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Psoriatic arthritis patients face more endocrine comorbidities
MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.
“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.
Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.
They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.
“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).
Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.
The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.
Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.
The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.
Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.
In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.
“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).
“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”
Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.
MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.
“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.
Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.
They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.
“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).
Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.
The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.
Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.
The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.
Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.
In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.
“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).
“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”
Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.
MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.
“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.
Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.
They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.
“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).
Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.
The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.
Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.
The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.
Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.
In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.
“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).
“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”
Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.
AT 2016 GRAPPA ANNUAL MEETING
Key clinical point:Patients with psoriatic disease had a significantly higher prevalence of diabetes mellitus and some other endocrine comorbidities.
Major finding: In a univariate analysis, the risk for Cushing’s disease was notably higher among psoriatic arthritis patients, compared with controls (odds ratio, 5.31).
Data source: Retrospective, cross-sectional comparison of 3,161 patients with psoriatic arthritis and 31,610 matched controls.
Disclosures: Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.
Diabetes prevalence in U.S. adolescents is under 1%
The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.
Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.
Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.
The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.
“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”
The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.
Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).
The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.
Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.
Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.
The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.
“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”
The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.
Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).
The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.
Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.
Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.
The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.
“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”
The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.
Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).
FROM JAMA
Study examines long-term trends in type 2 diabetes medication use
NEW ORLEANS – Treatment options for patients with type 2 diabetes mellitus have increased markedly post metformin therapy, results from a long-term study suggests. However, the proportion of patients who have maintained a hemoglobin A1c level of less than 7% has remained steady since 2008.
“It would seem that further research and guidance for personalized treatment pathways is needed to help patients achieve optimal diabetes control,” lead study author Victoria Higgins said at the annual scientific sessions of the American Diabetes Association.
Ms. Higgins, franchise director at Adelphi Real World, Cheshire, United Kingdom, presented data from the Adelphi Real World Diabetes Disease Specific Program, a cross-sectional, observational study of patients with type 2 diabetes in France, Germany, Italy, Spain, the United Kingdom, and the United States. Patients were older than 18 years of age with a confirmed diagnosis of type 2 diabetes and were prescribed at least one antidiabetic drug and/or insulin. Data were collected from the second quarter of 2000 to the second quarter of 2015, gleaned from face-to-face interviews with 3,555 diabetes specialists and 5,109 primary care physicians (PCPs) and completion of physician-reported forms from consultations with patients with type 2 diabetes. Ms. Higgins reported data from 70,657 patients. Of these, 38,489 consulted with a PCP, while 32,168 consulted with a diabetes specialist.
The researchers found that between 2000 and 2015, the number of PCPs who indicated that they would introduce insulin at an HbA1c level less than 8% fell from 24% to 7%, while among diabetes specialists, it fell from 34% to 7%. In addition, a similar proportion of respondents said they would introduce insulin at an HbA1c of 9% or higher in 2015 (42% of PCPs and 39% of diabetes specialists), than in 2004 (36% of PCPs and 24% of diabetes specialists). The introduction of new therapies – such as DPP-4, and more recently GLP-1 and SGLT2 agents – affected treatment patterns over the time period studied. “The main treatment is noninsulin only, but among specialists, a higher prevalence of patients are on noninsulin plus insulin, as well as insulin only,” Ms. Higgins said. “Also interesting to see is there are still some type 2 diabetics who are still on diet and exercise only.” (In 2015, the proportion on a diet and exercise only–regimen was 10% of patients who consulted with primary care physicians and 6% of patients who consulted with diabetes specialists.)
Between 2000 and 2015, the mean number of drugs per patient rose from 1.4 to 1.7 among those who consulted with PCPs, while the mean number of drugs per patient rose from 1.6 to 2.1 among those who consulted with diabetes specialists. A metformin-only regimen is used more often by PCPs than by diabetes specialists, moving toward a higher polypharmacy among the specialists.
Ms. Higgins and her colleagues also found that while there were improvements in HbA1c levels between 2000 and 2008, there has not been any substantial improvement in HbA1c since that time. In 2008, 48% of patients who consulted with PCPs achieved an HbA1c level of less than 7%, compared with 39% of those who consulted with diabetes care specialists. In 2015, those percentages were 50% and 36%, respectively.* Ms. Higgins reported having no financial disclosures.
*CORRECTION 11/7/16: An earlier version of this article misstated the percentage of patients who consulted with PCPs and achieved an HbA1c level of less than 7%.
NEW ORLEANS – Treatment options for patients with type 2 diabetes mellitus have increased markedly post metformin therapy, results from a long-term study suggests. However, the proportion of patients who have maintained a hemoglobin A1c level of less than 7% has remained steady since 2008.
“It would seem that further research and guidance for personalized treatment pathways is needed to help patients achieve optimal diabetes control,” lead study author Victoria Higgins said at the annual scientific sessions of the American Diabetes Association.
Ms. Higgins, franchise director at Adelphi Real World, Cheshire, United Kingdom, presented data from the Adelphi Real World Diabetes Disease Specific Program, a cross-sectional, observational study of patients with type 2 diabetes in France, Germany, Italy, Spain, the United Kingdom, and the United States. Patients were older than 18 years of age with a confirmed diagnosis of type 2 diabetes and were prescribed at least one antidiabetic drug and/or insulin. Data were collected from the second quarter of 2000 to the second quarter of 2015, gleaned from face-to-face interviews with 3,555 diabetes specialists and 5,109 primary care physicians (PCPs) and completion of physician-reported forms from consultations with patients with type 2 diabetes. Ms. Higgins reported data from 70,657 patients. Of these, 38,489 consulted with a PCP, while 32,168 consulted with a diabetes specialist.
The researchers found that between 2000 and 2015, the number of PCPs who indicated that they would introduce insulin at an HbA1c level less than 8% fell from 24% to 7%, while among diabetes specialists, it fell from 34% to 7%. In addition, a similar proportion of respondents said they would introduce insulin at an HbA1c of 9% or higher in 2015 (42% of PCPs and 39% of diabetes specialists), than in 2004 (36% of PCPs and 24% of diabetes specialists). The introduction of new therapies – such as DPP-4, and more recently GLP-1 and SGLT2 agents – affected treatment patterns over the time period studied. “The main treatment is noninsulin only, but among specialists, a higher prevalence of patients are on noninsulin plus insulin, as well as insulin only,” Ms. Higgins said. “Also interesting to see is there are still some type 2 diabetics who are still on diet and exercise only.” (In 2015, the proportion on a diet and exercise only–regimen was 10% of patients who consulted with primary care physicians and 6% of patients who consulted with diabetes specialists.)
