Wednesday, February 17, 2010

FDA approves Olmesartan (Benicar, Olmetec) for children....

Olmesartan (Benicar, Olmetec-by Ranbaxy) is an angiotensin II  receptor antagonist used to treat high blood pressure. 

Mode of action : Olmesartan works by blocking the binding of angiotensin II to the AT1 receptors in vascular muscle; it is therefore independent of angiotensin II synthesis pathways, unlike ACE inhibitors. By blocking binding rather than synthesis of angiotensin II, olmesartan inhibits the negative regulatory feedback on renin secretion. As a result of this blockage, olmesartan reduces vasoconstriction and the secretion of aldosterone. This lowers blood pressure by producing vasodilation, and decreasing peripheral resistance.

Now FDA has approved the hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age.  Benicar was originally approved in 2002 for the treatment of hypertension in adults (Daiichi Sankyo, Inc.).

The approval of this expanded indication was based on a phase III study examining the antihypertensive effects of Benicar in pediatric patients. The study found Benicar to be safe and efficacious in children ages 6-16 with hypertension, resulting in blood pressure reductions that were statistically different in comparison to placebo. Benicar was generally well tolerated in pediatric patients, and the adverse event profile was similar to that for adults.

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