In a large clinical trial, Onglyza (saxagliptin), a Type 2 diabetes medication, failed to reduce the risk of heart attacks and related disease compared with a placebo.
But the drug, co-marketed by Bristol-Myers Squibb and AstraZeneca, did not increase cardiovascular risks, 4-traders.com reports, and this could help alleviate safety concerns about this class of drugs, also known as incretin mimetics.
The U.S. Food and Drug Administration (FDA) approved Onglyza in 2009 to treat Type 2 diabetes, based on clinical data showing it improved measures of blood sugar. Onglyza belongs to the class of drugs known as DPP-4 inhibitors, which help control blood sugar by stimulating the pancreas to make more insulin, according to the FDA. At the time of the drug’s approval, the FDA required Bristol-Myers and AstraZeneca to conduct a clinical trial to assess the cardiovascular safety of Onglyza. The FDA had tightened requirements for demonstrating cardiovascular safety of diabetes drugs in 2008 after GlaxoSmithKline’s Avandia was linked to increased risk for cardiovascular events. The DPP-4 inhibitors have lately come under scrutiny because of concerns over possible connection to pancreatic disease.
People with diabetes are at increased risk of heart problems and many oral diabetes medications have failed to show a benefit for heart health, 4-traders.com reports. Some patients in the Onglyza clinical trial were given Onglyza once daily in addition to their standard regimen, while others were given a placebo on top of standard care. The study’s main efficacy goal was to determine whether Onglyza reduced the combined incidence of cardiovascular death, nonfatal heart attacks, and nonfatal strokes, versus placebo. The drug companies said Onglyza met the safety goal of noninferiority to a placebo, but it didn’t demonstrate superiority to a placebo.
Merck & Co. is conducting cardiovascular trials for Januvia, its DPP-4 drug, but results aren’t expected until late next year.
