Multicenter, double-blind clinical trial with different doses of pinacidil in patients with mild-to-moderate essential hypertension☆

Abstract The antihypertensive efficacy and therapeutic safety of pinacidil, 12.5 or 25 mg twice daily (BID), were assessed in a multicenter, double-blind, crossover trial. Seventy-seven patients (mean age, 47.3 years) with mild-to-moderate essential hypertension were enrolled in the study and randomly assigned to one of the following schedules: sequence A: pinacidil 12.5 mg BID for 3 weeks; 1-week washout period (two placebo capsules per day); pinacidil 25 mg BID for 3 weeks. Sequence B: pinacidil 25 mg BID for 3 weeks; 1-week washout (two placebo capsules per day); pinacidil 12.5 mg BID for 3 weeks. Both drug doses (25 or 50 mg/d) were equally effective, producing a similar and significant reduction in systolic and diastolic blood pressures in the sitting and standing positions. Systolic blood pressure was reduced by approximately 7% to 8% from baseline in both sequences A and B. Diastolic blood pressure, measured in both positions, was reduced by 8% to 9% from baseline. Heart rate did not appear to be influenced by either dose. Analysis of variance showed no significant differences between the sequences; the only highly significant difference was between the times ( P