Sharon Worcester

ATLANTA – A novel, low-resource bedside diagnostic tool that measures saliva urea nitrogen appears useful for identifying patients with advanced acute kidney injury who have an increased likelihood of requiring dialysis.

In a study involving 44 patients, the tool – a dipstick that measures saliva urea nitrogen (SUN), a marker of kidney function – reliably discriminated Acute Kidney Injury Network (AKIN) stage 3 AKI from earlier AKI stages, Dr. Roberto Picoits-Filho reported at Kidney Week 2013.

SUN, as measured using the dipstick, was significantly correlated with blood urea nitrogen, or BUN (R_s = 0.77), irrespective of AKIN stage or AKI etiology, Dr. Picoits-Filho reported during a press briefing at the conference, which was sponsored by the American Society of Nephrology

The diagnostic performances of the tests were comparable: For SUN, the area under the curve of a receiver operating characteristic curve (AUC ROC) was 0.76, and for BUN the value was 0.69, he said.

"We saw that the test was actually very good, particularly in patients with very severe stages of kidney injury, which is important, because those are the patients who most likely will need to go into dialysis or more complex treatment," said Dr. Picoits-Filho of the Pro-rim Foundation and Pontifícia Universidade Católica do Parana, Curitiba, Brazil.

Patients included in the study were adults (mean age, 59.5 years; 58% women) who were hospitalized with prerenal (67%), renal (24%), or postrenal (9%) suspected AKI. A third had AKIN stage 1 disease, 27% had stage 2 disease, and 40% had stage 3 disease.

Unstimulated saliva was applied to the dipstick to measure whether SUN concentrations were 5-14, 15-24, 25-34, 35-54, 55-74, or 75 or greater mg/dL; BUN was measured concomitantly.

The findings are notable because while AKI in the intensive care unit setting is usually due to acute tubular necrosis, a large proportion of AKI cases outside of the ICU are due to prerenal AKI, which is reversible if diagnosed early and treated aggressively, Dr. Picoits-Filho said.

One way of detecting AKI early on in both the hospital and outpatient settings is by criteria defined by recent consensus: "basically by glomerular filtration rate, but also by urine output," he said.

By using serum creatinine to estimate GFR, you can actually detect patients with AKI. This defines risk for developing more severe AKI (and can help in preventing the need for renal replacement therapy), and also predicts in-hospital mortality, he said.

"The problem is that you need a laboratory facility to get this measurement, and this is not always available, especially in remote areas of the world," he added.

The current findings suggest the SUN dipstick could improve the diagnosis of advanced AKI and aid in triaging patients – particularly in remote areas with limited access to clinical chemistry facilities – and may improve outcomes, he said.

While the test did not prove efficient as a screening tool for chronic kidney disease, it could potentially have a role in monitoring those with chronic kidney disease, he noted.

This study was supported by the Renal Research Institute, New York, and the International Society of Nephrology. Dr. Picoits-Filho reported having no other disclosures.

ATLANTA – A novel, low-resource bedside diagnostic tool that measures saliva urea nitrogen appears useful for identifying patients with advanced acute kidney injury who have an increased likelihood of requiring dialysis.

In a study involving 44 patients, the tool – a dipstick that measures saliva urea nitrogen (SUN), a marker of kidney function – reliably discriminated Acute Kidney Injury Network (AKIN) stage 3 AKI from earlier AKI stages, Dr. Roberto Picoits-Filho reported at Kidney Week 2013.

SUN, as measured using the dipstick, was significantly correlated with blood urea nitrogen, or BUN (R_s = 0.77), irrespective of AKIN stage or AKI etiology, Dr. Picoits-Filho reported during a press briefing at the conference, which was sponsored by the American Society of Nephrology

The diagnostic performances of the tests were comparable: For SUN, the area under the curve of a receiver operating characteristic curve (AUC ROC) was 0.76, and for BUN the value was 0.69, he said.

"We saw that the test was actually very good, particularly in patients with very severe stages of kidney injury, which is important, because those are the patients who most likely will need to go into dialysis or more complex treatment," said Dr. Picoits-Filho of the Pro-rim Foundation and Pontifícia Universidade Católica do Parana, Curitiba, Brazil.

Patients included in the study were adults (mean age, 59.5 years; 58% women) who were hospitalized with prerenal (67%), renal (24%), or postrenal (9%) suspected AKI. A third had AKIN stage 1 disease, 27% had stage 2 disease, and 40% had stage 3 disease.

Unstimulated saliva was applied to the dipstick to measure whether SUN concentrations were 5-14, 15-24, 25-34, 35-54, 55-74, or 75 or greater mg/dL; BUN was measured concomitantly.

The findings are notable because while AKI in the intensive care unit setting is usually due to acute tubular necrosis, a large proportion of AKI cases outside of the ICU are due to prerenal AKI, which is reversible if diagnosed early and treated aggressively, Dr. Picoits-Filho said.

One way of detecting AKI early on in both the hospital and outpatient settings is by criteria defined by recent consensus: "basically by glomerular filtration rate, but also by urine output," he said.

By using serum creatinine to estimate GFR, you can actually detect patients with AKI. This defines risk for developing more severe AKI (and can help in preventing the need for renal replacement therapy), and also predicts in-hospital mortality, he said.

"The problem is that you need a laboratory facility to get this measurement, and this is not always available, especially in remote areas of the world," he added.

The current findings suggest the SUN dipstick could improve the diagnosis of advanced AKI and aid in triaging patients – particularly in remote areas with limited access to clinical chemistry facilities – and may improve outcomes, he said.

While the test did not prove efficient as a screening tool for chronic kidney disease, it could potentially have a role in monitoring those with chronic kidney disease, he noted.

This study was supported by the Renal Research Institute, New York, and the International Society of Nephrology. Dr. Picoits-Filho reported having no other disclosures.

ATLANTA – A novel, low-resource bedside diagnostic tool that measures saliva urea nitrogen appears useful for identifying patients with advanced acute kidney injury who have an increased likelihood of requiring dialysis.

In a study involving 44 patients, the tool – a dipstick that measures saliva urea nitrogen (SUN), a marker of kidney function – reliably discriminated Acute Kidney Injury Network (AKIN) stage 3 AKI from earlier AKI stages, Dr. Roberto Picoits-Filho reported at Kidney Week 2013.

SUN, as measured using the dipstick, was significantly correlated with blood urea nitrogen, or BUN (R_s = 0.77), irrespective of AKIN stage or AKI etiology, Dr. Picoits-Filho reported during a press briefing at the conference, which was sponsored by the American Society of Nephrology

The diagnostic performances of the tests were comparable: For SUN, the area under the curve of a receiver operating characteristic curve (AUC ROC) was 0.76, and for BUN the value was 0.69, he said.

"We saw that the test was actually very good, particularly in patients with very severe stages of kidney injury, which is important, because those are the patients who most likely will need to go into dialysis or more complex treatment," said Dr. Picoits-Filho of the Pro-rim Foundation and Pontifícia Universidade Católica do Parana, Curitiba, Brazil.

Patients included in the study were adults (mean age, 59.5 years; 58% women) who were hospitalized with prerenal (67%), renal (24%), or postrenal (9%) suspected AKI. A third had AKIN stage 1 disease, 27% had stage 2 disease, and 40% had stage 3 disease.

Unstimulated saliva was applied to the dipstick to measure whether SUN concentrations were 5-14, 15-24, 25-34, 35-54, 55-74, or 75 or greater mg/dL; BUN was measured concomitantly.

The findings are notable because while AKI in the intensive care unit setting is usually due to acute tubular necrosis, a large proportion of AKI cases outside of the ICU are due to prerenal AKI, which is reversible if diagnosed early and treated aggressively, Dr. Picoits-Filho said.

One way of detecting AKI early on in both the hospital and outpatient settings is by criteria defined by recent consensus: "basically by glomerular filtration rate, but also by urine output," he said.

By using serum creatinine to estimate GFR, you can actually detect patients with AKI. This defines risk for developing more severe AKI (and can help in preventing the need for renal replacement therapy), and also predicts in-hospital mortality, he said.

"The problem is that you need a laboratory facility to get this measurement, and this is not always available, especially in remote areas of the world," he added.

The current findings suggest the SUN dipstick could improve the diagnosis of advanced AKI and aid in triaging patients – particularly in remote areas with limited access to clinical chemistry facilities – and may improve outcomes, he said.

While the test did not prove efficient as a screening tool for chronic kidney disease, it could potentially have a role in monitoring those with chronic kidney disease, he noted.

This study was supported by the Renal Research Institute, New York, and the International Society of Nephrology. Dr. Picoits-Filho reported having no other disclosures.

ORLANDO – A brief intervention regarding driving safety is effective for encouraging the use of a new parent resource that promotes safe driving among teens, according to Jean Thatcher Shope, Ph.D.

In a prospective study, 133 trained pediatricians each delivered the 2-minute intervention to up to 35 individual parents, directing them to the Checkpoints web-based safe driving program. More than 50% of the parents visited the website. The parents clicked on an average of 4.2 pages and spent an average of 3.5 minutes at the site, Dr. Shope reported at the annual meeting of the American Academy of Pediatrics (AAP).

©Vladimir Piskunov/iStockphoto.com

The Checkpoints Program is a free, evidence-based program that encourages parents to set limits on teen driving and to monitor novice drivers. It was developed by study coauthor Bruce Simons-Morton, Ed.D., at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The website includes teen driving statistics resources to help parents keep their teen drivers safe, and information about state-specific teen driving laws. It also includes an interactive component to help parents create a parent-teen driving agreement that addresses driving hours, number of passengers allowed, and other factors that can be modified over time as the driver becomes more experienced.

The website pages viewed most often were those on teen driving risks, site account registration, and state-specific teen driving laws, said Dr. Shope of the University of Michigan Transportation Research Institute, Ann Arbor.

Participating pediatricians were trained to deliver the brief intervention to parents of teens aged 14-17 years. The pediatricians used scripted materials, provided parents with a key chain imprinted with the website address, and referred parents to the website (youngdriverparenting.org), which will be sustained by the AAP. Parents were encouraged to register and use the interactive Checkpoints agreement and other materials.

The intervention was developed by Dr. Shope and her colleagues in collaboration with Pediatric Research in Office Settings (PROS) and the AAP’s practice-based research network.

Just a short message from a credible professional resource is effective for prompting the parents of teens to visit the Checkpoints website, Dr. Shope said, adding that with motor vehicle crashes topping the list of causes of death among teens, effective prevention measures above and beyond graduated driver licensing are needed.

Teen drivers whose parents are actively engaged in monitoring their driving are less risky drivers, and having a pediatrician deliver a brief intervention that guides parents to an evidence-based, web-based program has the potential to reach many families and to greatly enhance teen driver safety, she added.

This study was funded by the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control.

ORLANDO – A brief intervention regarding driving safety is effective for encouraging the use of a new parent resource that promotes safe driving among teens, according to Jean Thatcher Shope, Ph.D.

In a prospective study, 133 trained pediatricians each delivered the 2-minute intervention to up to 35 individual parents, directing them to the Checkpoints web-based safe driving program. More than 50% of the parents visited the website. The parents clicked on an average of 4.2 pages and spent an average of 3.5 minutes at the site, Dr. Shope reported at the annual meeting of the American Academy of Pediatrics (AAP).

