Nephrology

Female Pelvic Medicine and Reconstructive Surgery is now an official subspecialty of both obstetrics and gynecology and urology.

The American Board of Medical Specialties in March announced that it has granted subspecialty status to this growing area of urogynecology. The new subspecialty will be jointly boarded through the American Board of Obstetrics and Gynecology (ABOG) and the American Board of Urology (ABU).

Leaders in urogynecology have been laying the groundwork for this recognition for the last 15 years, said Dr. Dee E. Fenner, director of the ABU and ABOG Subspecialty Board for Female Pelvic Medicine and Reconstructive Surgery and director of benign gynecology at the University of Michigan in Ann Arbor. Officials at the ABU and the ABOG began by developing program requirements and criteria to begin accrediting fellowship programs in female pelvic medicine and reconstructive surgery. Today, there are 43 fellowship programs that have been accredited by these bodies, Dr. Fenner said in an interview. That robust level of training, plus the needs of the aging population are both reasons to proceed with subspecialty recognition.

In addition to the recognition of the subspecialty by ABMS, the American Council for Graduate Medical Education (ACGME) will now take over accreditation for fellowship programs in the specialty.

The ABOG and ABU are currently preparing for both a written and oral exam for the new subspecialty, and the first exams are likely to take place in 2013, Dr. Fenner said. Physicians who are currently working in the field will be able to apply for "grandfather" status for the next few years. However, residents graduating this year must complete a fellowship in female pelvic medicine and reconstructive surgery in order to be eligible to sit for the exam. Dr. Fenner said she anticipates that about 750 physicians, both gynecologists and urologists, who are currently practicing will seek certification in the new subspecialty.

"We need a lot of people because the demands are great for this subspecialty," said Dr. Cheryl Iglesia, a urogynecologist at Georgetown University in Washington, D.C., who serves as the chair of the committee for gynecologic practice at the American Congress of Obstetricians and Gynecologists (ACOG) and sits on the board of directors for the American Urogynecologic Society (AUGS).

Dr. Iglesia said there is a growing need to train more physicians who can provide these types of services to the aging baby boomers. Over the next few decades, the demand will jump dramatically, she said in an interview. In addition, there is an increasing level of clinical and basic research going on in the field that requires more physicians with advanced training.

As a result of recognition by both the accrediting and certifying bodies, patients will have the assurance that physicians who are board certified in female pelvic medicine have completed advanced training, Dr. Fenner said. General ob.gyns. also will know what they are getting when they refer complex cases to subspecialists.

Female Pelvic Medicine and Reconstructive Surgery is now an official subspecialty of both obstetrics and gynecology and urology.

The American Board of Medical Specialties in March announced that it has granted subspecialty status to this growing area of urogynecology. The new subspecialty will be jointly boarded through the American Board of Obstetrics and Gynecology (ABOG) and the American Board of Urology (ABU).

Leaders in urogynecology have been laying the groundwork for this recognition for the last 15 years, said Dr. Dee E. Fenner, director of the ABU and ABOG Subspecialty Board for Female Pelvic Medicine and Reconstructive Surgery and director of benign gynecology at the University of Michigan in Ann Arbor. Officials at the ABU and the ABOG began by developing program requirements and criteria to begin accrediting fellowship programs in female pelvic medicine and reconstructive surgery. Today, there are 43 fellowship programs that have been accredited by these bodies, Dr. Fenner said in an interview. That robust level of training, plus the needs of the aging population are both reasons to proceed with subspecialty recognition.

In addition to the recognition of the subspecialty by ABMS, the American Council for Graduate Medical Education (ACGME) will now take over accreditation for fellowship programs in the specialty.

The ABOG and ABU are currently preparing for both a written and oral exam for the new subspecialty, and the first exams are likely to take place in 2013, Dr. Fenner said. Physicians who are currently working in the field will be able to apply for "grandfather" status for the next few years. However, residents graduating this year must complete a fellowship in female pelvic medicine and reconstructive surgery in order to be eligible to sit for the exam. Dr. Fenner said she anticipates that about 750 physicians, both gynecologists and urologists, who are currently practicing will seek certification in the new subspecialty.

