Profile of carvedilol controlled-release: A new once-daily formulation of carvedilol

Expert Opinion on Pharmacotherapy

Volumn 7, Issue 18, 2006, Pages 2533-2546

  Fonarow, Gregg C ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Carvedilol; Carvedilol controlled release; Heart failure; Hypertension; Left ventricular dysfunction; Postmyocardial infarction

Indexed keywords

ACETYLSALICYLIC ACID; ANTIHYPERTENSIVE AGENT; ATENOLOL; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARVEDILOL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; LISINOPRIL; METOPROLOL; METOPROLOL SUCCINATE; METOPROLOL TARTRATE; NITRATE; PLACEBO; PROPRANOLOL;

ANGINA PECTORIS; CARDIOGENIC SHOCK; CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CORONARY ARTERY DISEASE; DIARRHEA; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRESSLER SYNDROME; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ESSENTIAL HYPERTENSION; HEART FAILURE; HEART FUNCTION; HEART LEFT VENTRICLE FAILURE; HEART OUTPUT; HEART REINFARCTION; HEART VENTRICLE TACHYCARDIA; HUMAN; HYPERTENSION; INSULIN RESISTANCE; INSULIN SENSITIVITY; KIDNEY PERFUSION; LOW DRUG DOSE; META ANALYSIS; METABOLISM; MONOTHERAPY; MORBIDITY; MORTALITY; ORTHOSTATIC HYPOTENSION; PATIENT COMPLIANCE; PHARMACODYNAMICS; PREVALENCE; PROGNOSIS; REVIEW; SIDE EFFECT; SUDDEN DEATH; SYSTEMATIC REVIEW; WEIGHT GAIN;

CARBAZOLES; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; HUMANS; PROPANOLAMINES; VENTRICULAR DYSFUNCTION, LEFT;

EID: 33845574557     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.7.18.2533     Document Type: Review

References (94)

