%0 Journal Article
%T Efficacy and safety of esaxerenone (CS-3150) for the treatment of essential hypertension: a phase 2 randomized, placebo-controlled, double-blind study
%J -
%D 2019
%R https://doi.org/10.1038/s41371-019-0207-x
%X This was a phase 2, multicenter, randomized, double-blind, placebo-controlled, open-label comparator study to investigate the efficacy and safety of esaxerenone (CS-3150), a novel non-steroidal mineralocorticoid receptor blocker, in Japanese patients with essential hypertension. Eligible patients (n£¿=£¿426) received esaxerenone (1.25, 2.5, or 5£¿mg/day), placebo, or eplerenone (50¨C100£¿mg/day) for 12 weeks. The primary efficacy endpoint was the change from baseline in sitting systolic and diastolic blood pressure (BP). Safety endpoints included adverse events and serum K+ elevation. There were significant dose¨Cresponse reductions in the 2.5 and 5£¿mg/day esaxerenone groups for sitting BP (both p£¿<£¿0.001) and 24-h BP (both p£¿<£¿0.0001) compared with placebo, with a mean (95% confidence interval) change in sitting BP of £¿7.0 (£¿9.5 to £¿4.6)/£¿3.8 (£¿5.2 to £¿2.4) mmHg in the placebo group, and £¿10.7 (£¿13.2 to £¿8.2)/£¿5.0 (£¿6.4 to £¿3.6) mmHg, £¿14.3 (£¿16.8 to £¿11.9)/£¿7.6 (£¿9.1 to £¿6.2) mmHg, and £¿20.6 (£¿23.0 to £¿18.2)/ £¿10.4 (£¿11.8 to £¿9.0) mmHg for the 1.25, 2.5, and 5£¿mg/day esaxerenone groups, respectively, while the change was £¿17.4 (£¿19.9 to £¿15.0)/£¿8.5 (£¿9.9 to £¿7.1) mmHg for eplerenone. The incidence of adverse events was similar in all treatment groups. Serum K+ levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12. Plasma esaxerenone concentration increased in proportion with the dose. In conclusion, esaxerenone is an effective and tolerable treatment option for patients with essential hypertension
%U https://www.nature.com/articles/s41371-019-0207-x