EVALUATION OF THE EFFICACY AND TOLERABILITY OF 2 DIFFERENT FORMULATIONS OF LERCANIDIPINE VERSUS PLACEBO AFTER ONCE-DAILY ADMINISTRATION IN MILD-TO-MODERATE HYPERTENSIVE PATIENTS

This study was designed to evaluate the efficacy and tolerability of o nce-daily dosing of lercanidipine (REC 15/2375) tablets and hard gelat in capsules versus placebo in the treatment of mild to moderate hypert ension. A total of 156 patients were recruited for this double-blind, randomized, multicenter trial. Each patient completed a 7-day washout period and a 21-day single-blind, placebo run-in. Patients were then r andomly assigned to receive lercanidipine 10-mg tablets, lercanidipine 10-mg hard gelatin capsules, or placebo for 1 week, followed by 3 wee ks of treatment at the beginning of which the dose was increased to 20 mg. The split-plot analysis of variance performed on the primary end- point (diastolic blood pressure [DBP] showed a highly significant diff erence among groups (P < 0.01). At the end of the placebo run-in, DBP was 101.29 +/- 5.20 mmHg, 101.30 +/- 5.00 mmHg, and 101.45 +/- 5.06 mm Hg in the placebo, tablet, and capsule groups, respectively. At the en d of treatment, the values were 95.10 +/- 7.48 mmHg, 91.39 +/- 7.68 mm Hg, and 91.04 +/- 8.09 mmHg, respectively. A statistically significant difference in efficacy was found between both formulations of lercani dipine and placebo (P < 0.01), but no statistical difference was obser ved between lercanidipine tablets and capsules. The percentage of pati ents with normalized blood pressure (DBP less-than-or-equal-to 90 mmHg at the end of treatment) was 51% in the lercanidipine tablet group, 5 8% in the lercanidipine capsule group, and 28% in the placebo group. T he percentage of patients who responded to treatment (defined as a DBP less-than-or-equal-to 90 mmHg or a reduction in DBP of at least 10 mm Hg) was 66% with lercanidipine tablets, 73% with lercanidipine capsule s, and 43% with placebo. No statistically significant differences were seen in systolic blood pressure or heart rate. Lercanidipine was well tolerated by patients in each treatment group. These results support the conclusion that once-daily administration of lercanidipine is effe ctive in the treatment of hypertension.