A Pilot Study of Dimethyl Fumarate in Pulmonary Arterial Hypertension Associated with Systemic Sclerosis.

ABSTRACT:

Introduction

Given the poor treatment options for pulmonary arterial hypertension associated systemic sclerosis (SSc-PAH) patients, we sought to determine clinical safety and efficacy of Dimethylfumarate (DMF), an Nrf2 agonist, and the effects on biomarkers of oxidative stress on SSc-PAH in an exploratory interventional clinical trial.

Objectives

The primary objectives were to assess the safety and efficacy of treatment with DMF in patients with SSc-PAH.

Methods

This was an investigator-initiated, double-blind, randomized, placebo-controlled trial conducted at two sites in the United States. The primary safety endpoint was the incidence of serious adverse events (SAEs) and all adverse events (AEs) in DMF compared to placebo-treated patients. The primary efficacy endpo

SUBMITTER: Kong K 

PROVIDER: S-EPMC8741170 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature