COPERNICUS
Trial question
What is the role of carvedilol on the morbidity of patients with severe chronic HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 2289
2289 patients (470 female, 1819 male).
Inclusion criteria: patients with symptoms of HF at rest or on minimal exertion and with an ejection fraction < 25% (but not volume-overloaded).
Key exclusion criteria: HF caused by uncorrected primary valvular disease or a reversible form of cardiomyopathy; severe primary pulmonary, renal, or hepatic disease; or contraindication to β-blocker therapy.
Interventions
N=1156 carvedilol (target dose of 25 mg BID for an average of 10.4 months).
N=1133 placebo (matching placebo for an average of 10.4 months).
Primary outcome
Death or hospitalization for a cardiovascular reason
30.2%
41.6%
41.6 %
31.2 %
20.8 %
10.4 %
0.0 %
Carvedilol
Placebo
Significant
decrease ▼
NNT = 8
Significant decrease in death or hospitalization for a cardiovascular reason (30.2% vs. 41.6%; RR 0.73, 95% CI 0.63 to 0.84).
Secondary outcomes
Significant decrease in death or hospitalization for HF (25.5% vs. 37.9%; RR 0.69, 95% CI 0.59 to 0.81).
Safety outcomes
Significant differences in serious adverse event (39.0% vs. 45.5%, p = 0.002).
Conclusion
In patients with symptoms of HF at rest or on minimal exertion and with an ejection fraction < 25% (but not volume-overloaded), carvedilol was superior to placebo with respect to death or hospitalization for a cardiovascular reason.
Reference
Packer M, Fowler MB, Roecker EB et al. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9.
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