©Vladimir Piskunov/iStockphoto.com

The Checkpoints Program is a free, evidence-based program that encourages parents to set limits on teen driving and to monitor novice drivers. It was developed by study coauthor Bruce Simons-Morton, Ed.D., at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The website includes teen driving statistics resources to help parents keep their teen drivers safe, and information about state-specific teen driving laws. It also includes an interactive component to help parents create a parent-teen driving agreement that addresses driving hours, number of passengers allowed, and other factors that can be modified over time as the driver becomes more experienced.

The website pages viewed most often were those on teen driving risks, site account registration, and state-specific teen driving laws, said Dr. Shope of the University of Michigan Transportation Research Institute, Ann Arbor.

Participating pediatricians were trained to deliver the brief intervention to parents of teens aged 14-17 years. The pediatricians used scripted materials, provided parents with a key chain imprinted with the website address, and referred parents to the website (youngdriverparenting.org), which will be sustained by the AAP. Parents were encouraged to register and use the interactive Checkpoints agreement and other materials.

The intervention was developed by Dr. Shope and her colleagues in collaboration with Pediatric Research in Office Settings (PROS) and the AAP’s practice-based research network.

Just a short message from a credible professional resource is effective for prompting the parents of teens to visit the Checkpoints website, Dr. Shope said, adding that with motor vehicle crashes topping the list of causes of death among teens, effective prevention measures above and beyond graduated driver licensing are needed.

Teen drivers whose parents are actively engaged in monitoring their driving are less risky drivers, and having a pediatrician deliver a brief intervention that guides parents to an evidence-based, web-based program has the potential to reach many families and to greatly enhance teen driver safety, she added.

This study was funded by the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control.

ORLANDO – A brief intervention regarding driving safety is effective for encouraging the use of a new parent resource that promotes safe driving among teens, according to Jean Thatcher Shope, Ph.D.

In a prospective study, 133 trained pediatricians each delivered the 2-minute intervention to up to 35 individual parents, directing them to the Checkpoints web-based safe driving program. More than 50% of the parents visited the website. The parents clicked on an average of 4.2 pages and spent an average of 3.5 minutes at the site, Dr. Shope reported at the annual meeting of the American Academy of Pediatrics (AAP).

©Vladimir Piskunov/iStockphoto.com

The Checkpoints Program is a free, evidence-based program that encourages parents to set limits on teen driving and to monitor novice drivers. It was developed by study coauthor Bruce Simons-Morton, Ed.D., at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The website includes teen driving statistics resources to help parents keep their teen drivers safe, and information about state-specific teen driving laws. It also includes an interactive component to help parents create a parent-teen driving agreement that addresses driving hours, number of passengers allowed, and other factors that can be modified over time as the driver becomes more experienced.

The website pages viewed most often were those on teen driving risks, site account registration, and state-specific teen driving laws, said Dr. Shope of the University of Michigan Transportation Research Institute, Ann Arbor.

Participating pediatricians were trained to deliver the brief intervention to parents of teens aged 14-17 years. The pediatricians used scripted materials, provided parents with a key chain imprinted with the website address, and referred parents to the website (youngdriverparenting.org), which will be sustained by the AAP. Parents were encouraged to register and use the interactive Checkpoints agreement and other materials.

The intervention was developed by Dr. Shope and her colleagues in collaboration with Pediatric Research in Office Settings (PROS) and the AAP’s practice-based research network.

Just a short message from a credible professional resource is effective for prompting the parents of teens to visit the Checkpoints website, Dr. Shope said, adding that with motor vehicle crashes topping the list of causes of death among teens, effective prevention measures above and beyond graduated driver licensing are needed.

Teen drivers whose parents are actively engaged in monitoring their driving are less risky drivers, and having a pediatrician deliver a brief intervention that guides parents to an evidence-based, web-based program has the potential to reach many families and to greatly enhance teen driver safety, she added.

This study was funded by the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control.

ATLANTA – Mindfulness meditation may improve blood pressure in hypertensive patients with chronic kidney disease, according to findings from a small randomized study.

This study involved 15 patients who had stage 3 chronic kidney disease and hypertension. Compared with a control condition involving blood pressure education, mindfulness meditation was associated with significantly greater reductions in systolic blood pressure (–10.2 vs. –0.8 mm Hg), diastolic blood pressure (–6.4 vs. –1.8 mm Hg), and mean arterial pressure (–7.7 vs. –1.4 mm Hg), Dr. Jeanie Park reported at Kidney Week 2013, sponsored by the American Society of Nephrology.

©Jupiterimages

Mindfulness meditation – a "type of meditation that is focused on awareness of sensations of the present moment without any type of cognitive elaboration of those sensations, without judgment, without trying to modify those sensations" – also was associated with a significantly greater reduction in muscle sympathetic nerve activity as measured using microneurography (–10.7 vs. 1.9 bursts/min), said Dr. Park of Emory University, Atlanta.

Study participants were male veterans who completed two study visits, undergoing – in randomized crossover fashion – 14 minutes of guided mindfulness meditation at one visit, and 14 minutes of a control condition involving blood pressure education at one visit.

Because a lower breathing rate was observed during mindfulness meditation, a subset of the patients completed a third visit in which they used controlled breathing as a second control measure. During this visit, they lowered their breathing rate to the same rate achieved during mindfulness meditation.

"What we saw was that during mindfulness meditation, there was a significant reduction in sympathetic nerve activity compared with the control, but during controlled breathing ... there was no difference in sympathetic activity. This suggests that slow breathing by itself is not sufficient to lower blood pressure and sympathetic activity, and that there is something unique about mindfulness meditation that might be modulating sympathetic activity and blood pressure in our patients," Dr. Park said.

Although mindfulness meditation has been shown in prior studies to have "modest but meaningful" effects in patients with high blood pressure, the current findings are among the first to demonstrate an association between mindfulness meditation and decreased blood pressure in hypertensive patients with chronic kidney disease. The effect appeared to be mediated by an acute reduction in sympathetic nervous system activity, Dr. Park said.