"We need a lot of people because the demands are great for this subspecialty," said Dr. Cheryl Iglesia, a urogynecologist at Georgetown University in Washington, D.C., who serves as the chair of the committee for gynecologic practice at the American Congress of Obstetricians and Gynecologists (ACOG) and sits on the board of directors for the American Urogynecologic Society (AUGS).

Dr. Iglesia said there is a growing need to train more physicians who can provide these types of services to the aging baby boomers. Over the next few decades, the demand will jump dramatically, she said in an interview. In addition, there is an increasing level of clinical and basic research going on in the field that requires more physicians with advanced training.

As a result of recognition by both the accrediting and certifying bodies, patients will have the assurance that physicians who are board certified in female pelvic medicine have completed advanced training, Dr. Fenner said. General ob.gyns. also will know what they are getting when they refer complex cases to subspecialists.

Female Pelvic Medicine and Reconstructive Surgery is now an official subspecialty of both obstetrics and gynecology and urology.

The American Board of Medical Specialties in March announced that it has granted subspecialty status to this growing area of urogynecology. The new subspecialty will be jointly boarded through the American Board of Obstetrics and Gynecology (ABOG) and the American Board of Urology (ABU).

Leaders in urogynecology have been laying the groundwork for this recognition for the last 15 years, said Dr. Dee E. Fenner, director of the ABU and ABOG Subspecialty Board for Female Pelvic Medicine and Reconstructive Surgery and director of benign gynecology at the University of Michigan in Ann Arbor. Officials at the ABU and the ABOG began by developing program requirements and criteria to begin accrediting fellowship programs in female pelvic medicine and reconstructive surgery. Today, there are 43 fellowship programs that have been accredited by these bodies, Dr. Fenner said in an interview. That robust level of training, plus the needs of the aging population are both reasons to proceed with subspecialty recognition.

In addition to the recognition of the subspecialty by ABMS, the American Council for Graduate Medical Education (ACGME) will now take over accreditation for fellowship programs in the specialty.

The ABOG and ABU are currently preparing for both a written and oral exam for the new subspecialty, and the first exams are likely to take place in 2013, Dr. Fenner said. Physicians who are currently working in the field will be able to apply for "grandfather" status for the next few years. However, residents graduating this year must complete a fellowship in female pelvic medicine and reconstructive surgery in order to be eligible to sit for the exam. Dr. Fenner said she anticipates that about 750 physicians, both gynecologists and urologists, who are currently practicing will seek certification in the new subspecialty.

"We need a lot of people because the demands are great for this subspecialty," said Dr. Cheryl Iglesia, a urogynecologist at Georgetown University in Washington, D.C., who serves as the chair of the committee for gynecologic practice at the American Congress of Obstetricians and Gynecologists (ACOG) and sits on the board of directors for the American Urogynecologic Society (AUGS).

Dr. Iglesia said there is a growing need to train more physicians who can provide these types of services to the aging baby boomers. Over the next few decades, the demand will jump dramatically, she said in an interview. In addition, there is an increasing level of clinical and basic research going on in the field that requires more physicians with advanced training.

As a result of recognition by both the accrediting and certifying bodies, patients will have the assurance that physicians who are board certified in female pelvic medicine have completed advanced training, Dr. Fenner said. General ob.gyns. also will know what they are getting when they refer complex cases to subspecialists.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

DENVER – A high intake of insoluble dietary fiber is associated with reduced inflammation and all-cause mortality in patients with chronic kidney disease, results from a large observational analysis showed.

The finding underscores the importance of a fiber-rich diet in this patient population, which often presents with a low intake of dietary fiber, Dr. Neelakanta A. Dadi said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“I think this study tells us that patients with chronic kidney disease need to consume more dietary fiber such as vegetables, fruits, and oatmeal,” said Dr. Dadi of the University of Utah, Salt Lake City.

He and his associates used the National Health and Nutrition Examination Survey III to evaluate the association between elevated C-reactive protein (defined as greater than 3 mg/L) and all-cause mortality in 1,105 patients with chronic kidney disease. The researchers estimated intake of insoluble dietary fiber from 24-hour recalls and obtained mortality data through the National Center for Health Statistics by linkage with National Death Index records through 2006.

