title: [A randomized, double-blind, double-dummy study comparing a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg to telmisartan 80 mg in Chinese hypertensive patients who failed to respond adequately to telmisartan 80 mg].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (TH) to telmisartan 80 mg (T) in Chinese patients who failed to respond adequately to treatment with T.
  
  
  METHODS
  This is a multi-center, randomized, double-blind, 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 > or = 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 weeks treatment, (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).
  
  
  CONCLUSIONS
  TH was more effective than T in patients not responded adequately to T in Chinese hypertensive patients.
authors.affiliation: Department of Hypertension, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai Institute of Hypertension, Shanghai 200025, China.
authors.forename: Shao-xing
authors.initials: SX
authors.lastname: Chen
authors.forename: Jin
authors.initials: J
authors.lastname: Zhang
authors.forename: Shao-liang
authors.initials: SL
authors.lastname: Chen
authors.forename: Jun-zhu
authors.initials: JZ
authors.lastname: Chen
authors.forename: Xiao-wei
authors.initials: XW
authors.lastname: Yan
authors.forename: Yuan-nan
authors.initials: YN
authors.lastname: Ke
authors.forename: Feng-he
authors.initials: FH
authors.lastname: DU
authors.forename: Cheng-zong
authors.initials: CZ
authors.lastname: Zhang
authors.forename: Yong-wen
authors.initials: YW
authors.lastname: Qin
authors.forename: Kui
authors.initials: K
authors.lastname: Pu
authors.forename: Ding-liang
authors.initials: DL
authors.lastname: Zhu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001565:Benzoates / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D006852:Hydrochlorothiazide; D000077333:Telmisartan