 nonresponders who received repeat injections. Variables associated with the need for repeat treatment included indicators of more severe incontinence, including leak point pressure of 60 cm H2O or lower (OR, 7.3), history of urethrolysis (OR, 6.2), low MUCP (OR, 3.5), VLPP of 60 cm H2O or lower (OR, 3.5), five or more incontinent episodes per day (OR, 3.0), and a positive empty supine test (OR, 2.7).

Dr. Karp stated that she had no disclosures. The study’s principal investigator, Dr. G. Willy Davila, is a consultant for and has received honoraria from Astellas Pharma US, Watson Pharmaceuticals, American Medical Systems, Novasys Medical, and CL Medical. He has also received research funding from American Medical Systems and Astellas Pharma US. He does not have a financial relationship with Uroplasty.

LAS VEGAS – Although women who had more severe stress urinary incontinence were more likely to require repeat injections, they were also more likely to respond to transurethral bulking agent injection therapy, results of a retrospective review of 124 cases showed.

"Clinical and urodynamic parameters may help predict treatment response and the likelihood of retreatment, such that patients with indicators of more severe incontinence have a significantly better treatment response, although they may require repeat injections to achieve this result," said Dr. Deborah R. Karp of the Cleveland Clinic Florida in Weston, who presented the results at the annual meeting of the AAGL.

The patients all underwent transurethral bulking with Uroplasty’s Macroplastique (MPQ) between July 2007 and September 2009. They had a mean age of 74 years and a mean body mass index of 28 kg/m2. Two-thirds had undergone previous anti-incontinence surgery, and 15% had previously received a different bulking agent.

A self-report incontinence severity scale was used, in which 0 was complete continence, 1 indicated one or two incontinent episodes per day, 2 indicated three or four episodes per day, and 3 indicated more than five episodes per day. Treatment response (defined as a decrease by at least 1 point on the incontinence severity score), was reported by 61% (76) of the women, whereas the other 39% (48) reported treatment failure (defined as either no change or an increase in the score).

Of the 76 responders, 66% (50) were treated with a single injection, whereas the rest (26) required multiple injections to achieve a response. The strongest variable associated with a positive treatment response was previous anterior colporrhaphy (odds ratio, 2.8). Other significant predictors included a maximum urethral closure pressure (MUCP) of less than or equal to 40 cm H2O (OR, 2.6), clinical reporting of mixed incontinence (OR, 2.4), use of three or more pads per day (OR, 2.1), five or more incontinent episodes per day (OR, 2.1), or a first leak of less than 50 mL on cystometrogram (OR, 2.0).

Factors found not to be associated with treatment response included urethral hypermobility, Valsalva leak point pressure (VLPP), previous sling, and the volume of MPQ injected, Dr. Karp reported.

A secondary analysis examined the combined group of 26 responders and 16 nonresponders who received repeat injections. Variables associated with the need for repeat treatment included indicators of more severe incontinence, including leak point pressure of 60 cm H2O or lower (OR, 7.3), history of urethrolysis (OR, 6.2), low MUCP (OR, 3.5), VLPP of 60 cm H2O or lower (OR, 3.5), five or more incontinent episodes per day (OR, 3.0), and a positive empty supine test (OR, 2.7).

Dr. Karp stated that she had no disclosures. The study’s principal investigator, Dr. G. Willy Davila, is a consultant for and has received honoraria from Astellas Pharma US, Watson Pharmaceuticals, American Medical Systems, Novasys Medical, and CL Medical. He has also received research funding from American Medical Systems and Astellas Pharma US. He does not have a financial relationship with Uroplasty.

LAS VEGAS – Although women who had more severe stress urinary incontinence were more likely to require repeat injections, they were also more likely to respond to transurethral bulking agent injection therapy, results of a retrospective review of 124 cases showed.

"Clinical and urodynamic parameters may help predict treatment response and the likelihood of retreatment, such that patients with indicators of more severe incontinence have a significantly better treatment response, although they may require repeat injections to achieve this result," said Dr. Deborah R. Karp of the Cleveland Clinic Florida in Weston, who presented the results at the annual meeting of the AAGL.