Chronic kidney disease is characterized by chronic sympathetic nervous system overactivity, which contributes to hypertension and mortality, she explained.

"In clinical practice, we aim to counteract sympathetic activity to lower blood pressure. We do this using antihypertensive medications such as beta-blockers and [clonazepam], but the problem with these medications is that oftentimes their use is limited due to their side effects ... so there certainly is a need to investigate alternative or additive therapies to counteract sympathetic activity and lower blood pressure in our patient group," she said.

The findings of this study suggest that mindfulness meditation may have real physiological effects on autonomic control, and may prove useful as a complementary therapy in chronic kidney disease patients, she concluded, noting that future studies are needed to determine whether long-term reductions in blood pressure can be achieved by using mindfulness meditation.

Dr. Park reported having no disclosures.

ATLANTA – Mindfulness meditation may improve blood pressure in hypertensive patients with chronic kidney disease, according to findings from a small randomized study.

This study involved 15 patients who had stage 3 chronic kidney disease and hypertension. Compared with a control condition involving blood pressure education, mindfulness meditation was associated with significantly greater reductions in systolic blood pressure (–10.2 vs. –0.8 mm Hg), diastolic blood pressure (–6.4 vs. –1.8 mm Hg), and mean arterial pressure (–7.7 vs. –1.4 mm Hg), Dr. Jeanie Park reported at Kidney Week 2013, sponsored by the American Society of Nephrology.

©Jupiterimages

Mindfulness meditation – a "type of meditation that is focused on awareness of sensations of the present moment without any type of cognitive elaboration of those sensations, without judgment, without trying to modify those sensations" – also was associated with a significantly greater reduction in muscle sympathetic nerve activity as measured using microneurography (–10.7 vs. 1.9 bursts/min), said Dr. Park of Emory University, Atlanta.

Study participants were male veterans who completed two study visits, undergoing – in randomized crossover fashion – 14 minutes of guided mindfulness meditation at one visit, and 14 minutes of a control condition involving blood pressure education at one visit.

Because a lower breathing rate was observed during mindfulness meditation, a subset of the patients completed a third visit in which they used controlled breathing as a second control measure. During this visit, they lowered their breathing rate to the same rate achieved during mindfulness meditation.

"What we saw was that during mindfulness meditation, there was a significant reduction in sympathetic nerve activity compared with the control, but during controlled breathing ... there was no difference in sympathetic activity. This suggests that slow breathing by itself is not sufficient to lower blood pressure and sympathetic activity, and that there is something unique about mindfulness meditation that might be modulating sympathetic activity and blood pressure in our patients," Dr. Park said.

Although mindfulness meditation has been shown in prior studies to have "modest but meaningful" effects in patients with high blood pressure, the current findings are among the first to demonstrate an association between mindfulness meditation and decreased blood pressure in hypertensive patients with chronic kidney disease. The effect appeared to be mediated by an acute reduction in sympathetic nervous system activity, Dr. Park said.

Chronic kidney disease is characterized by chronic sympathetic nervous system overactivity, which contributes to hypertension and mortality, she explained.

"In clinical practice, we aim to counteract sympathetic activity to lower blood pressure. We do this using antihypertensive medications such as beta-blockers and [clonazepam], but the problem with these medications is that oftentimes their use is limited due to their side effects ... so there certainly is a need to investigate alternative or additive therapies to counteract sympathetic activity and lower blood pressure in our patient group," she said.

The findings of this study suggest that mindfulness meditation may have real physiological effects on autonomic control, and may prove useful as a complementary therapy in chronic kidney disease patients, she concluded, noting that future studies are needed to determine whether long-term reductions in blood pressure can be achieved by using mindfulness meditation.

Dr. Park reported having no disclosures.

ATLANTA – Mindfulness meditation may improve blood pressure in hypertensive patients with chronic kidney disease, according to findings from a small randomized study.

This study involved 15 patients who had stage 3 chronic kidney disease and hypertension. Compared with a control condition involving blood pressure education, mindfulness meditation was associated with significantly greater reductions in systolic blood pressure (–10.2 vs. –0.8 mm Hg), diastolic blood pressure (–6.4 vs. –1.8 mm Hg), and mean arterial pressure (–7.7 vs. –1.4 mm Hg), Dr. Jeanie Park reported at Kidney Week 2013, sponsored by the American Society of Nephrology.

©Jupiterimages

Mindfulness meditation – a "type of meditation that is focused on awareness of sensations of the present moment without any type of cognitive elaboration of those sensations, without judgment, without trying to modify those sensations" – also was associated with a significantly greater reduction in muscle sympathetic nerve activity as measured using microneurography (–10.7 vs. 1.9 bursts/min), said Dr. Park of Emory University, Atlanta.

Study participants were male veterans who completed two study visits, undergoing – in randomized crossover fashion – 14 minutes of guided mindfulness meditation at one visit, and 14 minutes of a control condition involving blood pressure education at one visit.

Because a lower breathing rate was observed during mindfulness meditation, a subset of the patients completed a third visit in which they used controlled breathing as a second control measure. During this visit, they lowered their breathing rate to the same rate achieved during mindfulness meditation.

"What we saw was that during mindfulness meditation, there was a significant reduction in sympathetic nerve activity compared with the control, but during controlled breathing ... there was no difference in sympathetic activity. This suggests that slow breathing by itself is not sufficient to lower blood pressure and sympathetic activity, and that there is something unique about mindfulness meditation that might be modulating sympathetic activity and blood pressure in our patients," Dr. Park said.

Although mindfulness meditation has been shown in prior studies to have "modest but meaningful" effects in patients with high blood pressure, the current findings are among the first to demonstrate an association between mindfulness meditation and decreased blood pressure in hypertensive patients with chronic kidney disease. The effect appeared to be mediated by an acute reduction in sympathetic nervous system activity, Dr. Park said.

