Neutral results from phase III trial of Lyxumia (lixisenatide) for cardiovascular risk in type 2 diabetes- Sanofi

The ELIXA Phase IIIb study designed to assess the cardiovascular (CV) safety of Lyxumia (lixisenatide), from Sanofi, in adults with type-2 diabetes mellitus (T2DM) and a high CV risk, has reported a neutral effect on heart failure and other cardiovascular problems. In previously reported data, lixisenatide met the prespecified criterion of noninferiority versus placebo for the composite primary endpoint of CV death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina, but did not demonstrate superiority.

Additional safety findings include no signal for an increased risk of heart failure, pancreatitis, pancreatic cancer, or severe symptomatic hypoglycemia. Lixisenatide was generally safe and well tolerated. The complete results will be included in the new drug application for lixisenatide, which is on track to be resubmitted to the FDA in the third quarter of 2015.

Comment: "There has been a cloud of suspicion over all new diabetes drugs, including GLP-1 agonists, over whether they may increase the risk for cardiovascular problems," said Marc Pfeffer, MD, PhD, Dzau Professor of Medicine at Harvard Medical, senior physician in cardiology at Brigham and Women's Hospital and principal investigator for the ELIXA trial. "There has also been some hope that some of these drugs may improve cardiovascular health. GLP-1 receptor agonists were being used around the world while CVD safety had yet to be established. This is the first report of a clinical trial designed to assess cardiovascular outcomes in this class of drugs and we have shown that patients and their healthcare providers should have no cause for concern, even if they are at high risk for heart-related problems."