Статья
Роль нитратов в лечении сердечно-сосудистых заболеваний: научные доказательства и клиническая практика
В обзоре рассматриваются современные проблемы применения нитратов при лечении различных форм ишемической болезни сердца (ИБС). Основное внимание уделяется результатам рандомизированных, клинических испытаний нитратов при ИБС, а также роли, которая отводится препаратам этого класса в клинических рекомендациях. Рассматриваются преимущества применения изосорбида-5-мононитрата. Приводятся данные об эффективности разных режимов дозирования нитратов, а также обсуждаются вопросы безопасности их назначения больным сердечно-сосудистыми заболеваниями, особенно при сочтенном применении с препаратами других классов.
1. Murrell W. Nitroglycerine as a remedy for angina pectoris. Lancet 1879; 1(80-81): 113.
2. Bogaert MG. Organic nitrates in therapy: a 100-year development. Verh K Acad Geneeskd Belg 1984; 46(1): 53-61.
3. Марцевич С.Ю. Современные взгляды на терапию нитратами больных ишемической болезнью сердца. Сердце 2003; 2(8): 88-90.
4. Teo KK, Catellier DJ. Long-term nitrate use in chronic coronary artery disease: need for a randomized controlled trial. Am Heart J 1999; 138 (Pt 1): 400-2.
5. Verheugt FWA. Acute coronary syndromes: drug treatments. Lancet 1999; 353(Suppl II): 20-3.
6. Abrams J. Nitroglycerin and long-acting nitrates in clinical practice. Am J Med 1983; 74: 85-94.
7. Kaski JC, Plaza LR, Meran DO, et al. Improved coronary supply: prevailing mechanism of action of nitrates in chronic stable angina. Am Heart J 1985; 110: 238-45.
8. Lacoste LL, Theroux P, Lidon RM, et al. Antithrombotic properties of transdermal nitro-glycerin in stable angina pectoris. Am J Cardiol 1994; 73(15): 1058-62.
9. Parker JD, Parker JO. Nitrate Therapy for Stable Angina Pectoris. N Engl J Med 1998; 338: 520-31.
10. Bogaert MG. Pharmacokinetics of organic nitrates in man: an overview. Eur Heart J 1988; 9(Suppl A): 33-7.
11. Armstrong PW, Moffat JA, Marks GS. Arterial-venous nitroglycerin gradient during intravenous infusion in man. Circulation 1982; 66: 1273-6.
12. Murad F. Drugs used for the treatment of angina: organic nitrates, calcium-channel blockers, and b-adrenergic antagonists. In: Gilman A.G., Rall T.W., Nies A.S., Taylor P., eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press 1990; 764-83.
13. Fox K, Garcia MA, Ardissino D, et al. Guidelines on the management of stable angina pectoris: executive summary: the Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology. Eur Heart J 2006; 27: 1341-81.
14. Daly CA, Clemens F, Sendon JL, et al. The clinical characteristics and investigations planned in patients with stable angina presenting to cardiologists in Europe: from the Euro Heart Survey of Stable Angina. Eur Heart J 2005; 26: 996-1010.
15. Emanuelsson H, Ake H, Kristi M, Arina R. Effects of diltiazem and isosorbide-5-mononitrate, alone and in combination, on patients with stable angina pectoris. Eur J Clin Phar-macol 1989; 36: 561-5.
16. Akhras F, Jackson G. Efficacy of nifedipine and isosorbide mononitrate in combination with atenolol in stable angina. Lancet 1991; 338: 1036-9.
17. Ciampricotti R, Schotborgh CE, de Kam PJ, van Herwaarden RH. A comparison of nicorandil with isosorbide mononitrate in elderly patients with stable coronary heart disease: the SNAPE study. Am Heart J 2000; 139: 939-43.
18. Hall R, Chong C. A double-blind, parallel-group study of amlodipine versus long-acting nitrate in the management of elderly patients with stable angina. Cardiology 2001; 96: 72-7.
19. Glasser SP. Effect of extended-release isosorbide mononitrate one hour after dosing in patients with stable angina pectoris. IMDUR Study Group. Am J Cardiol 1997; 80(12): 1546-50.
