Doug Brunk

SAN DIEGO – About one-fourth of survivors after critical illness are substantially affected by symptoms of posttraumatic stress syndrome up to 1 year after discharge from the ICU, results from a large meta-analysis demonstrated.

"This incidence is as high as PTSD following other traumatic exposures, such as wartime combat," Dr. Ann Parker said in an interview in advance of an international conference of the American Thoracic Society, where the research was presented. "It is important for clinicians to recognize that patients with preexisting psychological symptoms, receiving benzodiazepines for sedation in the ICU or reporting memories of ‘frightening’ ICU experiences are at increased risk of developing PTSD following critical illness."

In a study led by Dr. Dale M. Needham, medical director of Johns Hopkins University’s critical care physical medicine and rehabilitation program, Dr. Parker and fellow first author Dr. Thiti Sricharoenchai searched PubMed and four other databases to perform a systematic review and meta-analysis of the prevalence of and risk factors for PTSD in survivors of critical illness.

"The number of studies investigating PTSD among critical illness survivors has doubled since the publication of prior reviews [in 2007 and 2008]," said Dr. Parker, who is a fellow in pulmonary and critical care medicine at Johns Hopkins University, Baltimore. "With these additional publications, there is greater similarity between studies regarding the timing of and instruments used for PTSD symptom assessment. As a result, we provide the first meta-analysis yielding a pooled prevalence of clinically important PTSD symptoms."

The researchers evaluated the databases from inception through July 15, 2012, for studies that included adult ICU survivors, used a validated PTSD instrument 1 month or more post-ICU discharge, focused on general ICU populations, and included at least 10 patients with substantial PTSD symptoms. In all, 28 articles on 25 unique cohorts representing a total of 3,437 patients were identified. The most common validated PTSD instrument used in the studies was the Impact of Events Scale (IES), a scoring system that ranges from 0-75, with higher scores indicating greater symptoms.

Dr. Parker reported that among 429 patients who were assessed 1-6 months post-ICU discharge, the pooled mean IES score was 19 and the pooled prevalence of clinically important PTSD symptoms ranged from 23% to 42%. Among 698 patients who were assessed 7-12 months post-ICU discharge, the pooled mean IES score was 17 and the pooled prevalence of clinically important PTSD symptoms ranged from 17% to 34%. In other studies the prevalence of PTSD symptoms ranged from 5% to 62%.

Risk factors for PTSD in critical illness survivors included patient-specific factors, such as younger age and preexisting mental health disorders, as well as ICU-specific factors, including sedation with benzodiazepines and memories of "frightening" experiences in the ICU. In addition, PTSD symptoms were associated with worse quality of life.

"It seems that patients’ memories of their ICU experiences after ICU discharge may play a more important role than the duration of their stay in the ICU or the severity of their illness," Dr. Parker said. "Patients who recalled ‘frightening’ memories were more likely to have substantial PTSD symptoms. These memories may be related to delirium in the ICU, but few studies have attempted to evaluate this theory. There are very few interventions with proven efficacy for reducing PTSD symptoms in critical illness survivors. One intervention that has shown promising results in two European studies is the ICU diary, which has not been rigorously evaluated in North America."

She acknowledged certain limitations of the study, including the fact that differences between studies regarding sample populations and PTSD symptom instruments "make direct comparison difficult. However, the use of meta-analysis to pool the results of the 10 studies using the IES for PTSD symptom assessment strengthens the assertion that PTSD symptoms are highly prevalent among general critical illness survivors."

Neither Dr. Parker nor her associates had relevant financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – About one-fourth of survivors after critical illness are substantially affected by symptoms of posttraumatic stress syndrome up to 1 year after discharge from the ICU, results from a large meta-analysis demonstrated.

"This incidence is as high as PTSD following other traumatic exposures, such as wartime combat," Dr. Ann Parker said in an interview in advance of an international conference of the American Thoracic Society, where the research was presented. "It is important for clinicians to recognize that patients with preexisting psychological symptoms, receiving benzodiazepines for sedation in the ICU or reporting memories of ‘frightening’ ICU experiences are at increased risk of developing PTSD following critical illness."

In a study led by Dr. Dale M. Needham, medical director of Johns Hopkins University’s critical care physical medicine and rehabilitation program, Dr. Parker and fellow first author Dr. Thiti Sricharoenchai searched PubMed and four other databases to perform a systematic review and meta-analysis of the prevalence of and risk factors for PTSD in survivors of critical illness.

"The number of studies investigating PTSD among critical illness survivors has doubled since the publication of prior reviews [in 2007 and 2008]," said Dr. Parker, who is a fellow in pulmonary and critical care medicine at Johns Hopkins University, Baltimore. "With these additional publications, there is greater similarity between studies regarding the timing of and instruments used for PTSD symptom assessment. As a result, we provide the first meta-analysis yielding a pooled prevalence of clinically important PTSD symptoms."

The researchers evaluated the databases from inception through July 15, 2012, for studies that included adult ICU survivors, used a validated PTSD instrument 1 month or more post-ICU discharge, focused on general ICU populations, and included at least 10 patients with substantial PTSD symptoms. In all, 28 articles on 25 unique cohorts representing a total of 3,437 patients were identified. The most common validated PTSD instrument used in the studies was the Impact of Events Scale (IES), a scoring system that ranges from 0-75, with higher scores indicating greater symptoms.

Dr. Parker reported that among 429 patients who were assessed 1-6 months post-ICU discharge, the pooled mean IES score was 19 and the pooled prevalence of clinically important PTSD symptoms ranged from 23% to 42%. Among 698 patients who were assessed 7-12 months post-ICU discharge, the pooled mean IES score was 17 and the pooled prevalence of clinically important PTSD symptoms ranged from 17% to 34%. In other studies the prevalence of PTSD symptoms ranged from 5% to 62%.

Risk factors for PTSD in critical illness survivors included patient-specific factors, such as younger age and preexisting mental health disorders, as well as ICU-specific factors, including sedation with benzodiazepines and memories of "frightening" experiences in the ICU. In addition, PTSD symptoms were associated with worse quality of life.

"It seems that patients’ memories of their ICU experiences after ICU discharge may play a more important role than the duration of their stay in the ICU or the severity of their illness," Dr. Parker said. "Patients who recalled ‘frightening’ memories were more likely to have substantial PTSD symptoms. These memories may be related to delirium in the ICU, but few studies have attempted to evaluate this theory. There are very few interventions with proven efficacy for reducing PTSD symptoms in critical illness survivors. One intervention that has shown promising results in two European studies is the ICU diary, which has not been rigorously evaluated in North America."

