To assess the risk of non-vertebral fracture associated with inhaled corticosteroid (ICS) use among older adults with diagnosed chronic obstructive pulmonary disease (COPD).
We conducted a population-based case-control study nested within a cohort of all diagnosed COPD patients aged 50 to 85 years in the General Practice Research Database (GPRD) in the UK (n=48,294), during years 1987 to 2000. Cases (n=2808) were the first non-vertebral fractures to occur at least twelve months after COPD diagnosis and matched to controls (n=8453) on age, sex, and general practice. Data on all drug prescriptions, COPD severity, and coexisting medical conditions were obtained for the time between cohort entry and index date. Average daily dose of ICS was calculated in beclomethasone (BDP) equivalents. Adjusted odds ratios and 95% confidence intervals (CI) were produced from conditional logistic regression models.
Adjusted risk of fracture was not associated with ever ICS use relative to never use (OR =0.70, 95%CI: 0.61, 0.79). The fracture risk for ICS use within 30 days prior to index date was increased relative to those with no use in the year prior (OR =1.42, 95%CI: 1.23, 1.65). Current use of BDP (OR=1.46, 95%CI: 1.26, 1.69) or budesonide (OR=1.41, 95%CI: 1.10, 1.79), but not fluticasone propionate (FP) (OR =0.78, 95%CI: 0.55, 1.09), was associated with fracture. Risk of fracture did not differ by ICS average daily dose (OR=1.39 vs. OR=1.32 for low and high doses, respectively). Fracture risk increased with bronchodilator use in the prior year (OR=2.47, p<0.05, for 2 to 5 prescriptions versus <2).CONCLUSIONS: The risk of non-vertebral fracture associated with ICS use among COPD patients was limited to use of BDP or budesonide in the 90 days prior to index date. There was not consistent evidence of a dose-response relationship between ICS use and risk of non-vertebral fracture
Recent use of ICS was associated with small increased risk of fracture in COPD patients, although risk was not elevated among FP users.
K.J. Davis, GlaxoSmithKline.