Low total dietary fiber intake was defined as less than 13.5 g/day while high dietary fiber intake was defined as 13.5 g/day or greater.

The mean age of patients was 69 years and 36% were male.

In a multivariate logistic regression analysis adjusted for age, sex, race, smoking, alcohol, systolic blood pressure, diastolic blood pressure, cancer, physical activity, calorie intake, protein intake, myocardial infarction, heart failure, and stroke, each 10-g/day increase in dietary fiber was associated with a significantly decreased odds of elevated serum C-reactive protein and all-cause mortality (OR, 0.56 and 0.80). A similar association was seen after further adjustment for waist circumference, diabetes, triglycerides, and HDL cholesterol level (OR, 0.56 and 0.76).

Dr. Dadi said that the observational design of NHANES III is a limitation. “It remains unclear what the major cause of mortality is in this population,” he said. “It could be cancer or cardiovascular events.”

The study was funded by a National Kidney Foundation Fellowship Grant and by grants from the Public Health Service and the National Center for Research Resources.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

In patients with chronic kidney disease, high serum levels of phosphorus appear to be associated with increases in all-cause mortality, results of a large meta-analysis suggest.

There were no strong or consistent associations between increased levels of calcium and parathyroid hormone and all-cause mortality in this population of patients.

Such findings, coupled with the absence of randomized controlled trials, suggest that the evidentiary basis for "recommended targets of serum phosphorus, parathyroid hormone, and calcium in chronic kidney disease is poor," Dr. Suetonia C. Palmer of the department of medicine at the University of Otago, Christchurch, New Zealand, and colleagues reported in the March 16 issue of JAMA.

The researchers assessed the strength of the evidence linking each of the biomarkers with the risk of death, cardiovascular mortality, and nonfatal cardiovascular events in individuals with chronic kidney disease by searching MEDLINE and EMBASE databases for relevant cohort studies published from the late 1940s to December 2010. They also combed through reference lists from primary studies, review articles, and clinical guidelines (JAMA 2011;305:1119-27).

Of the 8,380 citations identified, 47 studies with a total of 327,644 patients were included in the final analysis. The population sizes of the studies ranged from 99 to 78,420 participants. Random effects meta-regression was used to summarize data across studies.

The investigators found that the risk of death increased 18% for every 1-mg/dL increase in serum phosphorus, for a relative risk (RR) of 1.18. No significant associations were seen between all-cause mortality and every 100-pg/mL increase in serum level of parathyroid hormone (RR 1.01), or for every 1-mg/dL increase in serum calcium level (RR 1.08).

The researchers were not able to estimate the association between each of the biomarkers and the risk of cardiovascular death in particular, because relevant data were available from only one adequately adjusted cohort study.

"The current data do not support the hypothesis that individuals with chronic kidney disease should have treatment to achieve targeted levels of serum parathyroid hormone or calcium to reduce mortality or cardiovascular morbidity, except at extreme levels in which hypocalcemia and hypercalcemia result in immediate, clinically apparent adverse events such as tetany and seizures," the researchers wrote.

"Furthermore, treating high phosphorus levels is linked to a substantial pill burden that is associated with lower quality of life in individuals with chronic kidney disease. While we do not conclude that normalizing serum levels of calcium or phosphorus or avoiding upper or lower extremes of serum level of parathyroid hormone is futile, high-quality evidence is required before specific treatment should be advocated strongly."

The authors acknowledged certain limitations of their work, including the fact that the studies used in the meta-analysis "are vulnerable to the unpredictable confounding effects of measured and unmeasured variables," and that the study did not evaluate the association between mortality and serum levels of alkaline phosphatase or vitamin D, "which are both emerging as predictors of outcomes in populations with and without chronic kidney disease in cohort studies."

