MIBEFRADIL, A NOVEL CALCIUM-ANTAGONIST, IN ELDERLY PATIENTS WITH HYPERTENSION - FAVORABLE HEMODYNAMICS AND PHARMACOKINETICS

A multicenter, double-blind, placebo-controlled study of 310 elderly p atients with mild-to-moderate essential hypertension was conducted in 20 sites throughout Europe, Brazil, and Israel to assess the antihyper tensive efficacy, tolerability, safety, and dose-response characterist ics of the novel calcium antagonist mibefradil in the elderly. Patient s were randomly assigned to receive once-daily doses of 6.25, 12.5, 25 , 50, or 100 mg of mibefradil or placebo for 4 weeks. Statistically si gnificant and clinically relevant reductions in sitting diastolic bloo d pressure (SDBP) and sitting systolic blood pressure (SSBP) were obse rved with the 50 and 100 mg doses. Therapeutic responses reached 88.5% for SDBP and 76.5% for SSBP in the 100 mg group. Trough/peak ratios w ere >75% in SDBP and SSBP with the 50 mg and 100 mg doses. At doses of 50 to 100 mg once daily, mibefradil was well tolerated and effective with a high antihypertensive response rate and consistent 24-hour bloo d pressure control in elderly patients.