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The Cardiovascular Safety of Diabetes Drugs — Insights from the Rosiglitazone Experience
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Journal Article
The Cardiovascular Safety of Diabetes Drugs — Insights from the Rosiglitazone Experience
2013
Overview
A signal of cardiovascular harm with rosiglitazone led to a new FDA policy on diabetes-drug approval. As that signal has faded in recent analyses, should FDA policy change?
The management of type 2 diabetes has been challenged by uncertainty about possible cardiovascular effects related to treatment intensity and choice of drug. Although the Food and Drug Administration (FDA) considers a decrease in glycated hemoglobin an approvable end point, very intensive glycemic control is associated with increased cardiovascular and all-cause mortality.
1
The safety of specific drugs for type 2 diabetes — particularly the thiazolidinediones — has also been questioned. After rosiglitazone had been approved in the United States in 1999 and in Europe in 2000, a highly publicized meta-analysis in 2007 reported a 43% increase in myocardial infarction (P=0.03) . . .
Publisher
Massachusetts Medical Society
Subject
/ Cardiovascular Diseases - chemically induced
/ Cardiovascular Diseases - mortality
/ Diabetes
/ Diabetes Mellitus, Type 2 - drug therapy
/ Europe
/ Humans
/ Hypoglycemic Agents - adverse effects
/ Myocardial Infarction - chemically induced
/ Safety-Based Drug Withdrawals
