Efficacy and Tolerability of Lercanidipine vs. Captopril in Patients with Mild to Moderate Hypertension in a Double-Blind Controlled Study

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Abstract
The efficacy and tolerability of lercanidipine, a new dihydropyridine calcium antagonist, and of captopril were compared in a randomized, double-blind, multicenter trial in 115 patients affected by mild to moderate essential hypertension. After 3 weeks of placebo run-in, patients were randomized into two parallel groups receiving either lercanidipine 10 mg q.d. or captopril 50 mg (25 mg b.i.d.). After 4 and 8 weeks of treatment the dose was titrated up to 20 mg and 30 mg lercanidipine and up to 75 mg and 100 mg captopril in non-responder patients [diastolic blood pressure (DBP) >90 mm Hg or reduced by less than 10 mm Hg compared to baseline values). DBP, systolic blood pressure (SBP), and heart rate (HR) were recorded before (control) and after 4, 8, and 12 weeks of treatment. BP significantly decreased in both groups after 4 weeks of treatment: lercanidipine DBP −11.8 (p < 0.01), SBP −14.7 (p < 0.01); captopril DBP −10.5 (p < 0.01), SBP −12.4 (p < 0.01). The changes between the lercanidipine and the captopril group were not statistically different. HR did not change in both treatment groups. At this time, normalized patients (i.e., patients with DBP ≤90 mm Hg) were 81% in the lercanidipine group and 74% in the captopril group. After dose titration to 20 and 30 mg of lercanidipine and to 75 and 100 mg of captopril in non-responders, the percentage of normalized patients increased to 88 and 98% in the lercanidipine group and to 89 and 94% in the captopril group. In both groups, a few patients (lercanidipine group 3.6%, captopril group 3.4%) complained of side effects, defined by the patients as mild. Lercanidipine is as effective as captopril in lowering arterial pressure in mild to moderate essential hypertension, with good tolerability and without undesirable side effects.