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Sustained Antihypertensive Activity of Diltiazem SR: Double‐Blind, Placebo‐Controlled Study with 24‐Hour Ambulatory Blood Pressure Monitoring
Author(s) -
Whelton Andrew,
Eff Jack,
Magner David J.
Publication year - 1992
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1992.tb03887.x
Subject(s) - diltiazem , medicine , ambulatory , blood pressure , placebo , ambulatory blood pressure , double blind , pharmacology , anesthesia , cardiology , calcium , alternative medicine , pathology
A new polymeric matrix technology provides a sustained‐release formulation of diltiazem hydrochloride (diltiazem SR) suitable for once‐daily therapy. The efficacy and safety of diltiazem SR were evaluated in a multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. After a single‐blind, placebo lead‐in period, 275 patients with mild to moderate essential hypertension were assigned to receive placebo or diltiazem SR 120, 240, 360, or 480 mg once daily for 4 weeks. The efficacy evaluation was based on office and 24‐hour ambulatory blood pressure monitoring. Twenty‐four hours after the last dose in the 4‐week, double‐blind treatment period, the mean reduction from baseline in supine diastolic blood pressure ranged from 5.1 to 10.6 mm Hg in the diltiazem SR 120‐to 480‐mg groups, resulting in a significant linear trend across all treatments (P < .001). Reductions in systolic blood pressure were similar. Ambulatory blood pressure monitoring, performed in 138 patients, confirmed the dose‐response relationship and showed consistent antihypertensive activity throughout the 24‐hour dosing interval. The percentage of patients reporting adverse events was similar in the placebo‐ and active‐treated groups. The results of this study indicate that diltiazem SR is well tolerated, lowers blood pressure in a dose‐related manner, and provides sustained activity throughout the 24‐hour dosing interval.