578 Single-pill combination of telmisartan 80 mg/amlodipine 5 mg provides superior blood pressure reductions to amlodipine 5 mg in hypertensive patients whowere uncontrolled on amlodipine 5 mg monotherapy

Abstract

Objectives: To investigate the efficacy and safety of the single-pill combination of telmisartan 80 mg plus amlodipine 5 mg (T80/A5 SPC) versus amlodpine 5 mg (A5) in hypertensive Asian patients who were uncontrolled on amlodipine 5 mg (A5) monotherapy. Design and Methods: After a 6-weekopen-label run-in period with amlodipine 5 mg monotherapy, patients, who failed to respond adequately to A5 (defined as seated DBP ≥90 mmHg), underwent double-blind randomization with 160 and 164 patients assigned to receive either T80/A5 SPC or A5 monotherapy daily. The primary endpoint was change from baseline in mean seated trough DBP after 8 weeks of randomized treatment. Treatment groups were compared using an Analysis of Covariance (ANCOVA) model including treatment, country and the baseline measurement as a covariate. Results: In the full population (n = 314), seated trough mean ± SE BP reductions (mmHg) with T80/A5 vs A5 from baseline to Week 8 were –16.2 ± 1.3 vs –11.7 ± 1.3 for SBP (p < 0.001) and −12.4 ± 0.95 vs –10.2 ± 0.93 for DBP (p = 0.007). T80/A5 provided DBP goal attainment (<140/90 mmHg) in 64.5% vs 45.3% with A5 alone (p = 0.007) and DBP response rate (<90 mmHg or ≥10 mmHg reduction) was 80.0% vs 63.5% (p = 0.0017). The incidence of related AEs (including peripheral edema) was 1.9% with T80/A5 and 2.4% with A5. Conclusions: In Asian patients T80/A5 SPC provided superior BP reductions and goal rate achivement vs A5 monotherapy after 8 weeks of treatment, T80/A5 was well-tolerated and had a safety profile comparable to A5 monotherapy.