FDA recommends new prescribing info for Glaxo Avandia

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The FDA Monday updated GlaxoSmithKline’s prescribing information for Avandia to include clinical findings from ADOPT (A Diabetes Outcome Progression Trial).

ADOPT, a four to six international multi-center study data on Avandia, demonstrated that patients treated with Avandia achieved greater sustained glycemic control compared to metformin and sulfonylurea, according to the London-based GSK. Better glycemic control has been proven to reduce risks of serious complications associated with type 2 diabetes including blindness, loss of limbs and kidney failure, the company said.

The company indicated that percentage of patients with inadequate glucose control at five years was 34 percent with glyburide, 21 percent with metformin and only 15 percent with Avandia.

GSK noted that the difference between Avandia (rosiglitazone maleate), and the comparators was statistically significant. The data provides further information on Avandia as a safe and effective treatment option for type 2 diabetes patents.