SmithKline Beecham’s rosiglitazone (Avandia) received approval from FDA for treatment of type 2 diabetes as either monotherapy or in combination with metformin. Since the agent has not produced liver toxicities in patients in clinical trials, it is expected to largely displace use of troglitazone when it is released in a few days. SKB is copromoting the product with Bristol-Myers Squibb.
FDA approval was based on clinical studies involving more than 5,500 patients with type 2 diabetes. In these studies, rosiglitazone effectively lowered blood glucose levels of patients by an average of 76 mg/dL, compared with placebo, and maintained blood glucose control for up to 12 months. Patients achieved an average reduction in hemoglobin A1C levels up to 1.5 percentage points at a daily dose of 8 mg, demonstrating a statistically significant improvement in glycemic control relative to placebo and also in comparison to baseline.
Commonly reported side effects with rosiglitazone were upper respiratory tract infections, headaches, anemia, and edema. As with other members of this class, weight gain has been reported.