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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.

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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…
Meeting News Coverage

Femoropopliteal DCB effective in women, patients with diabetes, CTO

May 4, 2016
A drug-coated balloon was effective in women, in patients with diabetes and in those with chronic total occlusions, according to new data. Analyses…

In the Journals

Intensive glycemic control preserves muscle strength in patients with type 2 diabetes, heart failure

May 3, 2016
In patients with type 2 diabetes and chronic heart failure, 4 months of intensive glycemic control had no adverse effect on left ventricular…

Abbott to acquire St. Jude Medical

April 28, 2016
Abbott announced that it will acquire St. Jude Medical in an effort to enhance its global scale and diversify its portfolio. With the acquisition…

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PEGASUS-TIMI 54: Long-term ticagrelor benefits patients with history of MI, diabetes, PAD

April 28, 2016
CHICAGO — Two subanalyses of the PEGASUS-TIMI 54 study of stable patients with prior MI showed that ticagrelor reduced major adverse CV events…

In the Journals

Lipid-lowering therapy reduces risk for CVD, death in type 1 diabetes

April 26, 2016
People with type 1 diabetes without a history of cardiovascular disease may have reduced risk for cardiovascular disease and cardiovascular death…

In the Journals

Healthy diet may reduce hypertension risk in women with gestational diabetes

April 21, 2016
Women with gestational diabetes were 20% less likely to develop hypertension later in life if they maintained a healthy diet, researchers reported in…

Meeting News Coverage

Major bleeding risk low in real-world study of high-risk users of rivaroxaban

April 20, 2016
CHICAGO — A postmarketing study of users with nonvalvular atrial fibrillation taking rivaroxaban confirms that the real-world risk for major…

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

April 7, 2016
CHICAGO — At the American College of Cardiology Scientific Session, Deepak L. Bhatt, MD, MPH, provides investigator insight on a new…

Meeting News Coverage

STAMPEDE: Glycemic benefits of bariatric surgery sustained up to 5 years

April 6, 2016
CHICAGO — Patients with mild to moderate obesity and type 2 diabetes who underwent bariatric surgery had better glycemic control than patients…

Meeting News CoverageVideo

VIDEO: Diabetes may be risk equivalent for PAD, CAS

April 3, 2016
CHICAGO — In this video exclusive, Jeffrey S. Berger, MD, discusses new research on the prevalence of peripheral artery disease and carotid…

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