A randomized comparison between lercanidipine and amlodipine for efficacy and tolerability in patients with essential hypertension

Abstract

Background: Lercanidipine, a newly added dihydropyridine, was compared with one of its older and time tested congener- amlodipine for their efficacy and tolerability. Methods: This was a prospective, double blind, parallel group study. 100 patients according to inclusion and exclusion criteria were randomised into two groups of 50 each. One group received lercanidipine 10 mg while second group received tablet amlodipine 5 mg at the beginning, both once daily orally for 12 weeks of duration. Follow up was done at 2, 4, 8 and 12 weeks. Systolic and diastolic blood pressure was recorded in sitting position. If the patient did not attain target blood pressure of 140/90 mmHg, dose was titrated at 4, 8 weeks. Tolerability was assessed by questioning about adverse drug reactions at follow up and derangements of routine laboratory parameters at the end. Z test was used for analysis. Results: There was no statistical difference between antihypertensive efficacies of two drugs. Number of patients showing adverse reactions were significantly less in lercanidipine group compared to amlodipine. Though vasodilation related adverse reactions were less lercanidipine group, significant difference was observed only in occurrence of pedal edema. This difference in incidence of edema cannot be related to the extent of reduction in blood pressure. Conclusions: With the comparable antihypertensive efficacy, lercanidipine is associated with considerably lower incidence of vasodilation related side effects than amlodipine, especially pedal edema. This favourable tolerability profile can potentially enhance treatment outcome by promoting better adherence to drug therapy.