Chronic kidney disease is characterized by chronic sympathetic nervous system overactivity, which contributes to hypertension and mortality, she explained.

"In clinical practice, we aim to counteract sympathetic activity to lower blood pressure. We do this using antihypertensive medications such as beta-blockers and [clonazepam], but the problem with these medications is that oftentimes their use is limited due to their side effects ... so there certainly is a need to investigate alternative or additive therapies to counteract sympathetic activity and lower blood pressure in our patient group," she said.

The findings of this study suggest that mindfulness meditation may have real physiological effects on autonomic control, and may prove useful as a complementary therapy in chronic kidney disease patients, she concluded, noting that future studies are needed to determine whether long-term reductions in blood pressure can be achieved by using mindfulness meditation.

Dr. Park reported having no disclosures.

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

ATLANTA – Adding abatacept to low-dose intravenous cyclophosphamide did not improve the rate of complete renal response at 1 year, compared with IV cyclophosphamide alone, in patients with class III or IV lupus nephritis in the randomized, controlled ACCESS Trial.

The phase II findings suggested, however, that abatacept reduced the need for maintenance immunosuppression, and they also demonstrated for the first time that low-dose IV cyclophosphamide may have applicability in racially and ethnically diverse patients with lupus nephritis, Dr. Brad H. Rovin reported at Kidney Week 2013.

The overall complete renal response rates were similar at 33% and 31%, respectively, in 134 patients with class III or IV lupus nephritis who were enrolled in the trial, treated with a steroid taper and 500 mg of IV cyclophosphamide every 2 weeks for 6 weeks followed by 2 mg/kg of azathioprine daily. Patients then were randomized to receive abatacept or placebo at week 0, 2, and 4 and then monthly.

Complete plus partial responses occurred in 59% of patients in each arm, Dr. Rovin said at the conference, which was sponsored by the American Society of Nephrology.

Patients in the study had a urine protein-to-creatinine ratio (UPCR) greater than 1. Complete renal response was defined as a UPCR of less than 0.5, serum creatinine at normal or within 25% of baseline, and prednisone dose tapered to 10 mg daily or less. African Americans comprised 39% of the cohort, and Hispanic/Mestizo patients comprised 40%.

Among the African American patients, 33% in the treatment group, compared with 16% in the placebo group, achieved complete renal response. This difference was not statistically significant.

This finding is important, because while low-dose cyclophosphamide – the "Euro-Lupus regimen" – has been shown to be as effective as standard and more toxic higher dosing, studies had primarily included a European Caucasian population. It was unclear whether the low-dose regimen would be as effective in a multiracial and multiethnic population, said Dr. Rovin of Ohio State University Medical Center.

No differences were seen between the treatment and control groups with respect to anti-dsDNA or complement levels and/or the frequency of serious or infectious adverse events or study withdrawals.

Of note, azathioprine was stopped in treatment group patients who achieved complete renal response – but not control group patients who achieved complete renal response. These patients were followed to 52 weeks. At that time, 50% and 62% of the treatment group and control group patients, respectively, who were complete responders at 24 weeks still met the criteria for complete response, Dr. Rovin said.

While abatacept did not increase complete response rates, the treatment was associated with maintenance of complete renal response to 1 year despite discontinuation of maintenance immunosuppression in the treated patients and continued azathioprine treatment in the control group. This suggests that abatacept may reduce the need for maintenance immunosuppression, he said.

While it was disappointing that the addition of abatacept to background induction therapy with low-dose IV cyclophosphamide and corticosteroids did not improve the complete renal response rate in this study – despite murine models suggesting that the use of abatacept and IV cyclophosphamide act synergistically to arrest lupus nephritis progression – the findings offer two very important lessons for clinical practice, he said.

"We can take the low-dose cyclophosphamide regimen and potentially use that with good results in our [multiethnic, multiracial] patient population that we see here in this country, and I think that’s a huge step forward. It gives us another option to use besides mycophenolate mofetil and high-dose cyclophosphamide," he said, adding that the low-dose IV cyclophosphamide regimen is well tolerated and delivers a total dose of only 3 g of the drug – a dose that generally does not predispose to premature ovarian failure.

This is particularly important, because women of childbearing years comprise a majority of the patient population with lupus nephritis, he explained.

"We know from the Euro-Lupus trial that the low-dose regimen, over 10 years, provided the same maintenance of renal function as the high-dose regimen, so we have very good long-term follow-up. We don’t quite have that yet with mycophenolate mofetil, so I think that for those of us who are very frequent users of cyclophosphamide, this is a very good alternative to the high-dose, highly toxic regimen that has for so long been the standard of care," he said.

This study was funded by the National Institute of Allergy and Infectious Diseases via the Immune Tolerance Network. Bristol Myers Squibb provided the study drug. Dr. Rovin reported ties to Genentech, Questcor, TEVA, Biogen-IDEC, HGS, Johnson & Johnson, Roche, BMS, and TG Therapeutics.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ATLANTA – The global prevalence of maintenance dialysis for end-stage renal disease has increased 165% over the past 2 decades – a rate that has far outpaced that of population growth in most regions of the world, according to Dr. Bernadette A. Thomas.

The findings – the first to quantify the global burden of end-stage renal disease – underscore a need for improved detection of early chronic kidney disease and for treatment aimed at preventing end-stage renal disease (ESRD), because a continued rise in the prevalence of maintenance dialysis may not be sustainable, Dr. Thomas of the University of Washington, Seattle, said at Kidney Week 2013.

From 1990 to 2010, the global prevalence of maintenance dialysis in areas with universal dialysis access increased 134%, after adjustment for population growth and aging. The increase was 145% among women and 123% among men. Even in countries with a lack of universal access, the adjusted prevalence increased by 102% (116% for women and 90% for men).