She acknowledged certain limitations of the study, including the fact that differences between studies regarding sample populations and PTSD symptom instruments "make direct comparison difficult. However, the use of meta-analysis to pool the results of the 10 studies using the IES for PTSD symptom assessment strengthens the assertion that PTSD symptoms are highly prevalent among general critical illness survivors."

Neither Dr. Parker nor her associates had relevant financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – About one-fourth of survivors after critical illness are substantially affected by symptoms of posttraumatic stress syndrome up to 1 year after discharge from the ICU, results from a large meta-analysis demonstrated.

"This incidence is as high as PTSD following other traumatic exposures, such as wartime combat," Dr. Ann Parker said in an interview in advance of an international conference of the American Thoracic Society, where the research was presented. "It is important for clinicians to recognize that patients with preexisting psychological symptoms, receiving benzodiazepines for sedation in the ICU or reporting memories of ‘frightening’ ICU experiences are at increased risk of developing PTSD following critical illness."

In a study led by Dr. Dale M. Needham, medical director of Johns Hopkins University’s critical care physical medicine and rehabilitation program, Dr. Parker and fellow first author Dr. Thiti Sricharoenchai searched PubMed and four other databases to perform a systematic review and meta-analysis of the prevalence of and risk factors for PTSD in survivors of critical illness.

"The number of studies investigating PTSD among critical illness survivors has doubled since the publication of prior reviews [in 2007 and 2008]," said Dr. Parker, who is a fellow in pulmonary and critical care medicine at Johns Hopkins University, Baltimore. "With these additional publications, there is greater similarity between studies regarding the timing of and instruments used for PTSD symptom assessment. As a result, we provide the first meta-analysis yielding a pooled prevalence of clinically important PTSD symptoms."

The researchers evaluated the databases from inception through July 15, 2012, for studies that included adult ICU survivors, used a validated PTSD instrument 1 month or more post-ICU discharge, focused on general ICU populations, and included at least 10 patients with substantial PTSD symptoms. In all, 28 articles on 25 unique cohorts representing a total of 3,437 patients were identified. The most common validated PTSD instrument used in the studies was the Impact of Events Scale (IES), a scoring system that ranges from 0-75, with higher scores indicating greater symptoms.

Dr. Parker reported that among 429 patients who were assessed 1-6 months post-ICU discharge, the pooled mean IES score was 19 and the pooled prevalence of clinically important PTSD symptoms ranged from 23% to 42%. Among 698 patients who were assessed 7-12 months post-ICU discharge, the pooled mean IES score was 17 and the pooled prevalence of clinically important PTSD symptoms ranged from 17% to 34%. In other studies the prevalence of PTSD symptoms ranged from 5% to 62%.

Risk factors for PTSD in critical illness survivors included patient-specific factors, such as younger age and preexisting mental health disorders, as well as ICU-specific factors, including sedation with benzodiazepines and memories of "frightening" experiences in the ICU. In addition, PTSD symptoms were associated with worse quality of life.

"It seems that patients’ memories of their ICU experiences after ICU discharge may play a more important role than the duration of their stay in the ICU or the severity of their illness," Dr. Parker said. "Patients who recalled ‘frightening’ memories were more likely to have substantial PTSD symptoms. These memories may be related to delirium in the ICU, but few studies have attempted to evaluate this theory. There are very few interventions with proven efficacy for reducing PTSD symptoms in critical illness survivors. One intervention that has shown promising results in two European studies is the ICU diary, which has not been rigorously evaluated in North America."

She acknowledged certain limitations of the study, including the fact that differences between studies regarding sample populations and PTSD symptom instruments "make direct comparison difficult. However, the use of meta-analysis to pool the results of the 10 studies using the IES for PTSD symptom assessment strengthens the assertion that PTSD symptoms are highly prevalent among general critical illness survivors."

Neither Dr. Parker nor her associates had relevant financial disclosures.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

LAS VEGAS – In the opinion of Dr. David Cherney, it’s not uncommon for physicians to feel grim about the limited efficacy of available agents to treat chronic kidney disease in patients with type 1 and type 2 diabetes.

Over a 10-year period, about 20% of patients with type I diabetes treated with angiotensin-converting enzyme (ACE) monotherapy still develop progression of their kidney disease, according to Dr. Cherney of the department of medicine at the University of Toronto.

"The diabetic nephroprotection area has been incredibly disappointing in the last 5-8 years," he said at a meeting sponsored by the National Kidney Foundation. "Patients tend to progress despite therapy or have side effects, no matter what we do. Endothelial antagonists cause edema. Protein kinase C beta-antagonists have little therapeutic effect, and antioxidants such as bardoxolone caused serious side effects. None of the drugs that we think will work, based on animal studies, seem to work very well when translated into humans."

Neurohormonal pathway blockade with an ACE inhibitor or an angiotensin II receptor blocker corrects early hemodynamic abnormalities in type 1 diabetes, he noted. "But the effects are partial. Dual, renin-angiotensin-aldosterone system blockade is associated with risk. When we use dual blockade in patients with type 1 diabetes, we’re not able to reduce hyperfiltration. The development of novel and safe renal protective therapies is critical."

Enter sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which over the past decade have demonstrated positive endocrine effects in type 2 diabetes. According to Dr. Cherney, they lower hemoglobin A_1c by about 1% and lead to 2-4 kg of weight loss.

"That’s fantastic, compared with other agents such as insulin that cause weight gain," he said. "That weight loss is sustained for up to 2 years. These agents also seem to have a very low risk of hypoglycemia, and they also lower blood pressure."

Animal models of diabetes have used SGLT2 inhibitors such as empagliflozin (developed by Boehringer Ingelheim and Eli Lilly) to demonstrate a decline in hyperfiltration, a decrease in proteinuria, and a decrease in the structural evidence of nephropathy on histology. An SGLT2 inhibitor might offer renal protection in humans with diabetes by blocking sodium reabsorption proximally, restoring distal delivery, and normalizing afferent tone and glomerular filtration rate (GFR), Dr. Cherney said.

He and his associates conducted an open-label, pilot trial of empagliflozin in patients with type 1 diabetes, known as the ATIRMA study. The objectives were to assess the impact of empagliflozin on GFR under controlled conditions of euglycemia and hyperglycemia in type 1 diabetes patients with and without hyperfiltration, as well as to examine its safety and efficacy as an add-on therapy to insulin (Circulation 2014;129:587-97).

"We hypothesized that we would reduce hyperfiltration and improve glycemic parameters in type 1 diabetes," Dr. Cherney said. In all, 40 patients with a mean age of 25 years were screened and underwent a 2-week run-in period, then took empagliflozin 25 mg once daily for 8 weeks. There were 13 patients in the normofiltration group and 27 patients in the hyperfiltration group.

