FDA Issues Recommendations on Evaluating Cardiovascular Risk in Drugs Treating Type 2 Diabetes
December 18, 2008
The U.S. Food and Drug Administration (FDA) announced a recommendation that manufacturers developing type 2 diabetes drugs offer evidence that new therapies will not increase the risk of cardiovascular episodes such as heart attacks. The guidance applies to all diabetes drugs currently in development. Until now, companies were generally only required to show that treatments lower blood sugar.
More than 23 million people in the United States have type 2 diabetes or diabetes mellitus, a metabolic disease characterized by abnormally high blood sugar levels known as hyperglycemia. Diabetics are two-to-four times more likely to suffer from heart disease than non-diabetics. To date, none of the FDA approved antidiabetic therapies available on the market have been proven to reduce that risk. Because those patients afflicted with diabetes often require life-long treatment, the FDA feels that patients and prescribers need to know more about whether therapies to treat the disease put patients at an increased risk of a heart attack.
Specifically, the FDA is recommending that Phase 2 and Phase 3 clinical trials demonstrate that new treatments do not increase cardiovascular risks in comparison with existing treatments. The FDA is particularly concerned about elderly patients or those with advanced stage diabetes or renal impairment. Additionally, the FDA recommends that manufacturers have any cardiac episodes in their clinical trials reviewed by outside cardiologists who are unaware of which patients received the tested products and which patients were on placebo. This will better ensure that comprehensive information on safety and effectiveness is included on product labels. It will also allow prescribers and patients to make better-informed decisions regarding which course of treatment should be used in order to manage type 2 diabetes.
Although the FDA remains confident that currently marketed diabetes medicines are safe and effective when used properly, it will continue to evaluate how the newly issued recommendations will be applied to those drugs. A further guidance on this issue is expected.
If you or a loved one suffered a heart attack or other cardiac injury as the result of a diabetic therapy, contact us today for a confidential and free case evaluation.