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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

sicians consider starting with combination therapy for most patients with stage 2 hypertension," said Dr. Michael Weber, Professor of Medicine, SUNY Downstate College of Medicine. "In addition, the approval of AVALIDE(R) (irbesartan-hydrochlorothiazide) as a first-line therapy in patients likely to need multiple drugs to achieve their blood pressure goals provides physicians with an FDA-approved therapeutic option in one tablet."

ABOUT AVAPRO(R) (irbesartan) and AVALIDE

In the United States, AVAPRO is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

AVAPRO is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

AVALIDE is a fixed-dose combination of the angiotensin II receptor blocker (ARB) AVAPRO and a diuretic (hydrochlorothiazide).

AVALIDE is indicated for the treatment of hypertension.

AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.

AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

IMPORTANT SAFETY INFORMATION

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, AVAPRO or AVALIDE should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

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SOURCE Bristol-Myers Squibb Company
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