Merck has released top-line results from TECOS, its major cardiovascular-outcomes trial with the type 2 diabetes drug sitagliptin (Januvia), showing it achieved its main goal: noninferiority for the cardiovascular composite end point of first time to myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, or cardiovascular-related death.
Importantly, sitagliptin — a dipeptidyl peptidase-4 (DPP-4) inhibitor — did not increase hospitalization for heart failure, a secondary end point, the company has announced in a statement.
This is a key finding and should give some reassurance, because a signal for heart failure was observed in the cardiovascular-outcomes trial SAVOR-TIMI 53 with the DPP-4 inhibitor saxagliptin (Onglyza, AstraZeneca/Bristol-Myers Squibb), and a trend toward an increase in heart failure was seen in another CV outcomes study, EXAMINE, with the DPP-4 inhibitor alogliptin (Nesina, Takeda Pharmaceuticals).
These results led to a US Food and Drug Administration (FDA) advisory committee recommending, just 2 weeks ago, to update the label for saxagliptin to indicate there is an increased risk of heart failure with this drug based on SAVOR-TIMI 53 and a trend toward higher all-cause mortality.
For alogliptin, the panel also voted to update that label to warn of an increased risk of heart failure based on EXAMINE, although it acknowledged there was a lack of a real signal with this drug.
The issue has remained as to whether there is a classwide problem with regard to DPP-4 inhibitors and heart failure; the results of TECOS have been eagerly awaited, and although it is difficult to tell from these preliminary results, they should lift some of the concern.
TECOS was an event-driven trial conducted in adults with type 2 diabetes and a history of cardiovascular disease, comparing the cardiovascular safety of long-term treatment with sitagliptin as part of usual care compared with usual care without sitagliptin. It enrolled 14,724 participants from 38 countries between December 2008 and July 2012, and the median patient follow-up is approximately 3 years.
Full details of TECOS will be reported at the American Diabetes Association Scientific Sessions in Boston on June 8.
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Cite this: TECOS: No Increase in HF Hospitalization With Sitagliptin - Medscape - Apr 28, 2015.