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| |  Avalide Available In U.S. For High Blood Pressure Treatment PRINCETON, NJ and NEW YORK, NY -- May 13, 1999 -- Bristol-Myers Squibb Co.’s and Sanofi’s Avalide(R) (irbesartan/hydrochlorothiazide tablets), an angiotensin II receptor blocker (ARB) combined with a thiazide diuretic, is now available in the United States for use in the treatment of high blood pressure. Avalide combines BMS’ and Sanofi's Avapro(R) (irbesartan), an effective monotherapy that has been available for the first-line treatment of hypertension since October 1997, and hydrochlorothiazide, a diuretic commonly prescribed in combination with other antihypertensives. Avalide is available in two tablet formulations, 150 mg irbesartan/12.5 mg hydrochlorothiazide, and 300 mg irbesartan/12.5 mg hydrochlorothiazide. "The availability of Avalide provides physicians with an effective option for difficult-to-treat patients," said Joel Neutel, MD, director, Orange County Heart Institute and Research Center. Avalide can benefit patients whose blood pressure is inadequately controlled by irbesartan or hydrochlorothiazide alone. Avalide is not indicated for initial therapy. The Avapro component in Avalide specifically blocks the multiple cardiovascular effects of angiotensin II, dilating blood vessels and lowering blood pressure. Two head-to-head studies published in 1998 show that in patients with mild-to-moderate hypertension, irbesartan at its maximum once daily dose lowers blood pressure levels to a greater extent than the market leader, losartan, at its maximum once daily dose. Hydrochlorothiazide is a diuretic that lowers blood pressure by increasing the excretion of sodium and chloride via the kidneys. When combined, irbesartan/hydrochlorothiazide is proven to be effective in individuals for which irbesartan monotherapy is suboptimal. Avalide should not be used in women who are pregnant or by people who are allergic to any component of the medication. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Volume- or sodium-depleted patients (such as those vigorously treated with diuretics or on hemodialysis) should have such conditions corrected prior to administration of Avalide to avoid possible symptomatic hypotension. In general, treatment with Avalide was well tolerated. Adverse experiences have been limited to those that were reported previously with irbesartan and/or hydrochlorothiazide. The discontinuation of therapy due to clinical adverse experiences reported with Avalide was significantly less than placebo (3.6 percent versus 6.8 percent). The most common adverse experiences reported with Avalide versus placebo in double-blind, placebo-controlled trials were: fatigue (seven percent versus three percent), musculoskeletal pain (seven percent versus five percent), dizziness (eight percent versus four percent) and nausea/vomiting (three percent versus zero).
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