Dr. Palmer disclosed that she was the recipient of a Don and Lorraine Jacquot Fellowship from the Royal Australasian College of Physicians and received travel support from the Amgen Dompe fellowship to the Consorzio Mario Negri Sud. A coauthor of the study, Petra Macaskill, Ph.D., reported receiving grant support from the Australian National Health and Medical Research Council.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

ORLANDO – Costly and unnecessary imaging studies are being performed in men with low-risk and medium-risk prostate cancer, whereas a worrisome number of men with high-risk disease do not receive adequate imaging prior to treatment.

An analysis of 30,183 patients found that 36% of men who were diagnosed with low-risk and 49% of those with intermediate-risk prostate cancer underwent at least one imaging study for staging.

The National Comprehensive Cancer Network (NCCN) and the American Urological Association (AUA) recommend using CT, MRI, and bone scan studies following the diagnosis of prostate cancer only in the setting of high-risk pathological features.

Only 61% of men who were diagnosed with this type of cancer, however, received the recommended imaging prior to treatment, Dr. Sandip M. Prasad, a urologic oncology fellow at the University of Chicago Medical Center, reported.

"Given that the risk of having non–organ confined disease is higher in men with higher Gleason scores, [prostate specific antigen level], or clinical stage, it is critical that these men have appropriate staging to rule out metastatic disease before undergoing local therapy," he said in an interview.

During the study period, men with low- and intermediate-risk prostate cancer did not require any additional imaging per NCCN guidelines; however, the most recently revised (January 2011) NCCN practice guideline allows for some men with intermediate-risk prostate cancer to undergo bone scan.

Dr. Prasad hypothesized that defensive medicine – or a lack of awareness of the AUA and NCCN guidelines – may have played a role in the overuse of the tests. Imaging may also provide reassurance for lower-risk patients that they do not have evidence of metastatic disease, although the likelihood that they would is very low.

The unnecessary tests do expose patients to harmful radiation, and may have cost American taxpayers $35 million, based on a low rate of Medicare reimbursement, he said. The cost may actually be greater because private insurers often reimburse at a higher rate for younger men.

"The gap seen in men with high-risk disease is harder to explain, although one could hypothesize that patient desire to rapidly be treated may drive early treatment without complete staging," Dr. Prasad said. "Men may also choose to have no additional imaging or treatment following diagnosis."

The analysis was based on SEER (Surveillance, Epidemiology, and End Results)–Medicare linked data on 30,183 men who were diagnosed with prostate cancer in 2004-2005. In all, 9,640 men had low-risk prostate cancer, 12,966 men had medium-risk prostate cancer, and 7,577 men had high-risk prostate cancer. Their median ages were 71 years, 73 years and 75 years, respectively.

A multivariate analysis revealed that imaging was less common in men who were educated (odds ratio, 0.084) and was more common in men who were older than 75 years (OR, 1.25), black (OR, 1.11), had a median income of more than $60,000 (OR, 1.19) and lived in rural areas (OR, 1.22), Dr. Prasad and his associates reported in a poster at the Genitourinary Cancers Symposium.

Among low-risk men, imaging was significantly more common in those treated with radiation/brachytherapy (46%; OR, 1.82) or cryotherapy (37%; OR, 1.44), but significantly less common with watchful waiting (14%; OR, 0.27).

Among high-risk patients, imaging was significantly more common in those treated with proton beam therapy (80%; OR, 2.14), radiation/brachytherapy (79%; OR, 2.21), and cryotherapy (74%; OR, 1.64), but significantly less common when men received androgen therapy (44%; OR, 0.62) or watchful waiting (21%; OR, 0.16), the researchers reported at the meeting, which was cosponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Dr. Prasad and his coauthors report no conflicts of interest.

CANCUN, MEXICO - Scleroderma patients on angiotensin-converting enzyme inhibitors at the onset of scleroderma renal crisis do not appear to have worse outcomes than do those not taking the antihypertensive agents prior to the acute renal function deterioration, according to preliminary data from the largest prospective cohort study of incident scleroderma renal crisis to date.

The finding further fuels the ongoing debate over the role of angiotensin-converting enzyme (ACE) inhibitors as prophylaxis for scleroderma renal crisis (SRC), lead investigator Dr. Marie Hudson reported at the annual meeting of the Canadian Rheumatology.

