According to the FDA, more than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.
Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and the FDA said that none of the diabetic medications currently on the market has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack, the agency said.
The FDA decided to take a look at diabetes drug testing after Avandia was linked to an increased risk of heart attacks. Previously, the FDA required the makers of diabetes drugs to prove they lower blood sugar levels. But the Avandia debacle has led many experts to call on the agency to require drug makers to meet other bench marks, including whether they reduce the risk of cardiovascular problems – the number one killer of diabetics.
“We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage,” Mary Parks, M.D., director of the FDA Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research, said in a statement announcing the new standards. “FDA’s guidance outlines the agency’s recommendations for doing such an assessment.”
The new guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the FDA recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies — especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.
The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.
The FDA has provided written notice of the recommendations to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment. The new standards mean that it could take longer for drug makers to bring these new medications to market.