Harvard Heart Letter

No heart risk-or benefit-from diabetes drug Onglyza

Heart disease is the leading cause of death for people with diabetes. Diabetes drugs lower blood sugar, but that benefit must be weighed against possible harm to the heart—an evaluation now required by the FDA. Dr. Deepak L. Bhatt, editor in chief of the Harvard Heart Letter and professor of medicine at Harvard Medical School, co-led the most comprehensive study ever done of a diabetes drug's heart effects.

The drug, saxagliptin (Onglyza), was approved in 2009 for people with diabetes after clinical trials showed it improved blood sugar control. Data from those trials also suggested that it reduced heart disease. But the new two-year study, reported by Dr. Bhatt's team in The New England Journal of Medicine, found Onglyza did not reduce heart risk compared with placebo in 16,492 people with diabetes and at high risk of heart disease. Importantly, however, the drug did not increase the risk of cardiovascular disease or stroke.

"Concerns have been raised about older diabetes drugs raising heart attack risk, so lack of such a hazard is a step forward in our understanding the risks and benefits of newer diabetes drugs," stated Dr. Bhatt.

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