A randomized, double-blind, double-dummy study comparing a fixed dose combination of telmisartan 80 mg plus hydrochlothiazide 12.5 mg to telmisartan 80 mg in Chinese hypertensive patients who failed to respond adequately to telmisartan 80 mg
10.3321/j.issn:0253-3758.2008.04.004
- VernacularTitle:复方替米沙坦对单药控制不良高血压患者的有效性和安全性
- Author:
Shao-Xing CHEN
1
;
Jin ZHANG
;
Shao-Liang CHEN
;
Jun-Zhu CHEN
;
Xiao-Wei YAN
;
Yuan-Nan KE
;
Feng-He DU
;
Cheng-Zong ZHANG
;
Yong-Wen QIN
;
Kui PU
;
Ding-Liang ZHU
Author Information
1. 上海交通大学医学院附属瑞金医院
- Keywords:
Hypertension;
Angiotensin Ⅱ type 1 receptor blockers;
Hydrochlorothiazide;
Drug combinations;
Treatment outcome
- From:
Chinese Journal of Cardiology
2008;36(4):300-304
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of a fixed dose combination of telmisartan 80 mg plus hydrochlothiazide(HCTZ)12.5 mg(TH)to telmisartan 80 mg(T)in Chinese patients who failed to respond adequately to treatment with T.Method This is a multi-center, randomized, doubleblind, double-dummy clinical study.A total of 699 eligible hypertensive patients entered a one-week screening phase prior to the eight-week open-label T period.At the end of eight weeks,345 patients who failed to respond to T(DBP≥90 mm Hg,1 mm Hg=0.133 kPa)were randomized to receive either TH (175 patients)or T(170 patients)for another eight weeks.Sitting and standing BP were taken 24 hours post-dose and adverse events were documented at visit with 4 weeks interval.Laboratory.ECG and physical examination were performed at screening.at baseline and at the final visit.Results After 8 weekstreatment,(1)The mean trough reduction in sitting diastolic blood pressure(SiDBP)from baseline in TH group was greater than that in T group(10.1 mm Hg vs 7.7 mm Hg,P=0.0017).The mean trough reduction in sitting systolic blood pressure(SiSBP)from baseline was 14.2 mm Hg in TH group and 7.4 mm Hg in T group(P＜0.0001).(2)The mean trough reduction in standing DBP and standing SBP from baseline were significantly greater in TH group(8.7 mm Hg and 12.9 mm Hg)compared those in T group (7.3 mm Hg and 7.0 mmHg,P=0.0350,P＜0.0001).(3)The number and percentage of responders in TH group(129,74.6%)were significantly higher than in T group(100,59.2%,P=0.0016).(4)The incidence of the study drug-related adverse events was similar between TH and T group(3.5%vs.3.6%,P＞0.05).Conclusion TH was more effective than T in patients not responded adequately to T in Chinese hypertensive patients.
