FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels

The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the  saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

The announcement comes two years after an FDA panel recommended that the drugs’ labels should be updated but did not recommend any other harsher measures. The panel analyzed results from two large cardiovascular outcomes trials, SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals). The two drugs are members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class used to lower glucose.

In SAVOR, according to the FDA analysis, more saxagliptin patients were hospitalized for heart failure than placebo patients (3.5% versus 2.8%). A similar pattern emerged in EXAMINE, in which 3.9% of alopgliptin patients were hospitalized at least once compared to 3.3% of placebo patients.

The FDA is recommending that health care professionals consider discontinuing the drugs in patients who develop heart failure. They should continue to monitor their glucose and consider other drugs if glucose levels are not well-controlled.

Sanjay Kaul (Cedars Sinai) sent the following comment:

DPP-IV inhibitors have modest glycemic efficacy, and have neutral effects on BP, lipids and weight loss. They are not associated with excess MACE risk, but might increase the risk of heart failure. Despite the desirable low risk of hypoglycemia, I see no compelling reason for their use. That they have become blockbuster drugs speaks more to the success of the Big Pharma marketing machinery rather than a compelling benefit-risk profile.

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