Between 2000 and 2015, the mean number of drugs per patient rose from 1.4 to 1.7 among those who consulted with PCPs, while the mean number of drugs per patient rose from 1.6 to 2.1 among those who consulted with diabetes specialists. A metformin-only regimen is used more often by PCPs than by diabetes specialists, moving toward a higher polypharmacy among the specialists.
Ms. Higgins and her colleagues also found that while there were improvements in HbA1c levels between 2000 and 2008, there has not been any substantial improvement in HbA1c since that time. In 2008, 48% of patients who consulted with PCPs achieved an HbA1c level of less than 7%, compared with 39% of those who consulted with diabetes care specialists. In 2015, those percentages were 50% and 36%, respectively.* Ms. Higgins reported having no financial disclosures.
*CORRECTION 11/7/16: An earlier version of this article misstated the percentage of patients who consulted with PCPs and achieved an HbA1c level of less than 7%.
NEW ORLEANS – Treatment options for patients with type 2 diabetes mellitus have increased markedly post metformin therapy, results from a long-term study suggests. However, the proportion of patients who have maintained a hemoglobin A1c level of less than 7% has remained steady since 2008.
“It would seem that further research and guidance for personalized treatment pathways is needed to help patients achieve optimal diabetes control,” lead study author Victoria Higgins said at the annual scientific sessions of the American Diabetes Association.
Ms. Higgins, franchise director at Adelphi Real World, Cheshire, United Kingdom, presented data from the Adelphi Real World Diabetes Disease Specific Program, a cross-sectional, observational study of patients with type 2 diabetes in France, Germany, Italy, Spain, the United Kingdom, and the United States. Patients were older than 18 years of age with a confirmed diagnosis of type 2 diabetes and were prescribed at least one antidiabetic drug and/or insulin. Data were collected from the second quarter of 2000 to the second quarter of 2015, gleaned from face-to-face interviews with 3,555 diabetes specialists and 5,109 primary care physicians (PCPs) and completion of physician-reported forms from consultations with patients with type 2 diabetes. Ms. Higgins reported data from 70,657 patients. Of these, 38,489 consulted with a PCP, while 32,168 consulted with a diabetes specialist.
The researchers found that between 2000 and 2015, the number of PCPs who indicated that they would introduce insulin at an HbA1c level less than 8% fell from 24% to 7%, while among diabetes specialists, it fell from 34% to 7%. In addition, a similar proportion of respondents said they would introduce insulin at an HbA1c of 9% or higher in 2015 (42% of PCPs and 39% of diabetes specialists), than in 2004 (36% of PCPs and 24% of diabetes specialists). The introduction of new therapies – such as DPP-4, and more recently GLP-1 and SGLT2 agents – affected treatment patterns over the time period studied. “The main treatment is noninsulin only, but among specialists, a higher prevalence of patients are on noninsulin plus insulin, as well as insulin only,” Ms. Higgins said. “Also interesting to see is there are still some type 2 diabetics who are still on diet and exercise only.” (In 2015, the proportion on a diet and exercise only–regimen was 10% of patients who consulted with primary care physicians and 6% of patients who consulted with diabetes specialists.)
Between 2000 and 2015, the mean number of drugs per patient rose from 1.4 to 1.7 among those who consulted with PCPs, while the mean number of drugs per patient rose from 1.6 to 2.1 among those who consulted with diabetes specialists. A metformin-only regimen is used more often by PCPs than by diabetes specialists, moving toward a higher polypharmacy among the specialists.
Ms. Higgins and her colleagues also found that while there were improvements in HbA1c levels between 2000 and 2008, there has not been any substantial improvement in HbA1c since that time. In 2008, 48% of patients who consulted with PCPs achieved an HbA1c level of less than 7%, compared with 39% of those who consulted with diabetes care specialists. In 2015, those percentages were 50% and 36%, respectively.* Ms. Higgins reported having no financial disclosures.
*CORRECTION 11/7/16: An earlier version of this article misstated the percentage of patients who consulted with PCPs and achieved an HbA1c level of less than 7%.
AT THE ADA SCIENTIFIC SESSIONS
Key clinical point: Treatment options for patients with type 2 diabetes have increased markedly since 2000.
Major finding: Between 2000 and 2015, the mean number of drugs per patient rose from 1.4 to 1.7 among those who consulted with primary care physicians, while the mean number of drugs per patient rose from 1.6 to 2.1 among those who consulted with diabetes specialists.
Data source: A cross-sectional study of 38,489 type 2 diabetes patients who consulted with a PCP and 32,168 who consulted with a diabetes specialist between 2000 and 2015.
Disclosures: Ms. Higgins reported having no financial disclosures.
Infections, antibiotics more common in type 2 diabetes
People with type 2 diabetes are up to 55% more likely to experience hospital-treated infections and up to 30% more likely to receive an antibiotic prescription in the community setting, compared with the general population, but these associations moderated over an 8-year period – a phenomenon that could be at least partly related to better treatment of diabetes and an overall improvement in mean blood glucose levels, according to results of a large population-based study.
“These findings may be driven by earlier detection and treatment of milder type 2 diabetes cases over time,” or by improved therapy of hyperglycemia and other risk factors, wrote Anil Mor, MD, of Aarhus University Hospital, Denmark, and his associates (Clin Infect Dis. 2016 June 26. doi: 10.1093/cid/ciw345).
The study ran from 2004 to 2012 and used data from the Danish National Patient Registry. It tracked community- and hospital-treated infections in approximately 774,017 controls; of these, 155,158 had type 2 diabetes. Patients with diabetes were more likely to have serious medical comorbidities compared with controls (29% vs. 21%). These included myocardial infarction (5% vs. 3%), heart failure (4% vs. 2%), cerebrovascular diseases (7% vs. 5%), peripheral vascular diseases (4% vs. 2%), and chronic pulmonary disease (6% vs. 2%).