The patients all underwent transurethral bulking with Uroplasty’s Macroplastique (MPQ) between July 2007 and September 2009. They had a mean age of 74 years and a mean body mass index of 28 kg/m2. Two-thirds had undergone previous anti-incontinence surgery, and 15% had previously received a different bulking agent.

A self-report incontinence severity scale was used, in which 0 was complete continence, 1 indicated one or two incontinent episodes per day, 2 indicated three or four episodes per day, and 3 indicated more than five episodes per day. Treatment response (defined as a decrease by at least 1 point on the incontinence severity score), was reported by 61% (76) of the women, whereas the other 39% (48) reported treatment failure (defined as either no change or an increase in the score).

Of the 76 responders, 66% (50) were treated with a single injection, whereas the rest (26) required multiple injections to achieve a response. The strongest variable associated with a positive treatment response was previous anterior colporrhaphy (odds ratio, 2.8). Other significant predictors included a maximum urethral closure pressure (MUCP) of less than or equal to 40 cm H2O (OR, 2.6), clinical reporting of mixed incontinence (OR, 2.4), use of three or more pads per day (OR, 2.1), five or more incontinent episodes per day (OR, 2.1), or a first leak of less than 50 mL on cystometrogram (OR, 2.0).

Factors found not to be associated with treatment response included urethral hypermobility, Valsalva leak point pressure (VLPP), previous sling, and the volume of MPQ injected, Dr. Karp reported.

A secondary analysis examined the combined group of 26 responders and 16 nonresponders who received repeat injections. Variables associated with the need for repeat treatment included indicators of more severe incontinence, including leak point pressure of 60 cm H2O or lower (OR, 7.3), history of urethrolysis (OR, 6.2), low MUCP (OR, 3.5), VLPP of 60 cm H2O or lower (OR, 3.5), five or more incontinent episodes per day (OR, 3.0), and a positive empty supine test (OR, 2.7).

Dr. Karp stated that she had no disclosures. The study’s principal investigator, Dr. G. Willy Davila, is a consultant for and has received honoraria from Astellas Pharma US, Watson Pharmaceuticals, American Medical Systems, Novasys Medical, and CL Medical. He has also received research funding from American Medical Systems and Astellas Pharma US. He does not have a financial relationship with Uroplasty.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

DENVER– Over the course of 3 months, 28% of patients admitted to a major cancer hospital had clinical signs of acute kidney injury, results from a single-center analysis showed.

While the incidence of acute kidney injury is higher in hospitalized high-risk patients and has been shown to be directly associated with morbidity, mortality, and higher cost, "there is very little literature available about what happens to cancer patients admitted to the hospital," lead study author Dr. Abdulla K. Salahudeen said in an interview during a poster session at the annual meeting of the American Society of Nephrology. "Our study suggests that we need to take measures to mitigate acute kidney injury in cancer patients."

In what is believed to be the first study of its kind, Dr. Salahudeen and his associates reviewed the electronic medical records of 5,491 cancer patients who were hospitalized at MD Anderson Cancer Center, Houston, between May 1 and July 31, 2006. They obtained demographic information as well as laboratory and pharmacy data, and defined the incidence of acute kidney injury as having a rise in absolute serum creatinine of 0.3 mg/dL or greater.

Complete information was available on 5,013 of the 5,491 patients, reported Dr. Salahudeen, chief of the section of nephrology and director of the dialysis unit at University of Texas M.D. Anderson Cancer Center, Houston. The mean age of these patients was 55 years, 53% were male, and 72% were white. The researchers determined that 14% had preexisting acute kidney injury while another 14% developed the condition during their hospital stay.

On univariate analysis, the clinical risk factors significantly associated with acute kidney injury were use of antibiotics (odds ratio 2.06), use of IV contrast (OR 1.99), use of multiple antidiabetic agents (1.69), and use of chemotherapeutic agents (OR 1.38).

On multivariate logistic regression, clinical risk factors significantly associated with acute kidney injury were transfer to the ICU (OR 1.40), use of chemotherapeutic agents (OR 1.29), use of antibiotics (OR 1.30), and having diabetes (OR 1.06).

Multivariate regression analysis also revealed that patients who had acute kidney injury had higher rates of transfer to the ICU, (OR 1.44), mortality (OR 5.20), and length of hospitalization (OR 2.1), compared with their counterparts who did not have acute kidney injury.

