The FDA has cleared the antihypertensive agent Avalide (irbesartan and hydrochlorothiazide) as the first combination therapy for initial use in patients who are likely to need multiple drugs to achieve their BP goals.

The approval, following the recommendation of the agency’s Cardio-Renal Advisory Committee (FDA News, June 2007), is based on data from a pair of clinical trials involving more than 1,200 patients with moderate or severe high BP. Avalide achieved substantial mean reductions of 30.8 mm Hg systolic BP and 24.0 mm Hg diastolic BP at five weeks and 21.1/19.3 mm Hg (SBP/DBP) for irbesartan alone in a study of severely hypertensive patients.

It also demonstrated powerful mean BP reductions at eight weeks in a study of patients with moderate hypertension. Avalide previously had been indicated for patients who had remained uncontrolled on monotherapy.

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“Guidelines support initial combination therapy for severe hypertension based on the need to lower BP within weeks rather than months. Now with Avapro (irbesartan) and Avalide, physicians have more therapeutic options to treat mild, moderate and severe hypertension,” said Joel Neutel, MD, professor of medicine at the University of California, Irvine. Avalide is jointly marketed by Bristol-Myers Squibb and Sanofi-Aventis.