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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

f the hydrochlorothiazide component, AVALIDE is

contraindicated in patients with anuria or hypersensitivity to

sulfonamide-derived drugs

-- In patients with volume or sodium depletion (eg, patients vigorously

treated with diuretics or on dialysis), such depletion should be

corrected prior to administration of AVAPRO(R) (irbesartan) or

AVALIDE(R) (irbesartan-hydrochlorothiazide), or a lower initial dose of

AVAPRO (75 mg) should be used, to avoid possible symptomatic

hypotension

-- Hypersensitivity reactions to hydrochlorothiazide may occur in patients

with or without a history of allergy or bronchial asthma, but are more

likely in patients with such a history

-- Thiazide diuretics have been reported to cause exacerbation or

activation of systemic lupus erythematosus

-- Lithium generally should not be given with thiazides

-- Thiazides should be used with caution in patients with severe renal

disease and in patients with impaired hepatic function or progressive

liver disease, since minor alterations of fluid and electrolyte balance

may precipitate hepatic coma

-- In placebo-controlled hypertension studies, there were no significant

differences in adverse events (AEs) between AVAPRO and

placebo. Adverse events that occurred in at least 1% of patients

treated with AVAPRO and at a higher incidence vs placebo included

diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%) and fatigue (4% vs

3%)

-- Additionally, in a study of hypertensive type 2 diabetic patients with

renal disease (proteinuria greater than or equal to 900 mg/day), the

reported AEs for AVAPRO were similar to those seen in hypertension

studies, with the exception of an increased incidence of orthostatic

symptoms; AVAPRO compared to placebo (both groups received adjunc
'/>"/>

SOURCE Bristol-Myers Squibb Company
Copyright©2007 PR Newswire.
All rights reserved

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