title: 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.
  
  
  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.
  
  
  METHODS
  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.
authors.affiliation: Shanghai First People's Hospital of Shanghai Jiaotong University , Shanghai , China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Wu
authors.forename: Mengdan
authors.initials: M
authors.lastname: Xu
authors.forename: Hao
authors.initials: H
authors.lastname: Wang
authors.forename: Xin
authors.initials: X
authors.lastname: Xu
authors.forename: Shuiping
authors.initials: S
authors.lastname: Zhao
authors.forename: Mei
authors.initials: M
authors.lastname: Zhang
authors.forename: Huigen
authors.initials: H
authors.lastname: Jin
authors.forename: Jinchuan
authors.initials: J
authors.lastname: Yan
authors.forename: Bangning
authors.initials: B
authors.lastname: Wang
authors.forename: Jianbin
authors.initials: J
authors.lastname: Gong
authors.forename: Xiang
authors.initials: X
authors.lastname: Lu
authors.forename: Jianqiang
authors.initials: J
authors.lastname: Peng
authors.forename: Qiuyan
authors.initials: Q
authors.lastname: Dai
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004095:Dihydropyridines / Q000627:therapeutic use*; D015736:Felodipine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004095:Dihydropyridines; D015736:Felodipine; C060343:lercanidipine
keywords: Dihydropyridines; Felodipine; Hypertension; Lercanidipine