"It is possible that what we are seeing is an association between severity of cancer and level of kidney injury," said Dr. Salahudeen, who emphasized the preliminary nature of the study. "This is a complex group of patients, and the study underscores the importance of being aggressive with treatment of acute kidney injury as early as possible. The question is, if we were to screen these people as they come into the hospital, can we identify those who are at risk? That’s where acute kidney injury biomarkers are going to come in useful."

Dr. Salahudeen said that he had no relevant financial conflicts to disclose.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

CHICAGO – Acetylcysteine does not prevent contrast-induced nephropathy in patients undergoing angiography, according to a large randomized trial.

The Acetylcysteine for the Prevention of Contrast-Induced Nephropathy (ACT) trial was a double-blind study in which 2,308 patients with one or more risk factors for contrast-induced nephropathy (CIN) undergoing coronary or vascular angiography at 46 Brazilian medical centers were randomized to high-dose acetylcysteine or placebo.

The primary end point in ACT, incidence of CIN in the first 48 hours after the procedure, was identical, at 12.7%, in both study arms. A 0.5-mg/dL or greater increase in serum creatinine occurred in 3.9% of the acetylcysteine group and 3.8% of the placebo group. The composite end point of 30-day all-cause mortality or need for dialysis occurred in 2.2% of those who got acetylcysteine and 2.3% of controls, Dr. Otavio Berwanger reported at the annual scientific sessions of the American Heart Association.

This is by far the largest of the 47 trials of acetylcysteine for prevention of CIN conducted to date. ACT was undertaken because the efficacy of acetylcysteine remained unclear since most prior studies were small and/or inadequately designed. The ACT findings are, however, in close accord with those from the handful of prior high-quality trials featuring double-blind randomization and intent-to-treat analysis, said Dr. Berwanger, chair of the ACT steering committee and director of the research institute at the Heart Hospital in Sao Paulo.

Three-quarters of ACT participants had diabetes or a history of renal failure, the two main risk factors for CIN.

The dosing of acetylcysteine in ACT was 1,200 mg given orally twice on the day prior to the procedure and two doses given after the procedure.

Discussant Dr. Brahmajee K. Nallamathu of the University of Michigan, Ann Arbor, said ACT is a high-quality study that’s quickly going to change clinical practice. Acetylcysteine is widely utilized – it’s a class IIB recommendation for patients with chronic renal insufficiency in the latest European Society of Cardiology guidelines. Ten percent of all patients undergoing percutaneous coronary intervention in Michigan in 2009 received acetylcysteine, as did 30% of those with chronic renal insufficiency.

"The argument has consistently been made that, ‘We’re not sure about acetylcysteine, but it’s safe and cheap.’ But it’s important to understand that it could increase length of stay, particularly if it’s started the day before, and it obviously adds to the cost and inconvenience for patients," Dr. Nallamathu said.

He noted that 15 meta-analyses have been conducted since the first small favorable study of acetylcysteine for prevention of CIN generated great excitement among cardiologists upon publication in the New England Journal of Medicine 10 years ago.

"I think this is a great lesson for all of us," Dr. Nallamathu said. "Meta-analysis may exacerbate uncertainty and publication bias, leading to further confusion."

Dr. Mariell Jessup, chair of the AHA scientific sessions program committee, said she was particularly impressed by the excellent design of ACT and the fact that the Brazilian Ministry of Health saw fit to fund a large trial addressing an important clinical question.

Dr. Berwanger promised more good things to come: Already being planned for next year is the ACT II trial, which will compare sodium bicarbonate to normal saline for hydration, as well as several different types of contrast, he said.

Dr. Berwanger and Dr. Nallamathu reported having no relevant financial disclosures.

SAN DIEGO – Cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil induction regimens are equally effective, and can be combined with radiation and transurethral resection in a bladder-sparing protocol, preliminary results from an ongoing, randomized, phase II trial show.

Both regimens produce significant acute toxicity, yet more than 90% of patients completed induction and more than 80% completed consolidation without deviation, Dr. Anthony L. Zietman reported at the annual meeting of the American Society for Radiation Oncology.

After a median of 3 years, 73% of patients in the paclitaxel/cisplatin arm and 69% in the 5-FU/cisplatin arm were alive with intact bladders. The difference was not statistically significant.