1. AMERICAN HEART ASSOCIATION: Heart Disease and Stroke Statistics-2006 Update. Dallas, TX: American Heart Association (2006)
2. STEG PG, DABBOUS OH, FELDMAN LJ et al.: Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation (2004) 109(4):494-499.
3. JOSEPHSON M, WELLENS HJ: Implantable defibrillators and sudden cardiac death. Circulation (2004) 109(22):2685-2691.
4. LEVY D, KENCHAIAH S, LARSON MG et al.: Long-term trends in the incidence of and survival with heart failure. N. Engl. J. Med. (2002) 347(18):1397-402.
5. RICH MW: Management of heart failure in the elderly. Heart Fail. Rev. (2002) 7(1):89-97.
6. KRUMHOLZ HM, PARENT EM, TU N et al.: Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. Arch. Intern. Med. (1997) 157(1):99-104.
7. FONAROW GC: Strategies to improve the use of evidence-based heart failure therapies. Rev Cardiovasc Med. (2005) 6 (Suppl. 2):S32-S42.
8. KLAG MJ, WHELTON PK, RANDALL BL et al.: Blood pressure and end-stage renal disease in men. N. Engl. J. Med. (1996) 334(1):13-18.
9. HAIDER AW, LARSON MG, FRANKLIN SS, LEVY D: Systolic blood pressure, diastolic blood pressure, and pulse pressure as predictors of risk for congestive heart failure in the Framingham Heart Study. Ann. Intern. Med. (2003) 138(1):10-16.
10. CHOBANIAN AV, BAKRIS GL, BLACK HR et al.: Sev enth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Hypertension (2003) 42(6):1206-1252.
11. DORNHORST A, POWELL SH, PENSKY J: Aggravation by propranolol of hyperglycaemic effect of hydrochlorothiazide in Type II diabetics without alteration of insulin secretion. Lancet (1985) 1(8421):123-126.
12. SAYDAH SH, FRADKIN J, COWIE CC: Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA (2004) 291(3):335-342.
13. AACE HYPERTENSION TASK FORCE: American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of hypertension. Endocr. Pract. (2006) 12(2):193-222.
14. HUNT SA, ABRAHAM WF, CHIN MH et al.: ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J. Am. Coll. Cardiol. (2005) 46:1116-1143.
15. PACKER M, BRISTOW MR, COHN JN et al.: The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. US Carvedilol Heart Failure Study Group. N. Engl. J. Med. (1996) 334(21):1349-1355.
16. CIBIS-II INVESTIGATORS: The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet (1999) 353(9146):9-13.
17. MERIT-HF INVESTIGATORS: Effect of metoprolol CR/XL in chronic heart failure: Metoptolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet (1999) 353(9169):2001-2007.
18. PACKER M, FOWLER MB, ROECKER EB et al.: Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study. Circulation (2002) 106(17):2194-2199.
19. PACKER M, COATS AJ, FOWLER MB et al.: Effect of carvedilol on survival in severe chronic heart failure. N. Engl. J. Med. (2001) May 31;344(22):1651-1658.
20. COLUCCI WS, PACKER M, BRISTOW MR et al.: Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure, US Carvedilol Heart Failure Study Group. Circulation (1996) 94(11):2800-2806.
21. PACKER M, COLUCCI WS, SACKNER-BERNSTEIN JD et al.: Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise. Circulation (1996) 94(11):2793-2799.
22. KRUM H, ROECKER EB, MOHACSI P et al.: Effects of initiating carvedilol in patients with severe chronic heart failure: results from the COPERNICUS Study. JAMA (2003) 289(6):712-718.
23. β-BLOCKER EVALUATION OF SURVIVAL TRIAL INVESTIGATORS: A trial of the β-blocker bucindolol in patients with advanced chronic heart failure. N. Engl. J. Med. (2001) 344(22):1659-1667.
24. LEE DS, TU JV, JUURLINK DN et al.: Risk-treatment mismatch in the pharmacotherapy of heart failure. JAMA (2005) 294(10):1240-1247.
25. FONAROW GC, ADAMS K, STRAUSSER BP: ADHERE (Acute Decompensated Heart Failure National Registry): Rationale, design, and subject population. J. Card. Fail. (2002) 8(4 Suppl. 1):S49.
26. ANSARI M, SHILPAK MG, HEINDENREICH PA et al.: Improving guideline adherence: a randomized trial evaluating strategies to increase β-blocker use in heart failure. Circulation (2003) 107(19):2799-804.
27. ANTMAN EM, ANBE DT, ARMSTRONG PW et al.: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Circulation (2004) 110(9):e82-e293.
28. BRAUNWALD E, ANTMAN EM, BEASLEY JW et al.: ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients with Unstable Angina). J. Am. Coll. Cardiol. (2002) 40(7):1366-1374.
