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#55 Roflumilast – COPD relief at last?

Is roflumilast (Daxas®) beneficial as an add-on therapy in the management of COPD?

Roflumilast decreases the risk of COPD exacerbations for one in 24, with no effect on mortality and no clinically important improvements in quality of life. Roflumilast increases the risk of various adverse effects, including psychiatric (one in 28), diarrhea (one in 15), and weight loss (one in 17)The net benefit of roflumilast is questionable. 

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2017 Cochrane systematic review1 of 20 randomized trials (17,627 patients) of roflumilast, with follow-up ranging from 12 to 52 weeks: 
  • Statistically significant benefit: 
    • Reduced likelihood of one or more COPD exacerbations of moderate (requiring corticosteroids) or severe (requiring admission) severity31.7% in placebo versuss. 27.4% in roflumilast, Number Needed to Treat (NNT)=24. 
      • Benefit similar regardless of other COPD treatments. 
  • Not statistically and/or clinically significant: 
    • No reduction in mortality. 
    • Multiple quality of life and symptom scores with few reaching statistical significance and none reaching clinical importance. 
    • Statistically but not clinically important improvement in FEV1 with roflumilast (56 mL). 
  • Harms: 
    • More participants in the roflumilast groups experienced: 
      • Psychiatric adverse events, including anxiety, depression, and insomniaNumber Needed to Harm (NNH)=28. 
      • Weight loss NNH=17. 
      • Diarrhea NNH=15. 
      • Nausea NNH=31. 
      • Headache NNH=44. 
    • Weight loss is on average 2 kg over 24-52 weeks,2,3 though one study found this same weight loss within 1one month after starting roflumilast following a COPD exacerbation.4
  • Roflumilast is an oral phosphodiesterase 4 (PDE4) inhibitor that reduces the airway inflammation and bronchoconstriction seen in COPD. 
  • Change in FEV1 of 100 mL is considered the minimum clinically important difference.5 
    • However, the observed FEV1 improvement with roflumilast is similar to that for salmeterol or fluticasone in the TORCH trial.5 
  • In patients with previous COPD exacerbation, weight loss is a risk factor for re-hospitalization and death.7-9 
updated jan 13 2018 by ricky

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  • Christina Korownyk MD CCFP
  • G. Michael Allan MD CCFP

1. Chong J, Leung B, Poole P. Cochrane Database Syst Rev. 2017; 9:CD002309.

2. Calverley PM, Rabe KF, Goehring UM, et al. Lancet. 2009 Aug 29; 374(9691):685-94.

3. Fabbri LM, Calverley PM, Izquierdo-Alonso JL, et al. Lancet. 2009 Aug 29; 374(9691):695-703.

4. Mackay AJ, Patel ARC, Singh R, et al. Am J Resp Crit Care Med. 2017; 196:656-9.

5. Donohue JF. COPD. 2005 Mar; 2(1):111-24.

6. Calverley PM, Anderson JA, Celli B, et al. N Engl J Med. 2007 Feb 22; 356(8):775-89.

7. McGhan R, Radcliff T, Fish R, et al. Chest. 2007 Dec; 132(6):1748-55.

8. Hallin R, Gudmundsson G, Suppli Ulrik C, et al. Respir Med. 2007 Sep; 101(9):1954-60.

9. Cheng Y, Borrego ME, Frost FJ, et al. Springerplus. 2014 Jul 15; 3:359.

Authors do not have any conflicts of interest to declare.