April 13, 2015 — Patients who use Onglyza to treat type-2 diabetes may be significantly more likely to develop heart failure and more likely to die, according to an FDA analysis of clinical trial data.
The data came from the SAVOR clinical trial, which involved about 16,500 diabetic patients who had a high risk of cardiovascular disease. The patients were given either Onglyza or a placebo.
Last year, the FDA issued a Safety Communication to announce that preliminary results of the study suggested a 27% increased risk of heart failure associated with Onglyza.
Now, the FDA is warning that Onglyza may also increase the risk of “all cause mortality,” whether they developed heart problems or not.
The FDA did not determine why Onglyza might increase the risk of death. They asked an expert committee for their opinions, given the fact that “a large number of deaths were observed.”
Bloomberg talked to experts who said conclusions might be difficult because the patients in the study were already older, sicker, with diabetes and pre-existing cardiovascular risk-factors.
Onglyza belongs to a new class of diabetes drugs that work by inhibiting DPP-4, which helps the body control blood-sugar levels by increasing insulin production. The FDA is also investigating whether this mechanism of action might increase the risk of pancreatitis (pancreas inflammation) and pancreatic cancer.
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