29. SPENCER FA, MEYER TE, GORE JM, GOLDBERG RJ: Heterogeneity in the management and outcomes of patients with acute myocardial infarction complicated by heart failure: the National Registry of Myocardial Infarction. Circulation. (2002) 105(22):2605-2610.
30. FONAROW GC, STEVENSON LW, WALDEN JA et al.: Impact of a comprehensive heart failure management program on hospital readmission and functional status of patients with advanced heart failure. J. Am. Coll. Cardiol. (1997) 30(3):725-732.
31. WHELLAN DJ, GAULDEN L, GATTIS WA et al.: The benefit of implementing a heart failure disease management program. Arch. Intern. Med. (2001) 161(18):2223-2228.
32. EAGLE KA, KLINE-ROGERS E, GOODMAN SG et al.: Adherence to evidence-based therapies after discharge for acute coronary syndromes: an ongoing prospective, observational study. Am. J. Med. (2004) 117(2):73-81.
33. KRAMER JM, FETTEROLF D, CHARDE JP et al.: National evaluation of long-term adherence to β-blocker therapy after acute myocardial infarction in patients with commercial health insurance. Presented at: American College of Cardiology 2004 Annual Meeting; March 9, 2004; New Orleans, La. J. Am. Coll. Cardiol. (2004) 43:415A-6A.
34. POOLE-WILSON PA, SWEDBERG K, CLELAND JG et al.: 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(9377):7-13.
35. BRISTOW MR, GILBERT EM, ABRAHAM WT et al.: Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation (1996) 94(11):2807-2816.
36. CAPRICORN INVESTIGATORS: Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet (2001) 357:1385-1390.
37. BAKRIS GL, FONSECA V, KATHOLI RE et al.: Metabolic effects of carvedilol versus metoprolol in patients with Type 2 diabetes mellitus and hypertension: a randomized controlled trial. JAMA (2004) 292(18):2227-2236.
38. CARLBERG B, SAMUELSSON O, LINDHOLM LH: Atenolol in hypertension: is it a wise choice? Lancet (2004) 364(9446):1684-1689.
39. HAENNI A, LITHELL H: Treatment with a β-blocker with β 2-agonism improves glucose and lipid metabolism in essential hypertension. Metabolism (1994) 43(4):455-461.
40. GIUGLIANO D, ACAMPORA R, MARFELLA R et al.: Metabolic and cardiovascular effects of carvedilol and atenolol in non- insulin-dependent diabetes mellitus and hypertension. A randomized, controlled trial. Ann. Intern. Med. (1997) 126(12):955-959.
41. STRANDERS I, DIAMANT M, VAN GELDER RE et al.: Admission blood glucose level as risk indicator of death after myocardial infarction in patients with and without diabetes mellitus. Arch. Intern. Med. (2004) 164(9):982-988.
42. BASAT O, UCAK S, SEBER S et al.: After myocardial infarction carvedilol improves insulin resistance compared to metoprolol. Clin. Res. Cardiol. (2006) 95(2):99-104.
43. DE LEEUW PW, GAILLARD CA, BIRKENHAGER WH: Renal hemodynamic patterns in essential hypertension. In: Hypertension: Pathophysioloegy, Diagnosis, and Management (Two-Volume Set). Laragh JH (Ed.), Raven Press, Ltd, New York, NY: (1995):1857-1867.
44. TOMITA K, MAKUMO F: Effect of long-term carvedilol therapy on renal function in essential hypertension. J. Cardiovasc. Pharmacol. (1992) 19(Suppl. 1):S97-S101.
45. HEITMANN M, DAVIDSEN U, STOKHOLM KH et al.: Renal and cardiac function during α1-β-blockade in congestive heart failure. Scand. J. Clin Lab. Invest. (2002) 62(2):97-104.
46. DUPONT AG: Effects of carvedilol on renal function. Eur. J. Clin. Pharmacol. (1990) 38(Suppl. 2):S96-S100.
47. BAKRIS GL, HART P, RITZ E: β blockers in the management of chronic kidney disease. Kidney Int. Epub October 2006.
48. GATTIS WA, O'CONNOR CM: Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure. Am. J. Cardiol. (2004) 93(9A):74-76.
49. FONAROW GC, ABRAHAM WT, ALBERT NM et al.: Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF): rationale and design. Am. Heart J. (2004) 148(1):43-51.
50. FONAROW GC, ABRAHAM WT, ALBERT NM et al.: ACC/AHA performance measures for patients hospitalized with HF: are they predictive of clinical outcomes? Poster presented at the American College of Cardiology 55th Annual Scientific Session; March 11-14, 2006; Atlanta, Ga. J. Am. Coll. Cardiol. (2006) 47(4 suppl. 4):255A.
