New data examines step-wise withdrawal of inhaled corticosteroids in COPD

October 2, 2014

In patients with severe to very severe COPD and a history of exacerbation, the risk of moderate or severe exacerbations during 1 year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids (ICS) and those who discontinued ICS therapy in a step-wise manner, as long as patients continued to receive maintenance treatment with long-acting bronchodilators (tiotropium and a long-acting beta agonist [LABA]), according to data presented at the European Respiratory Society (ERS) International Congress 2014 and also published in The New England Journal of Medicine.

Dr McBryan

In patients with severe to very severe COPD and a history of exacerbation, the risk of moderate or severe exacerbations during 1 year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids (ICS) and those who discontinued ICS therapy in a step-wise manner, as long as patients continued to receive maintenance treatment with long-acting bronchodilators (tiotropium and a long-acting beta agonist [LABA]), according to data presented at the European Respiratory Society (ERS) International Congress 2014 and also published in The New England Journal of Medicine.

Results of the 12-month, double-blind, parallel-group, active-controlled WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial evaluated step-wise withdrawal of 2,400 ICS in patients with severe to very severe COPD and a history of exacerbation. In the trial, patients received triple therapy consisting of tiotropium 18 μg once daily, salmeterol 50 μg twice daily (LABA) and fluticasone 500 μg twice daily (ICS) for a 6-week run-in period.

“These patients were then randomly assigned 1:1 to continue triple therapy or step-wise withdrawal of ICS over 12 weeks [dose reduction every 6 weeks]” according to Danny McBryan, MD, vice president, clinical development & medical affairs – respiratory, Boehringer Ingelheim. “The primary end point was time to first moderate or severe on-treatment exacerbation.”

The time by which 25% of patients experienced a first moderate or severe exacerbation was 110 days in the ICS-withdrawal group and 107 days in the ICS-continuation group. The percentage of patients with any adverse event was 70.8% for those who continued on ICS and 71.7% for those where ICS was withdrawn.

Approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The study was sponsored by Boehringer Ingelheim.

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