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Onglyza Increases Heart Failure Hospitalization Risk Among Diabetics

Sep 9, 2013

Bristol-Myers Squibb, maker of the Type 2 diabetes drug Onglyza (saxagliptin), recently reported that its medication does not improve hospitalization rates for heart failure.

“Onglyza did not meet the primary [level of] superiority to placebo for the same composite endpoint,” Bristol-Myers Squibb noted while releasing the results of the SAVOR clinical trial. The drug trial included more than 16,000 diabetics taking the drug to test its ability to reduce cardiovascular death, non-fatal heart attack, and non-fatal stroke.

Based on our previous reports, heart disease is the leading cause of death among people suffering from Type 2 diabetes.

While Onglyza proved that it does not increase a person’s risk of developing non-fatal heart attacks, stroke, or cardiovascular death, it failed to show that it was effective at reducing a diabetic’s risk of hospitalization due to heart failure. In fact, Bristol-Myers Squibb noted that the SAVOR trial indicated that rates of hospitalization for heart failure actually rose among people taking Onglyza versus a placebo drug. Patients taking Onglyza in the clinical trial also experienced one more hypoglycemic event compared to the placebo group.

Our previous reports show that drugs used to treat Type 2 diabetes include an array of risks. Some even have potentially life-threatening side effects. Researchers and Bristol-Myers Squibb admit that more studies are needed to identify the risks associated with the many drugs used to treat Type 2 diabetes.

“Given the correlation between diabetes and cardiovascular complications, there is a need for thorough assessments of the cardiovascular risks among therapies that improve glycemic control,” said Deepak L. Bhatt, MD, MPH, Senior Investigator of the TIMI Study Group, Brigham and Women’s Hospital, and a Principal Investigator for the trial. “The results from SAVOR add important evidence to the overall body of data to further define the clinical profile of saxagliptin for the treatment of Type 2 diabetes.”

According to a report on the study at, editors identified in a federal database more than 2,500 adverse events in which Onglyza was named as a suspected cause of the reaction. In more than 1,800 of those events, Onglyza was picked as the primary suspect drug.

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