51. MASOUDI FA, BAILLIE CA, WANG Y et al.: The complexity and cost of drug regimens of older patients hospitalized with heart failure in the United States, 1998-2001. Arch. Intern. Med. (2005) 165(18):2069-2076.
52. CLAXTON AJ, CRAMER J, PIERCE C: A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. (2001) 23(8):1296-310.
53. BENNETT SJ, HUSTER CA, BAKER SL et al.: Characterization of the precipitants of hospitalization for heart failure decompensation. Am. J. Crit. Care. (1998) 7(3):168-174.
54. LEVENTHAL MJ, RIEGEL B, CARLSON B, DE GS: Negotiating compliance in heart failure: remaining issues and questions. Eur J. Cardiovasc. Nurs. (2005) 4(4):298-307.
55. KARDAS P: Comparison of once daily versus twice daily oral nitrates in stable angina pectoris. Am. J. Cardiol. (2004) 94(2):213-216.
56. HORWITZ RI, VISCOLI CM, BERKMAN L et al.: Treatment adherence and risk of death after a myocardial infarction. Lancet (1990) 336(8714):542-545.
57. CHENG JW, KALIS MM, FEIFER S: Patient-reported adherence to guidelines of the Sixth Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Pharmacotherapy (2001) 21(7):828-841.
58. BRISTOW MR, LARRABEE P, MULLER-BECKMANN B et al.: Effects of carvedilol on adrenergic receptor pharmacology in human ventricular myocardium and lymphocytes. Clin. Investig. (1992) 70(Suppl. 1):S105-S113.
59. FEUERSTEIN GZ, RUFFOLO RR, Jr. Carvedilol, a novel multiple action antihypertensive agent with antioxidant activity and the potential for myocardial and vascular protection. Eur. Heart J. (1995) 16(Suppl. F):38-42.
60. BRISTOW MR: Mechanism of action of β-blocking agents in heart failure. Am. J. Cardiol. (1997) 80(11A):26L-40L.
61. NICHOLS AJ, SULPIZIO AC, ASHTON DJ et al.: The interaction of the enantiomers of carvedilol with α 1- and β1-adrenoceptors. Chirality (1989) 1(4):265-270.
62. GILBERT EM, ABRAHAM WT, OLSEN S et al.: Comparative hemodynamic, left ventricular functional, and antiadrenergic effects of chronic treatment with metoprolol versus carvedilol in the failing heart. Circulation (1996) 94(11):2817-2825.
63. PACKER M: Do β-blockers prolong survival in heart failure only by inhibiting the β-receptor? A perspective on the results of the COMET trial. J. Card. Fail. (2003) 9(6):429-457.
64. PACKER M: β-adrenergic blockade in chronic heart failure: principles, progress, and practice. Prog. Cardiovasc. Dis. (1998) 41(1 Suppl. 1):39-52.
65. BRISTOW MR: β-adrenergic receptor blockade in chronic heart failure. Circulation (2000) 101(5):558-569.
66. JACOB S, RETT K, WICKLMAYR M et al.: Differential effect of chronic treatment with two β-blocking agents on insulin sensitivity: the carvedilol-metoprolol study. J. Hypertens. (1996) 14(4):489-494.
67. YUE TL, CHENC HY, LYSKO PG et al.: Carvedilol, a new vasodilator and β adrenoceptor antagonist, is an antioxidant and free radical scavenger. J. Pharmacol. Exp. Ther. (1992) 263(1):92-98.
68. BOOK WM. Carvedilol: a nonselective β blocking agent with antioxidant properties. Congest. Heart Fail. (2002) 8(3):173-7, 190.
69. YUE TL, MCKENNA PJ, GU JL et al.: Carvedilol, a new antihypertensive agent, prevents lipid peroxidation and oxidative injury to endothelial cells. Hypertension (1993) 22(6):922-928.
70. YUSUF S, PETO R, LEWIS J et al.: β blockade during and after myocardial infarction: an overview of the randomized trials. Prog. Cardiovasc. Dis. (1985) 27(5):335-371.
71. YOSHIKAWA T, PORT JD, ASANO K et al.: Cardiac adrenergic receptor effects of carvedilol. Eur. Heart J. (1996) 17(Suppl. B):8-16.
72. HENDERSON LS, TENERO DM, BAIDOO CA et al.: Pharmacokinetic and pharmacodynamic comparison of controlled-release carvedilol and immediate-release carvedilol at steady state in patients with hypertension. Am. J. Cardiol. (2006) 98(7):17L-26L.
73. PACKER M, LUKAS MA, TENERO DM, BAIDOO CA, GREENBERC BA, for the 369 Study Croup: Pharmacokinetic profile of controlled-release carvedilol in patients with left ventricular dysfunction associated with chronic heart failure or after myocardial infarction. Am. J. Cardiol. (2006) 98(7):39L-45L.
74. FONAROW GC: β-blockers for the post-myocardial infarction patient: current clinical evidence and practical considerations. Rev. Cardiovasc. Med. (2006) 7(1):1-9.