At the end of 8 weeks, patients in the hyperfiltration group had a dramatic increase in 24-hour urinary glucose excretion, to 140 g/day, "which is about twice what you see in the type 2 studies," he said. "They had very dramatic tubular flow response."

Patients in the hyperfiltration group also had a 20% reduction in their hyperfiltration, a fall in hyperperfusion, an increase in renal vascular resistance, and a small reduction in blood pressure. The researchers also observed a 0.4% reduction in HbA_1c, "which was highly statistically significant," Dr. Cherney said. "We also saw that weight and waist circumference decreased, fasting capillary glucose improved significantly, and their insulin doses decreased. As a consequence, they had less hypoglycemia."

How does this compare to currently used agents? ACE inhibitors reduce hyperfiltration by about 19.7%, Dr. Cheney said, while empagliflozin decreased hyperfiltration by 19.2% – almost an identical effect.

"But remember, ACE inhibitors are associated with hyperkalemia, acute kidney injury, and other potential side effects," he noted. SGLT2 inhibitors "don’t cause hyperkalemia. They don’t cause acute kidney injury, as far as we know. And as far as we know, they don’t have any important interactions with other RAAS inhibitors."

Dr. Cherney characterized the findings from ATIRMA as "promising first steps.

"We’ve been tricked many times before with other drugs," he noted. "We can’t by any means say that this is conclusive, but we need to have long-term renal protection studies to prove their relevance. I think we can clearly say that renal studies are warranted in type 1 and type 2 diabetes."

Research is also needed to assess the interaction between SGLT2 inhibitors and other RAAS inhibitors, Dr. Cherney added, as well as how they provide primary and secondary preventive therapy in type 1 and type 2 diabetes.

Dr. Cherney disclosed that he has received research funding, consulting fees, and speaker honoraria from Boehringer Ingelheim. He has also received research funding from Astellas, consulting fees from Janssen and Astellas, and speaker honoraria from Janssen.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Between 1999 and 2010, age-adjusted deaths from asthma in the United States declined modestly but significantly, deaths from angioedema increased significantly, and deaths from anaphylaxis remained stable.

Those are key findings from an analysis of Centers for Disease Control and Prevention (CDC) data presented by Dr. Susan J. Kim at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Dr. Kim, a first-year allergy fellow at Kaiser Permanente Los Angeles Medical Center, and her associate, Jordan C. Brooks, Ph.D., set out to document the number of deaths in the United States in which asthma or allergy played a role between 1990 and 2010, and to determine if there have been secular trends in the incidence of such deaths. The researchers queried the CDC’s online Multiple Cause of Death compressed mortality file for International Classification of Disease (ICD-10) codes relating to asthma, urticaria, angioedema, and anaphylaxis, and proceeded to calculate age-adjusted death rates for 1999-2004 (early period) and 2005-2010 (late period).

During the overall time period, there were 113,778 deaths from asthma of all types, 908 from angioedema, and 2,448 from anaphylaxis. Dr. Kim reported that the total number of deaths from asthma of all types (including status asthmaticus) dropped from 57,935 in the early period to 55,843 in the late period. This represented a significant decline, from a rate of 3.38 per 100,000 persons to 2.95 per 100,000 persons.

Blacks had a significantly higher rate of mortality from asthma than whites (5.85 per 100,000 persons vs. 2.55 per 100,000 persons). "This racial disparity might be attributed to a discrepancy in access to quality medical care and use of medications," Dr. Kim said.

She went on to note that women had a higher rate of mortality from asthma than men (3.61 per 100,000 vs. 2.56 per 100,000). "This is interesting, because when taking all causes of mortality in the United States – cardiovascular disease, malignancy, et cetera – men have a higher mortality rate," she said. "The cause may be due to estrogen and progesterone’s effects on airway contractility and immune function."

The researchers observed a significant increase in total deaths from angioedema, from 0.0157 per 100,000 persons during the early period to 0.0289 per 100,000 persons during the late period. "Perhaps an explanation is that there is a lack of awareness that life-threatening laryngeal attacks and asphyxiation can occur," Dr. Kim hypothesized.

At the same time, no significant trends in anaphylaxis death occurred between the early and late periods. Overall, the death rate from anaphylaxis was 0.0637 per 100,000, or 0.6 per million people. "This mortality rate remained stable between our two time periods," she said. "Previous estimates have ranged from 0.5 and 5.5 per million people."

Dr. Kim acknowledged certain limitations of the study, including the fact that the CDC database used for the analysis is subject to missing data, variability in coding, and miscoding. "There’s also no way for us to know how race was identified," she said. "It also lacked clinical details, including the sequence of events leading to death, and medication reconciliation."

Dr. Kim had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Between 1999 and 2010, age-adjusted deaths from asthma in the United States declined modestly but significantly, deaths from angioedema increased significantly, and deaths from anaphylaxis remained stable.

Those are key findings from an analysis of Centers for Disease Control and Prevention (CDC) data presented by Dr. Susan J. Kim at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Dr. Kim, a first-year allergy fellow at Kaiser Permanente Los Angeles Medical Center, and her associate, Jordan C. Brooks, Ph.D., set out to document the number of deaths in the United States in which asthma or allergy played a role between 1990 and 2010, and to determine if there have been secular trends in the incidence of such deaths. The researchers queried the CDC’s online Multiple Cause of Death compressed mortality file for International Classification of Disease (ICD-10) codes relating to asthma, urticaria, angioedema, and anaphylaxis, and proceeded to calculate age-adjusted death rates for 1999-2004 (early period) and 2005-2010 (late period).

During the overall time period, there were 113,778 deaths from asthma of all types, 908 from angioedema, and 2,448 from anaphylaxis. Dr. Kim reported that the total number of deaths from asthma of all types (including status asthmaticus) dropped from 57,935 in the early period to 55,843 in the late period. This represented a significant decline, from a rate of 3.38 per 100,000 persons to 2.95 per 100,000 persons.

Blacks had a significantly higher rate of mortality from asthma than whites (5.85 per 100,000 persons vs. 2.55 per 100,000 persons). "This racial disparity might be attributed to a discrepancy in access to quality medical care and use of medications," Dr. Kim said.

She went on to note that women had a higher rate of mortality from asthma than men (3.61 per 100,000 vs. 2.56 per 100,000). "This is interesting, because when taking all causes of mortality in the United States – cardiovascular disease, malignancy, et cetera – men have a higher mortality rate," she said. "The cause may be due to estrogen and progesterone’s effects on airway contractility and immune function."

