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3- CV death risk reduction claim for 3 diabetes meds gains FDA OK

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FDA to review 3 new diabetes drugs that reduce cardiovascular death risk

5 January 2017 • Author: Niamh Marriott, Digital Editor

The US Food and Drug Administration (FDA) approved supplemental new drug applications for three type 2 diabetes medicines within the empagliflozin family to include data from the empa-reg outcome trial.


The data show that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. The data have been added to the “clinical studies” sections of the prescribing information for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets, all of which are marketed by BoehringerIngelheim and Eli Lilly.

Synjardy, Synjardy XR and Glyxambi are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. Empagliflozin, a component of these medicines, is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. However, the effectiveness of the three new drugs has not been established.

Study specifics

In the trial, empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo; absolute risk reduction was 1.6% for empagliflozin versus placebo.
This primary finding was driven by a significant 38% reduction in the relative risk of cardiovascular death; absolute risk reduction was 2.2% for patients taking empagliflozin versus placebo. There was no change in the risk of non-fatal heart attack or non-fatal stroke. The cardiovascular benefits of empagliflozin were consistent among patient subgroups.

Potential harm

Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using it increases the risk of developing pancreatitis in these patients.
Synjardy and Synjardy XR can cause serious side effects, including lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Synjardy XR can cause dehydration, low blood pressure and increased ketones in the blood (ketoacidosis).

Reference: http://www.europeanpharmaceuticalreview.com/46724/news/industry-news/fda-review-new-diabetes/