75. MCMURRAY J, KOBER L, ROBERTSON M et al.: Antiarrhythmic effect of carvedilol after acute myocardial infarction: results of the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction (CAPRICORN) trial. J. Am. Coll. Cardiol. (2005) 45(4):525-530.
76. AUSTRALIA-NEW ZEALAND HEART FAILURE RESEARCH COLLABORATIVE GROUP: Effects of carvedilol, a vasodilator-β-blocker, in patients with congestive heart failure due to ischemic heart disease. Australia-New Zealand Heart Failure Research Collaborative Group. Circulation (1995) 92(2):212-218.
77. AUSTRALIA/NEW ZEALAND HEART FAILURE RESEARCH COLLABORATIVE GROUP: Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Australia/New Zealand Heart Failure Research Collaborative Group. Lancet (1997) 349(9049)375-380.
78. TORP-PEDERSEN C, POOLE-WILSON PA, SWEDBERG K et al.: Effects of metoprolol and carvedilol on cause-specific mortality and morbidity in patients with chronic heart failure-COMET. Am. Heart J. (2005) 149(2):370-376.
79. WEBER MA, SICA DA, TARKA EA, IYENGAR M, FLECK R, BAKRIS GL: Controlled-release carvedilol in the treatment of essential hypertension. Am. J. Cardiol. (2006) 98(7):32L-38L.
80. HAUPTMAN PJ, PRESSLER SJ, SACKNER-BERNSTEIN J, ORDRONNEAU P, UDELSON JE, for the CASPER Investigators: Rationale and design of CASPER: compliance and quality of life study comparing once-daily carvedilol CR and twice-daily carvedilol IR in patients with heart failure. Am. J. Cardiol. (2006) 98(7):60L-66L.
81. COHN JN, FOWLER MB, BRISTOW MR et al.: Safety and efficacy of carvedilol in severe heart failure. The US Carvedilol Heart Failure Study Group. J. Card. Fail. (1997) 3(3):173-179.
82. DOUGHTY RN, WHALLEY GA, GAMBLE G et al.: Left ventricular remodeling with carvedilol in patients with congestive heart failure due to ischemic heart disease. Australia-New Zealand Heart Failure Research Collaborative Group. J. Am. Coll. Cardiol. (1997) 29(5):1060-1066.
83. DOUGHTY RN, WHALLEY GA, WALSH HA et al.: Effects of carvedilol on left ventricular remodeling after acute myocardial infarction: the CAPRICORN Echo Substudy. Circulation (2004) 109(2):201-206.
84. GREENBERG BH, MEHRA M, TEERLINK JR, ORDRONNEAU P, MCCOLLUM D, GILBERT EM: COMPARE: comparison of the effects of carvedilol CR and carvedilol IR on left ventricular ejection fraction in patients with heart failure. Am. J. Cardiol. (2006) 98(7):53L-59L.
85. BAKRIS GL, TARKA EA, WATERHOUSE B, GOULDING MR, MADAN A, ANDERSON KA: Cardiovascular risk factors in hypertension: rationale and design of studies to investigate the effects of controlled-release carvedilol on regression of left ventricular hypertrophy and lipid profile. Am. J. Cardiol. (2006) 98(7):46L-52L.
86. KRUM H. Tolerability of carvedilol in heart failure: clinical trials experience. Am. J. Cardiol. (2004) 93(9A):58-63.
87. DI LENARDA A, REMME WJ, CHARLESWORTH A et al.: Exchange of β-blockers in heart failure patients. Experiences from the poststudy phase of COMET (the Carvedilol or Metoprolol European Trial). Eur. J. Heart Fail. (2005) 7(4):640-649.
88. KRUM H, NINIO D, MACDONALD P: Baseline predictors of tolerability to carvedilol in patients with chronic heart failure. Heart (2000) 84(6):615-619.
89. KRUM H, HILL J, FRUHWALD F et al.: Tolerability of β-blockers in elderly patients with chronic heart failure: The COLA II study. Eur. J. Heart Fail. (2006) 8(3):302-307.
90. ISKEDJIAN M, EINARSON TR, MACKEIGAN LD et al.: Relationship between daily dose frequency and adherence to antihypertensive pharmacotherapy: evidence from a meta-analysis. Clin. Ther. (2002) 24(2):302-316.
91. WETZELS GE, NELEMANS P, SCHOUTEN JS, PRINS MH. Facts and fiction of poor compliance as a cause of inadequate blood pressure control: a systematic review. J. Hypertens. (2004) 22(10):1849-1855.
92. TU W, MORRIS AB, LI J et al.: Association between adherence measurements of metoprolol and health care utilization in older patients with heart failure. Clin. Pharmacol. Ther. (2005) 77(3):189-201.
93. FONAROW GC: Practical considerations of β-blockade in the management of the post-myocardial infarction patient. Am. Heart J. (2005) 149(6):984-993.
94. ABRAHAM WT: Switching between β blockers in heart failure patients: rationale and practical considerations. Congest. Heart Fail. (2003) 9(5):271-278.