The FDA Investigates Data from DPP-4 Inhibitor Onglyza (saxagliptin) Trials
By Kelly Close
On February 11, the FDA released a Drug Safety Communication requesting data from the widely publicized cardiovascular outcomes trial for Onglyza (saxagliptin). The trial, called SAVOR-TIMI 53, showed a 27% increase in the risk of hospitalization associated with heart failure in people using Onglyza (heart failure is when the heart does not pump blood well enough). Overall, the trial did not find an increase in death rates associated with hospitalization due to heart failure, and there was also no observed increase in other major cardiovascular risks (e.g., heart attack and stroke), as we noted in a previous article. The FDA considers the data from the trial to be preliminary, and suggests that people with diabetes currently taking Onglyza or Kombiglyze XR (a combination of Onglyza and metformin) continue to take the drug and speak to their provider if they have any questions or concerns. Healthcare professionals should also continue to prescribe Onglyza as they normally would. According to the FDA, the analysis of the Onglyza clinical trial data will be a part of a broader investigation of the cardiovascular risks of DPP-4 inhibitor drugs for type 2 diabetes.
Onglyza was one of the first drugs to be approved under stricter rules from the FDA for diabetes drugs regarding cardiovascular disease and events. If the FDA does determine that Onglyza is responsible for an increased rate of heart failure in people with type 2 diabetes, it might well result in a warning added to the drug label. This would only continue the controversial debate over whether DPP-4 inhibitors as a class may be associated with heart failure risk. We’ll be back soon with more from the American College of Cardiology conference taking place in Washington DC right now – there was really exciting news on EXAMINE and alogliptin, that might confer cardioprotection for women taking this compound as well as those diagnosed in the last five years and those with healthy kidney function –AF/KC