Although the use of ACE inhibitors since the 1980s has dramatically improved the outcome of SRC patients – prior to their widespread use for this indication, SRC mortality was more than 80% – there is still room for substantial improvement, explained Dr. Hudson, noting that the 1- and 5-year survival rates hover around 75% and 65%, respectively, and approximately 19% die within 3 months of diagnosis. It is possible that earlier intervention with ACE inhibitors might improve SRC outcomes. Most likely to benefit are individuals considered at risk for the complication, including those with diffuse and rapidly progressing skin involvement, history of glucocorticoid use, and positive analysis of anti-RNA polymerase III antibodies. But not everyone agrees, she said. "[Opponents] have suggested that prophylactic ACE inhibition could delay the diagnosis [of SRC] because of normalized blood pressure and as a result lead to worse outcomes."

Because a trial of ACE inhibitors in non-SRC patients could carry some risk for participants, Dr. Hudson, a rheumatologist at the Jewish General Hospital and a faculty member at McGill University, Montreal, and her colleagues in the International Scleroderma Renal Crisis study instead sought to evaluate the outcomes of scleroderma patients who presented with incident SRC while taking ACE inhibitors immediately prior to the onset of the condition. To date, they have identified 94 cases of incident SRC nationwide using an ongoing, Internet-based survey in which the investigators e-mail nearly 600 participating physicians worldwide every other week to ask about new cases of SRC, she said. For each new case identified, the investigators collect data on patient demographics, disease characteristics, and exposure to ACE inhibitors. The investigators send recruiting physicians a follow-up case report form 1 year after a patient is identified, she explained, noting that the primary outcome measure is death or dialysis dependence at 1 year after SRC onset.

Of the 94 cases identified so far, 90% had hypertensive SRC and 10% had normotensive SRC; 47% had a history of glucocorticoid use immediately prior to SRC onset, at a mean dose of 17 mg prednisone/day; 15% had anti-RNA polymerase III antibodies; and 23% were on ACE inhibitors prior to the onset of disease, said Dr. Hudson. "Proportionally, more of the normotensive SRC patients were on ACE inhibitors than hypotensive SRC patients."

An analysis of the 1-year follow up data that have been collected to date showed that more than 50% of the patients have died or remain on dialysis at 1 year, Dr. Hudson reported. "So far, there is no evidence that those exposed to ACE inhibitors prior to SRC had worse outcomes," she said, stressing that the findings are preliminary as the collection of 1-year follow-up data is ongoing.

As new data are collected and the findings are validated through additional studies, "we hope to offer new insight into the role of ACE inhibitors in patients with scleroderma," said Dr. Hudson. The use of the Internet-survey technology, in particular, has streamlined the research process because it has facilitated international collaboration and allowed the collection of a substantial amount of information on a rare condition in a short period of time, she said.

Dr. Hudson disclosed a financial relationship with Pfizer, which manufactures several ACE inhibitors.

CANCUN, MEXICO - Scleroderma patients on angiotensin-converting enzyme inhibitors at the onset of scleroderma renal crisis do not appear to have worse outcomes than do those not taking the antihypertensive agents prior to the acute renal function deterioration, according to preliminary data from the largest prospective cohort study of incident scleroderma renal crisis to date.

The finding further fuels the ongoing debate over the role of angiotensin-converting enzyme (ACE) inhibitors as prophylaxis for scleroderma renal crisis (SRC), lead investigator Dr. Marie Hudson reported at the annual meeting of the Canadian Rheumatology.

Although the use of ACE inhibitors since the 1980s has dramatically improved the outcome of SRC patients – prior to their widespread use for this indication, SRC mortality was more than 80% – there is still room for substantial improvement, explained Dr. Hudson, noting that the 1- and 5-year survival rates hover around 75% and 65%, respectively, and approximately 19% die within 3 months of diagnosis. It is possible that earlier intervention with ACE inhibitors might improve SRC outcomes. Most likely to benefit are individuals considered at risk for the complication, including those with diffuse and rapidly progressing skin involvement, history of glucocorticoid use, and positive analysis of anti-RNA polymerase III antibodies. But not everyone agrees, she said. "[Opponents] have suggested that prophylactic ACE inhibition could delay the diagnosis [of SRC] because of normalized blood pressure and as a result lead to worse outcomes."