The regions that did not experience an increase in dialysis prevalence included Oceania, South Asia, Central Sub-Saharan Africa, Eastern Europe, and tropical Latin America, Dr. Thomas said at the conference, which was sponsored by the American Society of Nephrology.

The findings are based on data extracted from the Global Burden of Disease database, the largest existing database for global causes of morbidity and mortality. Prevalence estimates were based on national and regional ESRD registries and a structured literature review. Data from 23 countries with universal dialysis access and from 138 countries with partial access were included; data from 26 countries that lack routine access were excluded.

"The statistics are appalling," American Society of Nephrology President Bruce A. Molitoris of Indiana University, Indianapolis, noted during a press briefing. Dr. Molitoris called for stepped-up efforts to educate the public about the importance of kidney health.

"We have targeted the patients in the past [via] patient education, and we have not presented, I think, a fair outlook to the public of the potential importance of kidney disease," he said.

Up to one-third of U.S. residents will, at some point in their lives, have severe kidney disease, Dr. Molitoris said, and 8% of African Americans and 3.6% of the total population will go on dialysis or need a transplant.

"And yet, people think they are immune to kidney disease," he cautioned. "The field is in need of innovation; the field is in need of individualization of care. And to do that, we have to have public awareness."

Kidney disease ranks near the bottom when it comes to research funding, and public awareness will go a long way toward changing that, he added.

Dr. Molitoris said he is optimistic that as the pharmaceutical industry continues taking an interest in kidney disease, and as public awareness increases, funding – and therefore innovation – will also increase. He said he envisions a time when the public will be as aware of their kidney function level as they are of their cholesterol level.

"With what is going on in science and technology and biology, it’s not a far leap for us to make major strides," he said.

The study by Dr. Thomas was supported by a private foundation. Dr. Thomas reported having no relevant financial disclosures. Dr. Molitoris reported consultancy, ownership interest, research funding, honoraria, and/or a scientific advisory or membership role for numerous companies. He also reported a patent/invention with FAST Diagnostics, Indiana University.

ORLANDO – Most children presenting to the emergency department with a limp have a traumatic etiology, and in most cases, a thorough history and physical examination coupled with radiographs are sufficient for diagnosis, a retrospective study of cases at a tertiary care pediatric emergency department showed.

Of 16,056 children aged 10 months to 18 years (mean, 2.2 years) who presented to the ED between Jan. 1, 2010, and April 1, 2010, 1,776 (11%) presented with a musculoskeletal complaint, and 779 had a lower-extremity injury, a limp, and/or an inability to bear weight. Among those 779 patients, the most common diagnoses were sprain or strain (26%), contusion (19%), fracture (14%), cellulitis/abscess (9%), and abrasion/laceration/puncture (8%), Dr. Johnathan J. Whitaker reported at the annual meeting of the American Academy of Pediatrics.

Of the 779 patients, 527 (68%) had a traumatic injury and 252 (32%) had an atraumatic etiology.

Transient synovitis was discovered in 15 patients (1.9%), and septic arthritis was discovered in 2 patients (0.3%). Other causes of a limp, from among more than 50 diagnoses, were animal bites, an ingrown or avulsed toenail, back spasm, sickle cell crisis, apophysitis, a burn injury, frostbite, slipped capital femoral epiphysis (SCFE), psoas abscess, deep venous thrombosis, rhabdomyolysis, and testicular torsion, said Dr. Whitaker of the Philadelphia College of Osteopathic Medicine.

Overall, 59 patients (7.6%) were admitted, with most of those having a fracture (36%) or an infection (27%). Others who were admitted had transient synovitis (8.5%), sickle cell crisis (6.8%), or SCFE (1.7%).

Several differences were seen between patients who were admitted and patients who were not admitted, including average age, mechanism of injury, presence of a fever, inability to bear weight, past medical history, serum white blood cell count level, and the use of advanced imaging or a laboratory work-up for diagnosis.

For example, among those with a traumatic etiology, the average age was 14 years; among those with an atraumatic etiology, the average age was 10 years. Only 1% of those with a traumatic etiology had a fever, compared with 5% of those with an atraumatic etiology, Dr. Whitaker said.

The inability to bear weight, the presence of a fever greater than 101.5  F, younger age, and an atraumatic mechanism of injury were significant predictors of admission; increased age and a traumatic mechanism of injury were significantly associated with a decreased likelihood of admission, Dr. Whitaker said.

"Limping primarily results from orthopedic diagnoses. However, limping is a chief complaint for a wide variety of other diagnoses," he said.

Though limited by a relatively small number of limp-related presenting complaints and the fact that the study was conducted during winter months – which may have an impact on the types of injuries seen, the findings suggest that laboratory studies and advanced imaging to assist in establishing a diagnosis that may require admission or urgent treatment are best utilized for younger children with an atraumatic mechanism of injury, the inability to bear weight, or a fever upon presentation, he said.

Dr. Whitaker reported having no relevant financial disclosures.

ORLANDO – Most children presenting to the emergency department with a limp have a traumatic etiology, and in most cases, a thorough history and physical examination coupled with radiographs are sufficient for diagnosis, a retrospective study of cases at a tertiary care pediatric emergency department showed.

Of 16,056 children aged 10 months to 18 years (mean, 2.2 years) who presented to the ED between Jan. 1, 2010, and April 1, 2010, 1,776 (11%) presented with a musculoskeletal complaint, and 779 had a lower-extremity injury, a limp, and/or an inability to bear weight. Among those 779 patients, the most common diagnoses were sprain or strain (26%), contusion (19%), fracture (14%), cellulitis/abscess (9%), and abrasion/laceration/puncture (8%), Dr. Johnathan J. Whitaker reported at the annual meeting of the American Academy of Pediatrics.

Of the 779 patients, 527 (68%) had a traumatic injury and 252 (32%) had an atraumatic etiology.