"Adjuvant therapy remains a challenge after both regimens, with low rates of completion," said Dr. Zietman, professor of radiation oncology at Massachusetts General Hospital and Harvard Medical School, Boston. "This is a problem because many of these patients have occult micrometastatic disease, so we do want nontoxic adjuvant therapy."

In the RTOG (Radiation Therapy Oncology Group) 0233 study funded by the National Cancer Institute, Dr. Zietman and his associates at 33 institutions enrolled 97 patients with muscle-invading bladder cancer.

All patients underwent a transurethral resection and then were randomized into two chemotherapy arms: paclitaxel (50 mg/m2 weekly) plus cisplatin (15 mg/m2 on 3 days per week), or 5-FU (400 mg/m2 on 3 days per week on alternate weeks) plus the same cisplatin schedule. Patients in both arms also received radiotherapy twice daily to a total of 64.3 Gy, followed by adjuvant cisplatin/gemcitabine/paclitaxel chemotherapy.

Four patients were not eligible to complete the trial, leaving 46 in the paclitaxel/cisplatin arm and 47 in the 5-FU/cisplatin arm. Median follow-up was 3 years. The median age of patients was 66 years, 84% were men, and 95% had T2 disease.

Statistically similar proportions of patients in both arms had grade 2 or 3 toxicity during chemoradiation (70% in the paclitaxel/cisplatin arm and 62% in the 5-FU/cisplatin arm). The proportion with late toxicity reaching grade 3 or higher was also similar between the two groups (6% and 4%, respectively). The only case of grade 4 toxicity occurred in the paclitaxel/cisplatin arm.

"The big problem with the trial is with the adjuvant chemotherapy," Dr. Zietman said, noting that 86% of patients in the paclitaxel/cisplatin arm and 76% in the 5-FU/cisplatin arm had grade 3 or 4 toxicity during the later adjuvant treatment.

Dr. Zietman, the immediate past president of ASTRO, reported that 98% of patients in the paclitaxel/cisplatin arm completed induction; while 4 had grade 4 toxicity during induction, 11 had grade 4 toxicity during adjuvant therapy. Similarly, 96% of patients in the 5-FU/cisplatin arm completed induction; only 1 had grade 4 toxicity during induction, but 15 had grade 4 toxicity during adjuvant therapy.

The adjuvant cisplatin/gemcitabine/paclitaxel regimen "is standard chemotherapy given to [patients] after a cystectomy, but it really was a struggle to get them through it," he said. "It didn’t matter which chemotherapy regimen had been used up front. The outback chemotherapy was difficult. It was toxic."

After induction therapy, 87% of patients in the paclitaxel/cisplatin arm and 79% in the 5-FU/cisplatin arm were downstaged to T0, Ta, and Tcis bladder cancer; the difference was not statistically significant. Complete response was also statistically similar between the two arms (72% and 62%, respectively).

To date, Dr. Zietman concluded, "both regimens produce similarly high rates of tumor response and bladder preservation. I think it leaves you with a choice. Either regimen can be used."

Dr. Zietman said that he had no financial conflicts to disclose.

SAN DIEGO – Cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil induction regimens are equally effective, and can be combined with radiation and transurethral resection in a bladder-sparing protocol, preliminary results from an ongoing, randomized, phase II trial show.

Both regimens produce significant acute toxicity, yet more than 90% of patients completed induction and more than 80% completed consolidation without deviation, Dr. Anthony L. Zietman reported at the annual meeting of the American Society for Radiation Oncology.

After a median of 3 years, 73% of patients in the paclitaxel/cisplatin arm and 69% in the 5-FU/cisplatin arm were alive with intact bladders. The difference was not statistically significant.

"Adjuvant therapy remains a challenge after both regimens, with low rates of completion," said Dr. Zietman, professor of radiation oncology at Massachusetts General Hospital and Harvard Medical School, Boston. "This is a problem because many of these patients have occult micrometastatic disease, so we do want nontoxic adjuvant therapy."

In the RTOG (Radiation Therapy Oncology Group) 0233 study funded by the National Cancer Institute, Dr. Zietman and his associates at 33 institutions enrolled 97 patients with muscle-invading bladder cancer.