Over the study period, 62% of the diabetes patients received an antibiotic, compared with 55% of the controls – a 24% increased relative risk in a model that adjusted for factors such as alcohol use, Charlson comorbidity index, and cardiovascular and renal comorbidities. Cephalosporins were the most commonly prescribed drugs, followed by antimycobacterial agents, quinolones, and antibiotics commonly used for urinary tract and Staphylococcus aureus infections.
Hospital-treated infections were significantly more common among patients with diabetes, with 19% having at least one such infection compared with 13% of controls (RR 1.55). On a larger scale, at a median follow-up of 2.8 years, the hospital-treated rate among diabetes patients was 58 per 1,000 person/years vs. 39 per 1,000 person/years among controls – a relative risk of 1.49.
Patients were at highest risk for emphysematous cholecystitis (adjusted rate ratio 1.74) and abscesses, tuberculosis, and meningococcal infections. Pneumonia was approximately 30% more likely among patients.
The risk of a hospital-treated infection was highest among younger patients aged 40-50 years (RR 1.77) and lowest among those older than 80 years (RR 1.29). It was also higher among those with higher comorbidity scores. Statin use appeared to attenuate some of the risk, the authors noted. The authors did not discuss the possible cause of this association.
The annual risk of a hospital-treated infection among patients declined from a high of 1.89 in 2004 to 1.59 in 2011. The risk of receiving a community-based antibiotic prescription declined as well, from 1.31 in 2004 to 1.26 in 2011.
These changes were not seen in the control group, suggesting that patients with diabetes were experiencing a unique improvement in infections – earlier detection and treatment of type 2 diabetes, and better comorbidity management could be explanations, the investigators speculated.
The study was sponsored by the Danish Centre for Strategic Research in Type 2 Diabetes and the Program for Clinical Research Infrastructure established by the Lundbeck Foundation and the Novo Nordisk Foundation. Several of the coauthors reported financial ties with various pharmaceutical companies.
On Twitter @Alz_Gal
People with type 2 diabetes are up to 55% more likely to experience hospital-treated infections and up to 30% more likely to receive an antibiotic prescription in the community setting, compared with the general population, but these associations moderated over an 8-year period – a phenomenon that could be at least partly related to better treatment of diabetes and an overall improvement in mean blood glucose levels, according to results of a large population-based study.
“These findings may be driven by earlier detection and treatment of milder type 2 diabetes cases over time,” or by improved therapy of hyperglycemia and other risk factors, wrote Anil Mor, MD, of Aarhus University Hospital, Denmark, and his associates (Clin Infect Dis. 2016 June 26. doi: 10.1093/cid/ciw345).
The study ran from 2004 to 2012 and used data from the Danish National Patient Registry. It tracked community- and hospital-treated infections in approximately 774,017 controls; of these, 155,158 had type 2 diabetes. Patients with diabetes were more likely to have serious medical comorbidities compared with controls (29% vs. 21%). These included myocardial infarction (5% vs. 3%), heart failure (4% vs. 2%), cerebrovascular diseases (7% vs. 5%), peripheral vascular diseases (4% vs. 2%), and chronic pulmonary disease (6% vs. 2%).
Over the study period, 62% of the diabetes patients received an antibiotic, compared with 55% of the controls – a 24% increased relative risk in a model that adjusted for factors such as alcohol use, Charlson comorbidity index, and cardiovascular and renal comorbidities. Cephalosporins were the most commonly prescribed drugs, followed by antimycobacterial agents, quinolones, and antibiotics commonly used for urinary tract and Staphylococcus aureus infections.
Hospital-treated infections were significantly more common among patients with diabetes, with 19% having at least one such infection compared with 13% of controls (RR 1.55). On a larger scale, at a median follow-up of 2.8 years, the hospital-treated rate among diabetes patients was 58 per 1,000 person/years vs. 39 per 1,000 person/years among controls – a relative risk of 1.49.
Patients were at highest risk for emphysematous cholecystitis (adjusted rate ratio 1.74) and abscesses, tuberculosis, and meningococcal infections. Pneumonia was approximately 30% more likely among patients.
The risk of a hospital-treated infection was highest among younger patients aged 40-50 years (RR 1.77) and lowest among those older than 80 years (RR 1.29). It was also higher among those with higher comorbidity scores. Statin use appeared to attenuate some of the risk, the authors noted. The authors did not discuss the possible cause of this association.
The annual risk of a hospital-treated infection among patients declined from a high of 1.89 in 2004 to 1.59 in 2011. The risk of receiving a community-based antibiotic prescription declined as well, from 1.31 in 2004 to 1.26 in 2011.
These changes were not seen in the control group, suggesting that patients with diabetes were experiencing a unique improvement in infections – earlier detection and treatment of type 2 diabetes, and better comorbidity management could be explanations, the investigators speculated.
The study was sponsored by the Danish Centre for Strategic Research in Type 2 Diabetes and the Program for Clinical Research Infrastructure established by the Lundbeck Foundation and the Novo Nordisk Foundation. Several of the coauthors reported financial ties with various pharmaceutical companies.
On Twitter @Alz_Gal
People with type 2 diabetes are up to 55% more likely to experience hospital-treated infections and up to 30% more likely to receive an antibiotic prescription in the community setting, compared with the general population, but these associations moderated over an 8-year period – a phenomenon that could be at least partly related to better treatment of diabetes and an overall improvement in mean blood glucose levels, according to results of a large population-based study.
“These findings may be driven by earlier detection and treatment of milder type 2 diabetes cases over time,” or by improved therapy of hyperglycemia and other risk factors, wrote Anil Mor, MD, of Aarhus University Hospital, Denmark, and his associates (Clin Infect Dis. 2016 June 26. doi: 10.1093/cid/ciw345).
The study ran from 2004 to 2012 and used data from the Danish National Patient Registry. It tracked community- and hospital-treated infections in approximately 774,017 controls; of these, 155,158 had type 2 diabetes. Patients with diabetes were more likely to have serious medical comorbidities compared with controls (29% vs. 21%). These included myocardial infarction (5% vs. 3%), heart failure (4% vs. 2%), cerebrovascular diseases (7% vs. 5%), peripheral vascular diseases (4% vs. 2%), and chronic pulmonary disease (6% vs. 2%).