Because a trial of ACE inhibitors in non-SRC patients could carry some risk for participants, Dr. Hudson, a rheumatologist at the Jewish General Hospital and a faculty member at McGill University, Montreal, and her colleagues in the International Scleroderma Renal Crisis study instead sought to evaluate the outcomes of scleroderma patients who presented with incident SRC while taking ACE inhibitors immediately prior to the onset of the condition. To date, they have identified 94 cases of incident SRC nationwide using an ongoing, Internet-based survey in which the investigators e-mail nearly 600 participating physicians worldwide every other week to ask about new cases of SRC, she said. For each new case identified, the investigators collect data on patient demographics, disease characteristics, and exposure to ACE inhibitors. The investigators send recruiting physicians a follow-up case report form 1 year after a patient is identified, she explained, noting that the primary outcome measure is death or dialysis dependence at 1 year after SRC onset.

Of the 94 cases identified so far, 90% had hypertensive SRC and 10% had normotensive SRC; 47% had a history of glucocorticoid use immediately prior to SRC onset, at a mean dose of 17 mg prednisone/day; 15% had anti-RNA polymerase III antibodies; and 23% were on ACE inhibitors prior to the onset of disease, said Dr. Hudson. "Proportionally, more of the normotensive SRC patients were on ACE inhibitors than hypotensive SRC patients."

An analysis of the 1-year follow up data that have been collected to date showed that more than 50% of the patients have died or remain on dialysis at 1 year, Dr. Hudson reported. "So far, there is no evidence that those exposed to ACE inhibitors prior to SRC had worse outcomes," she said, stressing that the findings are preliminary as the collection of 1-year follow-up data is ongoing.

As new data are collected and the findings are validated through additional studies, "we hope to offer new insight into the role of ACE inhibitors in patients with scleroderma," said Dr. Hudson. The use of the Internet-survey technology, in particular, has streamlined the research process because it has facilitated international collaboration and allowed the collection of a substantial amount of information on a rare condition in a short period of time, she said.

Dr. Hudson disclosed a financial relationship with Pfizer, which manufactures several ACE inhibitors.

CANCUN, MEXICO - Scleroderma patients on angiotensin-converting enzyme inhibitors at the onset of scleroderma renal crisis do not appear to have worse outcomes than do those not taking the antihypertensive agents prior to the acute renal function deterioration, according to preliminary data from the largest prospective cohort study of incident scleroderma renal crisis to date.

The finding further fuels the ongoing debate over the role of angiotensin-converting enzyme (ACE) inhibitors as prophylaxis for scleroderma renal crisis (SRC), lead investigator Dr. Marie Hudson reported at the annual meeting of the Canadian Rheumatology.

Although the use of ACE inhibitors since the 1980s has dramatically improved the outcome of SRC patients – prior to their widespread use for this indication, SRC mortality was more than 80% – there is still room for substantial improvement, explained Dr. Hudson, noting that the 1- and 5-year survival rates hover around 75% and 65%, respectively, and approximately 19% die within 3 months of diagnosis. It is possible that earlier intervention with ACE inhibitors might improve SRC outcomes. Most likely to benefit are individuals considered at risk for the complication, including those with diffuse and rapidly progressing skin involvement, history of glucocorticoid use, and positive analysis of anti-RNA polymerase III antibodies. But not everyone agrees, she said. "[Opponents] have suggested that prophylactic ACE inhibition could delay the diagnosis [of SRC] because of normalized blood pressure and as a result lead to worse outcomes."

