Lercanidipine hydrochloride versus felodipine sustained-release for mild-to-moderate hypertension: a multi-center, randomized clinical trial

Abstract

Objective:

Lercanidipine hydrochloride and felodipine sustained-release tablets comparison for the treatment of patients with mild-to-moderate primary hypertension.

Research design and methods:

The study was designed as a multicenter, randomized, open-label, parallel-group clinical trial. A total of 281 adult patients (18–75 years) with a mild-to-moderate primary hypertension diagnosis were randomly assigned, in a 1:1 ratio, to lercanidipine hydrochloride (n = 139; 81 males) or felodipine sustained-release tablets (n = 142; 87 males). Study duration was 8 weeks, including two run-in weeks and 6 weeks of treatment.

Main outcome measures:

The mean seated diastolic blood pressure (BP) change from baseline to 6 weeks of treatment was the primary endpoint. Main secondary efficacy parameters were: (i) mean seated systolic BP change from baseline to 6 weeks of treatment; (ii) normalization BP rate. The incidence of adverse events was also considered.

Results:

BP monitoring showed a significant decrease compared with baseline in diastolic BP (lercanidipine: from 96 ± 4 to 83 ± 6 mmHg, p < 0.0001; felodipine: from 96 ± 4 to 82 ± 5 mmHg, p < 0.0001). The mean systolic BP decreased, when compared with baseline values, by 18 mmHg and 19 mmHg in the lercanidipine and felodipine arm, respectively (p < 0.0001 versus baseline for both comparisons). The normalization rates of BP were 79.5% and 87.2%, in the lercanidipine and felodipine groups, respectively (in-office monitoring; p = n.s.). In total, 73 patients experienced 103 AEs: 26.6% (37/139) in the lercanidipine group and 25.3% (36/142) in the felodipine arm (p = n.s.). The analysis of safety showed no unexpected adverse events.

Conclusions:

Although the overall short follow-up of the present study should be taken into account, lercanidipine is an effective and safe treatment option for BP control in adult patients with mild-to-moderate primary hypertension.

Keywords: :

• Dihydropyridines
• Felodipine
• Hypertension
• Lercanidipine

Transparency

Declaration of funding

Editorial support for this manuscript was funded by Recordati.

Declaration of financial/other relationships

Y.W., M.X., H.W., X.X., S.Z., M.Z., H.-J., J.Y., B.W., J.G., X.L., J.P., and Q.D. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

Editorial assistance was provided by Luisa Granziero PhD and Luca Giacomelli PhD of Content Ed Net.