Author + information
- Received October 28, 1994
- Revision received December 19, 1994
- Accepted January 4, 1995
- Published online May 1, 1995.
- Stephanie L. Olsen, MD,
- Edward M. Gilbert, MD, FACC1,**,
- Dale G. Renlund, MD, FACC,
- David O. Taylor, MD, FACC,
- Frank D. Yanowitz, MD, FACC and
- Michael R. Bristow, MD, PhD, FACC2
- ↵**Address for correspondence: Dr. Edward M. Gilbert, Division of Cardiology, University of Utah Health Sciences Center, 50 North Medical Drive, Salt Lake City, Utah 84132.
Objectives. This study assessed the safety and efficacy of carvedilol in patients with heart failure caused by idiopathic or ischemic cardiomyopathy.
Background. Carvedilol is a mildly beta1-selective betaadrenergic blocking agent with vasodilator properties. Beta-blockade may be beneficial in patients with heart failure, but the effects of carvedilol are not known.
Methods. Sixty patients with heart failure (New York Heart Association functional classes II to IV) and left ventricular ejection fraction ≤ 0.35 were enrolled in the study. All patients tolerated challenge with carvedilol, 3.125 mg twice a day, and were randomized to receive carvedilol (n = 36) versus placebo (n = 24). Study medication was titrated over 1 month from 6.25 to 25 mg twice a day (<75 kg) or 50 mg twice a day (>75 kg) and continued for 3 months. One placebo-treated and two carvedilol-treated patients did not complete the study.
Results. Carvedilol therapy resulted in a significant reduction in heart rate and mean pulmonary artery and pulmonary capillary wedge pressures and a significant increase in stroke volume and left ventricular stroke work. Left ventricular ejection fraction increased 52% in the carvedilol group (from 0.21 to 0.32, p < 0.0001 vs. placebo group). Carvedilol-treated patients also reported a significant lessening of heart failure symptoms (p < 0.05 vs. placebo group). Submaximal exercise duration tended to increase with carvedilol therapy (from 688 ± 31 s to 871 ± 32 s), but this change was not significantly different from that with placebo therapy by between-group analysis. Peak oxygen consumption during maximal exercise did not change.
Conclusions. Long-term carvedilol therapy improves rest cardiac function and lessens symptoms in patients with heart failure.
↵1 Dr. Gilbert was supported in part by a grant from the Beyer Fund for Cardiovascular Research. New York, New York.
↵2 Drs. Bristow and Gilbert are consultants to SmithKline Beecham Pharmaceuticals.
* This study was supported in part by Public Health and Safety Research Grant M01-RR00064 from the National Center for Research Resources. National Institutes of Health, Bethesda, Maryland and by a grant from SmithKline Beecham Pharmaceuticals. King of Prussia, Pennsylvania.
- Received October 28, 1994.
- Revision received December 19, 1994.
- Accepted January 4, 1995.
- American College of Cardiology