Double-blind, crossover study of lercanidipine versus amlodipine in the treatment of mild-to-moderate essential hypertension

The antihypertensive activity of lercanidipine was compared with that of amlodipine in a randomized, active-controlled, double-blind, crossover study in patients with mild-to-moderate essential hypertension. After a a-week washout period and a 3-week placebo-run-in period, 20 patients were treated with either lercanidipine 20 mg or amlodipine 10 mg once daily for 4 weeks. Subsequently, after 2 weeks of placebo washout, patients underwent another 4-week period of the alternative treatment. Heart rate and blood pressure were measured before and at the end of each treatment period by means of a standard sphygmomanometer and 24-hour ambulatory blood pressure monitoring (ABPM). The ABPM profiles were superimposable and demonstrated a delayed peak effect of both drugs. After 4 weeks of active treatment, lercanidipine-treated patients had significant decreases (P < 0.01) in systolic (SBP) and diastolic blood pressure (DBP) (20.31 mm Hg and 13.13 mm Hg, respectively) that mere greater, although not significantly greater, than those observed in the amlodipine group (13.25 mm Hg [P < 0.05] and 10.45 mm Hg [P < 0.05], respectively). Heart rate did not change Significantly. After the first 4 weeks, 86% and 56% of patients in the lercanidipine and amlodipine groups, respectively, responded-to treatment, whereas 67% and 86%, respectively, responded after the second 4-week treatment period. Results of this study suggest that lercanidipine was as effective as amlodipine in lowering SEP and DBP in patients with mild-to-moderate essential hyper-tension. Both drugs are known to exhibit a good safety profile; however, because of the Limited sample size, safety claims could not be made.