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Swiss medical weekly · Oct 2010
Randomized Controlled Trial Multicenter Study Comparative StudyShort versus conventional term glucocorticoid therapy in acute exacerbation of chronic obstructive pulmonary disease - the "REDUCE" trial.
- Philipp Schuetz, Jörg D Leuppi, Michael Tamm, Matthias Briel, Roland Bingisser, Ursula Dürring, Beat Müller, Christian Schindler, Sebastien Viatte, and Jonas Rutishauser.
- Clinic of Internal Medicine, University Hospital Basel, Switzerland.
- Swiss Med Wkly. 2010 Oct 18; 140: w13109.
BackgroundInternational guidelines advocate a 10 to 14-day course of systemic glucocorticoid therapy in the management of COPD exacerbations. The optimal duration of therapy is unknown and glucocorticoids have serious adverse effects. The aim of this trial is to demonstrate non-inferiority of a five-day compared to a 14-day course of systemic glucocorticoids with respect to COPD outcome, thereby significantly reducing steroid exposure and side effects in patients with COPD exacerbations.MethodsThis is a randomised, placebo-controlled, non-inferiority multicentre trial. Patients with acute COPD exacerbation are randomised to receive 40 mg of prednisone-equivalent daily for 14 days (conventional arm) or glucocorticoid treatment for 5 days, followed by placebo for another 9 days (intervention arm). Follow-up is 180 days. The primary endpoint is time to next exacerbation. Secondary endpoints include cumulative glucocorticoid dose, time to open-label glucocorticoid therapy, glucocorticoid-associated side effects and complications, duration of hospital stay, death, change in FEV1, need for assisted ventilation, clinical outcome assessed by standardised questionnaires, and suppression of the hypothalamic-pituitary-adrenal axis.ResultsMean age (± SD) of patients who finished the study was 70 ± 11 years. 12% had mild or moderate disease, whereas severe and very severe stages were found in 30 and 58%, respectively. At the time of inclusion, 20% of patients were under treatment with systemic glucocorticoids.ConclusionsIf the strategy of significantly reducing cumulative exposure to glucocorticoids while taking advantage of their beneficial short-term effects proves to be successful, it will warrant a change in common glucocorticoid prescription practice, thereby improving the management of COPD.
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