title: Cumulative burden of oral corticosteroid adverse effects and the economic implications of corticosteroid use in patients with systemic lupus erythematosus.
abstract: BACKGROUND
  Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population.
  
  
  OBJECTIVE
  To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE.
  
  
  METHODS
  In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged ≥18 years having ≥2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or ≥1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts.
  
  
  RESULTS
  Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers.
  
  
  CONCLUSIONS
  Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.
authors.affiliation: Xcenda LLC, Palm Harbor, FL 34685, USA. manan.shah@bms.com
authors.forename: Manan
authors.initials: M
authors.lastname: Shah
authors.forename: Sham
authors.initials: S
authors.lastname: Chaudhari
authors.forename: Trent P
authors.initials: TP
authors.lastname: McLaughlin
authors.forename: Hong J
authors.initials: HJ
authors.lastname: Kan
authors.forename: Benno
authors.initials: B
authors.lastname: Bechtel
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Dennis
authors.forename: Charles T
authors.initials: CT
authors.lastname: Molta
mesh_terms: D000305:Adrenal Cortex Hormones / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D012189:Retrospective Studies
chemical_list: D000305:Adrenal Cortex Hormones