FDA Investigating Heart Failure Threat Linked To Onglyza

The FDA said today that it was conducting an investigation of a feasible increased chance for heart failure connected with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its producer, BristolMyers-Squibb.)

The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial in which much more than sixteen,000 sort two diabetics have been randomized to the DPP-four inhibitor saxagliptin or placebo. The trial, presented final year at the European Society of Cardiology and published in the New England Journal of Medication, identified no considerable difference in the composite endpoint of cardiovascular death, MI, or ischemic stroke. However, there was a important excess in hospitalization in the saxagliptin group (three.five% versus two.8%, p=.007).

The FDA mentioned that it has requested trial data from the producer and that it considers present info from the trial to be preliminary. The FDA said that patients must not end taking the drug and must discuss their concerns with a healthcare specialist. The investigation of saxagliptin is part of a broader investigation of the cardiovascular threat of all medicines for kind two diabetes.

Comment: The simultaneous appearance final 12 months of the SAVOR-TIMI 53 trial and the EXAMINE trial with alogliptin (Nesina, Takeda), was a traditional excellent information/poor news setup. On the 1 hand, the overall cardiovascular safety of these diabetes drugs appeared safe. On the other hand, there was no cardiovascular benefit, leaving a lot of to wonder about the true worth of these medication. For now this question hangs in the balance. In the absence of a new big clinical trial especially examining this website link to heart failure it is unlikely that the FDA investigation will be able to supply a definitive reply. But if a thorough investigation turns up far more purpose for concern then these medicines could come under further strain and scrutiny.

FDA Investigating Heart Failure Threat Linked To Onglyza