An international, multidisciplinary team including investigators from Brigham and Women's Hospital (BWH) has found that lixisenatide, a member of a class of glucose-lowering drugs frequently prescribed in Europe to patients with diabetes, did not increase risk of cardiovascular events including heart failure. These results - the first to be reported on the cardiovascular safety of a glucagon-like peptide 1 (GLP-1) receptor agonist - were presented today at the American Diabetes Association's 75th Scientific Sessions.
"There are a large number of patients around the world who take this class of agents to help manage their glucose -based on our results patients and their healthcare providers should be reassured of the cardiovascular safety of lixisenatide even if they are at high risk for heart-related problems," said Marc Pfeffer, MD, PhD, a member of the Cardiovascular Medicine Division at BWH, professor at Harvard Medical School and principal investigator for the ELIXA (Evaluation of LIXisenatide in Acute Coronary Syndrome) trial.
Patients with type 2 diabetes are at high risk for developing cardiovascular disease and some glucose-lowering drugs have been associated with an additional increase risk of adverse cardiovascular effects. These observations prompted the US Food and Drug Administration and the European Medicines Agency to establish guidelines for clinical trials to ensure that new therapies do not put type 2 diabetes patients at increased cardiovascular risk.
In the ELIXA study, researchers enrolled more than 6,000 type 2 diabetes patients from 49 countries who had recently recovered from a heart attack or other acute coronary event to evaluate the effects of lixisenatide on a population at high risk of a cardiovascular event. The large, double-blind, placebo-controlled study measured multiple outcomes, including cardiovascular death, heart attack, stroke, hospitalization for chest pain and heart failure.
Overall, the research team found that the drug had a neutral effect on risk of cardiovascular problems - that is, it neither increased nor decreased risk, all within the limits of the FDA's safety guidelines. In addition, lixisenatide provided a modest benefit in terms of weight gain, and no increase in cancers or pancreatitis.
"ELIXA provides data showing that this treatment can be used in a safe manner without worsening cardiovascular prognosis of patients with type 2 diabetes, even among the highest risk population - those with a pre-existing history of heart failure," said Eldrin Lewis, MD MPH, a physician in the Cardiovascular Medicine Division at BWH and an associate professor at Harvard Medical School.
For researchers at the Brigham and their collaborators, the results of the study are just the beginning: the data collected from 6,000 patients all over the world will be used for future analysis to better understand the prognosis for patients with diabetes.
"We now have an expansive data set from patients with type 2 diabetes from around the globe, and we look forward to collaborating with our international ELIXA co-investigators to further explore data about cardiovascular outcomes in this patient population," said Brian Claggett, PhD, of BWH's Cardiovascular Medicine Division.
This research was supported by Sanofi.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in Massachusetts and employs nearly 15,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $650 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation's first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials group. For more information, resources and to follow us on social media, please visit BWH's online newsroom.