ESC studies dispel safety worries on Bristol-Myers' Onglyza, Takeda's Nesina

The DPP-4 class of diabetes drugs got a boost from two new safety trials. The studies, presented at the European Society of Cardiology meeting, found no increase in heart attack risks for patients using Bristol-Myers Squibb ($BMY) and AstraZeneca's ($AZN) Onglyza, and Takeda Pharmaceutical and Sanofi's ($SNY) Nesina.

It's a welcome bit of news for the diabetes drugs. As the Wall Street Journal notes, newer diabetes treatments are under a safety spotlight. Since studies raised a red flag on GlaxoSmithKline's Avandia treatment and its potential effects on heart safety, the FDA has stepped up its scrutiny of diabetes treatments, not only looking closely at existing treatments but also raising the bar for hopeful drug candidates.

One of the trials, SAVOR, looked at Onglyza safety, comparing patients using the BMS-AstraZeneca drug with those taking a placebo or another standard diabetes treatment. In two years of follow-up, Onglyza patients didn't see a higher risk of cardiovascular death, heart attack or stroke than the other patients did. There was an increase, however, in hospitalizations related to heart failure, with 3.5% of Onglyza patients hospitalized, compared with 2.8% of patients in the control arm.

The other trial checked out Nesina safety in almost 5,400 patients, for an average of 18 months. It, too, found no increase in heart attack risk for patients using the DPP-4 drug compared with the control arm.

Experts figure the new data will quell worries about possible heart-attack risks stemming from DPP-4 drugs. The heart-failure signal on Onglyza is an iffier result, the study author said. The data needs a closer look to verify it and to determine which patients might be at risk. "[T]his heart-failure finding was unexpected," Brigham & Women's Hospital physician Deepak Bhatt told the WSJ. "For that reason it's important to be a little bit cautious in interpreting it."

- get the release from Bristol-Myers
- see the WSJ piece

Special Reports: 10 Top-Selling Diabetes Drugs | Top 10 Cardio Drugs 2012

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