A randomised, double-blind trial comparing mibefradil and amlodipine: two long-acting calcium antagonists with similar efficacy but different tolerability profiles

Abstract

Objective: To compare the efficacy and tolerability of mibefradil (−11.5 ± 8.2 mm Hg) and 5/10 mg amlodipine (−13.2 ± 7.9 mm Hg). The number of patients with normibefradil and amlodipine in patients with uncomplicated mild-to-moderate essential hypertension. malised SDBP (р90 mm Hg) increased 23.3% in the mibefradil group and 19.5% in the amlodipine group Design: A double-blind, randomised, parallel group multicentre trial.(approximately 74% in both groups). Patients on mibefradil or amlodipine during the withdrawal period had Methods: 239 patients received 50 mg mibefradil or 5 mg amlodipine for 4 weeks, followed by a forced significantly larger decreases in SDBP than those on placebo. Patients on mibefradil had a decrease in heart titration to 100 mg mibefradil or 10 mg amlodipine for an additional 8 weeks. Patients then entered a 4-week rate of 5.5 bpm. Patients on amlodipine had no change in heart rate; however, cessation of amlodipine was withdrawal period either on therapy or switched to placebo.associated with a decrease in heart rate. Conclusions: Mibefradil was as effective as amlodiResults: Statistically equivalent reductions in trough sitting diastolic blood pressure (SDBP) were observed pine in reducing BP; both compounds were effective treatments of hypertension. after 12 weeks of once-daily treatment with 50/100 mg

Mibefradil, a T-Channel?Selective Calcium AntagonistClinical Trials in Hypertension

“…The high response rates and the magnitude of the decreases in blood pressure were comparable or superior to those produced by other CA, including diltiazem, 19 nifedipine, 21 and amlodipine. 20 The onset of the antihypertensive effect produced by the recommended doses of mibefradil was gradual. The maximum therapeutic effect was reached after 1 to 2 weeks of therapy.…”

Mibefradil: A New Class of Calcium-Channel Antagonists

“…A clinical response, defined as an SDBP less than 90 mm Hg or a reduction of at least 10 mm Hg, was achieved in 86% of patients receiving mibefradil 150 mg monotherapy and 69% taking nifedipine 90 mg GITS monotherapy (Table 3). 27,28,33, 34 The addition of lisinopril increased the response rate to 97% in the mibefradil group and 92% in the nifedipine GITS group. For the ambulatory blood pressure measurements, mibefradil induced a greater reduction in DBP than nifedipine GITS during the 24-hour period (p < 0.01).…”

“…The efficacy and tolerability of mibefradil was compared with that of amlodipine in a double-blind, randomized, forced-titration study. 34 Two hundred seventy-nine patients aged 20 -70 years with uncomplicated, mild-tomoderate essential hypertension entered a 4-week placebo run-in period. Of these, 239 were eligible (SDBP 95-114 mm Hg and compliance was ≥80% via capsule count) to be randomized to receive either mibefradil 50 mg/d or amlodipine 5 mg/d.…”

Potential Cardioprotective Effect of Mibefradil in the Long-Term Treatment of Hypertension

“…Mibefradil has, with regard to its safety profile, a promising risk-benefit ratio. It enables the normalization of blood pressure in many patients while being, at recommended doses (50-100 mg/day), generally well tolerated [23,26,27]. An advantage of mibefradil in comparison to dihydropyridines seems to be a lower incidence of leg edema [26,27].…”

“…The response rates, defined as a sitting diastolic blood pressure !90 mm Hg or a reduction in sitting diastolic blood pressure 610 mm Hg, appeared however substantially greater with mibefradil than with nifedipine GITS. In another double-blind trial, 239 hypertensive patients were assigned to a 4-week treatment with either mibefradil, 50 mg/day, or amlodipine, 5 mg/day [27]. This treatment phase was then followed by a forced titration to 100 mg mibefradil or 10 mg amlodipine for 8 additional weeks.…”