Long-Term (12-Month) Treatment with Lercanidipine in Patients with Mild to Moderate Hypertension

The long-term tolerability and antihypertensive effect of lercanidipine, a new calcium-entry blocker, was evaluated in this open, multicenter study. A total of 355 mild to moderately hypertensive patients (184 men and 171 women) aged 56.1 ± 8.3 years were selected after 2 weeks of wash-out and 3 weeks of placebo run-in and were enrolled for the 1-year treatment phase. The initial dose of lercanidipine 10 mg q.d. was increased every 4 weeks in non-responding patients up to 30 mg q.d. Then, if further BP reduction was needed, a diuretic, an angiotensin-converting enzyme (ACE) inhibitor, or a β-blocker was added to lercanidipine monotherapy. A total of 295 patients completed the study. After 4 weeks of treatment, lercanidipine 10 mg caused a significant reduction of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (−12.2 and −9.7 mm Hg, respectively; p < 0.001), which led to normalized DBP values in 49.1% of patients. The therapeutic response was consolidated by dose titration to 20 mg during the following 4 weeks and then was continued unmodified until the end of the study. Only a few patients required a dose increase to 30 mg, and even fewer needed a combination with other drugs. No tachycardia was observed at any dose. No clinically relevant changes in laboratory tests were recorded during the treatment period. There was, however, a significant decrease in the number of patients with glucose, total cholesterol, and creatinine plasma levels outside the normal range. Only 16 patients discontinued the study because of side effects. Lercanidipine therefore appears to be a useful alternative in long-term treatment of essential hypertension.