CLINICAL RESEARCH
Carvedilol increases two-year survivalin dialysis patients with dilated cardiomyopathy
A prospective, placebo-controlled trial
Gennaro Cice, MD*,*,
Luigi Ferrara, MD*,
Antonello D’Andrea, MD*,
Salvatore D’Isa, MD*,
Attilio Di Benedetto, MD ,
Antonio Cittadini, MD ,
Pina Elvira Russo, MD*,
Paolo Golino, MD, PhD* and
Raffaele Calabrò, MD*
* Division of Cardiology, Second University of Naples, Naples, Italy
Fresenius Medical Care-Italia, Naples-NephroCare Group, Naples, Italy
Department of Internal Medicine, University Federico II, Naples, Italy
Manuscript received June 23, 2002;
revised manuscript received November 25, 2002,
accepted November 27, 2002.
* Reprint requests and correspondence: Dr. Gennaro Cice, Division of Cardiology, Second University of Naples, Piazza L, Miraglia, 2-80138 Naples, Italy.
gennarocice{at}hotmail.com
OBJECTIVES: We sought to evaluate the effects of carvedilol on mortality and morbidity in dialysis patients with dilated cardiomyopathy.
BACKGROUND: Several lines of evidence support the concept that therapy with beta-blocking agents reduces morbidity and mortality in patients with congestive heart failure (HF), but the demonstration of such a survival benefit in dialysis patients with dilated cardiomyopathy is still lacking.
METHODS: A total of 114 dialysis patients with dilated cardiomyopathy were randomized to receive either carvedilol or placebo in addition to standard therapy. A first analysis was performed at one year and was followed by an additional follow-up period of 12 months.
RESULTS: Two-year echocardiographic data revealed a significant attenuation of pathologic remodeling, with smaller cavity diameters and higher ejection fractions in the active treatment group than in the placebo group. At two years, 51.7% of the patients died in the carvedilol group, compared with 73.2% in the placebo group (p < 0.01). Furthermore, there were significantly fewer cardiovascular deaths (29.3%) and hospital admissions (34.5%) among patients receiving carvedilol than among those receiving a placebo (67.9% and 58.9%, respectively; p < 0.00001). The exploratory analyses revealed that fatal myocardial infarctions, fatal strokes, and hospital admissions for worsening HF were lower in the carvedilol group than in the placebo group. A reduction in sudden deaths and pump-failure deaths was also observed, though it did not reach statistical significance.
CONCLUSIONS: Carvedilol reduced morbidity and mortality in dialysis patients with dilated cardiomyopathy. These data suggest the use of carvedilol in all dialysis patients with chronic HF.
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Abbreviations and Acronyms
| | ACE | = angiotensin-converting enzyme | | BP | = blood pressure | | CHF | = congestive heart failure | | CI | = confidence interval | | HF | = heart failure | | HR | = hazard ratio | | Kur | = kurtosis | | LV | = left ventricle/ventricular | | LVEDV | = left ventricular end-diastolic volume | | LVEF | = left ventricular ejection fraction | | LVESV | = left ventricular end-systolic volume | | MI | = myocardial infarction | | NYHA | = New York Heart Association | | Ske | = skewness |
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