MIBEFRADIL IN THE TREATMENT OF SYSTEMIC HYPERTENSION - COMPARATIVE-STUDIES WITH OTHER CALCIUM-ANTAGONISTS

This paper summarizes the results of 4 double-blind studies of antihyp ertensive therapy in which mibefradil was compared with other commonly used calcium antagonists (diltiazem CD, amlodipine, nifedipine SR, an d nifedipine GITS) at the recommended dose range. A total of 640 patie nts were included, with 361 randomized to mibefradil, 98 to diltiazem CD, 119 to amlodipine, 71 to nifedipine SR, and 36 to nifedipine GITS. Trials included an active treatment phase of 6 or 12 weeks in duratio n. Compared with diltiazem CD or nifedipine SR, mibefradil demonstrate d statistically significant greater efficacy. Decreases in sitting dia stolic blood pressure (SDBP) after treatment with mibefradil 100 mg on ce daily were 14.0 +/- 7.8 mm Hg compared with 9.5 +/- 7.5 mm Hg with diltiazem CD 360 mg once daily (p = 0.001), and 12.8 +/- 8.4 mm Hg com pared with 8.1 +/- 19.2 mm Hg with nifedipine SR 40 mg twice daily (p = 0.014). Patients on mibefradil also had higher normalization (SDBP r educed to less than or equal to 90 mm Hg) and response (SDBP reduction greater than or equal to 10 mm Hg or normalization) rates than did th ose on diltiazem CD or nifedipine SR. The overall incidence of adverse events was similar among these 3 compounds, but the number of prematu re withdrawals due to adverse events was greater with both comparators than with mibefradil. Treatment with 100 mg mibefradil or 10 mg amlod ipine once daily resulted in statistically significant decreases from baseline in SDBP of 11.5 +/- 8.2 mm Hg and 13.2 +/- 7.9 mm Hg, respect ively, which were statistically equivalent. However, patients treated with amlodipine had a considerably greater incidence of leg edema than did those treated with mibefradil (33.6% vs 4.2%, respectively). Simi larly, 100 mg mibefradil was equivalent in efficacy to 60 mg nifedipin e GITS once daily, but patients on mibefradil experienced fewer vasodi latory related adverse events. In summary, mibefradil demonstrated sup erior efficacy to diltiazem CD and nifedipine SR and equivalent effica cy to amlodipine and nifedipine GITS in the treatment of hypertension. (C) 1997 by Excerpta Medico, Inc.