Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs
EAST HANOVER, N.J., October 23, 2003 -- Novartis announced that the FDA had approved Starlix (nateglinide) for use in combination with a thiazolidinedione (TZD) in patients with type 2 diabetes who are not adequately controlled after a therapeutic response to a TZD.
TZDs are a commonly used class of oral antidiabetic agents in the treatment of type 2 diabetes. Starlix was approved in the U.S. in 2001 as monotherapy for drug-naive patients with type 2 diabetes and in combination with metformin, a leading oral antidiabetic agent. With this new indication of adding Starlix to a TZD, physicians now have a new option for controlling and maintaining blood sugar levels of patients with type 2 diabetes.
Research has shown that improved glycemic control, as measured by a reduction of HbA(1c) levels, may lead to a dramatic lowering of deaths and complications from diabetes. Even a 1 percent reduction in HbA(1c) can correlate to a 21 percent decrease in deaths from diabetes and a 14 percent decrease in heart attacks. Additional research shows that over time there is a progressive need for multiple therapies in order to effectively treat type 2 diabetes and maintain a target HbA(1c) of less than 7.0 percent.
FDA approval of this new indication is based on the findings of a 24-week, multi-center, double-blind, randomized study which compared the efficacy of Starlix (120 mg, taken before a meal) and placebo added to rosiglitazone (Avandia(R) 8 mg, q.d.) in 402 patients with type 2 diabetes who had not reached target HbA(1c) levels on rosiglitazone alone.
The study found that the addition of Starlix reduced HbA(1c) from 8.3 percent to 7.5 percent while HbA(1c) remained unchanged for patients on rosiglitazone and placebo. The overall safety, tolerability and effects on lipid parameters for the combination were similar to rosiglitazone alone. Weight gain associated with Starlix use in this study was 2 kg compared to placebo. Peripheral edema was no more common in patients using the combination of Starlix and rosiglitazone than in patients receiving rosiglitazone alone.
For a copy of the full prescribing information, search "Starlix" at www.pharma.us.novartis.com
Posted: October 2003
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