Betaxolol versus carvedilol in chronic heart failure (BETACAR study) rationale and design

Arzneimittel-Forschung/Drug Research

Volumn 49, Issue 4, 1999, Pages 311-317

  Böhler, Steffen ^a   Saubadu, Stéphane ^b   Scheldewaert, Rudy ^b   Figulla, Hans Reiner ^c  

^a Division Henning   (Germany)

^b SANOFI   (France)

^c FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

Author keywords

Beta blockers; BETACAR study; Betaxotol, multicenter trial; Carvedilol, multicenter trial; CAS 63659 18 7; CAS 72956 09 3; Chronic heart failure

Indexed keywords

BETAXOLOL; CARVEDILOL;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE CLASSIFICATION; DISEASE COURSE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG CONTRAINDICATION; DRUG EFFECT; DRUG SELECTIVITY; FEMALE; HEART DILATATION; HEART FAILURE; HUMAN; INOTROPISM; MAJOR CLINICAL STUDY; MALE; RANDOMIZED CONTROLLED TRIAL; SURVIVAL;

EID: 0032894346     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1300420     Document Type: Article

References (67)

1. [1] Gheorghiade, M., Bonow, R. O., Chronic Heart Failure in the United States. Circulation 97, 282 (1998)
2. [2] Consensus Trial Study Group, Effects of Enalapril on Mortality In Severe Congestive Heart Failure. N. Engl. J. Med. 316, 1429 (1987)
3. [3] Ruffolo, R.R., Feuerstein, G. Z., Carvedilol: preclinical profile and mechanisms of action in preventing the progression of congestive heart failure. Eur. Heart J. 19 (Suppl. B), B19 (1998)
4. [4] Packer, M., Colucci, W. S., Sackner-Bernstein, J. D. et al., Double-Blind, Placebo-Controlled Study of the Effects of Carvedilol in Patients with Moderate to Severe Heart Failure: the Prospective Randomized Evaluation of Carvedilol in Symptoms and Exercise (PRECISE) trial. Circulation 94, 2793 (1996)
5. [5] Cohn, J. N., Structural Basis for heart failure, ventricular remodeling and its pharmacological inhibition. Circulation 91, 2504 (1995)
6. [6] Packer, M., Do beta-blockers prolong survival in chronic heart failure? Eur. Heart J. 19 (Suppl. B), B40 (1998)
7. [7] Remme, W. J., Prevention of worsening heart failure: future focus. Eur. Heart J. 19 (Suppl. B), B47 (1998a)
8. [8] Remme, W. J., The sympathetic nervous system and ischaemic heart disease. Eur. Heart J. 19 (Suppl. F), F62 (1998b)
9. [9] Francis, G. S., Post-infarction myocardial remodelling: why does it happen? Eur. Heart J. 16, Suppl. N, 31 (1995)
10. [10] Messerli, F. H., Aristizabal, D., Soria, F., Reduction of left ventricular hypertrophy: How beneficial? Am. Heart J 125, 1520 (1993)
11. [11] Chambers, J., Left ventricular hypertrophy. BMJ 311, 273 (1995).
12. [12] Lenfant, C., Report of the Task Force on Research in Heart Failure. Circulation 90, 1118 (1994)
13. [13] The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N. Engl. J. Med. 336, 525 (1997)
14. [14] Cowburn, P. J., Cleland, J. G. F., Coats, A. J. S., et al., Risk stratification in chronic heart failure. Eur. Heart J. 19, 696 (1998)
15. [15] Cowie, M. R., Mosterd, A., Wood, D. A. et al, The epidemiology of heart failure. Eur. Heart J. 18, 208 (1997)
16. [16] Kannel, W. B., Belanger, A. J., Epidemiology of heart failure. Am. Heart J. 121, 951 (1991)
17. [17] Califf, R. M., Bounons, P., Harrell, F. E., et al, in: E. Braunwald (ed.), Congestive heart failure: current research and clinical applications, pp. 31-40, Grune & Stratton, New York (1982)
18. [18] Bart, B. A., Shaw, I. K., McCants, C. B. et al., Clinical determinants of mortality in patients with angiographically diagnosed ischemic or non-ischemic cardiomyopathy. J. Am. Coll. Cardiol. 30, 1002 (1997)
19. [19] Braunwald, E., Herzinsuffizienz, in: Harrisons Innere Medizin I. pp. 1181-1192, Blackwell Wissenschafts-Verlag GmbH, Berlin (1995)
20. [20] Figulla, H. R., Kreuzer, H., Arguments supporting the use of calcium antagonists in idiopathic dilated cardiomyopathy: theoretical considerations and clinical results. J. Cardiovasc. Pharmacol. 16, 45 (1990)
21. [21] Bonarjee, V. V. S., Dickstein, K., Novel Drugs and Current Therapeutic Approaches in the Treatment of Heart Failure, Drugs 51, 347 (1996)
