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 am lodipine in a randomized, active-controlled, double-blind, crossover study in patients with mild-to-moderate essential hypertension. After a a-week wa shout period and a 3-week placebo-run-in period, 20 patients were treated w ith 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 w ere measured before and at the end of each treatment period by means of a s tandard sphygmomanometer and 24-hour ambulatory blood pressure monitoring ( ABPM). The ABPM profiles were superimposable and demonstrated a delayed pea k effect of both drugs. After 4 weeks of active treatment, lercanidipine-tr eated patients had significant decreases (P < 0.01) in systolic (SBP) and d iastolic blood pressure (DBP) (20.31 mm Hg and 13.13 mm Hg, respectively) t hat mere greater, although not significantly greater, than those observed i n 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 w eeks, 86% and 56% of patients in the lercanidipine and amlodipine groups, r espectively, responded-to treatment, whereas 67% and 86%, respectively, res ponded after the second 4-week treatment period. Results of this study sugg est that lercanidipine was as effective as amlodipine in lowering SEP and D BP in patients with mild-to-moderate essential hyper-tension. Both drugs ar e known to exhibit a good safety profile; however, because of the Limited s ample size, safety claims could not be made.