The risk of nonvertebral fracture related to inhaled corticosteroid exposure among adults with chronic respiratory disease.
OBJECTIVE
To examine nonvertebral fracture risk in relation to inhaled corticosteroid (ICS) exposure among adults with respiratory disease.


METHODS
Nested case-control study within a cohort of 89,877 UnitedHealthcare members aged > or = 40 years with physician insurance claims for COPD or asthma, enrolled for > or = 1 year from January 1, 1997 to June 30, 2001.


METHODS
Cases (n = 1,722) represented patients with a first treated nonvertebral fracture (the index date is the first fracture claim). Control subjects (n = 17,220) were randomly selected from the person-time and assigned a random index date. ICS exposure was ascertained 1 month, 3 months, 6 months, and 12 months before the index date, with estimated cumulative dose through 0 to 6 months, 7 to 12 months, and 0 to 12 months. Covariates included demographics, oral corticosteroid and other medication exposure, comorbidities, and indicators of respiratory disease severity. Odds ratios (ORs) adjusted for all covariates were estimated by logistic regression.


RESULTS
No increased fracture risk with ICS exposure as a class or with fluticasone propionate alone was detected. ORs for exposure in the preceding 30 days were 1.05 (95% confidence interval [CI], 0.89 to 1.24), 1.13 (95% CI, 0.90 to 1.40), and 0.97 (95% CI, 0.78 to 1.21) for all ICS, fluticasone propionate, and other ICS, respectively. No dose-response effect was present. Among patients with COPD only (n = 6,932), no increased risk was found for recent ICS exposure (OR, 0.86; 95% CI, 0.59 to 1.25).


CONCLUSIONS
Concern about nonvertebral fracture risk should not strongly influence the decision to use recommended doses of ICS for adult patients with asthma or COPD in managed-care settings in the United States. This study could not evaluate very-high ICS dose, long-term ICS exposure, or vertebral fracture risk.
Johannes
Catherine B
CB
Ingenix Epidemiology, Auburndale, MA 02466, USA. kjohannes@epidemiology.com
Schneider
Gary A
GA
Dube
Timothy J
TJ
Alfredson
Tanya D
TD
Davis
Kourtney J
KJ
Walker
Alexander M
AM
D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D015897:Comorbidity; D050723:Fractures, Bone / Q000139:chemically induced / Q000453:epidemiology*; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
D005938:Glucocorticoids