Premium
Efficacy of prednisone for the treatment of ocular myasthenia (EPITOME): A randomized, controlled trial
Author(s) -
Benatar Michael,
Mcdermott Michael P.,
Sanders Donald B.,
Wolfe Gil I.,
Barohn Richard J.,
Nowak Richard J.,
Hehir Michael,
Juel Vern,
Katzberg Hans,
Tawil Rabi
Publication year - 2016
Publication title -
muscle and nerve
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.025
H-Index - 145
eISSN - 1097-4598
pISSN - 0148-639X
DOI - 10.1002/mus.24769
Subject(s) - pyridostigmine , prednisone , medicine , randomized controlled trial , placebo , adverse effect , ocular myasthenia , anesthesia , myasthenia gravis , tolerability , surgery , alternative medicine , pathology
: 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 group, P = 0.02 ( n = 6). Median time to sustained minimal manifestation status (MMS) was 14 weeks, requiring an average prednisone dose of 15 mg/day. Adverse events were infrequent and generally mild in both groups. Conclusions : A strategy of low‐dose prednisone with gradual escalation appears to be safe, well‐tolerated, and effective in treating OMG. Muscle Nerve 53: 363–369, 2016