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 likely to achieve target blood pressures with a single therapy. It also recommended further study in the elderly population and patients with renal dysfunction.

Dr Michael Lincoff (Cleveland Clinic, OH), a member of the panel, told heartwire that Bristol-Myers Squibb applied for a first-line indication for the product in severe hypertension. But the studies submitted showed benefits over monotherapy in both severe and moderate hypertension, and the panel actually suggested that it may be appropriate to give a first-line indication in moderate hypertension as well. "This was one of those rare occasions where the committee and the FDA asked for a more liberal label than the company applied for," he noted.

In the study in severe hypertension, 33% of patients reached target blood pressures on irbesartan alone, compared with 47% of those taking the combination product. A similar difference was seen in the study in moderate hypertension. Lincoff said that these observations are consistent with the latest JNC 7 guidelines, which recommend starting with dual therapy in patients with higher blood pressures. "Part of the drive behind our recommendations was the aim to get in line with the guidelines," Lincoff commented.

He also pointed out that, in this case, there was no major reason not to recommend dual therapy, as there was no additional toxicity associated with the combination, with dizziness and hypotension both occurring at similar rates as with irbesartan alone. "As there was no increased risk but a clear increase in effectiveness and there was a large body of safety data, it was decided that a first-line indication would be appropriate for patients not likely to achieve target blood pressures with a single therapy," he added.