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Olmesartan (Benicar) approved for treating blood pressure in kids in US : Daiichi Sankyo

Thursday, February 11, 2010, 14:34 This news item was posted in health category and has 0 Comments so far.

Olmesartan medoxomil which is sold in the brand name Benicar by Daiichi Sankyo, Inc. has been approved for treating high blood pressure in children and adolescents 6 to 16 years of age.

Olmesartan (Benicar) was originally approved in 2002 by U.S. Food and Drug Administration for the treatment of hypertension in adults.

Olmesartan is a member of the ARB class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels, which may lead to antagonizing the release of the hormone which causes salt retention and increased blood volume.

Angiotensin II is a hormone that interacts with a receptor on arterial blood vessels, which results in constriction and increasing blood pressure.

Angiotensin II stimulates the release of another hormone that causes enhanced sodium and chloride (salt) retention, with a resultant increase in vascular water retention and blood volume that also contributes to an elevation in blood pressure.

The average blood pressure of American children is on the rise, in parallel with the increase of children’s weight, studies have found.

An analysis of nearly 40 years of national surveys of high blood pressure trends in children and adolescents showed that the prevalence of elevated blood pressure among this group has been growing since the late 1980’s.

“As hypertension is on the rise also in a younger population, Daiichi Sankyo believes it is important to help doctors meet the challenge of treating these pediatric patients by providing a treatment option to help people effectively manage their hypertension,” stated Reinilde Heyrman, MD, vice president Clinical Development – Operations, Daiichi Sankyo Pharma Development.

Approximately 5 percent – or 3.6 million – American children suffer from high blood pressure, with the majority unaware they have the condition.

Pediatric hypertension is closely linked to childhood obesity, as obese children are at approximately a three-fold higher risk for hypertension than non-obese children.

Hypertension during childhood has been shown to be an independent risk factor for hypertension in adulthood, and to be associated with early markers of cardiovascular disease, making it important to treat this condition in children and adolescents.

Olmesartan has been studied in a phase III programme to examine its antihypertensive effects  in pediatric patients.

The study found olmesartan (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.

Olmesartan is indicated for the treatment of hypertension in adults and pediatric patients 6 to 16 years of age, alone or with other antihypertensive agents. Benicar may be used as initial therapy.

Headquartered in Parsippany, New Jersey, Daiichi Sankyo, Inc. is the U.S. subsidiary of Tokyo-based Daiichi Sankyo Co., Ltd.

Daiichi Sankyo was established in 2005 from the merger of two leading Japanese pharmaceutical companies.

A central focus of Daiichi Sankyo’s research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes and acute coronary syndrome.

Daiichi also discovers new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders.

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