Trandolapril and verapamil slow release in the treatment of hypertension: a dose-response assessment with the use of a multifactorial trial design
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摘要
In this multicenter, multifactorial placebo-controlled, double-masked trial, we assessed the tolerability and antihypertensive efficacy of monotherapy with trandolapril, an angiotensin-converting enzyme inhibitor, monotherapy with verapamil slow-release (SR) formulation, or combination therapy with the two drugs, all at various doses. After a 4-week, placebo run-in period, 726 patients with mild-to-moderate hypertension (sitting diastolic blood pressure [DBP], 95 to 114 mm Hg) were randomized to receive 1 of the 16 treatment combinations of placebo, trandolapril alone, verapamil SR alone, or varying combinations of trandolapril and verapamil SR for 6 weeks. Sitting DBP and systolic blood pressure were monitored during the trial. Satisfactory response was defined as a posttreatment sitting DBP <90 mm Hg or a ≥10-mm Hg decrease from baseline. Three trandolapril/verapamil SR combinations—2 mg/180 mg, 2 mg/240 mg, and 8 mg/240 mg—were significantly more effective in decreasing sitting DBP than monotherapy with either drug. Trandolapril alone, verapamil SR alone, and trandolapril combined with verapamil SR administered once daily were well tolerated in patients with mild-to-moderate hypertension.

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