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Message: American Diabetes Association meeting June 10-14

The American Diabetes Association meeting June 10-14, 2016 in New Orleans should be exciting this year. Resverlogix will have a poster presentation on June 11, Abstract #1208-P: "RVX-208 Affects Epigenetics to Lower Major Adverse Cardiovascular Events (MACE) in Atherosclerotic Patients and Especially in Ones with Diabetes Mellitus." Full abstracts are embargoed until June 3.

Perhaps more exciting will be the presentations on the LEADER and EMPA-REG OUTCOME trials on the effects of two diabetes medications, Liraglutide (Victoza; GLP-1 analog) and empaglifozin (Jardiance; SGLT2 inhibitor), on cardiovascular outcomes . We've already heard about the primary cardiovascular outcomes data from EMPA-REG Outcome Trial results released last year (summarized below), but they will present some new data on June 14. Additionally, the LEADER trial, which earlier this year released top-line data claiming a statistically significant reduction in cardiovascular risk, will show full results on June 13.

This is the competition right now. We'll see where the bar it set.

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From the American Diabetes Association meeting website:

Liraglutide Effect and Action in Diabetes—Evaluation of Cardiovascular Outcome Results (LEADER) Trial

Liraglutide is an analog of human GLP-1 approved for the treatment of type 2 diabetes in Europe since 2009 and in the United States since 2010. It has well-established glucose-lowering efficacy and is associated with moderate weight loss. To formerly assess its cardiovascular safety, the LEADER Trial (NCT01179048) was initiated in 2010. More than 9,000 patients were randomized and evaluated for up to 5 years for cardiovascular and safety endpoints. The results of this trial will be reported by the investigators on Monday, June 13, from 2:15 to 4:15 p.m.

EMPA-REG Outcome Trial

The EMPA-REG Outcome Trial is a recently reported clinical trial involving more than 7,000 patients with type 2 diabetes at high cardiovascular (CV) risk, randomized to either the SGLT2 inhibitor empagliflozin or placebo and followed for slightly more than 3 years. Some experts have proposed that this study might change the way we manage type 2 diabetes. Important new data from the trial will be presented, including the latest information on both macrovascular and microvascular outcomes. In addition a “mediation analysis” will be described, exploring possible underlying mechanisms of empagliflozin’s benefits.

The primary endpoint was the major adverse CV event (MACE) composite of nonfatal myocardial infarction, nonfatal stroke and CV death. The trial met its primary endpoint, demonstrating a 14% reduction in the hazard of MACE in the empagliflozin arm. This was predominately driven by a remarkable 38% reduction in CV death. In addition, patients assigned to the empagliflozin group had a 35% reduction in their rates of heart failure hospitalization, as well as a 32% reduction in the risk of all-cause mortality. This is the first clinical trial to demonstrate a benefit on CV mortality from a glucose-lowering drug in high-risk patients with type 2 diabetes. The results of the trial will be reported on Tuesday, June 14, from 8:00 to 10:00 a.m.

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BearDownAZ

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