Safety of High-Dose Corticosteroids for the Treatment of Autoimmune Inner Ear Disease
| Autor: | Richard A. Moscicki, Steven A. Telian, Michael H. Weisman, A. Julianna Gulya, Maureen T. Hannley, Ralph A. Nelson, Paul E. Hammerschlag, John K. Niparko, Patrick E. Brookhouser, Gordon B. Hughes, Mark A. Espeland, Bruce J. Gantz, Jennifer M. Derebery, Jeffrey P. Harris, Thomas H. Alexander, Steven D. Rauch |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Hearing loss Prospective data Weight Gain Autoimmune Diseases law.invention chemistry.chemical_compound Double-Blind Method Randomized controlled trial Adrenal Cortex Hormones Prednisone law Internal medicine Humans Medicine Adverse effect Aged business.industry Autoimmune inner ear disease Meth Middle Aged medicine.disease Dermatology Sensory Systems Endocrinology Otorhinolaryngology chemistry Ear Inner Hyperglycemia Toxicity Female Neurology (clinical) medicine.symptom business medicine.drug |
| Zdroj: | Otology & Neurotology. 30:443-448 |
| ISSN: | 1531-7129 |
| DOI: | 10.1097/mao.0b013e3181a52773 |
| Popis: | To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED).Prospective data collected as part of a multicenter, randomized, controlled trial for the treatment of corticosteroid-responsive AIED with methotrexate.Tertiary referral centers.One hundred sixteen patients with rapidly progressive, bilateral sensorineural hearing loss.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.Adverse events (AE) in patients treated with prednisone only.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.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. |
| Databáze: | OpenAIRE |
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