Late Monday afternoon Merck released the top line results ofTECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin). The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.”
The FDA has been wrestling for a number of years now with the problem of the cardiovascular effects– whether positive or negative– of diabetes drugs. The first large outcomes trials with two other DPP-4 inhibitors, saxagliptin (Onglyza, AstraZeneca) and alogliptin (Nesina, Takeda Pharmaceuticals) were reported in 2013 and found no impact of the drugs on cardiovascular outcomes.
However, a troubling signal emerged suggesting a possible raised risk for heart failure, though the endpoint was not rigorously studied in the trials. Two weeks ago the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed the trials and rejected recommendations from critics for new restrictions on their use, but they did say that information from the two clinical trials should be added to the drugs’ labels.
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