Transient synovitis was discovered in 15 patients (1.9%), and septic arthritis was discovered in 2 patients (0.3%). Other causes of a limp, from among more than 50 diagnoses, were animal bites, an ingrown or avulsed toenail, back spasm, sickle cell crisis, apophysitis, a burn injury, frostbite, slipped capital femoral epiphysis (SCFE), psoas abscess, deep venous thrombosis, rhabdomyolysis, and testicular torsion, said Dr. Whitaker of the Philadelphia College of Osteopathic Medicine.

Overall, 59 patients (7.6%) were admitted, with most of those having a fracture (36%) or an infection (27%). Others who were admitted had transient synovitis (8.5%), sickle cell crisis (6.8%), or SCFE (1.7%).

Several differences were seen between patients who were admitted and patients who were not admitted, including average age, mechanism of injury, presence of a fever, inability to bear weight, past medical history, serum white blood cell count level, and the use of advanced imaging or a laboratory work-up for diagnosis.

For example, among those with a traumatic etiology, the average age was 14 years; among those with an atraumatic etiology, the average age was 10 years. Only 1% of those with a traumatic etiology had a fever, compared with 5% of those with an atraumatic etiology, Dr. Whitaker said.

The inability to bear weight, the presence of a fever greater than 101.5  F, younger age, and an atraumatic mechanism of injury were significant predictors of admission; increased age and a traumatic mechanism of injury were significantly associated with a decreased likelihood of admission, Dr. Whitaker said.

"Limping primarily results from orthopedic diagnoses. However, limping is a chief complaint for a wide variety of other diagnoses," he said.

Though limited by a relatively small number of limp-related presenting complaints and the fact that the study was conducted during winter months – which may have an impact on the types of injuries seen, the findings suggest that laboratory studies and advanced imaging to assist in establishing a diagnosis that may require admission or urgent treatment are best utilized for younger children with an atraumatic mechanism of injury, the inability to bear weight, or a fever upon presentation, he said.

Dr. Whitaker reported having no relevant financial disclosures.

ORLANDO – Most children presenting to the emergency department with a limp have a traumatic etiology, and in most cases, a thorough history and physical examination coupled with radiographs are sufficient for diagnosis, a retrospective study of cases at a tertiary care pediatric emergency department showed.

Of 16,056 children aged 10 months to 18 years (mean, 2.2 years) who presented to the ED between Jan. 1, 2010, and April 1, 2010, 1,776 (11%) presented with a musculoskeletal complaint, and 779 had a lower-extremity injury, a limp, and/or an inability to bear weight. Among those 779 patients, the most common diagnoses were sprain or strain (26%), contusion (19%), fracture (14%), cellulitis/abscess (9%), and abrasion/laceration/puncture (8%), Dr. Johnathan J. Whitaker reported at the annual meeting of the American Academy of Pediatrics.

Of the 779 patients, 527 (68%) had a traumatic injury and 252 (32%) had an atraumatic etiology.

Transient synovitis was discovered in 15 patients (1.9%), and septic arthritis was discovered in 2 patients (0.3%). Other causes of a limp, from among more than 50 diagnoses, were animal bites, an ingrown or avulsed toenail, back spasm, sickle cell crisis, apophysitis, a burn injury, frostbite, slipped capital femoral epiphysis (SCFE), psoas abscess, deep venous thrombosis, rhabdomyolysis, and testicular torsion, said Dr. Whitaker of the Philadelphia College of Osteopathic Medicine.

Overall, 59 patients (7.6%) were admitted, with most of those having a fracture (36%) or an infection (27%). Others who were admitted had transient synovitis (8.5%), sickle cell crisis (6.8%), or SCFE (1.7%).

Several differences were seen between patients who were admitted and patients who were not admitted, including average age, mechanism of injury, presence of a fever, inability to bear weight, past medical history, serum white blood cell count level, and the use of advanced imaging or a laboratory work-up for diagnosis.

For example, among those with a traumatic etiology, the average age was 14 years; among those with an atraumatic etiology, the average age was 10 years. Only 1% of those with a traumatic etiology had a fever, compared with 5% of those with an atraumatic etiology, Dr. Whitaker said.

The inability to bear weight, the presence of a fever greater than 101.5  F, younger age, and an atraumatic mechanism of injury were significant predictors of admission; increased age and a traumatic mechanism of injury were significantly associated with a decreased likelihood of admission, Dr. Whitaker said.

"Limping primarily results from orthopedic diagnoses. However, limping is a chief complaint for a wide variety of other diagnoses," he said.

Though limited by a relatively small number of limp-related presenting complaints and the fact that the study was conducted during winter months – which may have an impact on the types of injuries seen, the findings suggest that laboratory studies and advanced imaging to assist in establishing a diagnosis that may require admission or urgent treatment are best utilized for younger children with an atraumatic mechanism of injury, the inability to bear weight, or a fever upon presentation, he said.

Dr. Whitaker reported having no relevant financial disclosures.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ATLANTA – The combined use of an angiotensin-converting enzyme inhibitor and an angiotensin receptor blocker was associated with an increased risk of hyperkalemia and acute kidney injury in patients with diabetic nephropathy in a randomized, controlled trial that was halted early because of these safety concerns.

"The risk-benefit ratio does not support the use of these medications – they’re not safe," noted Dr. Linda F. Fried, speaking at Kidney Week 2013.

The VA NEPHRON-D (Veterans Affairs Nephropathy in Diabetes) study involved 1,448 patients with type 2 diabetes and moderate diabetic nephropathy who were treated for at least 30 days with 100 mg daily of the angiotensin-receptor blocker (ARB) losartan, as is standard practice in patients with diabetes. The patients were randomized to also receive 10-40 mg daily of the angiotensin-converting enzyme (ACE) inhibitor lisinopril or placebo.

