Open AccessA 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
Author(s) -
Dingliang Zhu,
Pingjin Gao,
Werner Holtbruegge,
Chenglei Huang
Publication year - 2014
Publication title -
journal of international medical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.421
H-Index - 57
eISSN - 1473-2300
pISSN - 0300-0605
DOI - 10.1177/0300060513503756
Subject(s) - medicine , amlodipine , blood pressure , telmisartan , pill , adverse effect , clinical endpoint , tolerability , urology , randomized controlled trial , pharmacology
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.