Reducing exacerbations in patients with COPD : a comparison between roflumilast and placebo

Abstract

This dissertation evaluates literature regarding roflumilast; the use of which has recently been approved in the EU; and its effects on COPD exacerbations, which are a major source of morbidity and mortality. Using the PICO framework, the question formulated is: In the medical setting, does the use of oral roflumilast, when compared to a placebo, lead to reduced ex-acerbations in chronic obstructive pulmonary disease patients who are forty years or older? The population incorporates COPD patients who are 40 years or older. Oral roflumilast is the intervention, whilst placebo represents the comparison. The outcome is reduced exacerbations. Databases were searched for relevant literature, The inclusion criteria incorpo-rated studies comparing roflumilast with placebo in COPD patients, with the number of exacerbations as one of the outcomes; studies with participants aged 40 years or older, studies that were published between 2003-2014; systematic reviews, meta-analyses and primary sources. Contrastingly, studies which compared drugs other than roflumilast; studies with animals or asthma patients as participants; unpublished studies; studies published in a non-English language; as well as discussion articles, literature reviews and guidelines, were excluded. In this literature search, four meta-analyses, two system-atic reviews and six RCTs were retrieved. These were appraised using the CASP tools and a tool by Russo. The results were inconsistent and since various literature gaps were identified, more research is required. However, based on current evidence, it was concluded that roflumilast, when compared to a placebo, leads to reduced exacerbations only in pa-tients with severe or very severe COPD, chronic bronchitis and a history of recurrent exacerbations. Recommendations consist of bridging literature gaps; encouraging the adoption of a standardised definition of the term exacerbation; phenotyping COPD pa-tients; and educating healthcare professionals about COPD and roflumilast.