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.

Meeting News Coverage

Actos reduces type 2 diabetes risk in adults with prediabetes, prior stroke

June 16, 2016
NEW ORLEANS — The risk for developing type 2 diabetes, especially among those with prediabetes and/or who have had strokes may be reduced with the PPAR agonist…
FDA News

FDA strengthens kidney warnings on Invokana, Farxiga labels

June 14, 2016
The FDA issued a drug safety communication stating that it has revised the warning labels of SGLT2 inhibitors Invokana/Invokamet and Farxiga/Xigduo XR to include…
Meeting News Coverage

Jardiance slows kidney disease progression in adults with type 2 diabetes

June 14, 2016
NEW ORLEANS — The SGLT2 inhibitor Jardiance was associated with slower progression of kidney disease and fewer clinically relevant renal events compared with…
CME

The Patient With Atrial Fibrillation

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Atrial fibrillation is the most common type of tachyarrhythmia and is characterized by disorganization of the heart’s…
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Meeting News Coverage

VIDEO: PEGASUS-TIMI 54 analysis shows reduced risk for MACE in patients with diabetes

April 7, 2016
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Highlights from ACC Scientific Session

Highlights from ACC Scientific Session

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VIDEO: Data on smoking cessation, diabetes therapies promising for CVD prevention

January 5, 2016
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In the Journals

CTOs linked to mortality in patients with CAD, diabetes

March 31, 2016
In patients with CAD and diabetes, the presence of chronic total occlusion of coronary arteries was linked to increased mortality in patients…

Alirocumab reduces need for apheresis therapy

March 26, 2016
Sanofi and Regeneron announced positive topline results of from the ODYSSEY ESCAPE trial demonstrating that the addition of alirocumab to weekly or…

In the Journals

No increased heart failure risk with incretin therapies in type 2 diabetes

March 24, 2016
Treatment with incretin-based therapies is not associated with increased risk for heart failure in patients with type 2 diabetes vs. patients taking…

CME

The Patient with Uncontrolled Diabetes at High Risk for a Cardiovascular Event

March 15, 2016 Expires: 3/15/2017
The 2015 AACE guidelines incorporate an integrated consideration of micro- and macrovascular risk (including cardiovascular [CV] risk factors such as…

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In the Journals

Metabolic syndrome may increase risk for mild cognitive impairment, dementia

March 1, 2016
Metabolic syndrome was associated with elevated incidence of mild cognitive impairment and subsequent progression to dementia, according to study…

In the Journals

Pre-pregnancy cardiac dysfunction may identify risk for recurrent preeclampsia, future CVD

February 29, 2016
Evidence of diastolic and systolic dysfunction and elevated total vascular resistance in the nonpregnant state may predict a woman’s risk for…

In the Journals

Aggressive antihypertensive treatment may cause harm in people with diabetes

February 26, 2016
People with diabetes and systolic blood pressure levels less than 140 mm Hg have an increased risk for death from cardiovascular causes when they are…

CME

The Patient with Heart Failure

February 15, 2016 Expires: 2/15/2017
Over 5 million people in the United States (US) over the age of 20 years have heart failure (HF) and the prevalence of HF is expected to increase…

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Meeting News Coverage

LIBERTY 360° demographic analysis: Diabetes, renal disease, race correlate with PAD severity

February 15, 2016
HOLLYWOOD, Fla. — An interim demographic analysis of the LIBERTY 360° study population of patients with peripheral artery disease indicates…

In the Journals

Repatha shows promise for LDL reduction in type 2 diabetes

February 15, 2016
Adults with type 2 diabetes randomly assigned the PCSK9 inhibitor Repatha saw a 60% reduction in LDL cholesterol during 12 weeks vs. those assigned…

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