A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia.

Abstract

Few data are available regarding the efficacy and safety of a single-pill combination (SPC) consisting of four medications in patients with concomitant hypertension and dyslipidemia. We aimed to determine the efficacy and tolerability of a fixed-dose SPC consisting of 5 mg amlodipine, 100 mg losartan, 20 mg rosuvastatin, and 10 mg ezetimibe (A/L/R/E) in patients with concomitant hypertension and dyslipidemia. This was a 14-week, randomized, multicenter, double-blind, placebo-controlled, phase III clinical trial. In total, 145 patients were randomized to receive A/L/R/E, A/L, or L/R/E. The primary endpoints were the average change in the low-density lipoprotein cholesterol (LDL-C) level in the A/L/R/E and A/L groups and the sitting systolic blood pressure (sitSBP) in the A/L/R/E and L/R/E groups. The numbers of patients with adverse drug reactions (ADRs) were compared as safety variables. The average percentage change in the LDL-C level as the least squares mean (LSM) from the baseline LDL-C level at the end of the 8-week treatment was -59.0% in the A/L/R/E group and 0.2% in the A/L group (LSM difference -59.2, 95% confidence interval [CI] -68.1 to -50.4; p<0.0001). The average change in the sitSBP as the LSM was -15.8 mmHg in the A/L/R/E group and -4.7 mmHg in the L/R/E group (LSM difference -11.1, 95% CI -16.8 to -5.4; p=0.0002). No ADRs occurred in the A/L/R/E group. A/L/R/E as an SPC could be an effective treatment for patients with hypertension and dyslipidemia without significant safety issues. NCT04074551 (registered 30 August 2019).