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| Rosiglitazone |
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An oral thiazolidinedione hypoglycemic agent for the treatment of type 2 diabetes mellitus
Licensed Indication : Rosiglitazone is indicated only in oral combination treatment of type 2 diabetes mellitus in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:
-in combination with metformin only in obese patients
-in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.
* Rosiglitazone use is contraindicated in :
-Patients with cardiac failure or a history of cardiac failure(NYHA stages I to IV).
-Patients with hepatic impairment.
-Combination with insulin.
* Clinical Efficacy:
Rosiglitazone treatment in combination with metformin or a sulphonylurea has been evaluated in five, 26 week, double-blind randomized controlled trials in approx. 1500 patients with type 2 diabetes.Currently only two of these trials have been published in full. Rosiglitazone 4mg/day in combination with a sulphonylurea, and 4-8mg/day in combination with metformin significantly reduced HbA1c and fasting plasma glucose levels compared to baseline and control (sulphonylurea or metformin monotherapy).Open label extension studies suggest these benefits are maintained over the longer term. Trials are underway to evaluate the effects of Rosiglitazone on the micro- and macrovascular complications of diabetes. |
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| There are no existing companies to distribute selected chemical product |
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