Active Dose Findings for Lercanidipine in a Double-Blind, Placebo-Controlled Design in Patients with Mild to Moderate Hypertension

The purpose of the present study was to evaluate the efficacy and tolerability of lercanidipine vs. placebo in patients with mild to moderate essential hypertension. A randomized, double-blind, placebo-controlled study was conducted in 132 patients (mean age 54.7 ± 8.6 years; 58 men and 74 women) recruited from seven centers, allocated to three parallel groups, and treated respectively with placebo, 10 mg, and 20 mg of lercanidipine in a single daily dose. Patients were randomized at the and of a placebo runin period of 3 weeks if their diastolic blood pressure (DBP) was ≥95 ≤115 mm Hg and were followed for 16 weeks of double-blind treatment, with a visit every 4 weeks. At each visit, patients classified as non-responders (DBP >90 mm Hg or reduced by less than 10 mm Hg compared to baseline values) had the dose of lercanidipine titrated up in steps of 10 mg daily. The maximal dose of lercanidipine was 40 mg per day. A total of 116 patients completed the first 4 weeks of the study and were considered eligible for the efficacy evaluation. There were 16 drop-outs during the first 4 weeks, eight voluntary withdrawals and eight because of adverse effects. After the first 4 weeks of treatment, 53.7% of the patients in the 10 mg lercanidipine and 62.9% in the 20-mg lercanidipine groups normalized blood pressure (DBP ≤90 mm Hg), whereas this occurred in only 15% of the patients receiving placebo. The percentage of patients classified in the same period as responders was 22.5% with placebo, 65.9% with 10 mg lercanidipine, and 85.7% with 20 mg lercanidipine. Comparison between placebo and 10and 20-mg lercanidipine revealed highly significant differences (p <0.01) for both responder and normalized patients. Concerning tolerability, neither the heart rate nor the laboratory test parameters exhibited significant changes compared to baseline values. The adverse effects reported during the study were 9.0%, 5.1%. and 17.1% in the placebo, 10-mg, and 20-mg lercanidipine groups, respectively. We conclude that lercanidipine is an effective and well-tolerated antihypertensive agent for which the most appropriate dose regimen is 10 mg once a day.