All patients underwent a transurethral resection and then were randomized into two chemotherapy arms: paclitaxel (50 mg/m2 weekly) plus cisplatin (15 mg/m2 on 3 days per week), or 5-FU (400 mg/m2 on 3 days per week on alternate weeks) plus the same cisplatin schedule. Patients in both arms also received radiotherapy twice daily to a total of 64.3 Gy, followed by adjuvant cisplatin/gemcitabine/paclitaxel chemotherapy.

Four patients were not eligible to complete the trial, leaving 46 in the paclitaxel/cisplatin arm and 47 in the 5-FU/cisplatin arm. Median follow-up was 3 years. The median age of patients was 66 years, 84% were men, and 95% had T2 disease.

Statistically similar proportions of patients in both arms had grade 2 or 3 toxicity during chemoradiation (70% in the paclitaxel/cisplatin arm and 62% in the 5-FU/cisplatin arm). The proportion with late toxicity reaching grade 3 or higher was also similar between the two groups (6% and 4%, respectively). The only case of grade 4 toxicity occurred in the paclitaxel/cisplatin arm.

"The big problem with the trial is with the adjuvant chemotherapy," Dr. Zietman said, noting that 86% of patients in the paclitaxel/cisplatin arm and 76% in the 5-FU/cisplatin arm had grade 3 or 4 toxicity during the later adjuvant treatment.

Dr. Zietman, the immediate past president of ASTRO, reported that 98% of patients in the paclitaxel/cisplatin arm completed induction; while 4 had grade 4 toxicity during induction, 11 had grade 4 toxicity during adjuvant therapy. Similarly, 96% of patients in the 5-FU/cisplatin arm completed induction; only 1 had grade 4 toxicity during induction, but 15 had grade 4 toxicity during adjuvant therapy.

The adjuvant cisplatin/gemcitabine/paclitaxel regimen "is standard chemotherapy given to [patients] after a cystectomy, but it really was a struggle to get them through it," he said. "It didn’t matter which chemotherapy regimen had been used up front. The outback chemotherapy was difficult. It was toxic."

After induction therapy, 87% of patients in the paclitaxel/cisplatin arm and 79% in the 5-FU/cisplatin arm were downstaged to T0, Ta, and Tcis bladder cancer; the difference was not statistically significant. Complete response was also statistically similar between the two arms (72% and 62%, respectively).

To date, Dr. Zietman concluded, "both regimens produce similarly high rates of tumor response and bladder preservation. I think it leaves you with a choice. Either regimen can be used."

Dr. Zietman said that he had no financial conflicts to disclose.

SAN DIEGO – Cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil induction regimens are equally effective, and can be combined with radiation and transurethral resection in a bladder-sparing protocol, preliminary results from an ongoing, randomized, phase II trial show.

Both regimens produce significant acute toxicity, yet more than 90% of patients completed induction and more than 80% completed consolidation without deviation, Dr. Anthony L. Zietman reported at the annual meeting of the American Society for Radiation Oncology.

After a median of 3 years, 73% of patients in the paclitaxel/cisplatin arm and 69% in the 5-FU/cisplatin arm were alive with intact bladders. The difference was not statistically significant.

"Adjuvant therapy remains a challenge after both regimens, with low rates of completion," said Dr. Zietman, professor of radiation oncology at Massachusetts General Hospital and Harvard Medical School, Boston. "This is a problem because many of these patients have occult micrometastatic disease, so we do want nontoxic adjuvant therapy."

In the RTOG (Radiation Therapy Oncology Group) 0233 study funded by the National Cancer Institute, Dr. Zietman and his associates at 33 institutions enrolled 97 patients with muscle-invading bladder cancer.

All patients underwent a transurethral resection and then were randomized into two chemotherapy arms: paclitaxel (50 mg/m2 weekly) plus cisplatin (15 mg/m2 on 3 days per week), or 5-FU (400 mg/m2 on 3 days per week on alternate weeks) plus the same cisplatin schedule. Patients in both arms also received radiotherapy twice daily to a total of 64.3 Gy, followed by adjuvant cisplatin/gemcitabine/paclitaxel chemotherapy.

Four patients were not eligible to complete the trial, leaving 46 in the paclitaxel/cisplatin arm and 47 in the 5-FU/cisplatin arm. Median follow-up was 3 years. The median age of patients was 66 years, 84% were men, and 95% had T2 disease.

