Sichuan University researchers found that roflumilast led to improved lung function and reduction of acute exacerbations in patients with COPD.
The research team analyzed all published randomized controlled trials assessing roflumilast that included clinical measurements, such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), transition dyspnea index (TDI), St George’s Respiratory Questionnaire (SGRQ), and the incidence of COPD exacerbations and adverse events to see whether roflumilast was effective and safe.
The clinical trial information was obtained through a computer search spanning the years 1946 through November 2015. Researchers used the databases Pubmed, Embase, Medline, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and American College of Physician (ACP).
Results of the pooled analyses indicated that treatment with roflumilast resulted in significant improvements in pre- and post-bronchodilator FEV1, significant alleviation of dyspnea, and a decrease in acute exacerbations. However, researchers emphasized that roflumilast significantly increased the incidence of adverse events compared with a placebo.
“Roflumilast can be considered as an alternative therapy in selective patients with moderate-to-severe COPD due to the effect of lung function improvement, dyspnea alleviation, and acute exacerbation decrease, but increase of risk of adverse events. More large studies are needed, particularly with different follow-up and treatment duration, to further determine the role of roflumilast, including cost-effectiveness and time-to-survive, in patients with moderate-to-severe COPD,” the research team wrote in their article.