22. [22] Borchard, U., ß-Rezeptorenblocker, Klinik und Praxis, Exzerpt. Aesopus Verlag GmbH, Basel, (1996)
23. [23] Australia - New Zealand Heart Failure Research Collaborative Group, Randomized, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischemic heart disease. Lancet 349, 375 (1997)
24. [24] Australia - New Zealand Heart Failure Research Collaborative Group, Effects of Carvedilol, a Vasodilator-ß-Blocker, in Patients With Congestive Heart Failure Due to Ischemic Heart Disease. Circulation 92, 212 (1995)
25. [25] Bristow, M. R., Gilbert, E. M., Abraham, W. T., et al. for the MOCHA Investigators, Carvedilol Produces Dose-Related Improvements in Left Ventricular Function and Survival in Subjects with Chronic Heart Failure. Circulation 94, 2807 (1996)
26. [26] Colucci, W. S., Packer, M., Bristow, M. R., et al., Carvedilol Inhibits Clinical Progression in Patients with Mild Symptoms of Heart Failure. Circulation 94, 2800 (1996)
27. [27] Gilbert, F. M., Abraham, W. T., Olsen, S., et al., Comparative Hemodynamic, Left Ventricular Functional, and Antiadrenergic Effects of Chronic Treatment With Metoprolol Versus Carvedilol in the Failing Heart. Circulation 94, 2817 (1996)
28. [28] Krum, H., Sackner-Bernstein, J. D., Goldsmith, R. L., et al., Double-Blind, Placebo-Controlled Study of the Long-term Efficacy of Carvedilol in Patients With Severe Chronic Heart Failure. Circulation 92, 1499 (1995)
29. [29] Metra, M., Nardi, M., Giubbini, R., et al., Effects of Short-and Long-Term Carvedilol Administration on Rest and Exercise Hemodynamic Variables, Exercise Capacity and Clinical Conditions in Patients With Idiopathic Dilated Cardiomyopathy. J. Am. Coll. Cardiol. 24, 1678 (1994)
30. [30] Olsen, S.L., Gilbert, E. M., Renlund, D. G., et al., Carvedilol Improves Left Ventricular Function and Symptoms in Chronic Heart Failure: A Double-Blind Randomized Study. J. Am. Coll. Cardiol. 25, 1225 (1995)
31. [31] Packer, M., Bristow, M. R., Cohn, J. N., et al., The Effect of Carvedilol on Morbidity and Mortality in Patients with Chronic Heart Failure. N. Engl. J. Med. 334, 1349 (1996)
32. [32] Quaife, R. A., Gilbert, E. M., Christian, P. E., et al., Effects of Carvedilol on Systolic and Diastolic Left Ventricular Performance in Idiopathic Dilated Cardiomyopathy or Ischemic Cardiomyopathy. Am. J. Cardiol. 78, 779 (1996)
33. [33] Waagstein, F., Adrenergic beta-blocking agents in congestive heart failure due to idiopathic dilated cardiomyopathy. Eur. Heart J. 16 (Suppl. 0), 128 (1995)
34. [34] Cohn, J. N., The Management of Chronic Heart Failure. N. Engl. J. Med. 335, 490 (1996)
35. [35] Cleland, J. G. F., Beta-blocking agents in heart failure: 'Should they be used and how?' Eur. Heart J. 17, 629 (1996)
36. [36] Fowler, M. B., Controlled Trials with Beta Blockers in Heart Failure: Metoprolol as the Prototype. Am. J. Cardiol. 71, 45C (1993)
37. [37] Hampton, J. R., Choosing the Right ß-Blocker. Drugs 48, 549 (1994)
38. [38] Heidenreich, P. A., Effect of Beta-Blockade on Mortality in Patients With Heart Failure: A Meta-analysis of Randomized Clinical Trials. J. Am. Coll. Cardiol. 30, 27 (1997)
39. [39] Krum, H., ß-adrenoceptor blockers in chronic heart failure - a review. Br. J. Clin. Pharmacol. 44, 111 (1997)
40. [40] Waagstein, F., Hjalmarson, A., Wasir, H. S.., Apex cardiogram and systolic time intervals in acute myocardial infarction and effects of practolol. Br. Heart J. 36, 1109 (1974)
41. [41] Waagstein, F., Hjalmarson, A., Varnauskas, E., et al., Effect of chronic beta-adrenergic receptor blockade in congestive cardiomyopathy. Br. Heart J. 37, 1022 (1975)
42. [42] Waagstein, F., Bristow, M. R., Swedberg, K, et al., Beneficial effects of metoprolol in idiopathic dilated cardiomyopathy. Lancet 342, 1441 (1993)
43. [43] Norwegian Multicentre Study Group. Timolol-induced reduction in mortality and reinfarction in patients surviving acute myocardial infarction. N. Engl. J. Med. 322, 1350 (1981)
