EFFICACY AND TOLERABILITY OF LERCANIDIPINE ONCE-A-DAY VERSUS PLACEBO IN MILD-TO-MODERATE ARTERIAL-HYPERTENSION

The aim of this study was to evaluate the efficacy and safety of lerca nidipine administered once a day in the treatment of mild to moderate hypertension. Thirty patients were included in a double-blind, randomi zed study performed in one centre. Patients completed a 14 day wash-ou t period and 21 days of a single blind placebo run-in, after which the y were randomized to placebo, lercanidipine 10 mg or 20 mg for 4 weeks of treatment. Analysis of variance (split-plot), performed on the pri mary end-point of diastolic blood pressure (DBP), showed a statistical ly significant difference among groups (p<0.05). With regard to multip le comparisons, a statistically significant difference was found betwe en lercanidipine 10 mg and placebo (p<0.05) and between lercanidipine 20 mg and placebo (p<0.01). The percentage of patients normalized (DBP less-than-or-equal-to 90 mmHg) was 20% with placebo, 30% with lercani dipine 10 mg and 44% with lercanidipine 20 mg daily while the percenta ge of responders (DBP less-than-or-equal-to 90 mmHg or reduced by at l east 10 mmHg) was 20% with placebo, 50% with lercanidipine 10 mg and 7 8% with 20 mg. Analysis of systolic blood pressure and heart rate show ed no statistically significant differences between groups. Twenty-fou r hour blood pressure recordings were performed al the end of the run- in period and at the end of treatment. Lercanidipine was well tolerate d. Our results indicate that lercanidipine is active in a once-daily r egimen in the treatment of arterial hypertension.