Guidelines recommend inhaled corticosteroids for patients with severe chronic obstructive pulmonary disease (COPD) to reduce the number of exacerbations and improve health status. Systemic corticosteroids have been shown to negatively affect bone density, increasing the risk for osteoporosis and fractures, although data are inconsistent. One complication is that chronic disease is a risk factor for fracture, and patients with COPD have a 36 to 60 percent increased risk of osteoporosis because of the lung disease. Johannes and associates assessed the risk of nonvertebral fractures in relation to inhaled corticosteroids in adults with COPD.
The nested case-control study included patients with COPD or asthma who were enrolled in a large insurance program. Inclusion criteria were an age of at least 40 years, enrollment in the health plan for at least 12 months, and at least two claims for outpatient physician visits or one inpatient claim. Eligible participants who had a first-time treated nonvertebral fracture were included in the final analysis. A control group also was randomly selected from the database. Exposure to inhaled corticosteroids was established using pharmacy claims. The cumulative dose was estimated by multiplying the number of containers in each dispensing by the number of doses per container, then multiplying by the strength of the medication. The patients’ inhaled corticosteroid exposures were calculated at one, three, six, and 12 months before the fracture claim or before the random index date assigned to the control group. The patients were then divided into four categories (i.e., very low, low, medium, and high average daily dosages).
Within the cohort of 89,877 patients with insurance claims for COPD, asthma, or both, 1,722 were eligible for the fracture group and 17,220 were in the control group. The most common fracture sites were lower and upper limbs. Approximately 35 percent of patients in both groups were using inhaled corticosteroids, and approximately 27 percent were taking oral corticosteroids. After analyzing for fracture risk, the authors found no increased risk for patients using inhaled corticosteroids. The findings were the same when comparing different dosages.
The authors conclude that patients using inhaled corticosteroids are at no higher risk for nonvertebral fracture than those who do not use them. They caution that the results in patients receiving high dosages were highly variable because few patients were included in this category. The concern about the potential increase of fracture risk should not prevent physicians from prescribing inhaled corticosteroids for patients with COPD.