Diabetes

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FDA advisory committee splits on CV benefit claim for Jardiance

June 28, 2016

An FDA advisory panel on Tuesday voted 12 to 11 in favor of an expanded indication for the SGLT2 inhibitor Jardiance, supporting language in the prescribing information that the drug can reduce the incidence of cardiovascular death in patients with type 2 diabetes and a history of cardiovascular disease.

The decision follows an in-depth analysis of primary and secondary endpoints in the EMPA-REG Outcome trial, a randomized, double blind, placebo-controlled study that revealed a surprise CV benefit in patients with type 2 diabetes at high CV risk. The FDA requires that all diabetes drugs undergo testing for CV outcomes. Jardiance (empagliflozin, Boehringer Ingelheim/Lilly) was the first to demonstrate a CV benefit.

In the Journals

Lipid-lowering drug improves glucose control in type 2 diabetes

June 28, 2016
Plasma apolipoprotein C-III and triglycerides were reduced with volanesorsen, a second-generation antisense inhibitor of apolipoprotein C-III, according to study…
In the Journals

Low plasma glucose before bariatric surgery may predict postprandial hypoglycemia

June 28, 2016
Postprandial hypoglycemia after Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy may be predicted by low presurgery plasma glucose concentrations, high…
In the Journals

Triglyceride, HDL, BP levels not linked to type 2 diabetes risk

June 27, 2016
A higher risk for type 2 diabetes was found with a larger waist circumference and higher glucose levels, but plasma triglyceride, HDL levels and blood pressure were not…
CME

Avoiding “Loss of Chance”…Improving the Screening, Treatment, and Referral of Patients with Diabetic Retinopathy

This activity is supported by an educational grant from Genentech, Inc.

Despite a number of effective treatment options, diabetic eye disease is a leading cause of vision loss in the United…
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Video
Meeting News Coverage

VIDEO: Incisionless anastomosis system improves diabetes, reduces weight

June 13, 2016
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Featured
CME Video

Navigating a New Era of Personalized Type 2 Diabetes Care: Taking the Road Less Traveled

This activity is supported by an independent educational grant from Boehringer-Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.

In the United States, over 29 million people have diabetes, of which approximately 95% of cases are type 2 diabetes…
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FDA News

FDA advisory committee splits on CV benefit claim for Jardiance

June 28, 2016
An FDA advisory panel on Tuesday voted 12 to 11 in favor of an expanded indication for the SGLT2 inhibitor Jardiance, supporting language in the…

In the Journals

Lipid-lowering drug improves glucose control in type 2 diabetes

June 28, 2016
Plasma apolipoprotein C-III and triglycerides were reduced with volanesorsen, a second-generation antisense inhibitor of apolipoprotein C-III…

In the Journals

Low plasma glucose before bariatric surgery may predict postprandial hypoglycemia

June 28, 2016
Postprandial hypoglycemia after Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy may be predicted by low presurgery plasma glucose…

In the Journals

Triglyceride, HDL, BP levels not linked to type 2 diabetes risk

June 27, 2016
A higher risk for type 2 diabetes was found with a larger waist circumference and higher glucose levels, but plasma triglyceride, HDL levels and…

In the Journals

‘Mindful self-compassion’ reduces depression, diabetes distress

June 27, 2016
Adults with diabetes who participated in weekly sessions that included meditation and self-compassion practices reported fewer depressive symptoms…

In the Journals

Screening tool may underestimate diabetes risk by sex, age

June 27, 2016
The widely used Finnish Diabetes Risk Score does not fully capture the impact of age and sex on diabetes risk in Norwegian adults, recent study…

In the Journals

Genetically low birth weight may increase type 2 diabetes risk

June 26, 2016
A genetic susceptibility to low birth weight

In the Journals

Ghrelin mediates glucose metabolism after food intake

June 25, 2016
In healthy adults, exogenous ghrelin impairs beta-cell and glucose responses to food consumption and triggers acute insulin resistance, according to…

In the Journals

Pioglitazone may improve NASH, halt disease progression in type 2 diabetes

June 24, 2016
Adults with type 2 diabetes randomly assigned Actos therapy were more likely to experience a reduction in nonalcoholic steatohepatitis activity vs…

In the Journals

Increasing physical activity reduces atherosclerosis, CV risk in children with type 1 diabetes

June 24, 2016
Low physical activity level in children with type 1 diabetes is linked with early signs of atherosclerosis and adverse cardiovascular risk, according…

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