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Roflumilast improves lung function in COPD patients
The oral phosphodiesterase-4 inhibitor roflumilast helped prevent severe exacerbations and improved lung function in patients with severe COPD who had exacerbations despite inhaled combination therapy, according to study results.
“This is the first study that has demonstrated that an anti-inflammatory therapy can decrease exacerbations, including hospitalizations, despite current maximally available inhaled therapies,” Fernando J. Martinez, MD, of the University of Michigan Health System, told Healio.com/Pulmonology.
Martinez and colleagues conducted a 1-year, double blind, placebo-controlled, parallel group, multicenter study of 1,945 patients with severe COPD from 203 centers in 21 countries.
The study, held from April 2011 to May 2014, was conducted to see if roflumilast could decrease the number of yearly exacerbations in patients with COPD as well as increase post-bronchodilator forced expiratory volume in 1 second (FEV1).
Participants were assigned once-daily roflumilast 500 µg (n = 973) or placebo (n = 972).
The frequency of moderate-to-severe exacerbations was 13.2% lower in the roflumilast intention-to-treat group compared with placebo (RR = 0.868; 95% CI, 0.753-1.002). Treatment with roflumilast also led to a 24.3% reduction in severe events (RR = 0.757; 95% CI, 0.601-0.952) as well as a 23.9% reduction in exacerbations leading to hospital admission (RR = 0.761; 95% CI, 0.604-0.96). Treatment with roflumilast also improved post-bronchodilator FEV1 by 56 mL.
COPD exacerbations and pneumonia were the most frequently reported serious adverse events with 26% occurring among the roflumilast patients vs. 30% in the placebo group. Mortality was similar at 2% for each group. – by Ryan McDonald
Disclosure: Martinez reports participating in steering committees for COPD or idiopathic pulmonary fibrosis sponsored by Bayer, Centocor, Forest, Gilead Sciences, Janssen Biotech, GlaxoSmithKline, Nycomed/Takeda, and Promedior. He reports participating in advisory boards for COPD or idiopathic pulmonary fibrosis for Actelion, Amgen, AstraZeneca, Boehringer Ingelheim, Carden Jennings, CSA Medical, Ikaria, Forest, Genentech, GlaxoSmithKline, Janssen, Merck, Pearl, Nycomed/Takeda, Pfizer, Roche, Sudler & Hennessey, Veracyte, and Vertex. Please see the full study for the remainder of Martinez’s and all other authors’ relevant financial disclosures.