Rosiglitazone Plus Glimepiride Tablets (Avandaryl) Linked to Increased CV Risk i

The FDA approved safety labeling revisions for rosiglitazone maleate plus glimepiride tablets (Avandaryl, made by GlaxoSmithKline) to warn of the increased risk for rosiglitazone-related cardiovascular (CV) events in patients with New York Heart Association (NYHA) class 1 and 2 cardiac status. The warning was based on data from a 52-week, double-blind, echocardiographic study in 224 NYHA class 1/2 patients (ejection fraction, = 45%), showing that although no changes in ejection fraction occurred relative to baseline, patients receiving rosiglitazone rather than placebo experienced an increased rate of congestive heart failure worsening, new or worsening edema, and new or worsening dyspnea (6% vs 4%, 25% vs 9%, and 26% vs 17%, respectively). Rosiglitazone-treated patients were therefore also more likely to require increased doses of congestive heart failure medication (33% vs 18%) and CV hospitalization (19% vs 13%).

Ischemic adverse events, such as myocardial infarction and angina, were also more commonly reported in the rosiglitazone vs placebo group (5% vs 2% and 5% vs 3%, respectively).

The FDA advises that all patients be observed for signs and symptoms of heart failure and that therapy be discontinued if any deterioration in cardiac status occurs. Because the associated CV risk, patients with NYHA class 3 and 4 cardiac status were not studied in clinical trials of rosiglitazone; use of the combination drug in this population is not recommended.

Rosiglitazone plus glimepiride tablets are indicated for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are already receiving the drug combination, those who are inadequately controlled while taking a sulfonylurea alone, and patients who initially responded to rosiglitazone alone but require additional glycemic control.
FDA

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