Statistically similar proportions of patients in both arms had grade 2 or 3 toxicity during chemoradiation (70% in the paclitaxel/cisplatin arm and 62% in the 5-FU/cisplatin arm). The proportion with late toxicity reaching grade 3 or higher was also similar between the two groups (6% and 4%, respectively). The only case of grade 4 toxicity occurred in the paclitaxel/cisplatin arm.

"The big problem with the trial is with the adjuvant chemotherapy," Dr. Zietman said, noting that 86% of patients in the paclitaxel/cisplatin arm and 76% in the 5-FU/cisplatin arm had grade 3 or 4 toxicity during the later adjuvant treatment.

Dr. Zietman, the immediate past president of ASTRO, reported that 98% of patients in the paclitaxel/cisplatin arm completed induction; while 4 had grade 4 toxicity during induction, 11 had grade 4 toxicity during adjuvant therapy. Similarly, 96% of patients in the 5-FU/cisplatin arm completed induction; only 1 had grade 4 toxicity during induction, but 15 had grade 4 toxicity during adjuvant therapy.

The adjuvant cisplatin/gemcitabine/paclitaxel regimen "is standard chemotherapy given to [patients] after a cystectomy, but it really was a struggle to get them through it," he said. "It didn’t matter which chemotherapy regimen had been used up front. The outback chemotherapy was difficult. It was toxic."

After induction therapy, 87% of patients in the paclitaxel/cisplatin arm and 79% in the 5-FU/cisplatin arm were downstaged to T0, Ta, and Tcis bladder cancer; the difference was not statistically significant. Complete response was also statistically similar between the two arms (72% and 62%, respectively).

To date, Dr. Zietman concluded, "both regimens produce similarly high rates of tumor response and bladder preservation. I think it leaves you with a choice. Either regimen can be used."

Dr. Zietman said that he had no financial conflicts to disclose.

SILVER SPRING, Md. – The majority of the Food and Drug Administration’s Oncologic Drugs Advisory Committee on Dec. 1 voted that the risk-benefit profile of finasteride and dutasteride, when used as chemopreventive agents for reducing the risk of prostate cancer, was not favorable.

In two separate studies comparing the two 5-alpha reductase inhibitors with placebo in thousands of men aged 50 years and older, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to the drug, compared with those on placebo. However, one of the main concern panelists cited was the increase in high grade prostate cancers diagnosed among the men in the treatment groups in both studies compared to those on placebo. The panel was not asked to vote on whether these drugs should be approved for preventing prostate cancer.

Dutasteride, marketed as Avodart by GlaxoSmithKline, was approved for treating benign prostatic hypertrophy (BPH) in 2001. Finasteride, marketed as Proscar by Merck, was approved for BPH in 1992 and is available in generic formulations. GSK filed for approval of the prevention indication in the United States and in Europe. Merck has proposed that the results of a prevention study be added to the finasteride label only. Currently, no drug is approved for prostate cancer prevention.

In a 7-year study of more than 18,000 men aged 55 years and older, considered at low to moderate risk of developing prostate cancer with a normal digital exam and a PSA of 3.0 ng/mL or less, the risk of being diagnosed with prostate cancer was reduced by 26% among those who received finasteride 5 mg a day, compared with those on placebo. In a 4-year study of 8,231 men aged 50 to 75 years considered at an increased risk of prostate cancer because of an elevated PSA (2.5–10 ng/mL) and one negative biopsy, the risk of being diagnosed with prostate cancer was reduced by 23% over 4 years among those on 0.5 mg of dutasteride, compared with those on placebo.

But in both studies, the reduction in the risk of prostate cancers was largely limited to low-grade cancers, and the rates of high-grade prostate cancers were higher among those on the 5-alpha reductase inhibitor, when compared with those on placebo.

In considering the risk-benefit profile of these drugs for chemoprevention, panelists also said they were concerned about how the drugs might be used by general practitioners and about the potential negative public health impact if used in the general population. Several also pointed out that the bar for approving a drug to prevent prostate cancer in otherwise healthy men should be set far higher than a drug used to treat a disease, and that there was a need for longer follow-up data.

The FDA usually follows the recommendations of its advisory panels, members of which have been cleared of conflicts related to the topic of the meeting. In some cases, panel members with a conflict are granted a waiver, but not at this meeting.

