SALT-E 6

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Information about SALT-E 6

Published on May 13, 2016

Author: IsabellaLai

Source: slideshare.net

1. REDUCE LEUPPI JD, ET AL. "SHORT-TERMVS CONVENTIONAL GLUCOCORTICOID THERAPY IN ACUTE EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE:THE REDUCE RANDOMIZED CLINICALTRIAL". JAMA. 2013. 309(21):2223-2231. SALT-E: OVMC LANDMARK TRIAL SERIES 2016 ACCESSTHIS ONLINE: HTTP://TINYURL.COM/SALTE6

2. BACKGROUND  The SCCOPE trial in 1999 proved the efficacy of systemic steroids in the treatment of acute COPD exacerbation.  Subsequent studies suggested that IV and PO administration of steroids were equivalent and that low doses did not result in greater treatment failures compared to high doses  Prior to REDUCE, the GOLD COPD guidelines stated:  Systemic corticosteroids in COPD exacerbations shortens recovery time, improves lung function, reduces risk of early relapse, and shortens hospital stay (Grade A)  Prednisolone 30-40 mg daily are recommended for 10-14 days, though there is insufficient evidence regarding optimal duration of therapy (Grade D)  A Cochrane review in 2011 suggested that there was no difference in outcomes between a longer course of steroids versus a shorter course

3. CLINICAL QUESTION: In patient with an acute COPD exacerbation, is 5 days glucocorticoid treatment NON-INFERIOR to 14 days of glucocorticoid treatment in preventing repeat exacerbations?

4. DESIGN  Multicenter, double-blind, randomized, non-inferiority controlled trial  N=314  5-day treatment (n=156)  14-day treatment (n=155)  Setting: 5 academic centers in Switzerland  Follow-up: 6 months  Analysis: Intention-to-treat  Primary outcome: Rate of COPD re-exacerbation

5. SUBJECTS Inclusion Criteria:  Exacerbation of COPD, defined as two or more of:  Change in baseline dyspnea  Change in baseline cough  Change in sputum quantity or purulence  Age >40 years  ≥20 pack-years smoking history

6. INTERVENTION  Randomized to:  5-days of glucocorticoids with 9 days of placebo  14-days of glucocorticoids  Methylprednisolone 40 mg IV on day 1, then prednisone 40 mg PO daily for the remaining days  Additional treatments provided:  7 days of antibiotics  Nebulized short-acting bronchodilator 4-6 times daily  Tiotropium and inhaled glucocorticoid/long-acting beta-agonist combination inhalers daily

7. OUTCOMES  Primary Outcome  Rate of re-exacerbation: Defined as an acute clinical deterioration requiring interaction with a clinician.  38.3% vs. 36.7% (HR 0.93; 90% CI 0.68-1.26; P=0.005) (non-inferiority analysis)  Secondary Outcomes  No significant differences in all-cause mortality, need for mechanical ventilation, additional glucocorticoids during follow-up, any infection, new or worsening hyperglycemia or hypertension at discharge, other potential glucocorticoid adverse events including GI bleeding, symptomatic GERD, symptoms of HF or ischemic heart disease, sleep disturbance, fractures, or depression  Median hospital stay: 9 vs. 8 days (HR 1.25; 95% CI 0.99-1.59; P=0.04)

8. CRITICISMS  Baseline characteristics of study group skewed to severe and very severe COPD which limits generalizability to milder disease  GOLD: Class I: 0%, Class II: 12.1%, Class III: 35.6%, Class IV: 52.3%  Not powered to detect differences in the subgroups of GOLD classes  6 month follow-up period limits data on potential adverse events in patients with multiple exacerbations  Use of adjunctive treatments including antibiotics, inhaled corticosteroids, inhaled long-acting anticholinergics, and inhaled beta-agonists potentially limits generalizability

9. BOTTOM LINE A 5-day course of glucocorticoids is non-inferior to a 14-day course for treatment of acute COPD exacerbations in prevention of re-exacerbations

10. QUESTION 1: What steroid dose and duration would you prescribe for a patient with an acute COPD exacerbation?

11. QUESTION 2 Did the REDUCE trial demonstrate that a shorter course of steroids is better than a longer course in the treatment of acute COPD exacerbation?

12. QUESTION 3 What is a major limitation of the REDUCE trial?

13. CURRENT GOLD GUIDELINES Treatment options:  supplemental oxygen should be titrated to improve the patient’s hypoxaemia with a target saturation of 88–92%  short-acting inhaled β2-agonists with or without short-acting anticholinergics are the preferred bronchodilators for treatment of an exacerbation  systemic corticosteroids shorten recovery time, improve lung function (FEV1) and arterial hypoxaemia (PaO2), and reduce the risks of early relapse, treatment failure, and length of hospital stay. A dose of 40 mg prednisone per day for 5 days is recommended  antibiotics should be given to patients:  with the following three cardinal symptoms—increased dyspnoea, increased sputum volume, increased sputum purulence  with increased sputum purulence and one other cardinal symptom  who require mechanical ventilation

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