Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients

Details

Serval ID
serval:BIB_BC372A437FDF
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients
Journal
Circulation
Author(s)
Gradman  A. H., Schmieder  R. E., Lins  R. L., Nussberger  J., Chiang  Y., Bedigian  M. P.
ISSN
1524-4539 (Electronic)
Publication state
Published
Issued date
03/2005
Volume
111
Number
8
Pages
1012-8
Notes
Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: Mar 1
Abstract
BACKGROUND: Stopping the detrimental effects of the renin-angiotensin system at the most upstream point of the cascade offers theoretical advantages for cardiovascular protection. This study compares the antihypertensive efficacy and safety of the novel oral renin inhibitor aliskiren with placebo and an active comparator. METHODS AND RESULTS: The study was a randomized, multicenter, double-blind, placebo-controlled, active-comparator 8-week trial in patients with mild-to-moderate hypertension (mean sitting diastolic blood pressure [DBP] > or =95 and <110 mm Hg). After a 2-week, single-blind placebo run-in, 652 patients were randomized to receive double-blind treatment with once-daily oral doses of aliskiren (150, 300, or 600 mg), irbesartan 150 mg, or placebo. Aliskiren 150, 300, and 600 mg effectively lowered both trough mean sitting DBP and systolic blood pressure (SBP) (P<0.001 versus placebo for both variables). The least-squares mean reductions in trough DBP were 9.3+/-0.8, 11.8+/-0.8, and 11.5+/-0.8 mm Hg, respectively, versus 6.3+/-0.8 mm Hg for placebo, and the least-squares mean reductions in trough SBP were 11.4+/-1.3, 15.8+/-1.2, and 15.7+/-1.2 mm Hg, respectively, versus 5.3+/-1.2 mm Hg for placebo. The antihypertensive effect of aliskiren 150 mg was comparable to that of irbesartan 150 mg (8.9+/-0.7 and 12.5+/-1.2 mm Hg, least-squares reduction in mean sitting DBP and SBP, respectively, for irbesartan). Aliskiren 300 and 600 mg lowered mean sitting DBP significantly more than irbesartan 150 mg (P<0.05). Aliskiren showed safety and tolerability comparable to those of placebo and irbesartan; the incidence of adverse events and number of patients discontinuing therapy were similar in all groups. CONCLUSIONS: Once-daily oral treatment with aliskiren lowers blood pressure effectively, with a safety and tolerability profile comparable to that of irbesartan and placebo, in patients with mild-to-moderate hypertension. Aliskiren 150 mg is as effective as irbesartan 150 mg in lowering blood pressure.
Keywords
Administration, Oral Antihypertensive Agents/pharmacology/therapeutic use Biphenyl Compounds/pharmacology/therapeutic use Blood Pressure/drug effects Diastole Dose-Response Relationship, Drug Double-Blind Method Female Fumarates/administration & dosage/adverse effects/*pharmacology/therapeutic use Humans Hypertension/*drug therapy Male Middle Aged Placebos/adverse effects Renin/*antagonists & inhibitors Substance Withdrawal Syndrome Systole Tetrazoles/pharmacology/therapeutic use Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
05/03/2008 16:41
Last modification date
20/08/2019 15:30
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