News

Bydureon trial shows safety but not significant heart benefit

The GLP-1 receptor agonist drug Bydureon has met targets for heart safety but has not managed to show that it significantly benefits heart health.
The results come from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Bydureo, marketed by AstraZenecan, is the trade name for a form of the drug exenatide. Bydureon is taken once weekly and acts to improve the body’s hormone response to meals, including improving satiety.
The trial involved 14,000 people with type 2 diabetes and a range of heart disease risks and divided people into those taking Bydureon with those taking a placebo. The researchers reviewed the number of major cardiovascular events such as death from heart disease, non-fatal heart attack and nonfatal stroke.
The results showed that Bydureon met the targets for cardiovascular risk safety but did not show that it had statistically significant benefits in terms of heart disease prevention.
Cardiovascular safety and benefit has become an important topic for diabetes medications since problems were found with Avandia in 2010. A post-marketing clinical trial (a trial that is run after the drug has been approved and is in public use) showed that people on Avandia were showing higher risks of heart disease and the drug’s use was suspended in many countries.
Since then, the Food and Drug Administration (FDA) in the US required more evidence that drugs are not harmful to heart health.
To date, Jardiance, an SGLT2 inhibitor marketed by Lilly and Boehringer, is the only type 2 diabetes drug to be recognised showing distinct benefits for heart health.
On 9 June, a number of companies will present health data related to their medications at the annual meeting of the American Diabetes Association.

To Top