Efficacy and tolerability of lercanidipine in daily clinical practice. elypse study

Lercanidipine is a novel lipophilic calcium channel blocker (CCB) that has exhibited a good antihypertensive efficacy and an excellent tolerability in randomized clinical trials. But, as it has been noted, daily clinical practice sometimes differ to randomized clinical trials. Thus, with the aim to investigate the profile of this new antihypertensive agent we designed a study called ELYPSE. ELYPSE is a multicenter surveillance trial to analyze the efficacy and tolerability of Lercanidipine in clinical practice. Essential hypertensives, candidates to be treated with Lercanidipine are confered to this drug (10/20 mg od) during a 6-month follow up. Blood pressure and presence of adverse effects are determined at 1, 3 and 6 months. We present the preliminary results of the first 3 month follow up. To date, 7469 patients have been included (40% males, age 63 ± 19 years). 62% are grade 2 hypertensives. 36% were untreated and 64% previously treated. Among the treated patients, 971 (13%) were included in the study due to adverse effects (AEs) with other drugs. Mean blood pressure (BP) at baseline was: 162.1/96.9 mmHg. At 3-month follow up: 141.8/83.8 mmHg. Only 542 (7%) patients exhibited AEs. The most frequent AEs have been headache (2.7%) and ankle oedema (1.1%), the others (tachycardia, flushing …) are <1%. Lercanidipine has demonstrated to be an effective antihypertensive agent with an excellent tolerability in daily clinical practice. It is remarkable the very low incidence of the typical CCB-related AEs observed with this drug. These data confirm the results of randomized trials and support the potential benefit of this drug in terms of compliance in clinical practice.