TRANDOLAPRIL AND VERAPAMIL SLOW-RELEASE IN THE TREATMENT OF HYPERTENSION - A DOSE-RESPONSE ASSESSMENT WITH THE USE OF A MULTIFACTORIAL TRIAL DESIGN

In this multicenter, multifactorial placebo-controlled, double-masked trial, me assessed the tolerability and antihypertensive efficacy of m onotherapy with trandolapril, an angiotensin-converting enzyme inhibit or, monotherapy with verapamil slow-release (SR) formulation, or combi nation therapy with the two drugs, all at various doses. After a 4-wee k, placebo run-in period, 726 patients with mild-to-moderate hypertens ion (sitting diastolic blood pressure [DBP], 95 to 114 mm Hg) were ran domized to receive 1 of the 16 treatment combinations of placebo, tran dolapril alone, verapamil SR alone, or varying combinations of trandol april and verapamil SR for 6 weeks. Sitting DBP and systolic blood pre ssure were monitored during the trial. Satisfactory response was defin ed as a posttreatment sitting DBP <90 mm Hg or a greater than or equal to 10-mm Hg decrease from baseline. Three trandolapril/verapamil SR c ombinations - 2 mg/180 mg, 2 mg/240 mg, and 8 mg/240 mg - were signifi cantly 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.