SILVER SPRING, Md. – The majority of the Food and Drug Administration’s Oncologic Drugs Advisory Committee on Dec. 1 voted that the risk-benefit profile of finasteride and dutasteride, when used as chemopreventive agents for reducing the risk of prostate cancer, was not favorable.

In two separate studies comparing the two 5-alpha reductase inhibitors with placebo in thousands of men aged 50 years and older, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to the drug, compared with those on placebo. However, one of the main concern panelists cited was the increase in high grade prostate cancers diagnosed among the men in the treatment groups in both studies compared to those on placebo. The panel was not asked to vote on whether these drugs should be approved for preventing prostate cancer.

Dutasteride, marketed as Avodart by GlaxoSmithKline, was approved for treating benign prostatic hypertrophy (BPH) in 2001. Finasteride, marketed as Proscar by Merck, was approved for BPH in 1992 and is available in generic formulations. GSK filed for approval of the prevention indication in the United States and in Europe. Merck has proposed that the results of a prevention study be added to the finasteride label only. Currently, no drug is approved for prostate cancer prevention.

In a 7-year study of more than 18,000 men aged 55 years and older, considered at low to moderate risk of developing prostate cancer with a normal digital exam and a PSA of 3.0 ng/mL or less, the risk of being diagnosed with prostate cancer was reduced by 26% among those who received finasteride 5 mg a day, compared with those on placebo. In a 4-year study of 8,231 men aged 50 to 75 years considered at an increased risk of prostate cancer because of an elevated PSA (2.5–10 ng/mL) and one negative biopsy, the risk of being diagnosed with prostate cancer was reduced by 23% over 4 years among those on 0.5 mg of dutasteride, compared with those on placebo.

But in both studies, the reduction in the risk of prostate cancers was largely limited to low-grade cancers, and the rates of high-grade prostate cancers were higher among those on the 5-alpha reductase inhibitor, when compared with those on placebo.

In considering the risk-benefit profile of these drugs for chemoprevention, panelists also said they were concerned about how the drugs might be used by general practitioners and about the potential negative public health impact if used in the general population. Several also pointed out that the bar for approving a drug to prevent prostate cancer in otherwise healthy men should be set far higher than a drug used to treat a disease, and that there was a need for longer follow-up data.

The FDA usually follows the recommendations of its advisory panels, members of which have been cleared of conflicts related to the topic of the meeting. In some cases, panel members with a conflict are granted a waiver, but not at this meeting.

SILVER SPRING, Md. – The majority of the Food and Drug Administration’s Oncologic Drugs Advisory Committee on Dec. 1 voted that the risk-benefit profile of finasteride and dutasteride, when used as chemopreventive agents for reducing the risk of prostate cancer, was not favorable.

In two separate studies comparing the two 5-alpha reductase inhibitors with placebo in thousands of men aged 50 years and older, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to the drug, compared with those on placebo. However, one of the main concern panelists cited was the increase in high grade prostate cancers diagnosed among the men in the treatment groups in both studies compared to those on placebo. The panel was not asked to vote on whether these drugs should be approved for preventing prostate cancer.

Dutasteride, marketed as Avodart by GlaxoSmithKline, was approved for treating benign prostatic hypertrophy (BPH) in 2001. Finasteride, marketed as Proscar by Merck, was approved for BPH in 1992 and is available in generic formulations. GSK filed for approval of the prevention indication in the United States and in Europe. Merck has proposed that the results of a prevention study be added to the finasteride label only. Currently, no drug is approved for prostate cancer prevention.

In a 7-year study of more than 18,000 men aged 55 years and older, considered at low to moderate risk of developing prostate cancer with a normal digital exam and a PSA of 3.0 ng/mL or less, the risk of being diagnosed with prostate cancer was reduced by 26% among those who received finasteride 5 mg a day, compared with those on placebo. In a 4-year study of 8,231 men aged 50 to 75 years considered at an increased risk of prostate cancer because of an elevated PSA (2.5–10 ng/mL) and one negative biopsy, the risk of being diagnosed with prostate cancer was reduced by 23% over 4 years among those on 0.5 mg of dutasteride, compared with those on placebo.

