Quantification of leg oedema in postmenopausal hypertensive patients treated with lercanidipine or amlodipine

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Abstract
Of the study was to compare the leg oedema-forming potential of two different dihydropyridine calcium channel blockers in postmenopausal women. A total of 92 postmenopausal hypertensive patients [systolic blood pressure (SBP) 150-179 mmHg or diastolic blood pressure (DBP) 95-109 mmHg were randomized to receive a 4-week treatment with either 10 mg/day lercanidipine (n = 48) or 5 mg/day amlodipine (n = 44), with force-titration to 20 and 10 mg/day, respectively for an additional 4 weeks. Leg volume was measured by water displacement volumetry, patients were questioned for symptoms and a physical examination was performed to detect the presence of oedema. A total of 77 patients completed the study, without a major protocol violation and were included in the primary analysis. Leg volume increase from baseline was significantly higher in the amlodipine than in the lercanidipine group (60.4 +/- 8.6 versus 5.3 +/- 8.1 ml; P < 0.001). The percentage of patients with evidence of oedema on physical examination (33.3 versus 9.8%, P = 0.011) and with symptoms of leg swelling (63.9 versus 22%, P < 0.001) and leg heaviness (47.2 versus 12.2%, P < 0.001) was also greater with amlodipine compared with lercanidipine. A positive correlation was found between leg volume and sign or symptoms of oedema (P < 0.001). Both drugs reduced SBP and DBP, with no significant differences between treatments. No correlation was found between leg volume changes from baseline and the antihypertensive effect of either drug. In postmenopausal females with mild to moderate hypertension the oedema formation of Lercanidipine was significantly less than that of Amlodipine, despite no significant differences in the antihypertensive effect.