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(Circulation. 1996;94:2793-2799.)
© 1996 American Heart Association, Inc.
Articles |
Double-Blind, Placebo-Controlled Study of the Effects of Carvedilol in Patients With Moderate to Severe Heart Failure
The PRECISE Trial
the College of Physicians and Surgeons, Columbia University, New York, NY (M.P., J.D.S.-B., M.K.); Boston (Mass) University School of Medicine (W.S.C.); University of Rochester (NY) School of Medicine (C.-S.L.); Good Samaritan Hospital, Baltimore, Md (D.A.G.); Nassau County Medical Center, East Meadow, NY (I.F.); Mount Sinai School of Medicine, New York, NY (M.L.K., N.E.K.); Henry Ford Hospital, Grosse Pointe, Mich (V.K.); Tufts University School of Medicine, Boston, Mass (J.E.U.); University of Maryland, Baltimore (S.S.G.); Georgetown University School of Medicine, Washington, DC (D.P.); Ohio State University School of Medicine, Columbus (R.J.C.); Overlook Hospital, Summit, NJ (J.J.G.); Albert Einstein School of Medicine, Bronx, NY (T.H.L.); and SmithKline Beecham Pharmaceuticals, King of Prussia, Pa (S.T.Y., M.A.L., N.H.S.).
Reprint requests to Dr Milton Packer, Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, 630 W 168th St, New York, NY 10032.
Background Carvedilol has improved the symptomatic status of patients with moderate to severe heart failure in single-center studies, but its clinical effects have not been evaluated in large, multicenter trials.
Methods and Results We enrolled 278 patients with moderate to severe heart failure (6-minute walk distance, 150 to 450 m) and a left ventricular ejection fraction 
0.35 at 31 centers. After an open-label, run-in period, each patient was randomly assigned (double-blind) to either placebo (n=145) or carvedilol (n=133; target dose, 25 to 50 mg BID) for 6 months, while background therapy with digoxin, diuretics, and an ACE inhibitor remained constant. Compared with placebo, patients in the carvedilol group had a greater frequency of symptomatic improvement and lower risk of clinical deterioration, as evaluated by changes in the NYHA functional class (P=.014) or by a global assessment of progress judged either by the patient (P=.002) or by the physician (P<.001). In addition, treatment with carvedilol was associated with a significant increase in ejection fraction (P<.001) and a significant decrease in the combined risk of morbidity and mortality (P=.029). In contrast, carvedilol therapy had little effect on indirect measures of patient benefit, including changes in exercise tolerance or quality-of-life scores. The effects of the drug were similar in patients with ischemic heart disease or idiopathic dilated cardiomyopathy as the cause of heart failure.
Conclusions These findings indicate that, in addition to its favorable effects on survival, carvedilol produces important clinical benefits in patients with moderate to severe heart failure treated with digoxin, diuretics, and an ACE inhibitor. (Circulation. 1996;94:2793-2799.)
Key Words: heart failure • carvedilol • blockers, beta-adrenergic
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A. Hjalmarson, S. Goldstein, B. Fagerberg, H. Wedel, F. Waagstein, J. Kjekshus, J. Wikstrand, D. El Allaf, J. Vitovec, J. Aldershvile, et al. Effects of Controlled-Release Metoprolol on Total Mortality, Hospitalizations, and Well-being in Patients With Heart Failure: The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF) JAMA, March 8, 2000; 283(10): 1295 - 1302. [Abstract] [Full Text] [PDF]
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M. St. John Sutton Aortic stiffness: a predictor of acute coronary events? Eur. Heart J., March 1, 2000; 21(5): 342 - 344. [PDF]
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J. N. Cohn, R. Ferrari, N. Sharpe, and on Behalf of an International Forum on Cardiac Rem Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling J. Am. Coll. Cardiol., March 1, 2000; 35(3): 569 - 582. [Abstract] [Full Text] [PDF]
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M. R. Bristow {beta}-Adrenergic Receptor Blockade in Chronic Heart Failure Circulation, February 8, 2000; 101(5): 558 - 569. [Full Text] [PDF]
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 C. A. Walker, F. A. Crawford Jr, and F. G. Spinale MYOCYTE CONTRACTILE DYSFUNCTION WITH HYPERTROPHY AND FAILURE: RELEVANCE TO CARDIAC SURGERY J. Thorac. Cardiovasc. Surg., February 1, 2000; 119(2): 388 - 400. [Full Text] [PDF]
