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

摘要

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.