title: Acute and chronic systemic corticosteroid-related complications in patients with severe asthma.
abstract: BACKGROUND
  Many patients with severe asthma require maintenance treatment with systemic corticosteroids (SCSs) to control daily symptoms and prevent serious acute exacerbations, but chronic SCS use is associated with complications.
  
  
  OBJECTIVE
  We sought to evaluate the risk of SCS-related complications by SCS exposure and quantify the associated health care costs and resource use in patients with severe asthma.
  
  
  METHODS
  We performed a longitudinal, open-cohort, observational study using health insurance claims data (1997-2013: Medicaid) from Florida, Iowa, Kansas, Missouri, Mississippi, and New Jersey. Eligible patients were 12 years old or older with 2 or more asthma diagnoses and had more than 6 months of continuous SCS use. An open-cohort approach was used to classify patients' follow-up into low, medium, and high SCS exposure (≤ 6, >6-12, and >12 mg/d, respectively). Multivariate generalized estimating equation models were used to estimate the adjusted risk of SCS-related complications for patients with medium and high exposure compared with patients with low exposure and quantify the resulting health care resource use and costs.
  
  
  RESULTS
  The study included 3628 patients (mean age, 57.6 years; 68% female). Patients with medium and high SCS exposure had significantly higher risks of SCS-related complications, including infections and cardiovascular, metabolic, psychiatric, ocular, gastrointestinal, and bone-related complications (odds ratio, 1.23-2.12 by complication; P < .05 for all but one) versus those with low (reference group) SCS exposure. Medium and high SCS exposure were also associated with significantly more emergency department visits (incidence rate ratios, 1.31 [P = .0004] and 1.78 [P < .0001]) and inpatient visits (incidence rate ratios, 1.25 [P < .0001] and 1.59 [P < .0001]) versus low SCS exposure.
  
  
  CONCLUSIONS
  A significant dose-response relationship was demonstrated between chronic SCS use and risk of SCS-related complications in patients with severe asthma. Effective SCS-sparing strategies might reduce the burden associated with SCS-related complications in patients with severe asthma.
authors.affiliation: Groupe d'analyse, Ltée, Montreal, Quebec, Canada. Electronic address: Patrick.Lefebvre@analysisgroup.com.
authors.forename: Patrick
authors.initials: P
authors.lastname: Lefebvre
authors.affiliation: Analysis Group, Boston, Mass.
authors.forename: Mei Sheng
authors.initials: MS
authors.lastname: Duh
authors.affiliation: Groupe d'analyse, Ltée, Montreal, Quebec, Canada.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Lafeuille
authors.affiliation: Groupe d'analyse, Ltée, Montreal, Quebec, Canada.
authors.forename: Laurence
authors.initials: L
authors.lastname: Gozalo
authors.affiliation: Analysis Group, Boston, Mass.
authors.forename: Urvi
authors.initials: U
authors.lastname: Desai
authors.affiliation: Groupe d'analyse, Ltée, Montreal, Quebec, Canada.
authors.forename: Marie-Noëlle
authors.initials: MN
authors.lastname: Robitaille
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Frank
authors.initials: F
authors.lastname: Albers
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Steve
authors.initials: S
authors.lastname: Yancey
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Hector
authors.initials: H
authors.lastname: Ortega
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Mark
authors.initials: M
authors.lastname: Forshag
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Xiwu
authors.initials: X
authors.lastname: Lin
authors.affiliation: GlaxoSmithKline, Durham, NC.
authors.forename: Anand A
authors.initials: AA
authors.lastname: Dalal
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000191:economics; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents
keywords: Systemic corticosteroids; corticosteroid-related complications; cost; dose response; health care use; severe asthma