After reviewing the results of the ROADMAP and ORIENT trials (1), US FDA has determined that the benefits of Benicar (Olmesartan) continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label.(2)
Benicar (Olmesartan) is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.
ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.
Benicar (olmesartan) is in the class of drugs called angiotensin II receptor blockers (ARBs). These drugs and a closely related group of drugs called angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies involving thousands of patients at high-risk for cardiovascular events, such as patients who had a previous heart attack or had heart failure. No increased risk of cardiovascular-related death has been reported in these trials and, in fact, some of these studies indicate ARBs and ACEIs are useful as treatments for certain patients at high-risk for cardiovascular events.
(1) Haller H, Ito S, Izzo JL, et al. Olmesartan for the delay or prevention of microalbuminuria in Type 2 Diabetes. N Engl J Med 2011;364:907-17
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