FDA Panel Favors First-Line Use of Irbesartan/HCTZ Combo

April 19, 2007

April 19, 2007 (Rockville, MD) – The US FDA Cardiovascular and Renal Drugs Advisory Committee recommended extended use of the combination product irbesartan plus hydrochlorothiazide (Avalide, Bristol-Myers Squibb) for the first-line treatment of hypertension at its meeting on April 18, 2007. The product is already indicated for second-line use.

The committee voted 7-0 in favor of the first-line indication, saying that the product poses few risks and appears to have benefits for a range of patients, not just those with severe hypertension for whom Bristol-Myers Squibb sought the expanded use, a report from Bloomberg notes. But a Reuters report notes that advisers were still determining whether the Avalide expansion should include only severe hypertension or both severe and moderate hypertension.

The panel is said to have recommended revising the prescribing information to advise that the combination drug could be used initially when patients are unlikely to respond to a single agent and that doctors should be provided with data from the company's trials to help decide which patients would be most suitable for the combination. "Even those 20% who reach the goal on a single agent might have done even better on combination therapy,'' panel member Dr Michael Lincoff (Cleveland Clinic, OH) is quoted as saying. The panel is also reported to have requested further study on elderly patients and people with renal dysfunction.

Other reports note that the committee suggested that more data analysis, even postmarket studies, would be helpful in identifying the populations who may benefit most from Avalide.

The complete contents of Heart wire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

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