Antihypertensive Efficacy and Tolerability of Lercanidipine in Daily Clinical Practice. The ELYPSE Study

Abstract

Aim : Lercanidipine, a long-acting dihydropyridine with a good antihypertensive efficacy and tolerability in clinical use. With the aim to determine the efficacy and tolerability of this drug in usual clinical practice we performed the ELYPSE trial. Methods : Grade 1 or 2 essential hypertensive patients in whom their physicians considered to prescribe a dihydropyridine were conferred to Lercanidipine 10 mg once daily with a 3-month follow-up; 9059 patients were included (age: 63 &#45 11 years; 58% women, 60% over 60 years, 56% grade 2 hypertensives and 69% previously treated with other antihypertensive drugs). A subgroup of 1267 patients (14%) who were included in the study had experienced adverse reactions with other drugs. Electronic case-report forms and a central database (Internet) were used in this trial. Results : At baseline, blood pressure (BP) was 160.1 &#45 10.2/95.6 &#45 6.6 mmHg; and heart rate (HR) 77.3 &#45 9.3 beats/min. Significant reductions in both systolic and diastolic BP were attained at 1 month with slight additional decreases 2 months later. At 3 months, BP was 141.4 &#45 11.3/83.1 &#45 6.9 mmHg, and HR 75.2 &#45 8.2 beats/min ( p < 0.001 versus baseline). At the study end, 64% of the patients achieved a diastolic BP <90 mmHg, BP control (< 140/90 mmHg) was attained in 32%. In the subgroup of diabetics ( n = 1269) an adequate BP control (lt;130/85) was attained in only 16.4%. The overall incidence of adverse events was 6.5%, of which the most frequent were headache (2.9%), ankle oedema (1.2%), flushing (1.1%) and palpitations (0.6%). Withdrawal rate was < 1%. The efficacy and tolerability in the subgroup of patients included in the study due to adverse events with other drugs were similar to the whole study group. Conclusion : In this study Lercanidipine has shown a good efficacy and tolerability in daily clinical practice. These findings are concordant with those reported in randomized controlled trials. 130/85) was attained in only 16.4%.