44. [44] Beta-Blocker Heart Attack Trial Research Group (BHAT): A randomized trial of propranolol in patients with acute myocardial infarction. JAMA 247, 1707 (1982)
45. [45] Furberg, C., The ß-Blocker Heart Attack Trial (BHAT). Br. J. Clin. Pharmac. 14, 35 (1982)
46. [46] White, M., Rouleau, J.L., Pericak, D. et al., Effects of metoprolol-CR in patients with ischaemic and dilated cardiomyopathy: the RESOLVD pilot study (phase II). Eur. Heart J. 19 (Abstr. Suppl.), P1723 (1998)
47. [47] Cohn, J. N., Fowler, M. B., Bristow, M. R. et al, Safety and efficacy of carvedilol in severe heart failure. The U.S. Carvedilol Heart Failure Study Group. J. Card. Fail. 3, 173 (1997)
48. [48] Bristow, M. R., O'Connell, J. B., Gilbert, E. M., et al., Dose-Response of Chronic ß-Blocker Treatment in Heart Failure from either Idiopathic Dilated or Ischemic Cardiomyopathy. Circulation 89, 1632 (1994)
49. [49] Woodley, S. L., Gilbert, E. M., Anderson, J. L. et al., Beta-blockade with bucindolol in heart failure caused by idiopathic dilated vs. ischemic cardiomyopathy. Circulation 84, 2426 (1991)
50. [50] CIBIS Investigators and Committees, A Randomized Trial of ß-Blockade in Heart Failure. Circulation 90, 1765 (1994)
51. [51] CIBIS II Investigators and Committees, The Cardiac Insufficiency Bisoprolol Study II (CIBIS II): a randomised trial. Lancet 353, 9 (1999)
52. [52] Ikram, H., Fitzpatrick, D., Crozier, I. G., Therapeutic Controversies with Use of Beta-Adrenoceptor Blockade in Heart Failure. Am. J. Cardiol. 71, 54C (1993)
53. [53] The Xamoterol In Severe Heart Failure Study Group, Xamoterol in severe heart failure. Lancet 336, 1 (1990)
54. [54] MERIT-HF Study Group, Rationale, Design, and Organization of the Metoprolol CR1 XL Randomized Intervention Trial in Heart Failure (MERIT-HF). Am. J. Cardiol. 80 (9B), 54J (1997)
55. [55] BEST Steering Committee, Design of the Beta-Blocker Evaluation Survival Trial (BEST). Am. J. Cardiol. 75, 1220 (1995)
56. [56] McMurray J., Clcland, J., Cowley A. Ongoing and planned clinical trials in chronic heart failure and left ventricular dysfunction. Exp. Opin. Invest. Drugs 4, 1069 (1995)
57. [57] Follath F., Cleland, J., Klein, W., et al. Etiology and Response to Drug Treatment in Heart Failure. JACC 32, 1167 (1998)
58. [58] Beresford, R., Heel, R. C., Betaxolol - A Review of its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Efficacy in Hypertension. Drugs 31, 6 (1986)
59. [59] Frishman, W. H., Tepper, D., Lazar, E. J., et al., Betaxolol: A New Long-Acting Beta1-Selective Adrenergic Blocker. J. Clin. Pharmacol. 30, 686 (1990)
60. [60] Satoh, N., Suzuki, J., Bessho, H., et al., Effects of betaxolol on cardiohemodynamics and coronary circulation in anesthesized dogs: comparison with atenolol and propranolol. Japan. J. Pharmacol. 54, 113 (1990)
61. [61] Alpert, M. A., Singh, A., Holmes, R. A., et al., Effect of Beta Blockade with Betaxolol on Left Ventricular Systolic Function in Chronic Stable Angina Pectoris and Left Ventricular Dysfunction. Am. J. Cardiol. 57, 721 (1986)
62. [62] Chrysant, S. G., Bittar, N., Betaxolol in the treatment of angina pectoris. Cardiology 84, 316 (1994)
63. [63] Narahara, K.A., Double-blind comparison of once daily betaxolol versus propranolol four times daily in stable angina pectoris. Am. J. Cardiol. 65, 577 (1990)
64. [64] McLenachan, J. M., Findlay, I. N., Wilson, J. T. et al., Twenty-four hour ß-blockade in stable angina pectoris: a study of atenolol and betaxolol. J. Cardiovasc. Pharmacol. 20, 311 (1992)
65. [65] Dimitriou, R., de Gaudemaris, R, Debru, J. L. et al., Wirkung von Betaxolol auf die linksventrikuläre Hypertrophie beim Hypertoniker: Echokardiographische Studie. J. Amer. Med. Ass. 10, 29 (1985)
66. [66] Hjalmarson, A., Kneider, M., Waagstein, F., The Role of ß-Blockers in Left Ventricular Dysfunction and Heart Failure. Drugs 54, 501 (1997)
67. [67] Madsen, B. K., Hansen, J. F., Stokholm, K. H., et al. Chronic congestive heart failure. Description and survival of 190 consecutive patients with a diagnosis of chronic congestive heart failure based on clinical signs and symptoms. Eur. Heart J. 15, 303 (1994)