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Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension.

Author(s): Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P

Affiliation(s): Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. charlotte_jones@merck.com

Publication date & source: 2010-09, J Am Soc Hypertens., 4(5):219-26. Epub 2010 Aug 12.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The renin inhibitor MK-8141 (ACT-077825) demonstrates substantial immunoreactive active renin (ir-AR) increase (sevenfold) without a persistent plasma renin activity (PRA) decrease. The present study assessed the antihypertensive efficacy of MK-8141 in hypertensive patients. In this double-blind, placebo- and active comparator-controlled study, 195 patients with hypertension (trough sitting diastolic blood pressure >/=92 to <105 mm Hg, trough sitting systolic blood pressure <170 mm Hg, and 24-hour mean diastolic blood pressure [DBP] >/=80 mm Hg) were randomized to one of four treatments (stratified by race, black versus others): MK-8141 250 mg, MK-8141 500 mg, enalapril 20 mg, or placebo. Blood pressure was measured at trough and as 24-hour ambulatory blood pressure monitoring. The primary end point was change from baseline in 24-hour mean ambulatory DBP measured after 4 weeks. At week 4, the change from baseline in 24-hour mean (95% CI) ambulatory DBP compared with placebo was -1.6 mm Hg (-4.2, 1.1), -1.1 mm Hg (-3.9, 1.6), and -4.9 (-7.5, -2.2) for MK-8141 250 mg, MK-8141 500 mg, and enalapril 20 mg, respectively. Only mean ambulatory DBP-lowering with enalapril 20 mg was statistically significant. Enalapril, but not MK-8141, also significantly lowered 24-hour mean ambulatory systolic blood pressure (SBP) compared with placebo (-6.7 mm Hg [-10.5, -2.8]). Neither enalapril nor MK-8141 significantly lowered trough DBP and SBP compared with placebo. MK-8141 was generally well tolerated. In patients with hypertension, MK-8141 (ACT-077825) did not produce significant blood pressure-lowering efficacy despite a demonstrated effect of the drug on ir-AR, in the absence of durable PRA suppression. Copyright (c) 2010 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Page last updated: 2011-12-09

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