December 17, 2008
Diabetes drugs and cardio risks evaluated
The U.S. Food and Drug Administration is recommending companies developing type 2 diabetes drugs and biologics evaluate the products' cardiovascular risks.
The FDA said pharmaceutical companies should provide evidence the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation applies to all diabetes drugs currently under development.
We need to better understand the safety of new anti-diabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage,said Dr. Mary Parks, director of the FDA's division of metabolism and endocrinology products.
The federal agency said people with diabetes have a two- to four-times greater risk of heart disease than non-diabetics, and none of the currently approved anti-diabetic therapies has been convincingly proven to reduce that risk.
The 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 guidance recommends such studies demonstrate new anti-diabetic 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.