The researchers observed a significant increase in total deaths from angioedema, from 0.0157 per 100,000 persons during the early period to 0.0289 per 100,000 persons during the late period. "Perhaps an explanation is that there is a lack of awareness that life-threatening laryngeal attacks and asphyxiation can occur," Dr. Kim hypothesized.

At the same time, no significant trends in anaphylaxis death occurred between the early and late periods. Overall, the death rate from anaphylaxis was 0.0637 per 100,000, or 0.6 per million people. "This mortality rate remained stable between our two time periods," she said. "Previous estimates have ranged from 0.5 and 5.5 per million people."

Dr. Kim acknowledged certain limitations of the study, including the fact that the CDC database used for the analysis is subject to missing data, variability in coding, and miscoding. "There’s also no way for us to know how race was identified," she said. "It also lacked clinical details, including the sequence of events leading to death, and medication reconciliation."

Dr. Kim had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Between 1999 and 2010, age-adjusted deaths from asthma in the United States declined modestly but significantly, deaths from angioedema increased significantly, and deaths from anaphylaxis remained stable.

Those are key findings from an analysis of Centers for Disease Control and Prevention (CDC) data presented by Dr. Susan J. Kim at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Dr. Kim, a first-year allergy fellow at Kaiser Permanente Los Angeles Medical Center, and her associate, Jordan C. Brooks, Ph.D., set out to document the number of deaths in the United States in which asthma or allergy played a role between 1990 and 2010, and to determine if there have been secular trends in the incidence of such deaths. The researchers queried the CDC’s online Multiple Cause of Death compressed mortality file for International Classification of Disease (ICD-10) codes relating to asthma, urticaria, angioedema, and anaphylaxis, and proceeded to calculate age-adjusted death rates for 1999-2004 (early period) and 2005-2010 (late period).

During the overall time period, there were 113,778 deaths from asthma of all types, 908 from angioedema, and 2,448 from anaphylaxis. Dr. Kim reported that the total number of deaths from asthma of all types (including status asthmaticus) dropped from 57,935 in the early period to 55,843 in the late period. This represented a significant decline, from a rate of 3.38 per 100,000 persons to 2.95 per 100,000 persons.

Blacks had a significantly higher rate of mortality from asthma than whites (5.85 per 100,000 persons vs. 2.55 per 100,000 persons). "This racial disparity might be attributed to a discrepancy in access to quality medical care and use of medications," Dr. Kim said.

She went on to note that women had a higher rate of mortality from asthma than men (3.61 per 100,000 vs. 2.56 per 100,000). "This is interesting, because when taking all causes of mortality in the United States – cardiovascular disease, malignancy, et cetera – men have a higher mortality rate," she said. "The cause may be due to estrogen and progesterone’s effects on airway contractility and immune function."

The researchers observed a significant increase in total deaths from angioedema, from 0.0157 per 100,000 persons during the early period to 0.0289 per 100,000 persons during the late period. "Perhaps an explanation is that there is a lack of awareness that life-threatening laryngeal attacks and asphyxiation can occur," Dr. Kim hypothesized.

At the same time, no significant trends in anaphylaxis death occurred between the early and late periods. Overall, the death rate from anaphylaxis was 0.0637 per 100,000, or 0.6 per million people. "This mortality rate remained stable between our two time periods," she said. "Previous estimates have ranged from 0.5 and 5.5 per million people."

Dr. Kim acknowledged certain limitations of the study, including the fact that the CDC database used for the analysis is subject to missing data, variability in coding, and miscoding. "There’s also no way for us to know how race was identified," she said. "It also lacked clinical details, including the sequence of events leading to death, and medication reconciliation."

Dr. Kim had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – Slightly more than half of primary care physicians reported being unfamiliar with 14-year-old guidelines on nondiabetic chronic kidney disease, but 75% said they were willing to improve how they cared for patients with the condition, results from a Web-based survey showed.

Most non–dialysis-dependent chronic kidney disease (CKD) patients are cared for by their primary care physicians (PCPs). Studies suggest many CKD patients receive suboptimal care. Recently, CKD clinical practice guidelines were updated with additional emphasis on albuminuria, according to a report published in advance of its presentation by Dr. Khaled Abdel-Kader at a meeting sponsored by the National Kidney Foundation.

"Rigorous studies are needed to help identify systematic interventions that can overcome identified barriers and improve optimal CKD care delivery," Dr. Abdel-Kader said in an interview following his presentation. "Based on our findings, while overcoming knowledge deficits and attitudinal barriers remains important, many primary care physicians set appropriate care goals in CKD, but systems are needed to help them and their patients achieve these goals," (BMC Nephrol. 2014 April 22 [doi:10.1186/1471-2369-15-64]).

Dr. Neil Skolnik noted that CKD is an incredibly important topic, affecting more than 15% of the U.S. population. "This is an excellent study with a very good response rate for an e-mail survey, indicating that primary care physicians are interested in the care of patients with CKD.

"This interest is reflected in the answers provided on the survey. With half of primary care physicians unfamiliar with the CKD guidelines, and 75% expressing interest in improving their care of patients with CKD, the next step should focus on how to best disseminate information about the guidelines and provide tools for primary care physicians to best implement the guidelines," said Dr. Skolnik, who is professor of family and community medicine at Temple University, Philadelphia.

Dr. Abdel-Kader and his associates used data from the American Medical Association to conduct a cross-sectional, Web-based survey of PCPs in the United States in an effort to explore their understanding of CKD guidelines, self-reported practice behaviors, and barriers to implementing guideline recommendations, including albuminuria testing. The National Kidney Foundation issued its most recent update to its guidelines in 2000.

Of the 848 PCPs who opened an e-mail about the study, 165 (19.5%) responded. The majority of respondents (88%) spent at least half of their time in clinical care, and 46% were in private practice, said Dr. Abdel-Kader of the department of medicine at Vanderbilt University in Nashville, Tenn.

Nearly all respondents (96%) felt that glomerular filtration rate (GFR) values were helpful, while 75% and 91% reported testing for albuminuria in nondiabetic hypertensive patients with an estimated GFR (eGFR) of greater than 60 mL/min per 1.73 m² or less than 60 mL/min per 1.73 m², respectively. "However, frequent barriers cited included a lack of effect on management, limited time, and the perceived absence of guidelines recommending albuminuria testing," Dr. Abdel-Kader said.

"While PCPs expressed very high agreement with the definition of CKD in patients with marked decrements in eGFR (eGFR less than 45 mL/min per 1.73 m²) or decrements in eGFR coupled with albuminuria, agreement was less robust when eGFR was greater than 60 mL/min per 1.73 m² or in CKD stage 3a without albuminuria."

