After testing a once-weekly injectable form of glucose-lowering drug exenatide on type 2 diabetes patients for years, researchers have concluded the medication doesn’t have any effect on the incidence of major cardiovascular events.
Previous studies have assessed the effect of exenatide and other glucose-lowering agents on cardiovascular outcomes before, Adrian F. Hernandez, MD, and co-authors wrote in their study, published in the New England Journal of Medicine this month. Those trials didn’t reveal any impact on major adverse cardiovascular events, but Hernandez and colleagues zoned in on another form of exenatide approved to treat type 2 diabetes as an alternate possibility.
Injectable exenatide comes with the convenience of once-weekly use and extended release, according to the study, and the drug has been shown to lower blood glucose levels while simultaneously inducing slight decreases in body weight, blood pressure and lipid levels. However, it’s also been proven to increase heart rate in the past.
Researchers designed a double-blind, randomized, placebo-controlled and event-driven trial that would span across 687 sites in 35 countries. Nearly 15,000 patients were enrolled in the study, 73.1 percent of whom had known cardiovascular disease.
While Hernandez and co-authors hypothesized that once-weekly administration of exenatide would be on par with the placebo group in terms of safety, they believed it would be superior to the placebo group when it came to efficacy and outcome. However, that wasn’t the case.
“The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma and serious adverse events did not differ significantly between the two groups,” the authors reported.
Of the 7,356 patients who participated in the exenatide trial, 839 (11.4 percent) experienced a primary outcome event. Similarly, 905 of 7,396 patients (12.3 percent) placed in the placebo trial experienced an adverse event. Risk of death from any cause was 6.9 percent in the exenatide group and 7.9 percent in the placebo group. Cardiovascular death rates were similar in both groups, as well, and cardiovascular risk rates appeared unchanged overall, regardless of whether or not patients were taking exenatide.