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FDA: Diabetes Drug Onglyza (Saxagliptin) May Increase Death Rate

Clinical trial shows increased risk of hospitalizations due to heart failure

The diabetes treatment Onglyza (saxagliptin, AstraZeneca) may be associated with an increased rate of death, according to a preliminary review of data by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. The agency’s report comes ahead of an April 14 meeting of the advisory panel to discuss the drug’s safety.

A company-sponsored trial of more than 16,000 patients, known as SAVOR, previously showed that patients taking saxagliptin had an increased risk of hospitalizations due to heart failure. The agency’s analysis found that the heart failure risk is valid. It also identified a possible increased risk of death from all causes.

The overall trial results did not reveal a higher risk of death, but a more detailed analysis examining only patients who took the drug suggests “a significantly increased risk of all-cause mortality,” the review found.

The FDA said that the causes of death were often “multifactorial” and that some patients may have had serious medical conditions in the days and weeks prior to death. Still, the FDA said it “is not reassured” by the increased risk, “and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”

In December 2008, the FDA issued guidance requiring drug companies to conduct studies to show that new diabetes medications do not increase cardiovascular risk compared with current treatments. The guidance was developed amid growing concern about the safety of many diabetes drugs.

Onglyza (saxagliptin) was approved in 2009 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. It belongs to the class of antidiabetic agents known as dipeptidyl peptidase-4 (DPP4) inhibitors.

Sources: Reuters; April 10, 2015; and FDA Briefing Materials; April 10, 2015.

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