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Published ahead of print on April 26, 2007, doi:10.1164/rccm.200610-1563OC

Am. J. Respir. Crit. Care Med., Volume 176, Number 2, July 2007, 154-161

A more recent version of this article appeared on July 15, 2007
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Submitted on October 31, 2006
Accepted on April 26, 2007

Effect of One Year Treatment with Roflumilast in Severe Chronic Obstructive Pulmonary Disease

Peter MA Calverley1*, Fernando Sanchez-Toril2, Andrew McIvor3, Peter Teichmann4, Dirk Bredenbroeker4, and Leonardo M Fabbri5

1 Division of Infection and Immunity, Department of Medicine, Clinical Sciences, University Hospital Aintree, Liverpool, United Kingdom, 2 Hospital Arnau de Vilanova, Valencia, Spain, 3 Queen Elizabeth II Health Sciences Center, Halifax, Canada, 4 ALTANA Pharma AG, Konstanz, Germany, 5 Department of Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy

* To whom correspondence should be addressed. E-mail: pmacal{at}liverpool.ac.uk.

Rationale: The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast can improve lung function, in moderate COPD. Whether treatment is effective in more severe COPD (GOLD Stages III and IV) over a longer period is unknown. Methods: We conducted a randomized, placebo controlled, double blind, parallel group trial for one year. We recruited 1513 patients (mean post-bronchodilator FEV1 41% predicted), 760 receiving oral roflumilast 500µg and 753 placebo once daily. Measurements and main results: We recorded post-bronchodilator FEV1, exacerbation rate, St George's Respiratory Questionnaire (SGRQ) total score at the study end-point; and number and type of reported adverse events during treatment. Post-bronchodilator FEV1 increased by 39 ml with roflumilast compared with placebo by 52 weeks (p = 0.001). The mean exacerbation rate was low and comparable in both treatment groups (0.86 exacerbations/patient/year for roflumilast versus 0.92 for placebo). In a retrospective analysis, the exacerbation rate in GOLD Stage IV patients was 36% lower in patients treated with roflumilast than in those treated with placebo (1.01 exacerbations/patient/year versus 1.59, respectively; p = 0.024). The SGRQ total score did not differ between treatments. The commonest adverse events related to roflumilast treatment were diarrhea, nausea and headache, which usually subsided during continued treatment. However, roflumilast resulted in more withdrawals within the first three to four weeks of administration. Conclusions: In severe stable COPD PDE4 inhibition with roflumilast produced a modest but significant improvement in lung function without changing the exacerbation rate or health status. However, patients with very severe disease experienced fewer exacerbations with roflumilast.
Key words: Anti-inflammatory, chronic obstructive pulmonary disease, exacerbations, lung function, phosphodiesterase-4 inhibitor.




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