Efficacy of prednisone for the treatment of ocular myasthenia (EPITOME): A randomized, controlled trial.

ABSTRACT:

Introduction

In this study we evaluated the safety, tolerability, and efficacy of prednisone in patients with ocular myasthenia gravis (OMG) concurrently treated with pyridostigmine.

Methods

This investigation was a randomized, double-blind, placebo-controlled trial. Participants whose symptoms failed to remit on pyridostigmine were randomized to receive placebo or prednisone, initiated at 10 mg every other day, and titrated to a maximum of 40 mg/day over 16 weeks. The primary outcome measure was treatment failure.

Results

Fewer subjects were randomized than the 88 planned. Of the 11 randomized, 9 completed 16 weeks of double-blind therapy. Treatment failure incidence was 100% (95% CI 48%-100%) in the placebo group (n = 5) vs. 17% (95% CI 0%-64%) in the prednisone gro

SUBMITTER: Benatar M 

PROVIDER: S-EPMC6038933 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature