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 Heart Failure

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Over 5 million people in the United States (US) over the age of 20 years have heart failure (HF) and the prevalence of…
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VIDEO: Breaks in sitting time reduce cardiometabolic risk factors in type 2 diabetes

May 4, 2016
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Highlights from ACC Scientific Session 2016

Highlights from ACC Scientific Session 2016

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VIDEO: Changing landscape of diabetes care explored at CMHC 2015

October 24, 2015
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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…

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…

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…

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…

Meeting News Coverage

Diabetes Collaborative Registry highlights real-world clinical management of patients with diabetes

June 14, 2016
NEW ORLEANS — Clinicians who submit data to the Diabetes Collaborative Registry regularly adhere to four of seven quality metrics when treating…

Meeting News CoveragePerspective

LEADER trial: Victoza lowers risk for CV death, MI, stroke in high-risk type 2 diabetes

June 13, 2016
NEW ORLEANS — Patients with type 2 diabetes and a history of cardiovascular disease assigned Victoza therapy saw reduced risk for…

Meeting News CoveragePerspective

EXAMINE: CV events raise mortality risk for patients with diabetes

June 13, 2016
NEW ORLEANS — In patients with type 2 diabetes and a recent acute coronary syndrome in the EXAMINE trial, those who experienced nonfatal…

In the Journals

Onglyza does not increase risk for hospitalized heart failure

June 13, 2016
Recent findings published in the Annals of Internal Medicine showed that Onglyza did not increase the risk for hospitalized heart failure compared…

Meeting News Coverage

High maternal apolipoprotein B may indicate increased CV risk in children

June 12, 2016
NEW ORLEANS — Offspring of children born to mothers with elevated levels of apolipoprotein B had six times the likelihood of having high…

Meeting News Coverage

AHA metrics for heart health may translate to diabetes prevention in black adults

June 11, 2016
NEW ORLEANS — Black adults who met a higher number of the American Heart Association ideal cardiovascular health metrics also had a lower risk…

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