Patients with chronic obstructive pulmonary disease (COPD) are increasingly treated with inhaled corticosteroids (ICS). However, because these patients have increased risk for fractures, it is important to determine if ICS use further increases their fracture risk. The objective was to characterize the association between ICS use and non-vertebral fractures in veterans with COPD.
Nested case-control study in cohort of Veterans Affairs (VA) patients with COPD. Patients included had a COPD diagnosis between October 1, 1998 and September 30, 1999 and used VA services in the preceding 12-month period but did not have a COPD diagnosis. Cases had non-vertebral fractures occurring between January 1, 1999 and September 30, 2002. Controls were individually matched to cases (4:1) on date of COPD diagnosis, age, and sex. ICS exposure was identified through prescription records and converted to beclomethasone equivalents. Fracture risk associated with ICS exposure was estimated using conditional logistic regression and adjusted for potential confounders.
From an eligible cohort of 40,157 patients, 1708 cases and 6817 matched controls were identified. Patients were 94% male and average age was 62.7 years. ICS exposure was 21.4% in cases and 22.1% in controls. Ever exposure to ICS during follow-up was not associated with an increased fracture risk (Adjusted OR=0.97; 95% CI, 0.84 – 1.11). However, fracture risk was impacted by recent use (<30 days prior) and average daily dose (Figure). The proportion of patients in the recent use, high dose category differed by ICS product.CONCLUSIONS: After controlling for variables that affect fracture risk and corticosteroid use, COPD patients currently using ICS at high doses had a slight increase in the risk of non-vertebral fractures compared to COPD patients that never used ICS.
Based on results from this observational analysis, the small increase in fracture risk does not warrant stopping ICS treatment in COPD patients with improved lung function, symptoms and quality of life; however, the results suggest the lowest effective ICS dose be used.
T.A. Lee, GlaxoSmithKline, grant monies; Pfizer, grant monies; Boehringer-Ingelheim, grant monies.