Efficacy and safety of intravenous OPC-61815 compared with oral tolvaptan in patients with congestive heart failure.

ABSTRACT:

Aims

This multicentre, randomized, controlled, double-blind, parallel-group Phase III study was conducted to confirm the non-inferiority of OPC-61815 (tolvaptan sodium phosphate) intravenous injections to oral tolvaptan tablets in patients with congestive heart failure and volume overload despite receiving diuretics other than vasopressin antagonists.

Methods and results

Congestive heart failure patients with volume overload despite receiving diuretics other than vasopressin antagonists were randomly assigned (1:1) to receive OPC-61815 (16-mg injection; n = 149) or oral tolvaptan (15-mg tablet; n = 145) once daily for 5 days. Most patients were male; the mean age and weight were 74.7 years and 62.1 kg, respectively; other demographic and clinical characteristics were similar

SUBMITTER: Sato N 

PROVIDER: S-EPMC9715865 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature