PMID- 31656021 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 2198-6576 (Print) IS - 2198-6584 (Electronic) IS - 2198-6576 (Linking) VI - 6 IP - 4 DP - 2019 Dec TI - Risk of Potential Glucocorticoid-Related Adverse Events in Patients with Giant Cell Arteritis: Results from a USA-Based Electronic Health Records Database. PG - 599-610 LID - 10.1007/s40744-019-00180-9 [doi] AB - INTRODUCTION: Oral glucocorticoids (GC) have been the mainstay of treatment for giant cell arteritis (GCA). We estimated the risk and dose-effect relationship of potential GC-related adverse events (AEs) in patients with GCA. METHODS: This retrospective, observational cohort study utilized data from the IBM Explorys Electronic Health Records database from 2008 through 2016. Inclusion criteria included the presence of at least two GCA diagnostic codes in subjects aged 50 or older along with supporting laboratory [C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)], prescription data on oral GCs, and at least 12 months of follow-up before and after the first oral GC prescription for GCA (index date). Potential AEs captured on the basis of new diagnoses, prescriptions, and laboratory tests were assessed during the 12 months post-index date. Results were descriptively summarized across cohorts according to quartiles (Q) of mean daily GC dose measured over the first 6 months of follow-up (Q1, >/= 1.00 to 13.75 to 25.00 to 40.00 mg). RESULTS: We identified 785 eligible patients with GCA. The mean (SD) age of the cohort was 76 (9) years and 70% were female. The mean oral GC dose during the first 6 months post-index was 28.9 mg/day. A dose-effect response was observed from Q1 to Q4 in the following potential GC-related AEs: newly diagnosed type 2 diabetes/HbA1c > 7.5% (range 7.5-24.5%), blood glucose >/= 200 mg/dL (range 7.5-15%), serious infection (range 16.8-24.8%), cataracts (range 12.0-21.7%), gastrointestinal bleed/ulcer (range 6.0-11.8%), and increase in BMI >/= 5 units (range 4.1-6.4). CONCLUSIONS: In patients with GCA, potential GC-related AEs increased with higher daily oral GC doses. This highlights the need for effective therapies that reduce GC exposure and toxicity. FUNDING: Genentech, Inc. FAU - Best, Jennie H AU - Best JH AD - Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA. FAU - Kong, Amanda M AU - Kong AM AUID- ORCID: 0000-0002-6210-4185 AD - IBM Watson Health, 75 Binney Street, Cambridge, MA, USA. akong@us.ibm.com. FAU - Unizony, Sebastian AU - Unizony S AD - Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, USA. FAU - Tran, Oth AU - Tran O AD - IBM Watson Health, 75 Binney Street, Cambridge, MA, USA. FAU - Michalska, Margaret AU - Michalska M AD - Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA. LA - eng PT - Journal Article DEP - 20191026 PL - England TA - Rheumatol Ther JT - Rheumatology and therapy JID - 101674543 PMC - PMC6858477 OTO - NOTNLM OT - Adverse events OT - Electronic health records OT - Giant cell arteritis OT - Glucocorticoids EDAT- 2019/10/28 06:00 MHDA- 2019/10/28 06:01 PMCR- 2019/10/26 CRDT- 2019/10/28 06:00 PHST- 2019/09/26 00:00 [received] PHST- 2019/10/28 06:00 [pubmed] PHST- 2019/10/28 06:01 [medline] PHST- 2019/10/28 06:00 [entrez] PHST- 2019/10/26 00:00 [pmc-release] AID - 10.1007/s40744-019-00180-9 [pii] AID - 180 [pii] AID - 10.1007/s40744-019-00180-9 [doi] PST - ppublish SO - Rheumatol Ther. 2019 Dec;6(4):599-610. doi: 10.1007/s40744-019-00180-9. Epub 2019 Oct 26.