Abstract | OBJECTIVE: 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: 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/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. 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.
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Authors | 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 |
Journal | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
(Otol Neurotol)
Vol. 30
Issue 4
Pg. 443-8
(Jun 2009)
ISSN: 1537-4505 [Electronic] United States |
PMID | 19395984
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenal Cortex Hormones
- Prednisone
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Topics |
- Adrenal Cortex Hormones
(administration & dosage, adverse effects)
- Adult
- Aged
- Autoimmune Diseases
(drug therapy, physiopathology)
- Double-Blind Method
- Ear, Inner
(drug effects, physiopathology)
- Female
- Humans
- Hyperglycemia
(chemically induced)
- Male
- Middle Aged
- Prednisone
(administration & dosage, adverse effects)
- Weight Gain
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