title: [Efficacy comparison between 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension].
abstract: OBJECTIVE
  To compare the efficacy and safety of 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension.
  
  
  METHODS
  The study was designed as multicenter, randomized, double-blind, active controlled trial with two parallel groups enrolling 524 participants with mild to moderate essential hypertension. After 2-week run-in period, 186 patients were enrolled and randomly treated with 5 mg perindopril arginine salt and 183 patients were enrolled and randomly treated with 4 mg perindopril tert-butylamine salt. The random sequence was generated by the I.R.I.S., and a balance was made in each center. After double-blind treatment for 8 weeks, the dose could be doubled for patients with uncontrolled BP ((SBP) ≥ 140 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure (DBP) ≥ 90 mmHg) and patients were treated for another 4 weeks.
  
  
  RESULTS
  The sitting SBP was similarly decreased by (19.9 ± 17.2) mmHg in perindopril arginine group and (18.5 ± 14.7) mmHg (P = 0.000 5) in perindopril tert-butylamine group post 8 weeks treatment. Dose was doubled in 109 patients (59.9%) in perindopril arginine group and 116 patients (63.7%) in perindopril tert-butylamine group. At 12 weeks post therapy, the sitting SBP decreased by (19.8 ± 16.2) and (19.6 ± 16.3) mmHg respectively in the 2 groups. The decrease of sitting DBP was also similar in both groups (-12.0 ± 10.0) mmHg and (-11.0 ± 8.9) mmHg (P < 0.000 1), respectively. The control rate or response rate was also similar between the two groups (control rate over 8 weeks was 38.5% vs. 31.3%, 95% CI (-2.6-16.9), control rate over 12 weeks was 36.3% vs. 35.7%, 95% CI (-9.3-10.4), response rate over 8 weeks was 64.3% vs. 63.2%, 95% CI (-8.8-11.0), response rate over 12 weeks was 65.9% vs. 64.8%, 95% CI (-8.7-10.9)). Incidence of adverse events was low and similar in both therapy groups.
  
  
  CONCLUSIONS
  The results show that perindopril arginine salt 5 mg is as efficient as perindopril tert-butylamine 4 mg on lowering BP for patients with mild to moderate essential hypertension. Both drugs have good safety profile and are well tolerated by patients in this cohort.
authors.affiliation: Department of Cardiology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Litong
authors.initials: L
authors.lastname: Qi
authors.forename: Shuiping
authors.initials: S
authors.lastname: Zhao
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.forename: Geng
authors.initials: G
authors.lastname: Xu
authors.forename: Junbo
authors.initials: J
authors.lastname: Ge
authors.forename: Shirao
authors.initials: S
authors.lastname: Wu
authors.forename: Peizhi
authors.initials: P
authors.lastname: Miao
authors.forename: Yan
authors.initials: Y
authors.lastname: Jin
authors.forename: Jiefu
authors.initials: J
authors.lastname: Yang
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Wu
authors.forename: Changsheng
authors.initials: C
authors.lastname: Ma
authors.forename: Dingli
authors.initials: D
authors.lastname: Xu
authors.forename: Jun
authors.initials: J
authors.lastname: Luo
authors.forename: Bin
authors.initials: B
authors.lastname: Wang
authors.forename: Guangping
authors.initials: G
authors.lastname: Li
authors.forename: Fengzhi
authors.initials: F
authors.lastname: Wang
authors.forename: Farong
authors.initials: F
authors.lastname: Shen
authors.forename: Haiming
authors.initials: H
authors.lastname: Shi
authors.affiliation: Email: huoyong@263.net.cn.
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
mesh_terms: D000959:Antihypertensive Agents; D001120:Arginine; D001794:Blood Pressure; D002082:Butylamines; D004311:Double-Blind Method; D000075222:Essential Hypertension; D006801:Humans; D006973:Hypertension; D020913:Perindopril; D012965:Sodium Chloride
chemical_list: D000959:Antihypertensive Agents; D002082:Butylamines; D012965:Sodium Chloride; C025397:tert-butylamine; D001120:Arginine; D020913:Perindopril