Tolerability of long-term treatment with lercanidipine versus amlodipine and lacidipine in elderly hypertensives

Background: Irrespective of their clinical relevance, side effects cannot be considered a negligible problem in antihypertensive therapy. The aim of this trial was to evaluate the tolerability profile of lercanidipine with that of two other calcium antagonists (amlodipine and lacidipine) in elderly hypertensives. Methods: In a multicenter, double-blind, parallel study 828 elderly (aged greater than or equal to60 years) hypertensives were randomized to lercanidipine 10 mg/day (n = 420), amlodipine 5 mg/day (n = 200), or lacidipine 2 mg/day (n = 208) (ratio 2: 1: 1). If blood pressure (BP) control was unsatisfactory (systolic BP/diastolic BP greater than or equal to 140/90 mm Hg), the dose of the double-blind medication was doubled and, as a further step, enalapril or atenolol (plus diuretic, if needed) was added. Patients were treated for an average of 12 months. Results: Amlodipine patients had significantly (P < .001) higher rates of edema (19%) and of early study discontinuations due to edema (8.5%) compared with ler-canidipine (9% and 2.1 %) and lacidipine patients (4% and 1.4%). Similarly, edema-related symptoms (lower limb swelling and heaviness) occurred significantly (P < .01) more often with amlodipine (50% and 45%, respectively) than with lercanidipine (35% and 33%) and lacidipine (34% and 31%). Most edema cases occurred in the first 6 months, a between-treatment difference being evident since beginning of treatment. Other drug-related adverse events did not differ between treatments. Blood pressure was equally and effectively reduced in the three groups. Conclusions: The two lipophilic dihydropyridine calcium antagonists, lercanidipine and lacidipine, have an antihypertensive effect comparable to that of amlodipine, but abetter tolerability profile. Am J Hypertens 2002;15: 932-940 (C) 2002 American Journal of Hypertension, Ltd.