Quantification of leg edema in hypertensive patients treated with lercanidipine or amlodipine

Abstract

To compare changes in leg volume and blood pressure by two different calcium antagonist - lercanidipine versus amlodipine - in hypertensive patients. Postmenopausal hypertensive patients (systolic blood pressure 150-179 or diastolic blood pressure 95/109 mmHg) were included. After 2-week single-blind placebo run-in, patients were randomized to 8 weeks of double-blind treatment with either 10 mg/day lercanidipine (N= 48) or 5 mg/day amlodipine (N= 44), with dosages doubling to 20 mg/day lercanidipine and 10 mg/day amlodipine after 4 weeks. Leg volume was measured by water displacement volumetry at baseline and after 4 and 8 weeks of treatment. The presence of edema was assessed by physicians and patients. Sitting blood pressure was recorded before leg volume measurements. A total of 77 patients (41 lercanidipine and 36 amlodipine) were included in the per protocol analysis. Leg volume increase from baseline to the end of 8-weeks of treatment was significantly greater in the amlodipine group (60.4 ± 8.6 ml) than in the lercanidipine group (5.3 ± 8.1 ml, p<0.001). The percentage of patients with evidence of edema (33.3% vs 9.8%, p=0.011) and with symptoms of leg swelling (63.9% vs 22%, p<0.001) was also greater on amodipine compared to lercanidipine. A positive correlation was found between the leg water displacement volume and the presence of edema or complaints of edema symptoms (p<0.001). Both drugs were effective in reducing blood pressure, and no correlation was found between blood pressure change and leg volume change in either group. Leg volume quantification with a water displacement technique demonstrated that leg volume increase and clinical edema of lercanidipine is significantly less than that of amlodipine, despite no significant differences in the antihypertensive effect.