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Cozaar. (News & Approved).
(losartan, Merck)
An angiotensin receptor blocker (ARB) for treating diabetic nephropathy with an elevated serum creatine and proteinuria in patients with type 2 diabetes and a history of hypertension. Cozaar and Avapro (irbesartan) are the first ARBs approved for this indication. (Avapro will be reviewed here in December.) Previously approved for hypertension.
Recommended Dosage: Starting at 50 mg once daily, increasing to 100 mg once daily based on blood pressure response.
Special Considerations: In a study of 1,513 patients with type 2 diabetes and advanced nephropathy that led to the approval, adverse events were similar with placebo and Cozaar. Side effects reported more often in Cozaar-treated patients included hypotension (7% vs. 3%).
Comment: In the study the risks of a doubling of the serum creatinine and of endstage renal disease (ESRD) were reduced by 25% and 28%, respectively among those on Cozaar vs. placebo; the benefits were "beyond that attributable to blood pressure control" (N. Engl. J. Med. 345[12]861-69, 2001). There was no impact on ...