Over the study period, 62% of the diabetes patients received an antibiotic, compared with 55% of the controls – a 24% increased relative risk in a model that adjusted for factors such as alcohol use, Charlson comorbidity index, and cardiovascular and renal comorbidities. Cephalosporins were the most commonly prescribed drugs, followed by antimycobacterial agents, quinolones, and antibiotics commonly used for urinary tract and Staphylococcus aureus infections.
Hospital-treated infections were significantly more common among patients with diabetes, with 19% having at least one such infection compared with 13% of controls (RR 1.55). On a larger scale, at a median follow-up of 2.8 years, the hospital-treated rate among diabetes patients was 58 per 1,000 person/years vs. 39 per 1,000 person/years among controls – a relative risk of 1.49.
Patients were at highest risk for emphysematous cholecystitis (adjusted rate ratio 1.74) and abscesses, tuberculosis, and meningococcal infections. Pneumonia was approximately 30% more likely among patients.
The risk of a hospital-treated infection was highest among younger patients aged 40-50 years (RR 1.77) and lowest among those older than 80 years (RR 1.29). It was also higher among those with higher comorbidity scores. Statin use appeared to attenuate some of the risk, the authors noted. The authors did not discuss the possible cause of this association.
The annual risk of a hospital-treated infection among patients declined from a high of 1.89 in 2004 to 1.59 in 2011. The risk of receiving a community-based antibiotic prescription declined as well, from 1.31 in 2004 to 1.26 in 2011.
These changes were not seen in the control group, suggesting that patients with diabetes were experiencing a unique improvement in infections – earlier detection and treatment of type 2 diabetes, and better comorbidity management could be explanations, the investigators speculated.
The study was sponsored by the Danish Centre for Strategic Research in Type 2 Diabetes and the Program for Clinical Research Infrastructure established by the Lundbeck Foundation and the Novo Nordisk Foundation. Several of the coauthors reported financial ties with various pharmaceutical companies.
On Twitter @Alz_Gal
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point: Both hospital-treated infections and community-acquired antibiotics are more common among people with type 2 diabetes
Major finding: Hospital-treated infections were 55% more likely; community-dispensed antibiotics, 30% more common.
Data source: An observational study comprising almost 900,000 people in Denmark.
Disclosures: The study was sponsored by the Danish Centre for Strategic Research in Type 2 Diabetes and the Program for Clinical Research Infrastructure established by the Lundbeck Foundation and the Novo Nordisk Foundation. Several coauthors reported financial ties with various pharmaceutical companies.
Metabolic health declining among the obese, despite improvements in BP and lipids
Despite achieving significant improvements in blood pressure and cholesterol levels, obese Americans continue to grow fatter, with worsening blood glucose and an increasing incidence of diabetes.
From 1998 to 2014, national health data showed that mean diastolic and systolic blood pressures decreased in obese men and women in all racial and ethnic groups. Mean lipid measurements improved as well, including a “marked” 21-mg/dL decrease in total cholesterol and a significant increase in HDL cholesterol.
But markers of blood glucose health continued to decline over the same period, contributing to an overall worsening of metabolic health and a increase from 11% to 19% in the rate of diabetes, Fangjian Guo, MD, and W. Timothy Garvey, MD, reported in July 13 issue of the Journal of the American Heart Association (J Am Heart Assoc. 2016 Jul 13. 5:e003619 doi: 10.1161/JAHA.116.003619).
The rate of obese adults free of these three cardiovascular disease risk factors – diabetes, elevated cholesterol, and blood pressure – remained stable over the study period at about 15%. But the rate of obese adults with all three risk factors increased by 37% over the same period. By 2014, 22% reported having all three of those risk factors.
“The deteriorated blood glucose health among obese adults in the United States calls for lifestyle interventions (diet and exercise) on a national scale,” wrote Dr. Garvey, chair of nutrition science at the University of Alabama, Birmingham. “Community-based public health intervention programs may help increase physical activity and diet quality to alleviate the problem.”
The investigators examined trends in cardiometabolic health among 18,626 obese adults who participated in National Health and Nutrition Examination Surveys from 1988 to 2014. Over this period, mean body mass index increased significantly, from 34.7 to 36 kg/m2. Waist circumference increased as well, from 110 to 114.8 cm.
The picture was much better for blood pressure. Mean systolic pressures decreased about 2 points – from 126.1 to 124.4 mm Hg – in all age, racial and ethnic groups, and in both sexes. Mean diastolic blood pressure also decreased, dropping from 76.6 to 72.5 mm Hg. By 2014, 44% of the men and 51% of the women were below the blood pressure risk threshold.
Lipids also improved over the years, the investigators noted, with significant decreases in mean total cholesterol, from 214.5 to 193.7 mg/dL, and increases in HDL cholesterol, from 45.4 to 47.4 mg/dL.
Blood glucose worsened significantly, however. The mean hemoglobin A1c increased from 5.7% to 5.9%. The measurement rose in all ages, both sexes, and in all racial and ethnic groups except for non-Hispanic blacks.
Perhaps not surprisingly, the incidence of diabetes (a self-reported HbA1c of 6.5% or more) increased from 11% to 19% from 1988 to 2014. The increase occurred in all age groups and both sexes except for young adults aged 20-39 years. No racial or ethnic group was exempt from the increase.
The number of people having all three risk factors (hypertension, hypercholesterolemia, and hyperglycemia) increased from 16% in 1988 to 22% in 2014.
“The increase occurred in parallel with a decline in the prevalence of healthy blood glucose, which is the predominant explanation accounting for the rise in the prevalence of presence of all three risk factors,” the investigators said.
Only 15% of the study population was free from all of these risk factors – a percentage that remained unchanged during 1988-2014.
The findings should be a wake-up call for physicians and their patients, and a national call for action to improve cardiovascular health among obese adults, the team wrote.
“The increasing trend of obese people with all three cardiovascular risk factors, commensurate with a decline in those with one or two risk factors, suggests an overall deterioration in health among people with obesity. ... These patterns of worsening metabolic health constitute an increase in risk of type 2 diabetes mellitus and underlie increasing prevalence rates for diabetes mellitus,” the investigators wrote.
