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Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as the First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Their Blood
Date:11/19/2007

AVALIDE demonstrated powerful mean blood pressure reductions of 30.8 mm Hg systolic blood pressure (SBP) and 24.0 mm Hg diastolic blood pressure (DBP) at five weeks and 21.1/19.3 mm Hg (SBP/DBP) for irbesartan alone in a study

of patients with severe hypertension AVALIDE also demonstrated mean BP reductions of 27.1/14.6 mm Hg (SBP/DBP) at 8 weeks, and 22.1/11.6 mm Hg and 15.7/7.3 mm Hg (SBP/DBP) reductions respectively for irbesartan and HCTZ alone, in a study of patients with

moderate hypertension

PARIS and PRINCETON, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Sanofi- aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for the antihypertensive agent AVALIDE for initial use in patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals.

The approval is based on data from two clinical trials involving more than 1,200 patients with moderate or severe high blood pressure.

In the first double-blind, active-controlled, seven-week trial, patients with severe hypertension (mean baseline 172/113 mm Hg SBP/DBP) were randomly treated with either AVALIDE 150/12.5 mg (n=468) or irbesartan 150 mg monotherapy (n=227). After one week, all doses were doubled. At five weeks, AVALIDE(R) (irbesartan-hydrochlorothiazide) 300/25 mg demonstrated mean blood pressure reductions of 30.8/24.0 mm Hg versus 21.1/19.3 mm Hg (SBP/DBP) for irbesartan 300 mg alone (P<.0001).

In the second double-blind, active-controlled, 12-week trial, patients with moderate hypertension (mean baseli
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SOURCE Bristol-Myers Squibb Company
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