REDUCE (short-term corticosteroids)
Trial question
Is short-term systemic corticosteroid therapy noninferior to conventional corticosteroid therapy in patients with acute exacerbation of COPD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 311
311 patients (123 female, 188 male).
Inclusion criteria: patients presenting to the emergency department with acute COPD exacerbation.
Key exclusion criteria: history of asthma, ratio of FEV1 to FVC > 70% as evaluated by bedside postbronchodilator spirometry, radiological diagnosis of pneumonia, estimated survival < 6 months due to severe comorbidity, pregnancy or lactation.
Interventions
N=156 short-term treatment (40 mg of prednisone daily for 5 days).
N=155 conventional treatment (40 mg of prednisone daily for 14 days).
Primary outcome
Recurrent chronic obstructive pulmonary disease exacerbation at 6 months
35.9%
36.8%
36.8 %
27.6 %
18.4 %
9.2 %
0.0 %
Short-term
treatment
Conventional
treatment
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in recurrent COPD exacerbation at 6 months (35.9% vs. 36.8%; HR 0.95, 95% CI 0.7 to 1.29).
Secondary outcomes
No significant difference in need for mechanical ventilation (11% vs. 13.6%; OR 0.78, 95% CI 0.37 to 1.63).
Significant increase in hospital stay (8 days vs. 9 days; HR 1.25, 95% CI 0.99 to 1.59).
Safety outcomes
No significant differences in treatment-associated adverse reactions, including hyperglycemia and hypertension.
Significant differences in mean cumulative prednisone dose (379 vs. 793 mg, p < 0.001).
Conclusion
In patients presenting to the emergency department with acute COPD exacerbation, short-term treatment was noninferior to conventional treatment with respect to recurrent COPD exacerbation at 6 months.
Reference
Jörg D Leuppi, Philipp Schuetz, Roland Bingisser et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013 Jun 5;309(21):2223-31.
Open reference URL