20. Hennig L, Andresen D, Hennig A, et al. Comparison of the effect of isosorbide-5-mononitrate and isosorbide dinitrate in a slow-release form on exercise-induced myocardial ischemia. J Clin Pharmacol 1991; 31: 636-40.
21. Nyberg G. Current Status of Isosorbide-5-Mononitrate Therapy in Chronic Stable Angina Pectoris. Am J Ther 1994; 1(1): 93- 101.
22. Jansen R, Cleophas TJ, Zwinderman AH, Niemeijer MG. Chronic nitrate therapy in patients with angina with comorbidity. Am J Ther 2006; 13: 188-91.
23. Larrat EP. Cost-effectiveness study of nitrate therapy using a decision analysis methodology. Hosp Formul 1994; 29(4): 277-8.
24. Kou V, Nassisi D. Unstable angina and non-ST-segment myocardial infarction: an evidence-based approach to management. Mt Sinai J Med 2006; 73: 449-68.
25. 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—2002: summary article: 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). Circulation 2002; 106: 1893-900.
26. DePace N, Herling IM, Kotler MN, et al. Intravenous nitroglycerin for rest angina. Potential pathophysiologic mechanisms of action. Arch Intern Med 1982; 142: 1806-9.
27. Roubin GS, Harris PJ, Eckhardt I, et al. Intravenous nitroglycerine in refractory unstable angina pectoris. Aust N Z J Med 1982; 12: 598-602.
28. Kaplan KDR, Parker M, Przybylek J, et al. Intravenous nitroglycerin for the treatment of angina at rest unresponsive to standard nitrate therapy. Am J Cardiol 1983; 51: 694-8.
29. Gobel EJ, Hautvast RW, van Gilst WH, et al. Randomised, double-blind trial of intravenous diltiazem versus glyceryl trinitrate for unstable angina pectoris. Lancet 1995; 346: 1653-7.
30. Flather M, Collinson J, Wright A, et al. 71 Practice patterns for patients with unstable angina and myocardial infarction without ST elevation: UK prospective registry of acute ischaemic syndromes (PRAIS-UK). Lancet 1999; 353(Suppl 3): 65.
31. Cotter G, Faibel H, Barash P, et al. High-dose nitrates in the immediate management of unstable angina: optimal dosage, route of administration, and therapeutic goals. Am J Emerg Med 1998; 16(3): 219-24.
32. Figueras J, Lidon R, Cortadellas J. Rebound myocardial ischaemia following abrupt interruption of intra-venous nitroglycerin infusion in patients with unstable angina at rest. Eur Heart J 1991; 12: 405-11.
33. Yusuf S, Collins R, MacMahon S, Peto R. Effect of intravenous nitrates on mortality in acute myocardial infarction: an overview of randomised trials. Lancet 1988; 1: 1088-92.
34. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58050 patients with suspected acute myocardial infarction. Lancet 1995; 345: 669-85.
35. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico. GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction. Lancet 1994; 343: 1115-22.
36. Thadani U. Oral nitrates: more than symptomatic therapy in coronary heart disease? Cardiovasc Drugs Ther 1977; 11: 213-8.
37. Woods KL. Commentary: biostatistics, biological mechanisms and Bayes: lessons from the magnesium trials. Int J Epidemiol 2002 Feb; 31(1): 105-6.
38. Van de Werf F, Ardissino D, Betriu A, et al. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J 2003; 24: 28-66.
39. Nakamura Y, Moss AJ, Brown MW, et al. Long-term nitrate use may be deleterious in ischemic heart disease: A study using the databases from two large-scale postinfarction studies. Multicenter Myocardial Ischemia Research Group. Am Heart J 1999; 138(3 Pt 1): 577-85.
40. The Multicenter Diltiazem Postinfarction Trial Group. The effect of diltiazem on mortality and reinfarction after myocardial infarction. N Engl J Med 1988; 319: 385-92.
41. Moss AJ, Goldstein RE, Hall WJ, et al. Detection and significance of myocardial ischemia in stable patients after recovery from an acute coronary event. JAMA 1993; 269: 2379-85.
42. Nakamura Y, Kawai C, Moss AJ, et al. Comparison between Japan and North America in the posthospital course after recovery from an acute coronary event. Int J Cardiol 1996; 55: 245-54.
