The alert comes after evaluation of the SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53) and EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trials. In the former, saxagliptin did not increase overall risk of cardiovascular events, but there was a 27% increase in the rate of hospitalisation for heart failure compared with placebo (3.5% vs 2.8%) and a signal for increased risk of all-cause death. In EXAMINE, although there was no significant increase in heart failure risk, the study was not designed to detect this, and the FDA panel chose to add the warning to both drugs’ labels, as they are both in the same class.
The FDA recommends that healthcare professionals consider the risks and benefits of these two drugs prior to initiating treatment in patients at a higher risk of heart failure and observe them for signs and symptoms of this complication. If heart failure develops, they should consider discontinuing the drugs and monitor diabetes control. If blood glucose levels are not well controlled with a patient’s current regimen, other diabetes medicines may be required.
The advice can be read in full here.