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FDA Grants Marketing Approval for Benicar HCT (Olmesartan Medoxomil-Hydrochlorothiazide) Treatment For Hypertension

PARSIPPANY, NJ -- June 9, 2003 -- Sankyo Pharma Inc. announced today the marketing approval of Benicar HCT by the U.S. Food and Drug Administration (FDA) for second-line treatment of hypertension. Benicar HCT combines the angiotensin II receptor blocker (ARB) BenicarŪ (olmesartan medoxomil) with the diuretic hydrochlorothiazide (HCTZ), and produces significant placebo-adjusted average reductions in systolic and diastolic blood pressure - up to 24 mm Hg* and 14 mm Hg¹ respectively. Benicar HCT will be available in the second half of 2003.

"Studies prove that the combination of Benicar plus hydrochlorothiazide yields very significant blood pressure drops in hypertensive patients," said Steven Chrysant, MD, PhD, lead investigator of the combination's pivotal trial and Professor of Medicine, University of Oklahoma and Director, Oklahoma Cardiovascular and Hypertension Center. "Hypertension is a multifactorial disease, with many patients requiring more than one agent for adequate blood pressure control. The data on Benicar HCT demonstrate the effectiveness of combination therapy and are consistent with the new JNC 7 guidelines², which emphasize the need for more aggressive blood pressure lowering."

Benicar HCT Clinical Data
The safety and efficacy of Benicar HCT was evaluated in clinical trials of more than 1200 patients³. The results of the pivotal trial were presented at the American Society of Hypertension meeting last month⁴. This study was a double-blind, multicenter, factorial-design clinical study, which evaluated 502 men and women with mild-to-moderate hypertension (diastolic blood pressure 100-115 mm Hg). The subjects were randomized to 1 of 12 groups: placebo, monotherapy with Benicar (10 mg, 20 mg or 40 mg), monotherapy with HCTZ (12.5 mg or 25 mg), and Benicar/HCTZ combinations (including all possible combinations). The primary endpoint was the change from baseline in average diastolic blood pressure at Week 8. At Week 8, Benicar in conjunction with HCTZ demonstrated greater average reductions in systolic and diastolic blood pressure than did monotherapy with either component. In addition, all Benicar/HCTZ combinations significantly reduced average systolic and diastolic blood pressure compared with placebo.

* mm Hg = millimeters of mercury - units of blood pressure measurement

Important Safety Information
Benicar HCT(TM) (olmesartan medoxomil-hydrochlorothiazide) should not be used in women who are pregnant or by people who are allergic to any component of the medication. Because of the HCTZ component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

In volume or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur. Treatment should start under close medical supervision.

Benicar HCT has been evaluated for safety in more than 1200 hypertensive patients. Treatment with Benicar HCT was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of Benicar HCT.

In a placebo-controlled clinical trial, the following adverse events reported with Benicar HCT occurred in >2% of patients, and more often on the Benicar HCT combination than on placebo, regardless of drug relationship: dizziness (9%), upper respiratory tract infection (7%), hyperuricemia (4%), and nausea (3%).

USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Benicar HCT should be discontinued as soon as possible.

For full prescribing information, please refer to package insert.

About the Benicar Franchise
Benicar HCT combines the ARB Benicar with HCTZ. Benicar HCT will be available in three fixed-dose combinations: 20 mg olmesartan medoxomil / 12.5 mg HCTZ; 40 mg olmesartan medoxomil / 12.5 mg HCTZ; 40 mg olmesartan medoxomil / 25 mg HCTZ, offering a range of dosing options for hypertensive patients.

BenicarŪ (olmesartan medoxomil) was approved by the FDA in April 2002. Studies have shown that Benicar 20 mg taken once a day provides effective average diastolic blood pressure reductions versus baseline and has shown a demonstrated dose response in patients when titrated to 40 mg. In two separate clinical trials, Benicar established superior blood pressure-lowering efficacy over the ARB CozaarŪ (losartan potassium)⁵.

The only side effect that occurred in more than 1 percent of patients treated with Benicar and at a higher incidence versus placebo was dizziness (3% vs. 1%). Benicar and Benicar HCT are co-promoted by Sankyo Pharma and Forest Laboratories, Inc. (NYSE: FRX).

CozaarŪ is a registered trademark of Merck & Co.

1. Package Insert 2. The Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure issued its seventh report (JNC 7) which specified that two or more antihypertensive agents may be required to achieve goal blood pressure in many patients with hypertension. The report also states that at least one of the agents should be a thiazide-type diuretic such as HCTZ. 3. Data on file 4. Chrysant et al. 5. Data on file.


SOURCE: Sankyo Pharma Inc.

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