title: Incidence of outcomes potentially associated with corticosteroid therapy in patients with giant cell arteritis.
abstract: Giant cell arteritis (GCA) is an inflammatory disorder of blood vessels that preferentially affects large- and medium-sized arteries. High-dose oral corticosteroids (CS) are the mainstay of GCA therapy. Using data from the UK Clinical Practice Research Datalink, we quantified and compared the incidence of selected potentially CS-associated adverse outcomes in patients with and without GCA.
  
  
  
  We conducted a retrospective follow-up study of GCA and non-GCA patients to examine the incidence of adverse outcomes attributable to CS use. Eligibility criteria for the GCA group included a first-time diagnosis of GCA at age 50 years or older with receipt of ≥1 prescription(s) for prednisolone. GCA patients were matched to a GCA-free comparison group of equal size on age, sex, general practice, and calendar time. We estimated incidence rates and incidence rate ratios (IRRs) for diabetes, osteoporosis, glaucoma, fractures, serious infection requiring hospitalization, and death for GCA and non-GCA patients and compared all-cause hospitalizations between the two groups.
  
  
  
  The cohort consisted of 5011 GCA and 5011 matched non-GCA patients. Approximately 74% were women, and mean age at GCA diagnosis was 72.9 years. The IR for all outcomes was greater in the GCA group than the non-GCA group. IRRs [95% confidence intervals (CIs)] were as follows: diabetes 1.4 (1.2-1.7), osteoporosis 2.4 (2.1-2.8), fractures 1.4 (1.2-1.6), glaucoma 2.0 (1.6-2.5), serious infection requiring hospitalization 1.5 (1.3-1.7), and death 1.2 (1.0-1.3).
  
  
  
  Compared with age- and sex-matched non-GCA patients, patients with GCA were at increased risk for diabetes, osteoporosis, fracture, and glaucoma and at a marginally increased risk for death.
authors.affiliation: Basel Pharmacoepidemiology Unit, University of Basel, Basel, Switzerland.
authors.forename: Jessica C
authors.initials: JC
authors.lastname: Wilson
authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: Khaled
authors.initials: K
authors.lastname: Sarsour
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Collinson
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Tuckwell
authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Musselman
authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: Micki
authors.initials: M
authors.lastname: Klearman
authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: Pavel
authors.initials: P
authors.lastname: Napalkov
authors.affiliation: Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Jick
authors.affiliation: Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Stone
authors.affiliation: Basel Pharmacoepidemiology Unit, University of Basel, Basel, Switzerland; Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA; Hospital Pharmacy, University Hospital Basel, Basel, Switzerland. Electronic address: christoph.meier@usb.ch.
authors.forename: Christoph R
authors.initials: CR
authors.lastname: Meier
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D050723:Fractures, Bone / Q000453:epidemiology; D013700:Giant Cell Arteritis / Q000188:drug therapy* / Q000453:epidemiology; D005901:Glaucoma / Q000453:epidemiology; D005938:Glucocorticoids / Q000009:adverse effects*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000453:epidemiology; D011239:Prednisolone / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors; D017678:Sex Distribution; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone
keywords: Corticosteroids; Giant cell arteritis; Health services research; Outcomes research; Serious adverse events