Most respondents (an average of 78%) felt that angiotensin-converting enzyme inhibitors and angiotensin receptor blockers improved outcomes in patients with CKD, yet agreement was lower with severe vs. moderate albuminuria (78% vs. 85%, respectively; P = .03).

Slightly more than half of primary care physicians (51%) reported being unfamiliar with chronic kidney disease guidelines, yet 75% were receptive to systematic interventions in addition to CME to improve their care of CKD patients. "The importance of albuminuria in CKD has become a point of emphasis in guidelines relatively recently, and its value in CKD may not be clearly understood by many PCPs," Dr. Abdel-Kader said. "This is likely contributing to suboptimal targeting of CKD treatments in high-risk and low-risk patients. Working with PCPs to develop systematic interventions that help streamline and improve CKD care without disrupting work flow may have significant potential to improve CKD patient care."

The survey did have certain limitations, including its low response rate, he said. "Our respondents were younger and more likely to be internists than the PCPs we targeted," he noted. "Prior studies have shown that these characteristics tend to associate with greater familiarity with CKD guidelines and recommendations. Hence, recognition of CKD and guideline familiarity may be lower in the general PCP community than we document in our survey."

The study was supported by the National Institutes of Health. Dr. Abdel-Kader said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – Slightly more than half of primary care physicians reported being unfamiliar with 14-year-old guidelines on nondiabetic chronic kidney disease, but 75% said they were willing to improve how they cared for patients with the condition, results from a Web-based survey showed.

Most non–dialysis-dependent chronic kidney disease (CKD) patients are cared for by their primary care physicians (PCPs). Studies suggest many CKD patients receive suboptimal care. Recently, CKD clinical practice guidelines were updated with additional emphasis on albuminuria, according to a report published in advance of its presentation by Dr. Khaled Abdel-Kader at a meeting sponsored by the National Kidney Foundation.

"Rigorous studies are needed to help identify systematic interventions that can overcome identified barriers and improve optimal CKD care delivery," Dr. Abdel-Kader said in an interview following his presentation. "Based on our findings, while overcoming knowledge deficits and attitudinal barriers remains important, many primary care physicians set appropriate care goals in CKD, but systems are needed to help them and their patients achieve these goals," (BMC Nephrol. 2014 April 22 [doi:10.1186/1471-2369-15-64]).

Dr. Neil Skolnik noted that CKD is an incredibly important topic, affecting more than 15% of the U.S. population. "This is an excellent study with a very good response rate for an e-mail survey, indicating that primary care physicians are interested in the care of patients with CKD.

"This interest is reflected in the answers provided on the survey. With half of primary care physicians unfamiliar with the CKD guidelines, and 75% expressing interest in improving their care of patients with CKD, the next step should focus on how to best disseminate information about the guidelines and provide tools for primary care physicians to best implement the guidelines," said Dr. Skolnik, who is professor of family and community medicine at Temple University, Philadelphia.

Dr. Abdel-Kader and his associates used data from the American Medical Association to conduct a cross-sectional, Web-based survey of PCPs in the United States in an effort to explore their understanding of CKD guidelines, self-reported practice behaviors, and barriers to implementing guideline recommendations, including albuminuria testing. The National Kidney Foundation issued its most recent update to its guidelines in 2000.

Of the 848 PCPs who opened an e-mail about the study, 165 (19.5%) responded. The majority of respondents (88%) spent at least half of their time in clinical care, and 46% were in private practice, said Dr. Abdel-Kader of the department of medicine at Vanderbilt University in Nashville, Tenn.

Nearly all respondents (96%) felt that glomerular filtration rate (GFR) values were helpful, while 75% and 91% reported testing for albuminuria in nondiabetic hypertensive patients with an estimated GFR (eGFR) of greater than 60 mL/min per 1.73 m² or less than 60 mL/min per 1.73 m², respectively. "However, frequent barriers cited included a lack of effect on management, limited time, and the perceived absence of guidelines recommending albuminuria testing," Dr. Abdel-Kader said.

"While PCPs expressed very high agreement with the definition of CKD in patients with marked decrements in eGFR (eGFR less than 45 mL/min per 1.73 m²) or decrements in eGFR coupled with albuminuria, agreement was less robust when eGFR was greater than 60 mL/min per 1.73 m² or in CKD stage 3a without albuminuria."

Most respondents (an average of 78%) felt that angiotensin-converting enzyme inhibitors and angiotensin receptor blockers improved outcomes in patients with CKD, yet agreement was lower with severe vs. moderate albuminuria (78% vs. 85%, respectively; P = .03).

Slightly more than half of primary care physicians (51%) reported being unfamiliar with chronic kidney disease guidelines, yet 75% were receptive to systematic interventions in addition to CME to improve their care of CKD patients. "The importance of albuminuria in CKD has become a point of emphasis in guidelines relatively recently, and its value in CKD may not be clearly understood by many PCPs," Dr. Abdel-Kader said. "This is likely contributing to suboptimal targeting of CKD treatments in high-risk and low-risk patients. Working with PCPs to develop systematic interventions that help streamline and improve CKD care without disrupting work flow may have significant potential to improve CKD patient care."

The survey did have certain limitations, including its low response rate, he said. "Our respondents were younger and more likely to be internists than the PCPs we targeted," he noted. "Prior studies have shown that these characteristics tend to associate with greater familiarity with CKD guidelines and recommendations. Hence, recognition of CKD and guideline familiarity may be lower in the general PCP community than we document in our survey."

The study was supported by the National Institutes of Health. Dr. Abdel-Kader said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – Slightly more than half of primary care physicians reported being unfamiliar with 14-year-old guidelines on nondiabetic chronic kidney disease, but 75% said they were willing to improve how they cared for patients with the condition, results from a Web-based survey showed.

Most non–dialysis-dependent chronic kidney disease (CKD) patients are cared for by their primary care physicians (PCPs). Studies suggest many CKD patients receive suboptimal care. Recently, CKD clinical practice guidelines were updated with additional emphasis on albuminuria, according to a report published in advance of its presentation by Dr. Khaled Abdel-Kader at a meeting sponsored by the National Kidney Foundation.

"Rigorous studies are needed to help identify systematic interventions that can overcome identified barriers and improve optimal CKD care delivery," Dr. Abdel-Kader said in an interview following his presentation. "Based on our findings, while overcoming knowledge deficits and attitudinal barriers remains important, many primary care physicians set appropriate care goals in CKD, but systems are needed to help them and their patients achieve these goals," (BMC Nephrol. 2014 April 22 [doi:10.1186/1471-2369-15-64]).

