RT Journal Article
SR Electronic
T1 Short term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: “REDUCE*”, a non-inferiority multicenter trial. (*Reduction in the Use of Corticosteroids in Exacerbated COPD; ISRCTN19646069)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4293
VO 40
IS Suppl 56
A1 Jörg D. Leuppi
A1 Philipp Schütz
A1 Roland Bingisser
A1 Matthias Briel
A1 Tilman Drescher
A1 Ursula Dürring
A1 Christoph Henzen
A1 Yolanda Leibbrandt
A1 Sabrina Maier
A1 David Miedinger
A1 Beat Müller
A1 Andreas Scherr
A1 Christian Schindler
A1 Rolf Stöckli
A1 Sebastian Viatte
A1 Christophe von Garnier
A1 Michael Tamm
A1 Jonas Rutishauser
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/4293.abstract
AB Background: The optimal dose and duration of systemic glucocorticoid therapy for acute exacerbations of COPD (AECOPD) is unknown. In this trial, we aimed to demonstrate non-inferiority of 5-days vs 14-days of systemic glucocorticoids with respect to COPD exacerbation.Methods: Patients admitted to hospital with AECOPD were randomized to receive 40mg of prednisone-equivalent daily for either 5 or 14 days in a placebo-controlled fashion. Follow-up was 180 days. The primary endpoint was time to next exacerbation.Results: Of 721 evaluated patients, 327 underwent randomization, and 304 completed the study. Mean age was 63.9 ±23.2 years; mean FEV1%predicted 31.5 ±14.3% and 60.8% were male. Exacerbations occurred in 36.8% and 38.4% of patients in the 5 day and 14 day treatment arms, respectively (p=0.81). Time to exacerbation did not differ between groups in the intention-to-treat and per-protocol analyses (hazard ratios for the short treatment arm, 0.92 [95%-CI, 0.64 to 1.34; p=0.67] and 0.91 [95%-CI, 0.63 to 1.32; p=0.62], respectively); nor did time to death or the combined endpoint of exacerbation and/or death, with both hazard ratios for the short treatment arm being <1 as well. With respect to the primary outcome, short treatment was not inferior to conventional treatment, since the 95%-confidence intervals did not include the predefined non-inferiority threshold of 1.515.Conclusion: In AECOPD, 5-day treatment with systemic glucocorticoids is non-inferior to 14-day treatment with regard to re-exacerbation during 6 months of follow-up.