TECOS Study With Sitagliptin to Be Reported at ADA Meeting

February 05, 2015

The results of the eagerly awaited cardiovascular-outcomes trial with the type 2 diabetes drug sitagliptin (Januvia, Merck), are to be presented at the American Diabetes Association meeting in June.

Called TECOS, the study is expected to complete next month. Sitagliptin is Merck's best-selling product, bringing in $6 billion for the company in 2014.

The findings will be key because two other large outcomes trials with dipeptidyl peptidase-4 (DPP-4) inhibitors, Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-TIMI 53 and EXAMINE with alogliptin (Nesina, Takeda Pharmaceuticals), have unearthed a possible increased risk for heart failure associated with the use of these agents in patients with type 2 diabetes.

The SAVOR-TIMI 53 results showed a significantly increased risk for hospitalization for heart failure in those taking saxagliptin vs those on placebo (hazard ratio [HR], 1.27; P = .007). Following these findings, the US Food and Drug Administration announced a year ago that it would review heart-failure risk associated with saxagliptin.

While the signal with saxagliptin was significant in SAVOR-TIMI 53, in EXAMINE there was a trend toward a higher risk for HF hospitalization in those diabetic patients taking alogliptin.

And although experts have said that they still believe DPP-4 inhibitors are safe to use in diabetes patients with heart failure — unless they have very advanced heart failure and concomitant renal insufficiency — all eyes will be on the results of this new study.

Results to date from other studies with sitagliptin have yielded conflicting results with regard to the heart-failure question: some of the first information with regard to this was reported at the ICE/ENDO 2014 meeting last June.

But TECOS is seen as the big test: if it finds no increased risk for heart failure with sitagliptin, the DPP-4 inhibitor that has been on the market for the longest period of time, doctors treating diabetic patients with this agent (and likely the whole class of DPP-4 inhibitors) will breathe a sigh of relief, as will Merck.

If however, TECOS shows a similar signal when it comes to heart failure, this will be cause for concern.

The primary results will be presented at the ADA 2015 Scientific Sessions in Boston, Massachusetts, on Monday June 8, at 4:30 pm.

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