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Steroid inhalers increase fracture risk in COPD

Clinical Question:
Does the use of inhaled corticosteroids in typical doses increase the long-term risk of fracture?

Bottom Line:
The use of inhaled corticosteroids as a treatment for chronic obstructive pulmonary disease (COPD) in older adults increases the fracture risk somewhat, with a number needed to treat to harm of 83 over 3 years. This must be balanced against a number needed to treat of 6 per year to prevent exacerbations. (LOE = 1a)

Loke YK, Cavallazzi R, Singh S. Risk of fractures with inhaled corticosteroids in COPD: systematic review and meta-analysis of randomized controlled trials and observational studies. Thorax 2011;66(8):699-708.  [PMID:21602540]

Study Design:
Systematic review


Outpatient (any)

Previous studies have been mixed regarding the effect of inhaled corticosteroids like budesonide and fluticasone on bone density, and individual trials have been underpowered to look at the patient-oriented outcome of fractures. These authors did a careful search to identify all randomized trials and observational studies comparing a group of patients with COPD who received a corticosteroid with a group of similar patients who did not. This included placebo-controlled studies, and studies where both groups also received another drug, such as a long-acting beta agonist. The authors identified 16 randomized controlled trials (RCTs) with 17,513 patients, as well as 7 large cross-sectional or nested case-control studies with approximately 69,000 patients. The RCTs ranged from 24 weeks to 156 weeks in duration, with patient age means in the 60s. Allocation concealment and randomization methodology were adequate for approximately half the studies and unclear in the rest. A single large 3-year clinical trial with 3088 patients dominated the results, accounting for a majority of fractures. The relative risk for any fracture was 1.27 in the RCTs, with a 95% confidence interval from 1.01 to 1.58, and a number needed to treat to harm of 83 over 3 years. The observational studies found similar results (relative risk = 1.21 - 1.27, depending on the subgroup).


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