Dr. Neil Skolnik noted that CKD is an incredibly important topic, affecting more than 15% of the U.S. population. "This is an excellent study with a very good response rate for an e-mail survey, indicating that primary care physicians are interested in the care of patients with CKD.

"This interest is reflected in the answers provided on the survey. With half of primary care physicians unfamiliar with the CKD guidelines, and 75% expressing interest in improving their care of patients with CKD, the next step should focus on how to best disseminate information about the guidelines and provide tools for primary care physicians to best implement the guidelines," said Dr. Skolnik, who is professor of family and community medicine at Temple University, Philadelphia.

Dr. Abdel-Kader and his associates used data from the American Medical Association to conduct a cross-sectional, Web-based survey of PCPs in the United States in an effort to explore their understanding of CKD guidelines, self-reported practice behaviors, and barriers to implementing guideline recommendations, including albuminuria testing. The National Kidney Foundation issued its most recent update to its guidelines in 2000.

Of the 848 PCPs who opened an e-mail about the study, 165 (19.5%) responded. The majority of respondents (88%) spent at least half of their time in clinical care, and 46% were in private practice, said Dr. Abdel-Kader of the department of medicine at Vanderbilt University in Nashville, Tenn.

Nearly all respondents (96%) felt that glomerular filtration rate (GFR) values were helpful, while 75% and 91% reported testing for albuminuria in nondiabetic hypertensive patients with an estimated GFR (eGFR) of greater than 60 mL/min per 1.73 m² or less than 60 mL/min per 1.73 m², respectively. "However, frequent barriers cited included a lack of effect on management, limited time, and the perceived absence of guidelines recommending albuminuria testing," Dr. Abdel-Kader said.

"While PCPs expressed very high agreement with the definition of CKD in patients with marked decrements in eGFR (eGFR less than 45 mL/min per 1.73 m²) or decrements in eGFR coupled with albuminuria, agreement was less robust when eGFR was greater than 60 mL/min per 1.73 m² or in CKD stage 3a without albuminuria."

Most respondents (an average of 78%) felt that angiotensin-converting enzyme inhibitors and angiotensin receptor blockers improved outcomes in patients with CKD, yet agreement was lower with severe vs. moderate albuminuria (78% vs. 85%, respectively; P = .03).

Slightly more than half of primary care physicians (51%) reported being unfamiliar with chronic kidney disease guidelines, yet 75% were receptive to systematic interventions in addition to CME to improve their care of CKD patients. "The importance of albuminuria in CKD has become a point of emphasis in guidelines relatively recently, and its value in CKD may not be clearly understood by many PCPs," Dr. Abdel-Kader said. "This is likely contributing to suboptimal targeting of CKD treatments in high-risk and low-risk patients. Working with PCPs to develop systematic interventions that help streamline and improve CKD care without disrupting work flow may have significant potential to improve CKD patient care."

The survey did have certain limitations, including its low response rate, he said. "Our respondents were younger and more likely to be internists than the PCPs we targeted," he noted. "Prior studies have shown that these characteristics tend to associate with greater familiarity with CKD guidelines and recommendations. Hence, recognition of CKD and guideline familiarity may be lower in the general PCP community than we document in our survey."

The study was supported by the National Institutes of Health. Dr. Abdel-Kader said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

LAS VEGAS – The majority of patients with proteinuria who are admitted to hospitals affiliated with academic medical centers are not placed on life-prolonging therapy, results from a small study showed.

In addition, the 41% of patients with the condition were taking NSAIDS, which can worsen kidney function.

Image courtesy of Dr. Javier Neyra

"Recognizing proteinuria and initiating the appropriate treatment are extremely important," Dr. Vishesh Kumar, a resident physician at Albany (N.Y.) Medical College, said in an interview following a meeting sponsored by the National Kidney Foundation, where the study was presented.

"If left untreated, proteinuria has been associated with cardiovascular mortality and progression of kidney disease. Both are very poor outcomes, and both can be either slowed in their onset, or in some cases prevented altogether. Our study has shed some light onto the scope of the problem."

Dr. Kumar, along with Dr. Arif Asif, professor of medicine at the medical college, and their associates conducted a multicenter retrospective study that set out to identify patients admitted to the hospital service with proteinuria and to establish whether they were optimally treated. "We know that it is easy to screen for proteinuria using a simple urine dipstick," he said. "We also have several antiproteinuric agents [to use] such as ACE [angiotensin-converting enzyme] inhibitors, angiotensin II receptor blockers, spironolactone, diltiazem, and verapamil. These medications have been shown in landmark trials in nephrology to help to reduce proteinuria, improve cardiovascular mortality, and slow the progression of kidney disease."

The study population included 298 patients (mean age, 60 years) who were admitted to two hospitals over a 6-month period. Of the 298 patients, 199 (66%) were confirmed to have proteinuria. Of these, 74 (37%) were treated with an antiproteinuric agent, and 81 (41%) were taking NSAIDs. Dr. Kumar said that he and his colleagues were very surprised "by the fact that many patients with proteinuria were taking NSAIDs, which can worsen proteinuria, and many of which are available over the counter. We have a huge opportunity for improvement of care in these patients."

He also reported that 63 of the patients (32%) had proteinuria and hypertension. Among this subset of patients, only 27 (43%) received an antiproteinuric agent.

Dr. Kumar acknowledged that certain limitations of the study, including its small sample size and the fact that "we did not collect any data involving these patients’ primary care. One could generalize that patients that come into hospital may not have as good a relationship with primary care providers and may not be screened with a urine analysis as an outpatient as frequently. Many of these things can be addressed in future studies."

The researchers reported having no financial conflicts of interest.

LAS VEGAS – The majority of patients with proteinuria who are admitted to hospitals affiliated with academic medical centers are not placed on life-prolonging therapy, results from a small study showed.

In addition, the 41% of patients with the condition were taking NSAIDS, which can worsen kidney function.

Image courtesy of Dr. Javier Neyra

"Recognizing proteinuria and initiating the appropriate treatment are extremely important," Dr. Vishesh Kumar, a resident physician at Albany (N.Y.) Medical College, said in an interview following a meeting sponsored by the National Kidney Foundation, where the study was presented.

"If left untreated, proteinuria has been associated with cardiovascular mortality and progression of kidney disease. Both are very poor outcomes, and both can be either slowed in their onset, or in some cases prevented altogether. Our study has shed some light onto the scope of the problem."

