Abstract

RANDOMIZED OPEN LABEL PARALLEL GROUP COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMLODIPINE VERSUS LERCANIDIPINE IN MILD TO MODERATE HYPERTENSIVE SUBJECTS

*Dr. V. Gowri, Dr. S. Sneha Aishwarya, Dr. Srinivasan Radhakrishnan, Dr. Srinivasan Ramadurai and Dr. V. Punnagai

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. 84 patients according to inclusion and exclusion criteria were randomised into two groups of 42 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 4, 8, 12 and 14 weeks. Systolic and diastolic blood pressure was recorded in sitting position. Tolerability was assessed by questioning about adverse drug reactions at follow up and derangements of routine laboratory parameters at the end. 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. Lercanidipine can be used as monotherapy in treatment of hypertension and can also be used as first line drug in treatment of hypertension.

Keywords: Lercanidipine, Amlodipine, Hypertension, Edema.