Aggressive treatment will be necessary to reverse these trends. This might include treatment with weight-loss medications in conjunction with lifestyle interventions, which should be especially targeted at obese individuals who are already metabolically unhealthy and in those who have complications or are at risk for developing them.
“In the context of the current data, those obese adults who are metabolically unhealthy or perhaps those with suboptimal metabolic health represent patients who will benefit most from intensive obesity management … coordinated efforts aligning cardiovascular disease prevention and control activities across the public and private sectors in the United States are needed reduce the burden of cardiovascular disease among the obese population,” Dr. Garvey concluded.
The study was supported by the Department of Veterans Affairs, the National Institutes of Health, and the University of Alabama Diabetes Research Center.
Dr. Guo had no financial disclosures. Dr. Garvey disclosed relationships with multiple pharmaceutical companies.
Despite achieving significant improvements in blood pressure and cholesterol levels, obese Americans continue to grow fatter, with worsening blood glucose and an increasing incidence of diabetes.
From 1998 to 2014, national health data showed that mean diastolic and systolic blood pressures decreased in obese men and women in all racial and ethnic groups. Mean lipid measurements improved as well, including a “marked” 21-mg/dL decrease in total cholesterol and a significant increase in HDL cholesterol.
But markers of blood glucose health continued to decline over the same period, contributing to an overall worsening of metabolic health and a increase from 11% to 19% in the rate of diabetes, Fangjian Guo, MD, and W. Timothy Garvey, MD, reported in July 13 issue of the Journal of the American Heart Association (J Am Heart Assoc. 2016 Jul 13. 5:e003619 doi: 10.1161/JAHA.116.003619).
The rate of obese adults free of these three cardiovascular disease risk factors – diabetes, elevated cholesterol, and blood pressure – remained stable over the study period at about 15%. But the rate of obese adults with all three risk factors increased by 37% over the same period. By 2014, 22% reported having all three of those risk factors.
“The deteriorated blood glucose health among obese adults in the United States calls for lifestyle interventions (diet and exercise) on a national scale,” wrote Dr. Garvey, chair of nutrition science at the University of Alabama, Birmingham. “Community-based public health intervention programs may help increase physical activity and diet quality to alleviate the problem.”
The investigators examined trends in cardiometabolic health among 18,626 obese adults who participated in National Health and Nutrition Examination Surveys from 1988 to 2014. Over this period, mean body mass index increased significantly, from 34.7 to 36 kg/m2. Waist circumference increased as well, from 110 to 114.8 cm.
The picture was much better for blood pressure. Mean systolic pressures decreased about 2 points – from 126.1 to 124.4 mm Hg – in all age, racial and ethnic groups, and in both sexes. Mean diastolic blood pressure also decreased, dropping from 76.6 to 72.5 mm Hg. By 2014, 44% of the men and 51% of the women were below the blood pressure risk threshold.
Lipids also improved over the years, the investigators noted, with significant decreases in mean total cholesterol, from 214.5 to 193.7 mg/dL, and increases in HDL cholesterol, from 45.4 to 47.4 mg/dL.
Blood glucose worsened significantly, however. The mean hemoglobin A1c increased from 5.7% to 5.9%. The measurement rose in all ages, both sexes, and in all racial and ethnic groups except for non-Hispanic blacks.
Perhaps not surprisingly, the incidence of diabetes (a self-reported HbA1c of 6.5% or more) increased from 11% to 19% from 1988 to 2014. The increase occurred in all age groups and both sexes except for young adults aged 20-39 years. No racial or ethnic group was exempt from the increase.
The number of people having all three risk factors (hypertension, hypercholesterolemia, and hyperglycemia) increased from 16% in 1988 to 22% in 2014.
“The increase occurred in parallel with a decline in the prevalence of healthy blood glucose, which is the predominant explanation accounting for the rise in the prevalence of presence of all three risk factors,” the investigators said.
Only 15% of the study population was free from all of these risk factors – a percentage that remained unchanged during 1988-2014.
The findings should be a wake-up call for physicians and their patients, and a national call for action to improve cardiovascular health among obese adults, the team wrote.
“The increasing trend of obese people with all three cardiovascular risk factors, commensurate with a decline in those with one or two risk factors, suggests an overall deterioration in health among people with obesity. ... These patterns of worsening metabolic health constitute an increase in risk of type 2 diabetes mellitus and underlie increasing prevalence rates for diabetes mellitus,” the investigators wrote.
Aggressive treatment will be necessary to reverse these trends. This might include treatment with weight-loss medications in conjunction with lifestyle interventions, which should be especially targeted at obese individuals who are already metabolically unhealthy and in those who have complications or are at risk for developing them.
“In the context of the current data, those obese adults who are metabolically unhealthy or perhaps those with suboptimal metabolic health represent patients who will benefit most from intensive obesity management … coordinated efforts aligning cardiovascular disease prevention and control activities across the public and private sectors in the United States are needed reduce the burden of cardiovascular disease among the obese population,” Dr. Garvey concluded.
The study was supported by the Department of Veterans Affairs, the National Institutes of Health, and the University of Alabama Diabetes Research Center.
Dr. Guo had no financial disclosures. Dr. Garvey disclosed relationships with multiple pharmaceutical companies.
Despite achieving significant improvements in blood pressure and cholesterol levels, obese Americans continue to grow fatter, with worsening blood glucose and an increasing incidence of diabetes.
From 1998 to 2014, national health data showed that mean diastolic and systolic blood pressures decreased in obese men and women in all racial and ethnic groups. Mean lipid measurements improved as well, including a “marked” 21-mg/dL decrease in total cholesterol and a significant increase in HDL cholesterol.
But markers of blood glucose health continued to decline over the same period, contributing to an overall worsening of metabolic health and a increase from 11% to 19% in the rate of diabetes, Fangjian Guo, MD, and W. Timothy Garvey, MD, reported in July 13 issue of the Journal of the American Heart Association (J Am Heart Assoc. 2016 Jul 13. 5:e003619 doi: 10.1161/JAHA.116.003619).
