Efficacy and safety of esaxerenone (CS-3150) for the treatment of essential hypertension: a phase 2 randomized, placebo-controlled, double-blind study

J Hum Hypertens. 2019 Jul;33(7):542-551. doi: 10.1038/s41371-019-0207-x. Epub 2019 May 21.

Abstract

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 (50-100 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-response 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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / pharmacokinetics
  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure / drug effects*
  • Double-Blind Method
  • Essential Hypertension / diagnosis
  • Essential Hypertension / drug therapy*
  • Essential Hypertension / physiopathology
  • Humans
  • Japan
  • Middle Aged
  • Mineralocorticoid Receptor Antagonists / adverse effects
  • Mineralocorticoid Receptor Antagonists / pharmacokinetics
  • Mineralocorticoid Receptor Antagonists / therapeutic use*
  • Pyrroles / adverse effects
  • Pyrroles / pharmacokinetics
  • Pyrroles / therapeutic use*
  • Sulfones / adverse effects
  • Sulfones / pharmacokinetics
  • Sulfones / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Mineralocorticoid Receptor Antagonists
  • Pyrroles
  • Sulfones
  • esaxerenone