Lercanidipine in Two Different Dosage Regimens as a Sole Treatment for Severe Essential Hypertension

The aim of this study was to verify the efficacy and tolerability of lercanidipine as monotherapy in two different dosage regimens (once or twice a day) in patients with severe essential hypertension. Fifty patients were enrolled and randomly assigned to group 1 (q.d. administration) or group 2 (b.i.d. administration) and were treated with lercanidipine as monotherapy for 3 months. In both groups, the starting daily dose was lercanidipine 20 mg titrated up to 40 mg during the first 2 months of treatment. During the last month, the individual effective dose of lercanidipine was maintained constant. In both groups of patients, diastolic blood pressure (DBP) progressively and significantly decreased during the entire period of lercanidipine treatment. After 30, 60, and 90 days of treatment, DBP changes from baseline in group 1 (−21.2, −30.1, and −31.4 mm Hg) were equal to those observed in group 2 (−21.6, −29.9, and −33.7 mm Hg). Similar results were obtained when systolic blood pressure (SBP) was considered. In addition, the percentages of responding and normalised patients in group 1 (91% and 73%, respectively) were not significantly different from values obtained in group 2 (96% and 84%, respectively). Heart rate did not change, and no clinically relevant changes in ECG and laboratory findings were observed during lercanidipine treatment. Adverse events were recorded in 11 patients, but the therapy was stopped only in four patients. These data indicate that lercanidipine either q.d. or b.i.d. is effective in lowering BP in patients with severe essential hypertension. The good tolerability profile of this new drug is also shown by these results.