At a median follow-up of 2.2 years as of the time the study was stopped, 152 patients in the combination-therapy group and 132 in the placebo group (21% vs. 18.2%) experienced the composite primary endpoint of first occurrence of a predefined change in the estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), or death (hazard ratio with combination therapy, 0.88). The difference between the groups was not statistically significant, said Dr. Fried, professor of medicine, epidemiology, and clinical and translational science at the University of Pittsburgh and chief of peritoneal dialysis at Veterans Affairs Pittsburgh Healthcare System.

Despite an early trend toward benefit, this trend diminished over time so that no significant difference was seen between the groups in the secondary renal end point of a first occurrence of a decline in the eGFR or ESRD (hazard ratio, 0.78). Also, no difference was seen between the groups with respect to the safety outcome of mortality (HR for death, 1.04). The rate of cardiovascular events in the groups was also similar.

However, there was a greater than twofold increase in the risk of hyperkalemia in the combination therapy group, compared with the placebo group (6.3 vs. 2.6 events/100 person-years), and a nearly twofold increase in the risk of acute kidney injury in the combination therapy group (12.2 vs. 6.7 event/100 person-years), Dr. Fried said at the conference, which was sponsored by the American Society of Nephrology.

The findings were published concurrently in the New England Journal of Medicine (2013 Nov. 9 [doi10.1056/NEJMoa1303154]).

Patients in the study had type 2 diabetes, a urinary albumin-to-creatinine ratio of at least 300, and an eGFR of 30.0 to 89.9 mL/minute per 1.73 m² or body-surface area. Change in eGFR as specified for the composite primary endpoint of the study was a decline of at least 30 mL/minute per 1.73 m² in those with an initial eGFR of at least 60 mL/minute per 1.73 m², or a decline of at least 50% if the initial eGFR was less than 60 mL/minute per 1.73 m².

Treatment with medications that block angiotensin are known to slow loss of kidney function in individuals with diabetes and proteinuria. This is true for both ACE inhibitors and ARBs, which have different mechanisms of action, but the percentage of patients who progress to dialysis despite treatment with one of these medications remains high, Dr. Fried said.

"So we need more treatments. A question that comes up is, ‘Would more intensive blockade of angiotensin – using two (drugs) together – slow decline?’ ... The thought was that treatments that lowered proteinuria should lower progression. We did see the lower proteinuria but without the benefit on the endpoints," she said during a press briefing in advance of the presentation of the late-breaking abstract.

Instead, it became clear that the treatment was associated with significantly more hyperkalemia and kidney injury, she said, noting that significantly more patients in the combination therapy group experienced acute kidney injury requiring hospitalization, indicating the problem was not just one of "lab abnormalities."

In fact, for every 100 persons followed for 1 year, there were 17 more admissions to the hospital, Dr. Fried said, noting that "these were not small differences in safety outcomes."

"The risk-benefit ratio does not support the use of these medications – they’re not safe." she concluded.

The VA-Nephron-D study was supported by the cooperative studies program of the Department of Veterans Affairs Office of Research and Development. The Investigator-Initiated Studies Program of Merck provided the study drugs. Dr. Fried reported receiving support from Reata Pharmaceuticals as a site investigator for a study. Other studies authors reported receiving lecture or consulting fees from Merck, Sanofi-Aventis, Complex, and/or CytoPherx.

ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.

ORLANDO – A novel smartphone otoscope attachment provides clear, transmittable images of the ear drum or tympanic membrane, and could revolutionize the approach to diagnosing and managing ear infections, according to Dr. Kathryn Rappaport.

In a prospective study involving 63 children who presented to an emergency department between May and December 2012 with upper respiratory tract symptoms, the technology was as effective as a conventional otoscope, and was widely accepted by parents, Dr. Rappaport of Baylor College of Medicine, Houston, reported at the annual meeting of the American Academy of Pediatrics.

Courtesy CellScope

After receiving clinical care, each child in the study underwent bilateral otic videoscopy using both the smartphone otoscope (CellScope Oto) and a camera-fitted conventional otoscope. The procedures were performed in random order, said Dr. Rappaport, who was at Emory University in Atlanta when the study was conducted.

Of the children, who had a mean age of 2.9 years, 49 received a clinical diagnosis of acute otitis media by an ED practitioner. Based on independent scoring by four physicians who evaluated 31 CellScope Oto videos and 31 conventional otoscope videos from 26 subjects, there was no difference between the two technologies in either the diagnostic quality of the images or diagnosis confidence ratings.

Diagnosis and treatment decision making were similar with each device. Overall, the physician raters were in fair agreement regarding the clinical ED diagnosis of acute otitis media, while two of the raters had moderate to substantial agreement with the ED diagnosis and two had poor agreement with the ED diagnosis from images obtained via conventional otoscope, Dr. Rappaport said, noting that there was a significant correlation between antimicrobial use and image quality.

This indicated that higher-quality images were more likely to be associated with a definitive diagnosis, she said.

As for parent reactions to the use of the device, most (95%) responded favorably, stating that the CellScope Oto images improved their understanding of their child’s management. Also, 90% said they thought the technology would be easy to use, and they would feel comfortable using it remotely to transmit images to a provider.

The CellScope Oto has the potential to improve diagnosis and management, and to reduce costs associated with acute otitis media in children, Dr. Rappaport said.

The video images can provide a baseline, as well as ongoing documentation of a child’s condition. The video documentation could allow a child to be followed over a period of time – without the need for regular office visits – to help monitor for progression or resolution of middle ear effusion and to guide diagnosis and treatment decision making, she explained.

"Acute otitis media is the most common reason for antimicrobial prescriptions in children. In the future, we would like to study whether the ability to monitor for resolution of a patient’s middle ear effusion using digital imaging with the smartphone otoscope will lead to decreased antimicrobial prescriptions for acute otitis media in children," she said in an interview.

Dr. Rappaport reported having no relevant financial disclosures.