Clinical effectiveness and safety of amlodipine/losartan-based single-pill combination therapy in patients with hypertension: Findings from real-world, multicenter observational databases

Abstract

Various single-pill combinations (SPCs) have been introduced to improve drug compliance and clinical efficacy. However, there is a lack of real-world evidence regarding the effectiveness of these SPCs for hypertension. This study evaluated the real-world clinical efficacy and safety of amlodipine/losartan-based SPC therapies in patients with hypertension in a real-world setting. A total of 15 538 patients treated with amlodipine/losartan-based SPCs [amlodipine + losartan (AL), amlodipine + losartan + rosuvastatin (ALR), and amlodipine + losartan + chlorthalidone (ALC)] were selected from the database of three tertiary hospitals in Korea. The efficacy endpoints were target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) achievement rates. Safety was evaluated based on laboratory parameters. Drug adherence was defined as the proportion of medication days covered (PDC). The target BP attainment rate was above 90% and was similar among the three groups. Although many patients in the AL and ALC groups took statins, the target LDL-C attainment rate was significantly higher in the ALR group than in the AL and ALC groups. Safety endpoints were not significantly different among the groups, except serum uric acid level and incidence rate of new-onset hyperuricemia, which were significantly lower in the AL and ALR groups than in the ALC group. The PDC was > 90% in all groups. In the real-world hypertensive patients, amlodipine/losartan-based SPC therapy demonstrated good target BP achievement rates. Especially, rosuvastatin-combination SPC showed better target LDL-C goal achievement rate compared to the other SPCs. All three amlodipine/losartan-based SPC had excellent drug adherence.