One member of a widely prescribed class of drugs used to lower blood glucose levels in people with diabetes has a neutral effect on heart failure and other cardiovascular problems, according to the first clinical trial to examine cardiovascular safety in a GLP-1 receptor agonist, presented at the American Diabetes Association’s 75th Scientific Sessions.
The Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study also found a modest benefit for weight control, and no increase of risk for hypoglycemia or pancreatic injury in those who took lixisenatide, one of several GLP-1 receptor agonists being prescribed around the world to treat people with type 2 diabetes. GLP-1 receptor agonists are derived from gut hormones and may be used as a secondary therapy when other medications fail to sufficiently lower blood glucose levels.
“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.”
Specifically, the ELIXA study found no increased risk for cardiovascular death, heart attack, stroke, unstable angina (chest pain) or heart failure in people with type 2 diabetes who had recently experienced acute coronary syndrome events (an umbrella term referring to when blood supplied to the heart muscle is suddenly blocked) and were therefore at high risk for additional heart problems. The study examined 6,068 people from 49 countries, randomly assigning them to lixisenatide or placebo, with a follow-up period of more than two years.
Heart disease and stroke are the number one causes of death and disability among people with type 2 diabetes, who are two to four times more likely than those who do not have diabetes to suffer from these conditions. Because of this, the U.S. Food and Drug Administration has recently augmented cardiovascular surveillance for new drugs prescribed to treat elevated blood glucose in patients with type 2 diabetes, including GLP-1 receptor agonists.
The ELIXA trial also showed that those who took lixisenatide were not more likely to have problems with hypoglycemia (low blood glucose) than those who took placebo, despite better blood glucose control.
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