Dr. Kumar, along with Dr. Arif Asif, professor of medicine at the medical college, and their associates conducted a multicenter retrospective study that set out to identify patients admitted to the hospital service with proteinuria and to establish whether they were optimally treated. "We know that it is easy to screen for proteinuria using a simple urine dipstick," he said. "We also have several antiproteinuric agents [to use] such as ACE [angiotensin-converting enzyme] inhibitors, angiotensin II receptor blockers, spironolactone, diltiazem, and verapamil. These medications have been shown in landmark trials in nephrology to help to reduce proteinuria, improve cardiovascular mortality, and slow the progression of kidney disease."

The study population included 298 patients (mean age, 60 years) who were admitted to two hospitals over a 6-month period. Of the 298 patients, 199 (66%) were confirmed to have proteinuria. Of these, 74 (37%) were treated with an antiproteinuric agent, and 81 (41%) were taking NSAIDs. Dr. Kumar said that he and his colleagues were very surprised "by the fact that many patients with proteinuria were taking NSAIDs, which can worsen proteinuria, and many of which are available over the counter. We have a huge opportunity for improvement of care in these patients."

He also reported that 63 of the patients (32%) had proteinuria and hypertension. Among this subset of patients, only 27 (43%) received an antiproteinuric agent.

Dr. Kumar acknowledged that certain limitations of the study, including its small sample size and the fact that "we did not collect any data involving these patients’ primary care. One could generalize that patients that come into hospital may not have as good a relationship with primary care providers and may not be screened with a urine analysis as an outpatient as frequently. Many of these things can be addressed in future studies."

The researchers reported having no financial conflicts of interest.

LAS VEGAS – The majority of patients with proteinuria who are admitted to hospitals affiliated with academic medical centers are not placed on life-prolonging therapy, results from a small study showed.

In addition, the 41% of patients with the condition were taking NSAIDS, which can worsen kidney function.

Image courtesy of Dr. Javier Neyra

"Recognizing proteinuria and initiating the appropriate treatment are extremely important," Dr. Vishesh Kumar, a resident physician at Albany (N.Y.) Medical College, said in an interview following a meeting sponsored by the National Kidney Foundation, where the study was presented.

"If left untreated, proteinuria has been associated with cardiovascular mortality and progression of kidney disease. Both are very poor outcomes, and both can be either slowed in their onset, or in some cases prevented altogether. Our study has shed some light onto the scope of the problem."

Dr. Kumar, along with Dr. Arif Asif, professor of medicine at the medical college, and their associates conducted a multicenter retrospective study that set out to identify patients admitted to the hospital service with proteinuria and to establish whether they were optimally treated. "We know that it is easy to screen for proteinuria using a simple urine dipstick," he said. "We also have several antiproteinuric agents [to use] such as ACE [angiotensin-converting enzyme] inhibitors, angiotensin II receptor blockers, spironolactone, diltiazem, and verapamil. These medications have been shown in landmark trials in nephrology to help to reduce proteinuria, improve cardiovascular mortality, and slow the progression of kidney disease."

The study population included 298 patients (mean age, 60 years) who were admitted to two hospitals over a 6-month period. Of the 298 patients, 199 (66%) were confirmed to have proteinuria. Of these, 74 (37%) were treated with an antiproteinuric agent, and 81 (41%) were taking NSAIDs. Dr. Kumar said that he and his colleagues were very surprised "by the fact that many patients with proteinuria were taking NSAIDs, which can worsen proteinuria, and many of which are available over the counter. We have a huge opportunity for improvement of care in these patients."

He also reported that 63 of the patients (32%) had proteinuria and hypertension. Among this subset of patients, only 27 (43%) received an antiproteinuric agent.

Dr. Kumar acknowledged that certain limitations of the study, including its small sample size and the fact that "we did not collect any data involving these patients’ primary care. One could generalize that patients that come into hospital may not have as good a relationship with primary care providers and may not be screened with a urine analysis as an outpatient as frequently. Many of these things can be addressed in future studies."

The researchers reported having no financial conflicts of interest.

LAS VEGAS – Moderate intake of wine was associated with a 37% lower prevalence of chronic kidney disease in healthy adults, compared with no wine consumption at all, according to an analysis of data from the National Health and Nutrition Examination Survey.

In addition, survey respondents with chronic kidney disease (which increases the risk of cardiovascular disease) who drank less than one glass of wine a day had 29% lower odds of cardiovascular disease, compared with those who drank no wine at all.

"Since this is an observational study and we looked at the data as a cross-sectional analysis, we can’t say that there’s a cause and effect relationship," lead author Dr. Tapan Mehta emphasized in an interview at a meeting sponsored by the National Kidney Foundation. "But this is the first time that [the link between] wine intake and cardiovascular disease risk has been studied in patients who have kidney disease."

Dr. Mehta, of the division of renal disease and hypertension at the University of Colorado Anschutz Medical Center, Aurora, and his associates performed a cross-sectional analysis of 5,852 men and women aged 21 years and older who participated in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2006. The researchers analyzed wine intake in three categories: none, less than one glass per day, and one or more glasses per day. They examined the prevalence of chronic kidney disease (defined as MDRD [Modification of Diet in Renal Disease Study Group] estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² or albumin/creatinine ratio of 30 mg/g or greater) according to wine intake. Next, they examined the relationship between wine intake and cardiovascular disease (CVD), defined as history of angina, myocardial infarction, or stroke.

The mean age of study participants was 48 years, and 52% were female. Of the 5,852 individuals, 2,455 drank less than one glass of wine per day, and 1,031 had kidney disease.

In unadjusted analysis, those who drank less than one glass of wine per day had a 0.63 reduced odds of chronic kidney disease (CKD), compared with those who did not drink wine (P less than .0001). This association remained significant after adjustment for demographics, waist circumference, diabetes, hypertension, HDL cholesterol, and triglycerides (odds ratio, 0.75; P = .004).

The researchers observed that the relationship between wine intake and kidney disease appeared to be driven by a significant association between consumption of less than one glass of wine per day and microalbuminuria, which was defined as an albumin/creatinine ratio of 30 mg/g or greater (OR, 0.62; P = .006). No association between wine intake and an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² was seen. "We didn’t expect that," Dr. Mehta said.

When the analysis was limited to the 1,031 individuals with CKD, the odds of CVD was 0.71 (P =.02) for those drinking less than one glass of wine per day, compared with nondrinkers after adjustment for demographics and CVD risk factors.

Dr. Mehta acknowledged certain limitations of the study, including its observational design and the potential for recall bias in the food intake component of NHANES. "Also, there is no specification as to red wine or white wine consumption," he said. "We also did not look at other alcohol, such as beer or liquor."

Dr. Mehta had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

Doug Brunk/Frontline Medical News

LAS VEGAS – Moderate intake of wine was associated with a 37% lower prevalence of chronic kidney disease in healthy adults, compared with no wine consumption at all, according to an analysis of data from the National Health and Nutrition Examination Survey.

