2011 - Review: Oral phosphodiesterase 4 inhibitors reduce exacerbations but increase adverse events in COPD

Ram, Felix S.F.
September 2011
ACP Journal Club;9/20/2011, Vol. 155 Issue 3, p1
Academic Journal
Question What are the efficacy and safety of oral phosphodiesterase 4 (PDE[sub 4]) inhibitors in patients with stable chronic obstructive pulmonary disease (COPD)? Review scope Included studies compared oral PDE[sub 4] inhibitors (roflumilast or cilomilast) with placebo in patients é>18 years of age with COPD (FEV[sub 1] after bronchodilation <>80% of predicted value, ratio of FEV[sub 1] to FVC >70%). Exclusion criteria included single-dose trials, patients with acute exacerbations, and patients requiring mechanical ventilation. Primary outcomes were lung function (e.g., FEV[sub 1]) and quality of life (QOL) (St. Georges Respiratory Questionnaire [SGRQ] total score, lower scores = better QOL); other outcomes included exacerbations and adverse events. Review methods Cochrane Airways Group Specialized Register, US Food and Drug Administration Web site, and US National Institutes of Health clinical trials registry were searched to August 2010 for randomized controlled trials (RCTs). Reference lists were hand-searched, and authors and drug companies were contacted. 23 RCTs (n =>15>668) met the selection criteria: 9 assessed roflumilast (n =>9211), and 14 assessed cilomilast (n =>6457). 7 roflumilast trials reported adequate allocation concealment, and 6 described method of blinding; no cilomilast trials reported adequate concealment or described method of blinding. Main results Meta-analysis showed that PDE[sub 4] inhibitors improved FEV[sub 1] (21 comparisons, n =>14>307, mean difference in change in FEV[sub 1] 46 mL, 95% CI 39 to 52) and QOL (11 comparisons, n =>7898, mean difference in change in SGRQ total score 1.04, CI 1.66 to 0.41) and reduced exacerbations (Table) compared with placebo. Overall, PDE[sub 4] inhibitors increased risk for adverse events, specifically diarrhea, nausea, vomiting, and headache (Table). Drug-specific meta-analyses showed that cilomilast, 15 mg twice daily, increased vomiting (relative risk increase [RRI] 283%, CI 169 to 445), dyspepsia (RRI 197%, CI 121 to 299), and abdominal pain (RRI 86%, CI 50 to 132); roflumilast, 500 &Bgr;g/d, increased weight loss (RRI 326%, CI 216 to 474). Conclusion In patients with stable chronic obstructive pulmonary disease, oral phosphodiesterase 4 inhibitors reduce exacerbations but increase adverse events.


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