Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease.
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.
Alexander
Thomas H
TH
Division of Otolaryngology-Head and Neck Surgery, University of California San Diego, San Diego, CA 92103, USA.
Weisman
Michael H
MH
Derebery
Jennifer M
JM
Espeland
Mark A
MA
Gantz
Bruce J
BJ
Gulya
A Julianna
AJ
Hammerschlag
Paul E
PE
Hannley
Maureen
M
Hughes
Gordon B
GB
Moscicki
Richard
R
Nelson
Ralph A
RA
Niparko
John K
JK
Rauch
Steven D
SD
Telian
Steven A
SA
Brookhouser
Patrick E
PE
Harris
Jeffrey P
JP
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
D000305:Adrenal Cortex Hormones; D011241:Prednisone