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 (NCT01103960).
Methods Design and Methods After a 6-week open-label run-in period with amlodipine 5 mg monotherapy, patients, who failed to respond adequately to A5 (defined as seated DBP≥90 mm Hg), underwent double-blind randomisation 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 randomised 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 (mm Hg) 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 mm Hg) in 64.5% vs 45.3% with A5 alone (p=0.007) and DBP response rate (<90 mm Hg or ≥10 mm Hg reduction) was 80.0% vs 63.5% (p=0.0017). The incidence of related AEs (including peripheral oedema) was low and similar in both treatments group.
Conclusions In Asian patients T80/A5 SPC provided superior BP reductions and goal rate achievement versus A5 monotherapy after 8 weeks of treatment, T80/A5 was well-tolerated and had a safety profile comparable to A5 monotherapy.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.