The rate of obese adults free of these three cardiovascular disease risk factors – diabetes, elevated cholesterol, and blood pressure – remained stable over the study period at about 15%. But the rate of obese adults with all three risk factors increased by 37% over the same period. By 2014, 22% reported having all three of those risk factors.
“The deteriorated blood glucose health among obese adults in the United States calls for lifestyle interventions (diet and exercise) on a national scale,” wrote Dr. Garvey, chair of nutrition science at the University of Alabama, Birmingham. “Community-based public health intervention programs may help increase physical activity and diet quality to alleviate the problem.”
The investigators examined trends in cardiometabolic health among 18,626 obese adults who participated in National Health and Nutrition Examination Surveys from 1988 to 2014. Over this period, mean body mass index increased significantly, from 34.7 to 36 kg/m2. Waist circumference increased as well, from 110 to 114.8 cm.
The picture was much better for blood pressure. Mean systolic pressures decreased about 2 points – from 126.1 to 124.4 mm Hg – in all age, racial and ethnic groups, and in both sexes. Mean diastolic blood pressure also decreased, dropping from 76.6 to 72.5 mm Hg. By 2014, 44% of the men and 51% of the women were below the blood pressure risk threshold.
Lipids also improved over the years, the investigators noted, with significant decreases in mean total cholesterol, from 214.5 to 193.7 mg/dL, and increases in HDL cholesterol, from 45.4 to 47.4 mg/dL.
Blood glucose worsened significantly, however. The mean hemoglobin A1c increased from 5.7% to 5.9%. The measurement rose in all ages, both sexes, and in all racial and ethnic groups except for non-Hispanic blacks.
Perhaps not surprisingly, the incidence of diabetes (a self-reported HbA1c of 6.5% or more) increased from 11% to 19% from 1988 to 2014. The increase occurred in all age groups and both sexes except for young adults aged 20-39 years. No racial or ethnic group was exempt from the increase.
The number of people having all three risk factors (hypertension, hypercholesterolemia, and hyperglycemia) increased from 16% in 1988 to 22% in 2014.
“The increase occurred in parallel with a decline in the prevalence of healthy blood glucose, which is the predominant explanation accounting for the rise in the prevalence of presence of all three risk factors,” the investigators said.
Only 15% of the study population was free from all of these risk factors – a percentage that remained unchanged during 1988-2014.
The findings should be a wake-up call for physicians and their patients, and a national call for action to improve cardiovascular health among obese adults, the team wrote.
“The increasing trend of obese people with all three cardiovascular risk factors, commensurate with a decline in those with one or two risk factors, suggests an overall deterioration in health among people with obesity. ... These patterns of worsening metabolic health constitute an increase in risk of type 2 diabetes mellitus and underlie increasing prevalence rates for diabetes mellitus,” the investigators wrote.
Aggressive treatment will be necessary to reverse these trends. This might include treatment with weight-loss medications in conjunction with lifestyle interventions, which should be especially targeted at obese individuals who are already metabolically unhealthy and in those who have complications or are at risk for developing them.
“In the context of the current data, those obese adults who are metabolically unhealthy or perhaps those with suboptimal metabolic health represent patients who will benefit most from intensive obesity management … coordinated efforts aligning cardiovascular disease prevention and control activities across the public and private sectors in the United States are needed reduce the burden of cardiovascular disease among the obese population,” Dr. Garvey concluded.
The study was supported by the Department of Veterans Affairs, the National Institutes of Health, and the University of Alabama Diabetes Research Center.
Dr. Guo had no financial disclosures. Dr. Garvey disclosed relationships with multiple pharmaceutical companies.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point: Blood glucose and diabetes are on the rise among America’s obese.
Major finding: Twenty-two percent of obese Americans now have three serious cardiovascular risk factors: hypertension, hypercholesterolemia, and hyperglycemia.
Data source: The 26-year observational study comprised more than 18,600 people.
Disclosures: The study was supported by the Department of Veterans Affairs, the National Institutes of Health, and the University of Alabama Diabetes Research Center. Dr. Guo had no financial disclosures. Dr. Garvey disclosed relationships with multiple pharmaceutical companies.
Newer insulin glargine formula curbs nocturnal hypoglycemia
NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.
The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”
Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m3; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).
Outcomes of interest were change in HbA1c from baseline to month 6, and the percentages of patients achieving an HbA1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.
Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m3. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.
The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.
NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.
The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”
Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m3; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).
Outcomes of interest were change in HbA1c from baseline to month 6, and the percentages of patients achieving an HbA1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.
Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m3. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.
The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.
NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.
The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”
Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m3; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).
Outcomes of interest were change in HbA1c from baseline to month 6, and the percentages of patients achieving an HbA1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.
Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m3. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.
The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Insulin glargine 300 U/mL provided glycemic control comparable to insulin glargine 100 U/mL, but it reduced the risk of nocturnal hypoglycemia by a greater margin, regardless of renal function.
Major finding: The risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group.
Data source: A post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies.
Disclosures: The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.
‘Clarion call’ to screen for, treat aldosteronism
The Endocrine Society’s updated Clinical Practice Guideline for managing primary aldosteronism is “a clarion call” for physicians to recognize the impact of this substantial public health problem and dramatically ramp up their screening and treatment efforts and was published in the Journal of Clinical Endocrinology and Metabolism.
This update differs from the previous (2008) version of the guideline in “the explicit recognition of primary aldosteronism as a major public health issue and not merely a matter of case detection, diagnosis, and treatment of individual patients,” wrote John W. Funder, MD, and his associates on the task force that compiled the guideline.
Many physicians in current practice were taught that the disorder “is a rare and benign cause of hypertension, [and] thus merely a footnote to the management of hypertension as a whole. Cardiologists usually write guidelines for hypertension with some input from nephrologists and clinical pharmacologists [but] little or none from endocrinologists,” they noted.
As a result, most patients with hypertension and occult aldosteronism are never screened for the disorder and receive suboptimal care. Primary care providers must be “made keenly aware” that the proportion of people with hypertension who have aldosteronism is much higher than previously thought (at roughly 10%), that another 20% of hypertensive people have “inappropriate aldosterone secretion,” and that both groups respond remarkably well to medical therapy, particularly to mineralocorticoid-receptor antagonists. This is critical because hypertensive patients with aldosteronism are at much greater risk for cardiovascular morbidity and mortality than their age-, sex-, and BP-matched counterparts who don’t have aldosteronism, said Dr. Funder of the Hudson Institute of Medical Research, Clayton (VIC), Australia, and his associates.