But in both studies, the reduction in the risk of prostate cancers was largely limited to low-grade cancers, and the rates of high-grade prostate cancers were higher among those on the 5-alpha reductase inhibitor, when compared with those on placebo.

In considering the risk-benefit profile of these drugs for chemoprevention, panelists also said they were concerned about how the drugs might be used by general practitioners and about the potential negative public health impact if used in the general population. Several also pointed out that the bar for approving a drug to prevent prostate cancer in otherwise healthy men should be set far higher than a drug used to treat a disease, and that there was a need for longer follow-up data.

The FDA usually follows the recommendations of its advisory panels, members of which have been cleared of conflicts related to the topic of the meeting. In some cases, panel members with a conflict are granted a waiver, but not at this meeting.

To the Editor: I read with interest the excellent review by Dr. Kashyap and coauthors of bariatric surgery for patients with type 2 diabetes.¹ I am writing to contribute an additional caveat to their otherwise detailed list of postoperative complications—the increased risk of nephrolithiasis.^2,3 The majority of kidney stones that develop after bariatric surgery tend to be composed of calcium oxalate. Increased intestinal absorption of oxalate appears to promote hyperoxaluria.^2,3

Vitamin C deficiency is not usual after bariatric surgery, and the dietary reference intake of vitamin C for adults is no more than 90 mg. Therefore, I was surprised to see Dr. Kashyap recommend supplementation with vitamin C 500 mg daily (in Table 4 of her article). In my practice I have avoided supplemental vitamin C, other than that in a multivitamin, because of the risk of increasing urinary oxalate and stone formation.⁴

Iron deficiency can be a challenge after bariatric surgery. Although they do not state it in the review, the authors may believe that additional vitamin C can improve iron absorption. However, there are no compelling data of which I am aware for this belief in patients who have undergone gastric bypass,⁵ and the benefit of taking vitamin C along with iron in otherwise normal people with iron deficiency remains controversial.⁶

To the Editor: I read with interest the excellent review by Dr. Kashyap and coauthors of bariatric surgery for patients with type 2 diabetes.¹ I am writing to contribute an additional caveat to their otherwise detailed list of postoperative complications—the increased risk of nephrolithiasis.^2,3 The majority of kidney stones that develop after bariatric surgery tend to be composed of calcium oxalate. Increased intestinal absorption of oxalate appears to promote hyperoxaluria.^2,3

Vitamin C deficiency is not usual after bariatric surgery, and the dietary reference intake of vitamin C for adults is no more than 90 mg. Therefore, I was surprised to see Dr. Kashyap recommend supplementation with vitamin C 500 mg daily (in Table 4 of her article). In my practice I have avoided supplemental vitamin C, other than that in a multivitamin, because of the risk of increasing urinary oxalate and stone formation.⁴

Iron deficiency can be a challenge after bariatric surgery. Although they do not state it in the review, the authors may believe that additional vitamin C can improve iron absorption. However, there are no compelling data of which I am aware for this belief in patients who have undergone gastric bypass,⁵ and the benefit of taking vitamin C along with iron in otherwise normal people with iron deficiency remains controversial.⁶

To the Editor: I read with interest the excellent review by Dr. Kashyap and coauthors of bariatric surgery for patients with type 2 diabetes.¹ I am writing to contribute an additional caveat to their otherwise detailed list of postoperative complications—the increased risk of nephrolithiasis.^2,3 The majority of kidney stones that develop after bariatric surgery tend to be composed of calcium oxalate. Increased intestinal absorption of oxalate appears to promote hyperoxaluria.^2,3

Vitamin C deficiency is not usual after bariatric surgery, and the dietary reference intake of vitamin C for adults is no more than 90 mg. Therefore, I was surprised to see Dr. Kashyap recommend supplementation with vitamin C 500 mg daily (in Table 4 of her article). In my practice I have avoided supplemental vitamin C, other than that in a multivitamin, because of the risk of increasing urinary oxalate and stone formation.⁴

Iron deficiency can be a challenge after bariatric surgery. Although they do not state it in the review, the authors may believe that additional vitamin C can improve iron absorption. However, there are no compelling data of which I am aware for this belief in patients who have undergone gastric bypass,⁵ and the benefit of taking vitamin C along with iron in otherwise normal people with iron deficiency remains controversial.⁶