Activity of Lercanidipine in Double-Blind Comparison with Nitrendipine in Combination Treatment of Patients with Resistant Essential Hypertension

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Abstract
This study was performed to assess the efficacy and tolerability of lercanidipine compared to nitrendipine in patients with essential hypertension resistant to monotherapy with another antihypertensive drug. Eighty patients with resistant hypertension (diastolic blood pressure >100 mm Hg) under treatment with β-blocking agents, angiotensin-converting enzyme (ACE) inhibitors, or diuretics were enrolled in this randomized, double-blind, parallel study. Patients were treated either with lercanidipine 10 mg q.d. or with nitrendipine 10 mg q.d. for 12 weeks. In each group, non-responding patients after 4 weeks of combined therapy were treated with lercanidipine 20 mg or nitrendipine and then, after 8 weeks, with 30 mg of both drugs. Diastolic and systolic blood pressure significantly decreased in both groups of patients after 4 weeks of treatment and further decreased during the entire period of the combination therapy. The decrease in BP was equal in both groups of patients. In addition, the percentage of normalized patients was similar in both groups after 4 weeks, 77% and 65% in the lercanidipine and nitrendipine groups, respectively. At the end of the 12-week treatment period, 89% of patients treated with lercanidipine and 91% of those treated with nitrendipine were normalized. The good tolerability profile of both drugs was demonstrated by the lack of reflex tachycardia, the absence of significant changes in ECG and laboratory parameters, and the low incidence of adverse events related to drug treatment. Four patients treated with nitrendipine 10 mg and one patient treated with lercanidipine 20 mg withdrew from therapy because of drug-related side effects. These results indicate that lercanidipine and nitrendipine can be successfully and safely used for combination treatment of patients with resistant essential hypertension.