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Risk of exacerbations of COPD not increased in patients discontinuing inhaled glucocorticoids
The risk of moderate or severe exacerbations in patients with severe but stable chronic obstructive pulmonary disease (COPD) who receive tiotropium plus salmeterol has been found to be similar among subjects discontinuing inhaled glucocorticoids and subjects continuing their use. Nevertheless, in making decisions about maintenance therapy for these patients the effect of withdrawal of glucocorticoids on their symptoms and pulmonary function should be carefully considered.
The risk of moderate or severe exacerbations in patients with severe but stable chronic obstructive pulmonary disease (COPD) who receive tiotropium plus salmeterol has been found to be similar among subjects discontinuing inhaled glucocorticoids and subjects continuing their use. Nevertheless, in making decisions about maintenance therapy for these patients the effect of withdrawal of glucocorticoids on their symptoms and pulmonary function should be carefully considered.
Study findings on the effects of withdrawal of inhaled glucocorticoids and exacerbations of COPD were recently published in the New England Journal of Medicine (2014;371[14]:1285–1294). Investigators conducted the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial to ascertain if there would be similar outcomes in COPD patients receiving combined long-acting muscarinic antagonist (tiotropium) and long-acting β-agonist (salmeterol) therapy with inhaled glucocorticoids, whether or not glucocorticoids were withdrawn or continued.
The WISDOM trial was a 12-month, double-blind, parallel-group study including 2485 patients with a history of exacerbations of COPD. During a 6-week run-in period the study patients were given a triple therapy of tiotropium 18 µg once daily, salmeterol 50 µg twice daily, and fluticasone propionate (an inhaled glucocorticoid) 500 µg twice daily. Following the initial run-in period, patients were randomly assigned to a 3-step withdrawal of fluticasone propionate or to continued triple therapy over the course of 12 weeks. The time to the first moderate or severe exacerbation of COPD served as the primary end point of the study.
As concerned the first moderate or severe COPD exacerbation the withdrawal of the glucocorticoid met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval when compared with continued glucocorticoid use. Further, the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second (FEV1) when withdrawal was completed at week 18 was observed to be 38 mL greater in the withdrawal group than in the group continuing on the glucocorticoid (P<.001). At week 52, a similar between-group difference of 43 mL was observed (P=.001).
The authors comment, however, that there was a greater decrease in lung function during the last step of withdrawal. Thus their recommendation that the consequences of withdrawal on lung function, as well as symptoms, be taken into account when making decisions about the therapeutic approach to managing patients with severe but stable COPD.
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