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G. Z. Feuerstein and P. R. Young Apoptosis in cardiac diseases: stress- and mitogen-activated signaling pathways Cardiovasc Res, February 1, 2000; 45(3): 560 - 569. [Abstract] [Full Text] [PDF]
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B. N. Singh Initial Antiarrhythmic Drug Therapy During Resuscitation from Sudden Cardiac Death: A Time for a Fundamental Change in Strategy? Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 2000; 5(1): 3 - 9. [PDF]
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S. Doshi and B. N. Singh Reducing Perioperative Cardiac Risk in Noncardiac Surgery: A Time to Delineate Simpler Strategies? Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 2000; 5(2): 69 - 75. [PDF]
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J. E. Sanderson, S. K. W. Chan, G. Yip, L. Y. C. Yeung, K. W. Chan, K. Raymond, and K. S. Woo Beta-blockade in heart failure: A comparison of carvedilol with metoprolol J. Am. Coll. Cardiol., November 1, 1999; 34(5): 1522 - 1528. [Abstract] [Full Text] [PDF]
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 C.H. Davies and Y. Bashir Beta-blockers for heart failure-time to think the unthinkable? QJM, November 1, 1999; 92(11): 673 - 678. [Full Text] [PDF]
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H Kitaoka, J Takata, T Yabe, N Hitomi, T Furuno, and Y L Doi Low dose dobutamine stress echocardiography predicts the improvement of left ventricular systolic function in dilated cardiomyopathy Heart, May 1, 1999; 81(5): 523 - 527. [Abstract] [Full Text]
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D. L. Dries, D. V. Exner, B. J. Gersh, H. A. Cooper, P. E. Carson, and M. J. Domanski Racial Differences in the Outcome of Left Ventricular Dysfunction N. Engl. J. Med., February 25, 1999; 340(8): 609 - 616. [Abstract] [Full Text] [PDF]
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A. M. Richards, R. Doughty, M. G. Nicholls, S. Macmahon, H. Ikram, N. Sharpe, E. A. Espiner, C. Frampton, and T. G. Yandle Neurohumoral Prediction of Benefit From Carvedilol in Ischemic Left Ventricular Dysfunction Circulation, February 16, 1999; 99(6): 786 - 792. [Abstract] [Full Text] [PDF]
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P. P. Sharma, J. S.M. Sarma, and B. N. Singh Effects of Sotalol on the Circadian Rhythmicity of Heart Rate and QT Intervals With a Noninvasive Index of Reverse-Use Dependency Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1999; 4(1): 15 - 21. [Abstract] [PDF]
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W. H. Frishman Carvedilol N. Engl. J. Med., December 10, 1998; 339(24): 1759 - 1765. [Full Text] [PDF]
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H. Watanabe, M. Kakihana, S. Ohtsuka, and Y. Sugishita Randomized, double-blind, placebo-controlled study of carvedilol on the prevention of nitrate tolerance in patients with chronic heart failure J. Am. Coll. Cardiol., November 1, 1998; 32(5): 1194 - 1200. [Abstract] [Full Text] [PDF]
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H. Watanabe, M. Kakihana, S. Ohtsuka, and Y. Sugishita Preventive effects of carvedilol on nitrate tolerance--a randomized, double-blind, placebo-controlled comparative study between carvedilol and arotinolol J. Am. Coll. Cardiol., November 1, 1998; 32(5): 1201 - 1206. [Abstract] [Full Text] [PDF]
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P. Lechat, M. Packer, S. Chalon, M. Cucherat, T. Arab, and J.-P. Boissel Clinical Effects of ß-Adrenergic Blockade in Chronic Heart Failure : A Meta-Analysis of Double-Blind, Placebo-Controlled, Randomized Trials Circulation, September 22, 1998; 98(12): 1184 - 1191. [Abstract] [Full Text] [PDF]
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V. A. Umans, J. H. Cornel, C. Hic, J. Soto, C. Avendano, F. G. Vilchez, M. Bohm, S. Zoneraich, S. Yusuf, R. Gorlin, et al. Digoxin in Patients with Heart Failure N. Engl. J. Med., July 10, 1997; 337(2): 129 - 131. [Full Text]
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K. Ogunyankin and B. N. Singh Reflections on Recent Clinical Trials in Patients With Heart Failure and Those With Reduced Ventricular Function Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1997; 2(3): 147 - 152. [PDF]
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 MORE STUDIES SUPPORT CARVEDILOL FOR HEART FAILURE Journal Watch (General), December 31, 1996; 1996(1231): 1 - 1. [Full Text]
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K. Chatterjee Heart Failure Therapy in Evolution Circulation, December 1, 1996; 94(11): 2689 - 2693. [Full Text]
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