FDA OKs Two Medicines for Cardiovascular Disease in Type 2 Diabetes
People with diabetes have two to three times the increased risk for cardiovascular disease and death as those in the general population. Cardiovascular disease also accounts for two out of every three deaths in those with diabetes.
For people with Type 2 diabetes and pre-existing heart disease, the Food and Drug Administration (FDA) recently approved a change in the prescribing information for Jardiance (generic name empagliflozin) and Victoza (liraglutide), indicating they can be used to reduce the risk of cardiovascular disease in this group. Empagliflozin received an indication to only reduce cardiac death. Liraglutide received a broader indication, including reduction of heart attack, stroke, and death.
FDA Requires heart disease outcomes research
“Until 2008, the FDA approved diabetes medications based only their effects on blood sugar and evidence that they were reasonably safe,” said Steven Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic. “Since then, they have required the performance of additional trials focusing on cardiovascular disease outcomes.”
Most of the research on cardiovascular disease onoutcomes from Type 2 diabetes medications has shown limited or no benefits for the heart. So far, these are the only two exceptions, leading to the changes in prescribing information.
“The FDA staff and their committees thought that the evidence was sufficiently robust to warrant a label claim,” said Nissen. “From the point of view of the patients, this is a big deal because it means after decades of drug development, we have drugs for d Continue reading