In addition, survey respondents with chronic kidney disease (which increases the risk of cardiovascular disease) who drank less than one glass of wine a day had 29% lower odds of cardiovascular disease, compared with those who drank no wine at all.

"Since this is an observational study and we looked at the data as a cross-sectional analysis, we can’t say that there’s a cause and effect relationship," lead author Dr. Tapan Mehta emphasized in an interview at a meeting sponsored by the National Kidney Foundation. "But this is the first time that [the link between] wine intake and cardiovascular disease risk has been studied in patients who have kidney disease."

Dr. Mehta, of the division of renal disease and hypertension at the University of Colorado Anschutz Medical Center, Aurora, and his associates performed a cross-sectional analysis of 5,852 men and women aged 21 years and older who participated in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2006. The researchers analyzed wine intake in three categories: none, less than one glass per day, and one or more glasses per day. They examined the prevalence of chronic kidney disease (defined as MDRD [Modification of Diet in Renal Disease Study Group] estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² or albumin/creatinine ratio of 30 mg/g or greater) according to wine intake. Next, they examined the relationship between wine intake and cardiovascular disease (CVD), defined as history of angina, myocardial infarction, or stroke.

The mean age of study participants was 48 years, and 52% were female. Of the 5,852 individuals, 2,455 drank less than one glass of wine per day, and 1,031 had kidney disease.

In unadjusted analysis, those who drank less than one glass of wine per day had a 0.63 reduced odds of chronic kidney disease (CKD), compared with those who did not drink wine (P less than .0001). This association remained significant after adjustment for demographics, waist circumference, diabetes, hypertension, HDL cholesterol, and triglycerides (odds ratio, 0.75; P = .004).

The researchers observed that the relationship between wine intake and kidney disease appeared to be driven by a significant association between consumption of less than one glass of wine per day and microalbuminuria, which was defined as an albumin/creatinine ratio of 30 mg/g or greater (OR, 0.62; P = .006). No association between wine intake and an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² was seen. "We didn’t expect that," Dr. Mehta said.

When the analysis was limited to the 1,031 individuals with CKD, the odds of CVD was 0.71 (P =.02) for those drinking less than one glass of wine per day, compared with nondrinkers after adjustment for demographics and CVD risk factors.

Dr. Mehta acknowledged certain limitations of the study, including its observational design and the potential for recall bias in the food intake component of NHANES. "Also, there is no specification as to red wine or white wine consumption," he said. "We also did not look at other alcohol, such as beer or liquor."

Dr. Mehta had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

Doug Brunk/Frontline Medical News

LAS VEGAS – Moderate intake of wine was associated with a 37% lower prevalence of chronic kidney disease in healthy adults, compared with no wine consumption at all, according to an analysis of data from the National Health and Nutrition Examination Survey.

In addition, survey respondents with chronic kidney disease (which increases the risk of cardiovascular disease) who drank less than one glass of wine a day had 29% lower odds of cardiovascular disease, compared with those who drank no wine at all.

"Since this is an observational study and we looked at the data as a cross-sectional analysis, we can’t say that there’s a cause and effect relationship," lead author Dr. Tapan Mehta emphasized in an interview at a meeting sponsored by the National Kidney Foundation. "But this is the first time that [the link between] wine intake and cardiovascular disease risk has been studied in patients who have kidney disease."

Dr. Mehta, of the division of renal disease and hypertension at the University of Colorado Anschutz Medical Center, Aurora, and his associates performed a cross-sectional analysis of 5,852 men and women aged 21 years and older who participated in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2006. The researchers analyzed wine intake in three categories: none, less than one glass per day, and one or more glasses per day. They examined the prevalence of chronic kidney disease (defined as MDRD [Modification of Diet in Renal Disease Study Group] estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² or albumin/creatinine ratio of 30 mg/g or greater) according to wine intake. Next, they examined the relationship between wine intake and cardiovascular disease (CVD), defined as history of angina, myocardial infarction, or stroke.

The mean age of study participants was 48 years, and 52% were female. Of the 5,852 individuals, 2,455 drank less than one glass of wine per day, and 1,031 had kidney disease.

In unadjusted analysis, those who drank less than one glass of wine per day had a 0.63 reduced odds of chronic kidney disease (CKD), compared with those who did not drink wine (P less than .0001). This association remained significant after adjustment for demographics, waist circumference, diabetes, hypertension, HDL cholesterol, and triglycerides (odds ratio, 0.75; P = .004).

The researchers observed that the relationship between wine intake and kidney disease appeared to be driven by a significant association between consumption of less than one glass of wine per day and microalbuminuria, which was defined as an albumin/creatinine ratio of 30 mg/g or greater (OR, 0.62; P = .006). No association between wine intake and an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² was seen. "We didn’t expect that," Dr. Mehta said.

When the analysis was limited to the 1,031 individuals with CKD, the odds of CVD was 0.71 (P =.02) for those drinking less than one glass of wine per day, compared with nondrinkers after adjustment for demographics and CVD risk factors.

Dr. Mehta acknowledged certain limitations of the study, including its observational design and the potential for recall bias in the food intake component of NHANES. "Also, there is no specification as to red wine or white wine consumption," he said. "We also did not look at other alcohol, such as beer or liquor."

Dr. Mehta had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

Doug Brunk/Frontline Medical News

LAS VEGAS – Consuming less than one glass of wine per day may help keep the kidneys healthy and may protect the heart in patients who already have chronic kidney disease, according to an analysis of data from the National Health and Nutrition Examination Survey.

In this video interview from a meeting sponsored by the National Kidney Foundation, Dr. Tapan Mehta, a renal fellow at the University of Colorado, Aurora, highlights the findings and discusses the potential clinical implications.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

LAS VEGAS – Consuming less than one glass of wine per day may help keep the kidneys healthy and may protect the heart in patients who already have chronic kidney disease, according to an analysis of data from the National Health and Nutrition Examination Survey.

In this video interview from a meeting sponsored by the National Kidney Foundation, Dr. Tapan Mehta, a renal fellow at the University of Colorado, Aurora, highlights the findings and discusses the potential clinical implications.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

LAS VEGAS – Consuming less than one glass of wine per day may help keep the kidneys healthy and may protect the heart in patients who already have chronic kidney disease, according to an analysis of data from the National Health and Nutrition Examination Survey.

In this video interview from a meeting sponsored by the National Kidney Foundation, Dr. Tapan Mehta, a renal fellow at the University of Colorado, Aurora, highlights the findings and discusses the potential clinical implications.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk