This Article Full Text Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Armstrong, P. W. Articles by Borer, J. Search for Related Content PubMed PubMed Citation Articles by Armstrong, P. W. Articles by Borer, J.

(Circulation. 2002;106:e9011.)
© 2002 American Heart Association, Inc.

July 18th and 19th, 2002

Paul W. Armstrong, MD; Beverly H. Lorell, MD; Steven Nissen, MD; Jeffrey Borer, MD

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Candesartan

The Committee was asked to assess the request of AstraZeneca for a proposed change in the labeling of candesartan cilextil, a selective angiotensin I subtype receptor antagonist initially approved for use in 1998 for hypertension. The sponsor proposed a labeling change to support a claim of greater antihypertensive efficacy for candesartan than losartan as monotherapy. The application was based on 2 identically designed and concurrently conducted randomized, double-blind trials that used a forced titration approach comparing candesartan started at 16 mg once daily and forced titrated to 32 mg at 2 weeks, with losartan started at 50 mg and forced titrated to 100 mg once daily. The 2 studies were conducted in 1265 subjects with essential hypertension who had mean diastolic blood pressures between 95 and 114 mm Hg. At the end of 8 weeks, candesartan lowered systolic and diastolic pressure by 3 and 2 mm Hg, respectively, at trough, when compared with losartan.

The Committee noted that the present labels for losartan and candesartan include the recommendation that twice-daily dosing might have a greater antihypertensive effect in some patients, and hence that any claim for superiority must be restricted to once-daily dosing. Additional discussion unfolded on the likelihood that clinical benefits would be associated with the demonstrated average blood pressure decline and it was agreed that, given the similar pharmacology of the 2 agents (both angiotensin I subtype receptor antagonists), this was a reasonable supposition. It was also agreed that such a claim would be more difficult to support . . . [Full Text of this Article]