Bydureon shown to be safe for heart but does not prevent cardiovascular events

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The type 2 diabetes drug Bydureon (exenatide) is safe for the heart but does not help to prevent cardiovascular events, a new study reveals.
University of Oxford scientists report that Bydureon fell just short of showing signs of cardiovascular benefit and did not help reduce the risk of cardiovascular events occurring. However, the researchers stressed that there is “solid evidence the GPL-1 class is safe and efficacious” for people with type 2 diabetes.
The findings are similar to a study published in May earlier this year which showed Bydureon met targets for cardiovascular risk safety but did not have statistically significant benefits in terms of heart disease prevention.
Bydureon, a GLP-1 analogue, is delivered as a once-weekly injection that helps keep blood glucose levels lower in people with type 2 diabetes. It is also known to enable weight loss, but there is little data regarding its cardiovascular benefits.
The Oxford team randomised 14,752 people with type 2 diabetes, with or without previous cardiovascular disease, to weekly Bydureon or placebo. They were then followed for an average of 3.2 years.
While there were less incidences of nonfatal myocardial infarction or nonfatal stroke in the Bydureon group, the drug was not superior to placebo with respect to efficacy. All in all, there were no significant differences between the two groups, including safety.
Overall serious adverse events were not increased following Bydureon treatment, although heart rate was slightly elevated in the drug group.
The researchers attributed the lack of cardiovascular efficacy to a number of factors, including differences in baseline HbA1c levels between patients and a relatively short follow-up period.
One of the limitations of the trial was the high discontinuation rate: 43 per cent with Bydureon, 45 per cent in the placebo group. “We speculate that probable factors for discontinuation were the complexity of the first-generation injection device that was used and the fact that our trial had no run-in period,” said the researchers.
The findings have been published in the New England Journal of Medicine.