Because a trial of ACE inhibitors in non-SRC patients could carry some risk for participants, Dr. Hudson, a rheumatologist at the Jewish General Hospital and a faculty member at McGill University, Montreal, and her colleagues in the International Scleroderma Renal Crisis study instead sought to evaluate the outcomes of scleroderma patients who presented with incident SRC while taking ACE inhibitors immediately prior to the onset of the condition. To date, they have identified 94 cases of incident SRC nationwide using an ongoing, Internet-based survey in which the investigators e-mail nearly 600 participating physicians worldwide every other week to ask about new cases of SRC, she said. For each new case identified, the investigators collect data on patient demographics, disease characteristics, and exposure to ACE inhibitors. The investigators send recruiting physicians a follow-up case report form 1 year after a patient is identified, she explained, noting that the primary outcome measure is death or dialysis dependence at 1 year after SRC onset.

Of the 94 cases identified so far, 90% had hypertensive SRC and 10% had normotensive SRC; 47% had a history of glucocorticoid use immediately prior to SRC onset, at a mean dose of 17 mg prednisone/day; 15% had anti-RNA polymerase III antibodies; and 23% were on ACE inhibitors prior to the onset of disease, said Dr. Hudson. "Proportionally, more of the normotensive SRC patients were on ACE inhibitors than hypotensive SRC patients."

An analysis of the 1-year follow up data that have been collected to date showed that more than 50% of the patients have died or remain on dialysis at 1 year, Dr. Hudson reported. "So far, there is no evidence that those exposed to ACE inhibitors prior to SRC had worse outcomes," she said, stressing that the findings are preliminary as the collection of 1-year follow-up data is ongoing.

As new data are collected and the findings are validated through additional studies, "we hope to offer new insight into the role of ACE inhibitors in patients with scleroderma," said Dr. Hudson. The use of the Internet-survey technology, in particular, has streamlined the research process because it has facilitated international collaboration and allowed the collection of a substantial amount of information on a rare condition in a short period of time, she said.

Dr. Hudson disclosed a financial relationship with Pfizer, which manufactures several ACE inhibitors.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.

DENVER – Moderate alcohol consumption among renal transplant recipients is inversely associated with posttransplant diabetes and all-cause mortality, results from a large single-center study showed.

The finding contradicts the notion that renal transplant recipients should refrain from alcohol use because of possible interaction with their immunosuppressive drugs, lead investigator Dorien M. Zelle said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

"After renal transplantation, patients have a lot of restrictions," said Ms. Zelle, a PhD candidate at University Medical Center Groningen, The Netherlands. "Doctors advise them not to smoke, and they have to take a lot of medications. We should not advise them against moderate alcohol consumption, because we have shown that nondrinkers are doing worse than moderate drinkers after transplantation."

She went on to note that the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Care of Kidney Transplant Recipients does mention specific alcohol restrictions for kidney transplant patients.

Ms. Zelle and her associates studied 600 renal transplant recipients who visited the medical center’s outpatient clinic between 2001 and 2003 and were at least 1 year post transplant. They filled out self-report questionnaires about their alcohol use and the researchers recorded mortality and graft failure until May 2009. Study participants were classified into one of four groups: abstainers, sporadic drinkers, moderate drinkers (range of 1 unit per week to 3 units per day), and heavy drinkers (4 or more units per day).

At baseline, the mean age of the 600 patients was 51 years and 12% had posttransplant diabetes. Nearly half (288, or 48%) were abstainers, 94 (16%) were sporadic drinkers, 210 (35%) were moderate drinkers, and 8 (1%) were heavy drinkers.

Ms. Zelle reported that during a median follow-up of 7 years, moderate drinkers had a 67% lower risk for diabetes compared with respondents in the other groups (OR = 0.33). In addition, 33 (15.7%) of the moderate drinkers died, compared with 75 (26%) of the abstainers, 23 (24.5%) of the sporadic drinkers, and 2 (25%) of the heavy drinkers.

Univariate Cox regression analysis revealed that moderate drinkers were 44% less likely to die after transplantation compared with respondents in the other groups (HR = 0.56). Adjustment for potential confounders including diabetes and smoking did not change this association.

Ms. Zelle acknowledged certain limitations of the study, including its single center design and the fact that alcohol consumption was measured at a single point in time. "It could be that some patients started drinking more or quit drinking during the course of the study," she said.

Ms. Zelle said that she had no relevant financial disclosures to make.