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

作者：Wu Ying; Xu Mengdan; Wang Hao; Xu Xin; Zhao Shuiping; Zhang Mei; Jin Huigen; Yan Jinchuan; Wang Bangning; Gong Jianbin; Lu Xiang; Peng Jianqiang; Dai Qiuyan^*

来源：Current Medical Research and Opinion, 2015, 31(1): 171-176.

DOI：10.1185/03007995.2014.960073

• Dihydropyridines
• Felodipine
• Hypertension
• Lercanidipine

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.

• 单位
  1; 中南大学; 安徽医科大学; 中国人民解放军南京军区南京总医院; 上海交通大学; 河南省人民医院; 南京医科大学; 山东大学; 湖南省人民医院; 2; 江苏大学