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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

ne 162/98 mm Hg SBP/DBP) were randomly treated with AVALIDE 150/12.5 mg (n=328), irbesartan 150 mg monotherapy (n=106), or hydrochlorothiazide 12.5 mg monotherapy (n=104). After two weeks, all doses were doubled. The primary endpoint was mean change in SBP from baseline to Week 8. At eight weeks, AVALIDE 300/25 mg demonstrated mean blood pressure reductions of 27.1/14.6 mm Hg (SBP/DBP), which was significantly greater than irbesartan 300 mg or hydrochlorothiazide 25 mg alone, 22.1/11.6 mm Hg (P<.01) and 15.7/7.3 mm Hg (P<.0001) (SBP/DBP), respectively.

In the severe hypertension study, the incidences of pre-specified adverse events on AVALIDE vs. irbesartan were: syncope (0% vs. 0%), hypotension (0.6% vs. 0%), dizziness (3.6% vs. 4.0%), headache (4.3% vs. 6.6%), hyperkalemia (0.2% vs. 0%), and hypokalemia (0.6% vs. 0.4%). In the moderate hypertension study, the incidences of pre-specified adverse events on AVALIDE vs. irbesartan or hydrochlorothiazide monotherapy were: hypotension (0.9% vs. 0% and 0%), dizziness (3.0% vs. 3.8% and 1.0%), headache (5.5% vs. 3.8% and 4.8%), hyperkalemia (1.2% vs. 0% and 1.0%), and hypokalemia (0.9% vs. 0% and 0%).

"Guidelines support initial combination therapy for severe hypertension based on the need to lower BP within weeks rather than months," said Dr. Joel Neutel, Professor of Medicine, University of California in Irvine.

"Now with AVAPRO(R) (irbesartan) and AVALIDE physicians have more therapeutic options to treat mild, moderate and severe hypertension," added Dr. Neutel.

AVAPRO is indicated for the treatment of hypertension and also helps to slow the progression of nephropathy in type 2 diabetic hypertensive patients. AVALIDE may be used in appropriate patients whose blood pressure is not adequately controlled on monotherapy and now can be used as initial therapy in appropriate patients who are likely to need multiple drugs to achieve their blood pressure goals.

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SOURCE Bristol-Myers Squibb Company
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