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QUESTION: In patients with severe chronic heart failure, does carvedilol, a β-blocker, reduce mortality and hospitalisation?
Design
Randomised {allocation concealed*}†, blinded (patients and clinicians),* placebo controlled trial with mean follow up of 10.4 months (Carvedilol Prospective Randomized Cumulative Survival Study [COPERNICUS]).
Setting
334 centres in 21 countries.
Patients
2289 patients (mean age 63 y, 80% men). Inclusion criteria were dyspnoea or fatigue at rest or on minimal exertion for ≥ 2 months; left ventricular ejection fraction ≤ 25%; absence of rales and ascites; minimal or no peripheral oedema; not hospitalised for intensive care or continued inpatient care; and no recent intravenous inotropic agents or vasodilators. Exclusion criteria included chronic heart failure caused by uncorrected primary valvular disease or reversible cardiomyopathy; recent coronary revascularisation, acute myocardial, or cerebral ischaemic event, or ventricular tachycardia or fibrillation; systolic blood pressure < 85 mm Hg; heart rate 68 beats/minute; or serum creatinine level 2.8 mg/dl. Follow up was 100%.
Intervention
Patients were allocated to carvedilol 3.125 g twice daily for 2 weeks, which was then titrated to 25 mg twice dailyif tolerated …
Footnotes
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Sources of funding: Roche Pharmaceuticals and GlaxoSmithKline.
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↵† †Information provided by author.
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For correspondence: Dr M Packer, Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, 630 West 168th Street, New York, NY 10032, USA. Fax +1 212 305 7439.