In addition to recommendations regarding screening and treatment and summaries of the evidence on which those recommendations are based, the new guideline offers a remarks section for each recommendation, which includes technical suggestions to help clinicians implement them in real-world practice.
Among the Guideline’s recommendations:
• Screen for primary aldosteronism all patients who have sustained BP above 150/100 mm Hg, hypertension resistant to three conventional antihypertensive drugs, hypertension that requires four or more drugs to control it, hypertension plus hypokalemia, hypertension plus adrenal incidentaloma, hypertension plus sleep apnea, hypertension plus a family history of early-onset hypertension or stroke at a young age, and hypertension plus a first-degree relative with primary aldosteronism.
Use the plasma aldosterone/renin ratio for this screening.
• Do one or more confirmatory tests to definitively confirm the diagnosis before proceeding to subtype classification. The exception to this recommendation is patients who develop spontaneous hypokalemia.
• Do adrenal CT as the initial step in subtype classification, to exclude large masses that may signal adrenocortical carcinoma and to help interventional radiologists and surgeons make anatomic assessments.
Before surgery, an experienced radiologist should determine whether adrenal disease is unilateral or bilateral using adrenal venous sampling.
Order genetic testing for patients with disease onset before age 20 years and for those who have a family history of either aldosteronism or early stroke.
• Laparoscopic adrenalectomy is the surgery of choice for most patients with unilateral adrenal disease. For patients unwilling or unable to undergo surgery or further investigations, prescribe a mineralocorticoid-receptor antagonist.
Medical therapy is the treatment of choice for bilateral adrenal disease. Spironolactone is the first-line agent, and eplerenone is an alternative agent to offer. This guideline is intended to be revised further as management evolves over the next 5 years. It is likely that by then, a rapid, inexpensive confirmatory test will be available to definitively establish the diagnosis and that third- and perhaps fourth-generation mineralocorticoid-receptor antagonists will be available for treatment. Simpler and more accurate methods of measuring plasma aldosterone concentration and direct renin concentration, which “would be a game changer for the primary care physician,” are currently being developed, Dr. Funder and his associates said (J. Clin. Endocrinol. Metab. 2016 May;101:1889-916).
In the meantime, “the main strategy is to convince primary-care physicians to screen for primary aldosteronism in all at-risk hypertensive patients,” they noted.
Copies of the full Guideline are available at [email protected] or by calling 202-971-3636.
The Endocrine Society’s updated Clinical Practice Guideline for managing primary aldosteronism is “a clarion call” for physicians to recognize the impact of this substantial public health problem and dramatically ramp up their screening and treatment efforts and was published in the Journal of Clinical Endocrinology and Metabolism.
This update differs from the previous (2008) version of the guideline in “the explicit recognition of primary aldosteronism as a major public health issue and not merely a matter of case detection, diagnosis, and treatment of individual patients,” wrote John W. Funder, MD, and his associates on the task force that compiled the guideline.
Many physicians in current practice were taught that the disorder “is a rare and benign cause of hypertension, [and] thus merely a footnote to the management of hypertension as a whole. Cardiologists usually write guidelines for hypertension with some input from nephrologists and clinical pharmacologists [but] little or none from endocrinologists,” they noted.
As a result, most patients with hypertension and occult aldosteronism are never screened for the disorder and receive suboptimal care. Primary care providers must be “made keenly aware” that the proportion of people with hypertension who have aldosteronism is much higher than previously thought (at roughly 10%), that another 20% of hypertensive people have “inappropriate aldosterone secretion,” and that both groups respond remarkably well to medical therapy, particularly to mineralocorticoid-receptor antagonists. This is critical because hypertensive patients with aldosteronism are at much greater risk for cardiovascular morbidity and mortality than their age-, sex-, and BP-matched counterparts who don’t have aldosteronism, said Dr. Funder of the Hudson Institute of Medical Research, Clayton (VIC), Australia, and his associates.
In addition to recommendations regarding screening and treatment and summaries of the evidence on which those recommendations are based, the new guideline offers a remarks section for each recommendation, which includes technical suggestions to help clinicians implement them in real-world practice.
Among the Guideline’s recommendations:
• Screen for primary aldosteronism all patients who have sustained BP above 150/100 mm Hg, hypertension resistant to three conventional antihypertensive drugs, hypertension that requires four or more drugs to control it, hypertension plus hypokalemia, hypertension plus adrenal incidentaloma, hypertension plus sleep apnea, hypertension plus a family history of early-onset hypertension or stroke at a young age, and hypertension plus a first-degree relative with primary aldosteronism.
Use the plasma aldosterone/renin ratio for this screening.
• Do one or more confirmatory tests to definitively confirm the diagnosis before proceeding to subtype classification. The exception to this recommendation is patients who develop spontaneous hypokalemia.
• Do adrenal CT as the initial step in subtype classification, to exclude large masses that may signal adrenocortical carcinoma and to help interventional radiologists and surgeons make anatomic assessments.
Before surgery, an experienced radiologist should determine whether adrenal disease is unilateral or bilateral using adrenal venous sampling.
Order genetic testing for patients with disease onset before age 20 years and for those who have a family history of either aldosteronism or early stroke.
• Laparoscopic adrenalectomy is the surgery of choice for most patients with unilateral adrenal disease. For patients unwilling or unable to undergo surgery or further investigations, prescribe a mineralocorticoid-receptor antagonist.
Medical therapy is the treatment of choice for bilateral adrenal disease. Spironolactone is the first-line agent, and eplerenone is an alternative agent to offer. This guideline is intended to be revised further as management evolves over the next 5 years. It is likely that by then, a rapid, inexpensive confirmatory test will be available to definitively establish the diagnosis and that third- and perhaps fourth-generation mineralocorticoid-receptor antagonists will be available for treatment. Simpler and more accurate methods of measuring plasma aldosterone concentration and direct renin concentration, which “would be a game changer for the primary care physician,” are currently being developed, Dr. Funder and his associates said (J. Clin. Endocrinol. Metab. 2016 May;101:1889-916).
