title: A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients.
abstract: OBJECTIVE
  To investigate the efficacy and safety of telmisartan 80 mg/amlodipine 5 mg (T80/A5) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy.
  
  
  METHODS
  Asian patients ≥18 years old, with inadequately controlled blood pressure (BP) at enrolment, who failed to achieve a seated diastolic BP (DBP) goal (≥90 mmHg) following 6-weeks' open-label A5 treatment, were randomly allocated 1 : 1 to 8 weeks' double-blind treatment with T80/A5 single-pill combination or A5.
  
  
  RESULTS
  A total of 324 patients entered the double-blind treatment phase. The adjusted mean ± SE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 (12.4 ± 1.0 mmHg) than A5 (10.2 ± 0.9 mmHg [primary endpoint, n = 314]). Results were similar in the subset of 262 Chinese patients. Treatment-related adverse events were 1.9% with T80/A5 and 2.4% with A5.
  
  
  CONCLUSIONS
  In Asian patients with hypertension, T80/A5 single-pill combination provided improved BP reduction after 8 weeks' treatment compared with A5 monotherapy. Both treatments were well tolerated.
authors.affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Dingliang
authors.initials: D
authors.lastname: Zhu
authors.forename: Pingjin
authors.initials: P
authors.lastname: Gao
authors.forename: Werner
authors.initials: W
authors.lastname: Holtbruegge
authors.forename: Chenglei
authors.initials: C
authors.lastname: Huang
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D001565:Benzoates / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D004338:Drug Combinations; D017311:Amlodipine; D000077333:Telmisartan
keywords: Amlodipine; Asian; Chinese; essential hypertension; randomized controlled trial; renin–angiotensin system inhibitor; single-pill combination; telmisartan