Open AccessEfficacy and Safety of Darusentan in Patients With Resistant Hypertension: Results From a Randomized, Double‐Blind, Placebo‐Controlled Dose‐Ranging Study
Author(s) -
Black Henry R.,
Bakris George L.,
Weber Michael A.,
Weiss Robert,
Shahawy Mahfouz El,
Marple Richard,
Tannoury Georges,
Linas Stuart,
Wiens Brian L.,
Linseman Jennifer V.,
Roden Robert,
Gerber Michael J.
Publication year - 2007
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1524-6175.2007.07244.x
Subject(s) - medicine , placebo , blood pressure , ambulatory blood pressure , adverse effect , diuretic , randomized controlled trial , ambulatory , diastole , dose ranging study , anesthesia , double blind , alternative medicine , pathology
In this phase 2, randomized, double‐blind, placebo‐controlled forced dose‐titration study, 115 patients with resistant hypertension, receiving background therapy with ≥3 antihypertensive medications including a diuretic at full doses, were randomized 2:1 to increasing doses of darusentan (10, 50, 100, 150, and 300 mg), a selective endothelin receptor antagonist, or matching placebo once daily for 10 weeks. Darusentan treatment decreased mean systolic and diastolic blood pressure levels in a dose‐dependent fashion compared with placebo; the largest reductions were observed at week 10 (300‐mg dose) (systolic, −11.5±3.1 mm Hg [ P =.015]; diastolic, −6.3±2.0 mm Hg [ P =.002]). Darusentan (300 mg) also decreased mean 24‐hour, daytime, and nighttime ambulatory blood pressures from baseline to week 10. Darusentan was generally well tolerated; mild to moderate edema and headache were the most common adverse events. This study demonstrates a clinical benefit from a new class of antihypertensive agent in patients classified as resistant by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines.