Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease

Thomas H. Alexander, Michael H. Weisman, Jennifer M. Derebery, Mark A. Espeland, Bruce J. Gantz, A. Julianna Gulya, Paul E. Hammerschlag, Maureen Hannley, Gordon B. Hughes, Richard Moscicki, Ralph A. Nelson, John K. Niparko, Steven D. Rauch, Steven A. Telian, Patrick E. Brookhouser, Jeffrey P. Harris

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED). STUDY DESIGN: Prospective data collected as part of a multicenter, randomized, controlled trial for the treatment of corticosteroid-responsive AIED with methotrexate. SETTING: Tertiary referral centers. PATIENTS: One hundred sixteen patients with rapidly progressive, bilateral sensorineural hearing loss. INTERVENTION: All patients completed a 1-month course of prednisone (60 mg/d). In Phase 2, 67 patients with improvement in hearing underwent a monitored 18-week prednisone taper, resulting in 22 weeks of prednisone therapy at an average dose of 30 mg per day. Thirty-three patients were randomized to receive methotrexate in Phase 2. Thirty-four patients received prednisone and placebo. MAIN OUTCOME MEASURE: Adverse events (AE) in patients treated with prednisone only. RESULTS: Of 116 patients, 7 had to stop prednisone therapy during the 1-month challenge phase due to AE. Of 34 patients, 5 were unable to complete the full 22-week course of prednisone due to AE. The most common AE was hyperglycemia, which occurred in 17.6% of patients participating in Phase 2. Weight gain was also common, with a mean increase in body mass index of 1.6 kg/m (95% confidence interval, 0.77-2.3) during the 22-week steroid course. Patients entering Phase 2 were followed for a mean of 66 weeks. No fractures or osteonecrosis were reported. CONCLUSION: Although high-dose corticosteroids are associated with known serious side effects, prospective data in the literature are limited. The present study suggests that with appropriate patient selection, monitoring, and patient education, high-dose corticosteroids are a safe and effective treatment of AIED.

Original languageEnglish (US)
Pages (from-to)443-448
Number of pages6
JournalOtology and Neurotology
Volume30
Issue number4
DOIs
StatePublished - Jun 2009

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Keywords

  • Adverse events
  • Autoimmune inner ear disease
  • Corticosteroids
  • Hearing loss
  • Prednisone
  • Toxicity

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Clinical Neurology
  • Sensory Systems

Cite this

Alexander, T. H., Weisman, M. H., Derebery, J. M., Espeland, M. A., Gantz, B. J., Gulya, A. J., Hammerschlag, P. E., Hannley, M., Hughes, G. B., Moscicki, R., Nelson, R. A., Niparko, J. K., Rauch, S. D., Telian, S. A., Brookhouser, P. E., & Harris, J. P. (2009). Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease. Otology and Neurotology, 30(4), 443-448. https://doi.org/10.1097/MAO.0b013e3181a52773