Abstract
Background & Aims: The COMET trial was a prospective, double-blind, randomised trial comparing carvedilol, a comprehensive adrenergic receptor antagonist, with metoprolol, a beta-1-selective agent in patients with heart failure and left ventricular systolic dysfunction. The trial showed a reduction in mortality with carvedilol that was consistent across subgroups. The purpose of this report is to describe in greater detail the heterogeneity of this population at baseline with particular reference to the impact of symptomatic severity, age and gender on patient characteristics.
Methods: A descriptive report using data entered in the COMET study data-base.
Results: The characteristics of the population studied were similar to those reported in previous trials of beta-blockers. Almost all patients were receiving diuretics and ACE inhibitors with few patients taking angiotensin receptor blockers. As expected, older patients had more co-morbidity. Older patients and women reported worse symptoms and poorer well-being despite similar ventricular dimensions and systolic dysfunction. NT-proBNP was higher in patients with more severe symptoms and older patients but not in women, although differences in NT-proBNP may have been confounded by differences in renal function.
Conclusion: Age and gender, as well as the severity of cardiac dysfunction, appear to have an important effect on the severity of heart failure symptoms and patient ‘well-being’. This could have important implications for the relationship between symptoms and prognosis and therefore the way in which patients are selected for clinical trials and the goals of treatment. This will be the subject of further analyses.
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References
Cleland JGF, Clark AL. Delivering the cumulative benefits of triple therapy for heart failure. Too many cooks will spoil the broth. JACC 2003;42:1226–1233.
Coletta AP, Cleland JGF, Freemantle N, Loh H, Memon A, Clark AL. Clinical trials update from the European Society of Cardiology: CHARM, BASEL, EUROPA and ESTEEM. Eur J Heart Failure 2003.
Cleland JGF, McMurray JJF, Cowburn PJ. Heart Failure: A Systematic Approach for Clinical Practice, 1st ed. London: Science Press, 1997.
Poole-Wilson PA, Cleland JGF, Hanrath P, et al., on behalf of the COMET Study Investigators. Rationale and design of the carvedilol or metoprolol european trial in patients with chronic heart failure; the COMET trial. Eur J Heart Fail 2002;4(3):321–329.
Poole-Wilson PA, Swedberg K, Cleland JGF, et al., for the COMET investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol or Metoprolol European Trial (COMET): Randomised controlled trial. Lancet 2003;362:7–13.
Cleland JGF, Bristow M, Erdmann E, Remme WJ, Swedberg K, Waagstein F. Beta-blocking agents in heart failure. Should they be used and how? Eur Heart J 1996;17:1629–1639.
Packer M, Antonopoulos GV, Berlin JA, Chittams J, Konstam MA, Udelson JE. Comparative effects of carvedilol and metoprolol on left ventricular ejection fraction in heart failure: Results of a meta-analysis. Am Heart J 2001;141:899–907.
Levey AS, Greene T, Kusek JW, Beck GJ. A simplified equation to predict glomerular filtration rate from serum creatinine. Am Soc Nephrol 2000;11:A0828. Ref Type: Abstract
CIBIS-II Investigators and Committee. The Cardiac insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial. Lancet 1999;353:9–13.
MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;333:2001–2007.
Packer M, Bristow MR, Cohn JN, et al., for the US carvedilol study group. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. New Engl J Med 1996;334:1349–1355.
Cleland JGF, Swedberg K, Follath F, et al., for the study group on diagnosis of the working group on Heart Failure of the European Society of Cardiology, Freemantle N, Eastaugh J, Mason J. The EuroHeart failure survey programme: Survey on the quality of care among patients with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis. Eur Heart J 2003;24:422–463.
Banerjee P, Banerjee T, Khand A, Clark AL, Cleland JGF. Diastolic heart failure-neglected or misdiagnosed? J Am Coll Cardiol 2002;39(1):138–141.
Caruana L, Petrie MC, Davie AP, McMurray JV. Do patients with suspected heart failure and preserved left ventricular systolic function suffer from “diastolic heart failure” or from misdiagnosis? A prospective descriptive study. BMJ 2000;321:215–218.
Carson P, Johnson G, Fletcher R, Cohn J. Mild systolic dysfunction in heart failure (left ventricular ejection fraction >35%): Baseline characteristics, prognosis and response to therapy in the Vasodilator in Heart Failure Trials (V-HeFT). J Am Coll Cardiol 1996;27:642–649.
Cohn JN, Archibald DG, Francis GS, et al. Veterans Administration Cooperative Study on Vasodilator Therapy of Heart Failure: Influence of prerandomization variables on the reduction of mortality by treatment with hydralazine and isosorbide dinitrate. Circulation 1987;75:IV-49–IV-54.
Swedberg K, Idanpaan Heikkila U, Remes J, for the CONSENSUS trial study group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). New Engl J Med 1987;316:1429–1435.
Richards AM, Nicholls MG, Espiner EA, et al. B-type natriuretic peptides and ejection fraction for prognosis after myocardial infarction. Circulation 2003;107:2786–2792.
Richards AM, Nicholls MG, Yandle TG, et al. Plasma N-Terminal Pro-Brain natriuretic peptide and adrenomedullin. New neurohormonal predictors of left ventricular function and prognosis after myocardial infarction. Circulation 1998;97:1921–1929.
Remme WJ, Cleland JGF, et al., European Society of Cardiology. Guidelines for the management of heart failure. Eur Heart J 1997;18:736–753.
Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341(10):709–717.
Cowburn PJ, Cleland JGF, Coats AJS, Komajda M. Risk stratification in chronic heart failure. Eur Heart J 1998;19:696–710.
Dutka DP, Olivotto I, Ward S, Oakley CM, Impallomeni M, Cleland JGF. Effects of aging on neuroendocrine activation in subjects and patients in the presence and absence of heart failure with left ventricular systolic function. Am J Cardiol 1996;77:1197–1201.
McDonagh TA, Morrison CE, Lawrence A, et al. Symptomatic and asymptomatic left-ventricular systolic dysfunction in an urban population. Lancet 1997;350:829–833.
Dutka DP, Olivotto I, Ward S, et al. Plasma neuroendocrine activity in very elderly subjects and patients with and without heart failure. Eur Heart J 1995;16:1223–1230.
Rathore SS, Wang Y, Krumholz HM. Sex-based differences in the effect of digoxin for the treatment of heart failure. New Engl J Med 2002;347:1403–1411.
Os I, Bratland B, Dahlof B, et al. Female sex as an important determinant of lisinopril-induced cough. Lancet 1992;339:303–310.
Goodwin JF, Oakley CM. The cardiomyopathies. Br Heart J 1972;34:545–552.
Richardson P, McKenna W, Bristow M, et al. Report of the 1995 World Health Organization/International Society and Federation of Cardiology Task Force on the definition and classification of cardiomyopathies. Circulation 1996;93:841–842.
Cleland JGF, Alamgir F, Nikitin N, Clark A, Norell M. What is the optimal medical management of ischaemic heart failure? Prog Cardiovasc Dis 2001;43(5):433–455.
Cleland JGF. Is aspirin ‘The Weakest Link’ in cardiovascular prophylaxis. The surprising lack of evidence supporting the use of aspirin for cardiovascular disease. Prog Cardiovasc Dis 2002;44:275–292.
Cleland JGF, Freemantle N, Ball SG, et al. The heart failure revascularization trial (HEART): Rationale design and methodolog. Eur J Heart Fail 2003;5(3):295–303.
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Cleland, J.G., Goode, K., Erhardt, L. et al. A Description of the Clinical Characteristics at Baseline of Patients Recruited into the Carvedilol or Metoprolol European Trial (COMET). Cardiovasc Drugs Ther 18, 139–152 (2004). https://doi.org/10.1023/B:CARD.0000029032.46744.56
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DOI: https://doi.org/10.1023/B:CARD.0000029032.46744.56