In the meantime, “the main strategy is to convince primary-care physicians to screen for primary aldosteronism in all at-risk hypertensive patients,” they noted.
Copies of the full Guideline are available at [email protected] or by calling 202-971-3636.
The Endocrine Society’s updated Clinical Practice Guideline for managing primary aldosteronism is “a clarion call” for physicians to recognize the impact of this substantial public health problem and dramatically ramp up their screening and treatment efforts and was published in the Journal of Clinical Endocrinology and Metabolism.
This update differs from the previous (2008) version of the guideline in “the explicit recognition of primary aldosteronism as a major public health issue and not merely a matter of case detection, diagnosis, and treatment of individual patients,” wrote John W. Funder, MD, and his associates on the task force that compiled the guideline.
Many physicians in current practice were taught that the disorder “is a rare and benign cause of hypertension, [and] thus merely a footnote to the management of hypertension as a whole. Cardiologists usually write guidelines for hypertension with some input from nephrologists and clinical pharmacologists [but] little or none from endocrinologists,” they noted.
As a result, most patients with hypertension and occult aldosteronism are never screened for the disorder and receive suboptimal care. Primary care providers must be “made keenly aware” that the proportion of people with hypertension who have aldosteronism is much higher than previously thought (at roughly 10%), that another 20% of hypertensive people have “inappropriate aldosterone secretion,” and that both groups respond remarkably well to medical therapy, particularly to mineralocorticoid-receptor antagonists. This is critical because hypertensive patients with aldosteronism are at much greater risk for cardiovascular morbidity and mortality than their age-, sex-, and BP-matched counterparts who don’t have aldosteronism, said Dr. Funder of the Hudson Institute of Medical Research, Clayton (VIC), Australia, and his associates.
In addition to recommendations regarding screening and treatment and summaries of the evidence on which those recommendations are based, the new guideline offers a remarks section for each recommendation, which includes technical suggestions to help clinicians implement them in real-world practice.
Among the Guideline’s recommendations:
• Screen for primary aldosteronism all patients who have sustained BP above 150/100 mm Hg, hypertension resistant to three conventional antihypertensive drugs, hypertension that requires four or more drugs to control it, hypertension plus hypokalemia, hypertension plus adrenal incidentaloma, hypertension plus sleep apnea, hypertension plus a family history of early-onset hypertension or stroke at a young age, and hypertension plus a first-degree relative with primary aldosteronism.
Use the plasma aldosterone/renin ratio for this screening.
• Do one or more confirmatory tests to definitively confirm the diagnosis before proceeding to subtype classification. The exception to this recommendation is patients who develop spontaneous hypokalemia.
• Do adrenal CT as the initial step in subtype classification, to exclude large masses that may signal adrenocortical carcinoma and to help interventional radiologists and surgeons make anatomic assessments.
Before surgery, an experienced radiologist should determine whether adrenal disease is unilateral or bilateral using adrenal venous sampling.
Order genetic testing for patients with disease onset before age 20 years and for those who have a family history of either aldosteronism or early stroke.
• Laparoscopic adrenalectomy is the surgery of choice for most patients with unilateral adrenal disease. For patients unwilling or unable to undergo surgery or further investigations, prescribe a mineralocorticoid-receptor antagonist.
Medical therapy is the treatment of choice for bilateral adrenal disease. Spironolactone is the first-line agent, and eplerenone is an alternative agent to offer. This guideline is intended to be revised further as management evolves over the next 5 years. It is likely that by then, a rapid, inexpensive confirmatory test will be available to definitively establish the diagnosis and that third- and perhaps fourth-generation mineralocorticoid-receptor antagonists will be available for treatment. Simpler and more accurate methods of measuring plasma aldosterone concentration and direct renin concentration, which “would be a game changer for the primary care physician,” are currently being developed, Dr. Funder and his associates said (J. Clin. Endocrinol. Metab. 2016 May;101:1889-916).
In the meantime, “the main strategy is to convince primary-care physicians to screen for primary aldosteronism in all at-risk hypertensive patients,” they noted.
Copies of the full Guideline are available at [email protected] or by calling 202-971-3636.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Key clinical point: The Endocrine Society’s updated Clinical Practice Guideline for managing primary aldosteronism is “a clarion call” for physicians to ramp up screening for and treatment of this major public health problem.
Major finding: Primary care physicians must be convinced to screen all at-risk hypertensive patients for primary aldosteronism.
Data source: A comprehensive review of the literature and detailed update of a Clinical Practice Guideline for managing primary aldosteronism.
Disclosures: The Endocrine Society provided all the support for this Guideline. Dr. Funder’s and his associates’ conflicts of interest are available from the Endocrine Society.
Statement warns of drugs causing or exacerbating heart failure
Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.
This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.
Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.
NSAIDs
The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).
“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.
Metformin
Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m2. The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.
Antihypertensives, biologics, and more
Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.
The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.
Managing myriad meds
The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.
“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”
Dr. Page had no disclosures.
On Twitter @mitchelzoler
Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.
This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.
Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.
NSAIDs
The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).
“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.
Metformin
Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m2. The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.
Antihypertensives, biologics, and more
Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.
The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.
Managing myriad meds
The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.
“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”
Dr. Page had no disclosures.
On Twitter @mitchelzoler
Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.
This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.
Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.
NSAIDs
The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).
“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.
Metformin
Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m2. The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.
Antihypertensives, biologics, and more
Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.
The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.
Managing myriad meds
The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.
“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”
Dr. Page had no disclosures.
On Twitter @mitchelzoler
Endobariatrics: Coming to a clinic near you
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
AT DDW® 2016
High rates of early complications seen in youth with diabetes
NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.
“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”
The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.
Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.
Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.
The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.
NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.
“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”
The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.
Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.
Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.
The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.
NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.
“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”
The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.
Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.
Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.
The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: There is a high prevalence of early complications in youth with either type of diabetes.
Major finding: About 32% of youths with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication.
Data source: A cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes who were diagnosed before 20 years of age assembled from the population-based SEARCH Registry in five U.S. sites, and who were registered upon diagnosis between 2002 and 2008.
Disclosures: The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.