Adjusting Overall Survival Estimates of Macitentan in Pulmonary Arterial Hypertension After Treatment Switching: Results from the SERAPHIN Study.

ABSTRACT:

Introduction

Evaluating overall survival in randomized controlled trials (RCTs) can often be confounded by bias introduced by treatment switching. SERAPHIN was a large RCT that evaluated the effects of long-term treatment with the endothelin receptor antagonist macitentan in patients with pulmonary arterial hypertension. In an intent-to-treat (ITT) analysis, a non-significant decrease in the risk of all-cause mortality up to study closure was reported with macitentan 10 mg versus placebo. As patients could switch treatment when experiencing symptoms of disease progression, this analysis attempts to adjust for the confounding effects on overall survival.

Methods

The inverse probability of censoring weighted (IPCW) and rank-preserving structural failure time (RPSFT) models wer

SUBMITTER: Di Scala L 

PROVIDER: S-EPMC9402487 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature