ANTIHYPERTENSIVE EFFICACY AND TOLERABILITY OFLERCANIDIPINE IN DAILY CLINICAL PRACTICE. THE ELYPSE STUDY

Aim: Lercanidipine, a long-acting dihydropyridine with a good antihypertensive efficacy and tolerability. The aim of the ELYPSE trial was to determine the efficacy and tolerability of this medication in daily clinical practice. Methods: Patients with Stage 1-2 essential hypertension, in whom their physicians considered to prescribe a dihydropyridine, were administered lercanidipine 10 mg once daily, with a 3-month follow-up. The study included 9059 patients (mean age 63±11 years; 58% women, 60% over 60 years, 56% with Stage 2 hypertension, and 69% previously treated with other antihypertensive drugs). A subgroup of 1267 patients (14%) experienced adverse reactions, related to pre-administered antihypertensive therapy. Electronic case-report forms and a central Internet database were used for the data collection. Results: Baseline levels of blood pressure (BP) and heart rate (HR) were 160,1±10,2/95,6±6,6 mm Hg and 77,3±9,3 bpm, respectively. Significant reductions in both systolic and diastolic BP were attained at 1 month, with some additional reduction 2 months later. At 3 months, BP level was 141,4±11,3/83,1±6,9 mm Hg, and HR level was 75,2±8,2 bpm (p<0,001 vs. baseline). At the end of the study, 64% of the patients achieved the levels of diastolic BP ><90 mm Hg, and BP control (><140/90 mm Hg) was attained in 32%.><0,001 vs. baseline). At the end of the study, 64% of the patients achieved the levels of diastolic BP <90 mm Hg, and BP control (><140/90 mm Hg) was attained in 32%.><90 mm Hg, and BP control (<140/90 mm Hg) was attained in 32%.><140/90 mm Hg) was attained in 32%. In the subgroup of diabetics (n=1269), adequate BP control (<130/85 mm Hg) was achieved only in 16,4%. The overall incidence of adverse events was 6,5%; the most frequent ones were headache (2,9%), ankle edema (1,2%), flushing (1,1%), and palpitations (0,6%). Withdrawal rate was ><1%. The efficacy and tolerability of lercanidipine in the subgroup of patients included in the study due to adverse events of other antihypertensive drugs were similar to those in the whole study population.><130/85 mm Hg) was achieved only in 16,4%. The overall incidence of adverse events was 6,5%; the most frequent ones were headache (2,9%), ankle edema (1,2%), flushing (1,1%), and palpitations (0,6%). Withdrawal rate was<1%. The efficacy and tolerability of lercanidipine in the subgroup of patients included in the study due to adverse events of other antihypertensive drugs were similar to those in the whole study population. Conclusion: In this study, lercanidipine has demonstrated good efficacy and tolerability in daily clinical practice. These findings are consistent with the results of randomized controlled trials.

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