PMID- 25576458 OWN - NLM STAT- MEDLINE DCOM- 20160525 LR - 20181113 IS - 1720-8386 (Electronic) IS - 0391-4097 (Linking) VI - 38 IP - 2 DP - 2015 Feb TI - Prospectively recorded and MedDRA-coded safety data of intravenous methylprednisolone therapy in Graves' orbitopathy. PG - 177-82 LID - 10.1007/s40618-014-0227-x [doi] AB - CONTEXT: Safety of intravenous (IV) steroid pulses in patients with Graves' orbitopathy (GO) is still controversial while steroid dose and treatment application have not been finalized. Frequency, severity and characterization of adverse events (AE) were prospectively analyzed. SETTING: Academic referral orbital center with a joint thyroid-eye clinic. PATIENTS: Eighty consecutive and unselected patients with active and severe GO. METHODS: During an established treatment with IV methylprednisolone (cumulative dose 4.5 g) occurring AE were prospectively coded according to the standardized and recognized medical dictionary for regulatory activities (MedDRA). Outcome and severity of AE were documented. AEs judged as at least possibly related to drug treatment were graded as side effect (SE). AEs matching a seriousness criteria as defined by the ICH guideline E6 (good clinical practice) were graded as serious. RESULTS: A total of 38.75% (31/80) of the treated GO patients reported at least one AE while 18 patients (22.5%) reported at least one SE. All SE were within the safety profile of IV methylprednisolone; 31/32 SE (96.87%) were mild-moderate and reversible and only 1/80 patient (1.25%) stopped steroid treatment due to exacerbation of her depression. Most AE were accessory symptoms of the underlying disease and a few only were directly related to IV steroids. Most AEs (90.6%) were graded as mild. Only six patients (7.5%) were hospitalized, three of them due to a dysthyroid optic neuropathy. CONCLUSIONS: Prospective and standardized evaluation with MedDRA and the ICH guideline demonstrated the good pharmacological tolerance and low morbidity of this moderate steroid regimen. FAU - Riedl, M AU - Riedl M AD - Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. AD - Interdisciplinary Center for Clinical Trials, Johannes Gutenberg University Medical Center, Mainz, Germany. FAU - Kolbe, E AU - Kolbe E AD - Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. FAU - Kampmann, E AU - Kampmann E AD - Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. FAU - Kramer, I AU - Kramer I AD - Central Pharmacy, Johannes Gutenberg University Medical Center, Mainz, Germany. FAU - Kahaly, G J AU - Kahaly GJ AD - Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. kahaly@uk-mainz.de. LA - eng PT - Journal Article DEP - 20150110 PL - Italy TA - J Endocrinol Invest JT - Journal of endocrinological investigation JID - 7806594 RN - X4W7ZR7023 (Methylprednisolone) SB - IM MH - Administration, Intravenous MH - Adult MH - Adverse Drug Reaction Reporting Systems/*standards MH - Aged MH - Female MH - Gastrointestinal Diseases/chemically induced MH - Graves Ophthalmopathy/*diagnosis/*drug therapy MH - Heart Diseases/chemically induced MH - Humans MH - Male MH - Methylprednisolone/*administration & dosage/*adverse effects MH - Middle Aged MH - Prospective Studies MH - *Severity of Illness Index MH - Young Adult OTO - NOTNLM OT - Graves' orbitopathy OT - ICH guideline OT - Intravenous steroids OT - Medical dictionary for regulatory activities (MedDRA) OT - Safety EDAT- 2015/01/13 06:00 MHDA- 2016/05/26 06:00 CRDT- 2015/01/11 06:00 PHST- 2014/12/01 00:00 [received] PHST- 2014/12/09 00:00 [accepted] PHST- 2015/01/11 06:00 [entrez] PHST- 2015/01/13 06:00 [pubmed] PHST- 2016/05/26 06:00 [medline] AID - 10.1007/s40618-014-0227-x [pii] AID - 10.1007/s40618-014-0227-x [doi] PST - ppublish SO - J Endocrinol Invest. 2015 Feb;38(2):177-82. doi: 10.1007/s40618-014-0227-x. Epub 2015 Jan 10.