"Steroids for acute COPD--but for how long? Not only was a shorter course of glucocorticoid therapy as effective as a 14-day regimen, but there was no difference in the time to next exacerbation."Prescribe a 5-day regimen of glucocorticoid therapy for acute chronic obstructive pulmonary disease (COPD) exacerbations; the shorter course of treatment appears to be as effective as a 14-day regimen

Asher, Gary N.

Mounsey, Anne L.

English

University of Missouri: MOspace

Priority Updates from the Research Literature from the Family Physicians Inquiries Network PURLs®Gary N. Asher, MD, MPH; Anne Mounsey, MDDepartment of Family Medicine, University  of North Carolina  at Chapel Hill P U R L s  E D i t o RJames J. Stevermer, MD, MSPH Department of Family and Community Medicine,University  of Missouri - ColumbiaSteroids for acute COPD— but for how long? Not only was a shorter course of glucocorticoid therapy as effective as a 14-day regimen,  but there was no difference in the time to next exacerbation.Practice changerPrescribe a 5-day regimen of glucocorticoid therapy for acute chronic obstructive pul-monary disease (COPD) exacerbations; the shorter course of treatment appears to be as effective as a 14-day regimen.1 StRENGtH oF RECoMMENDAtioNB:  Based on a single well-done randomized controlled trial (RCT). Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013;309:2223-2231.illustrative caseA 55-year-old man with COPD presents to the emergency department (ED) because of pro-gressive shortness of breath, cough, and spu-tum production over the past 4 days. He is diagnosed with a COPD exacerbation, treated with corticosteroids, and admitted to the hospital. His inpatient treatment includes an-tibiotics, inhaled albuterol and ipratropium, supplemental oxygen, and oral corticosteroids. How many days should he take oral steroids? Severe exacerbations of COPD are inde-pendently associated with mortality,2 regardless of baseline severity. Guide-lines and systematic reviews highlight the im-portance of using oral glucocorticoids in the management of acute COPD exacerbations, as the drugs have been found to shorten re-covery time and length of hospital stay, im-prove lung function, and reduce the risk of early relapse and treatment failure.3-5 What is not clear is how long the course of oral ste-roids should be.  What we know (and don’t know)  about duration Data supporting a 14-day course of ste-roids vs a longer (8-week) duration comes from the Systemic Corticosteroids in COPD Exacerbations trial.6 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria suggest a 10- to-14-day regimen (30-40 mg/d), but acknowledge that there is a lack of data from clinical and observational studies to support this recommendation.3 A recent Cochrane review compared a short course of treatment (3-7 days) with a longer regimen (10-15 days) and found that the evi-dence to support a clinical practice change was inconclusive.5The study detailed in this PURL—a dou-ble-blind RCT comparing 5-day with 14-day oral steroid treatment in patients hospitalized for acute COPD exacerbation—had more de-finitive results.1study summaryShorter and longer regimens  produce equal results Leuppi et al1 used noninferiority method-ology to compare a 5- vs a 14-day course of prednisone (40 mg/d) to treat patients with 29jFPONLINE.COm VOL 63, NO 1  |  jANUARy 2014  |  THE jOURNAL OF FAmILy PRACTICEPURLs®COPD exacerbations.  A patient was consid-ered to have a COPD exacerbation if he or she had a change from baseline in ≥2 of the fol-lowing: dyspnea, cough, sputum quantity, or purulence.  Participants were patients who came to the EDs of 5 Swiss teaching hospitals be-tween March 2006 and February 2011. To be eligible, individuals had to be 40 years or older and have ≥20 pack-years of smok-ing. Exclusion criteria included asth-ma, mild obstruction (forced expiratory volume in one second/forced vital capac-ity >70%), pneumonia, an estimated survival <6 months, pregnancy, and lactation. All the participants (N=311) received 40 mg methylprednisolone intravenously on Day 1, followed by prednisone 40 mg orally on Days 2 through 5. The researchers then randomly divided participants into 2 groups: One group continued to take prednisone 40 mg/d and the other group received a matching placebo for an additional 9 days. Participants in both groups also received antibiotics for 7 days, twice daily inhaled steroids, daily tiotropium, and nebulized al-buterol, as needed; additional oral glucocor-ticoids could be administered, as well, at the discretion of the treating physicians.  The primary outcome was the time to the next COPD exacerbation, up to 180 days. Noninferiority between the groups was de-fined as no more than a 15% absolute in-crease in exacerbations. The dropout rate was 5.7%, evenly divided between groups.  Inten-tion to treat and per-protocol analyses were conducted, and hazard ratios (HRs) were cal-culated using the Kaplan-Meier method and Cox proportional hazards models. z the time to next CoPD exacerba-tion did not differ between the study groups: 56 days for those on the 5-day steroid regimen vs 57 days for those on the 14-day regimen in the intention to treat analysis (HR=0.95;  90% confidence interval, 0.70–1.29; P=.006).  Sen-sitivity analyses adjusting for baseline char-acteristics provided similar results, as did the per-protocol analysis. z Secondary outcomes (overall survival; need for mechanical ventilation; need for addi-tional corticosteroids; and clinical performance measures, such as dyspnea score and qual-ity of life) also did not differ between groups. Nor were there differences in hyperglycemia, worsening hypertension, infection, or other adverse effects typically associated with gluco-corticoid use. The active treatment group took >400 mg more prednisone than the placebo group (mean, 793 mg vs 379 mg; P<.001).What’s neWNow we know: 5 days is enoughWhile randomized trials have found that glu-cocorticoids improve COPD symptoms, the optimal treatment dose and duration were not known. Indeed, current guidelines rec-ommend treatment for >5 days.3  This trial clearly demonstrated that 40 mg prednisone for 5 days is at least as good as a 14-day treat-ment course. Furthermore, it is unnecessary to taper the short-course therapy, which sim-plifies the regimen.caveatsWill the results apply to those  less severely ill? More than 80% of patients with acute COPD exacerbations can be managed in an out-patient setting.3 However, participants in this trial were hospitalized for a median of 8.5 days, and most had severe or very severe COPD—and thus, were not fully represen-tative of COPD patients typically seen in an outpatient practice. Yet patients with less severe disease should be at least as likely to respond to short-course steroids as those whose COPD is more severe. It is important to note that participants in this study all received optimal guideline-based therapies during hospitalization, which may be difficult to achieve for some patients treated in an outpatient setting. Finally, treat-ment adherence observed during the hospi-talization period in this trial is unlikely to be replicated in the outpatient setting. challenges to imPlementationidentifying patients who need steroids for a longer durationFor patients with new COPD exacerbations or those successfully treated using short-course this trial clearly demonstrated that 40 mg  prednisone for  5 days is at least as good as a  14-day regimen. What’s more, it  is not necessary  to taper the  short-course therapy, which simplifies  treatment.  30 THE jOURNAL OF FAmILy PRACTICE  |   jANUARy 2014  |   VOL 63, NO 132 THE jOURNAL OF FAmILy PRACTICE  |   jANUARy 2014  |   VOL 63, NO 1PURLs®References therapy in the past, a 5-day regimen may be appropriate.  For those who have failed prior attempts at short-course treatment, however, a 14-day course of treatment may be more ad-visable.  That said, no guidelines are available to help us determine which of those who were previously treated with a longer regimen may fail on the shorter course of treatment.         JFPACkNoWLEDGEMENtThe PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the Uni-versity of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.Copyright ©2014. The Family Physicians Inquiries Network. All rights reserved.  1.  Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs conven-tional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clini-cal trial. JAMA. 2013;309:2223-2231. 2.  Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60:925-931. 3.  Global Initiative for Chronic Obstructive Lung Disease, Inc. The global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease.  Available  at: http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed December 13, 2013.  4.  Quon BS, Gan WQ, Sin DD. Contemporary management of acute exacerbations of COPD: a systematic review and metaanalysis. Chest.  2008;133:756-766. 5.  Walters JA, Wang W, Morley C,et al. Different durations of cortico-steroid therapy for exacerbations of chronic obstructive pulmo-nary disease. Cochrane Database Syst Rev. 2011(10):CD006897. 6.  Niewoehner DE, Erbland ML, Deupree RH, et al. Effect of sys-temic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. Department of Veterans Affairs Cooperative Study Group. 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Steroids for acute COPD - but for how long?

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Steroids for acute COPD - but for how long?

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