title: Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease.
abstract: OBJECTIVE
  To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED).
  
  
  METHODS
  Prospective data collected as part of a multicenter, randomized, controlled trial for the treatment of corticosteroid-responsive AIED with methotrexate.
  
  
  METHODS
  Tertiary referral centers.
  
  
  METHODS
  One hundred sixteen patients with rapidly progressive, bilateral sensorineural hearing loss.
  
  
  METHODS
  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.
  
  
  METHODS
  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/m2 (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, University of California San Diego, San Diego, CA 92103, USA.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Alexander
authors.forename: Michael H
authors.initials: MH
authors.lastname: Weisman
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Derebery
authors.forename: Mark A
authors.initials: MA
authors.lastname: Espeland
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Gantz
authors.forename: A Julianna
authors.initials: AJ
authors.lastname: Gulya
authors.forename: Paul E
authors.initials: PE
authors.lastname: Hammerschlag
authors.forename: Maureen
authors.initials: M
authors.lastname: Hannley
authors.forename: Gordon B
authors.initials: GB
authors.lastname: Hughes
authors.forename: Richard
authors.initials: R
authors.lastname: Moscicki
authors.forename: Ralph A
authors.initials: RA
authors.lastname: Nelson
authors.forename: John K
authors.initials: JK
authors.lastname: Niparko
authors.forename: Steven D
authors.initials: SD
authors.lastname: Rauch
authors.forename: Steven A
authors.initials: SA
authors.lastname: Telian
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Brookhouser
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Harris
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D000368:Aged; D001327:Autoimmune Diseases / Q000188:drug therapy / Q000503:physiopathology; D004311:Double-Blind Method; D007758:Ear, Inner / Q000187:drug effects / Q000503:physiopathology; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D015430:Weight Gain
chemical_list: D000305:Adrenal Cortex Hormones; D011241:Prednisone