Efficacy and Tolerability of Lercanidipine in Comparison to and in Combination with Atenolol in Patients with Mild to Moderate Hypertension in a Double-Blind Controlled Study

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Abstract
The efficacy and tolerability of lercanidipine, a new dihydropyridine calcium antagonist, were assessed in comparison with atenolol in a randomized, double-blind, multicenter trial in patients with mild to moderate essential hypertension. After 3 weeks of placebo run-in, 217 eligible patients were divided into two parallel groups receiving either lercanidipine 10 mg or atenolol 50 mgonce a day. Systolic (SBP) and diastolic (DBP) blood pressure and heart rate (HR) were measured at weeks 4, 8, 12, and 16 of treatment, 24 ± 2 h after the last dose. After the first 4 weeks of treatment, in non-responder patients (DBP >90 mm Hg or reduction < 10 mm Hg compared to baseline) lercanidipine was initially tritated up to 20 mg and atenolol up to 100 mg. Then, after 8 weeks in patients still unresponsive, the two study drugs were combined. After 4 weeks, BP was significantly (p < 0.01) reduced in both treatment groups compared to control values: lercanidipine DBP −10.26 mm Hg, SBP −12.09 mm Hg; atenolol DBP −11.98 mm Hg, SBP −14.69 mm Hg. The changes observed in the lercanidipine group were not significantly different from those observed in the atenolol group. HR did not change in the lercanidipine group, whereas it significantly decreased in the atenolol group. After the first 4 weeks, patients with normalized DBP included 64.7% in the lercanidipine group and 75.5% in the atenolol group. By doubling the dose of the drug in the nonresponding patients, the percentage of normalized patients in the lercanidipine and atenolol groups increased to 82.2 and 85.7% respectively. Adverse events reported included 10.2% and 8.3% in the lercanidipine group receiving 10 and 20 mg respectively, whereas they were 7.2% and 4.1% in the atenolol group receiving 50 and 100 mg, respectively. The severity of the events was generally mild or moderate. The efficacy of lercanidipine and of atenolol in lowering blood pressure in mild to moderate essential hypertension is similar. However, unlike atenolol, lercanidipine is devoid of any effects on HR. The few adverse events observed with lercanidipine treatment confirmed the good tolerability profile of this new calcium antagonist.