43. Kloner RA, Shook T, Przyklenk K, et al. Previous angina alters in-hospital outcome in TIMI 4: a clinical correlate to preconditioning? Circulation 1995; 91: 37-47.
44. Rakhita RD, Marberb MS. Nitric oxide: an emerging role in cardioprotection? Heart 2001; 86: 368-72.
45. Qu XB, Xiao X, Liu Q, Liu YS. Prognostic effect of angina before acute myocardial infarction in elderly patients. Hunan Yi Ke Da Xue Xue Bao 2000; 25(1): 80-2.
46. Hill M, Takano H, Tang XL, et al. Nitroglycerin induces late preconditioning against myo-cardial infarction in conscious rabbits despite development of nitrate tolerance. Circulation 2001; 104(6): 694-9.
47. Jugdutt BI, Khan MI, Jugdutt SJ, et al. Impact of left ventricular unloading after late reperfusion of canine anterior myocardial infarction on remodeling and function using isosorbide-5- mononitrate. Circulation 1995; 92: 926-34.
48. Jugdutt BI, Warnica JW. Intravenous nitroglycerin therapy to limit myocardial infarct size, expansion and complication: effect of timing, dosage and infarct location. Circulation 1988; 78: 906- 19.
49. Mahmarian JJ, Moyо LA, Chinoy DA, et al. Transdermal nitroglycerin patch therapy im-proves left ventricular function and prevents remodeling after acute myocardial infarction: results of a multicenter prospective randomized, double-blind, placebo- controlled trial. Circulation 1998; 97: 2017-24.
50. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico. Six-month effects of early treatment with lisinopril and transdermal glyceryl trinitrate singly and together withdrawn six weeks after acute myocardial infarction: the GISSI-3 trial. JACC 1996; 27: 337-44.
51. Katz RJ, Levy WS, Buff L, et al. Prevention of nitrate tolerance with angiotensin converting enzyme inhibitors. Circulation 1991; 83: 1271-7.
52. Meredith IT, Alison JF, Zhang F-M, et al. Captopril potentiates the effects of nitroglycerin in the coronary vascular bed. JACC 1993; 22: 581-7.
53. Elkayam U, Johnson JV, Shotan A, et al. Double-blind, placebo-controlled study to evaluate the effect of organic nitrates in patients with chronic heart failure treated with angiotensin-con- verting enzyme inhibition. Circulation 1999; 99: 2652-7.
54. Latini R, Staszewsky L, Maggioni AP, et al. Beneficial effects of angiotensin-converting enzyme inhibitor and nitrate association on left ventricular remodeling in patients with large acute myocardial infarction: the Delapril Remodeling after Acute Myocardial Infarction (DRAMI) trial. Am Heart J 2003; 146(1): 133-41.
55. Tingberg E, Roijer A, Thilen U, et al. Randomized, double-blind, placebo-controlled long-term study of isosor-bide-5-mononitrate therapy in patients with left ventricular dysfunction after acute myocardial infarction. Am Heart J 2003; 145(1): E1.
56. Sutton MG, Sharpe N. Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation 2000; 101: 2981-8.
57. Lewis BS, Rabinowitz B, Schlesinger Z, et al. Effect of isosorbide-5-mononitrate on exercise performance and clinical status in patients with congestive heart failure. Results of the Nitrates in Congestive Heart Failure (NICE) Study. Cardiology 1999; 91(1): 1-7.
58. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: Executive Summary A Report of the American College of Cardiol-ogy/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure): Developed in Collaboration With the International Soci-ety for Heart and Lung Transplantation; Endorsed by the Heart Failure Society of America. Circulation 2001; 104(24): 2996-3007.
59. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med 1996; 334: 1349-55.
60. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomized trial. Lancet 999; 353: 9-13.
61. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999; 353: 2001-7.
62. Elkayam U, Johnson JV, Shotan A, et al. Intermittent large dose nitrates added to standard therapy, improves left ventricular function and exercise capacity in patients with chronic heart failure. JACC 1999; 33: 188A.
63. Sussex BA, Campbell NR, Raju MK, McKay DW. The antianginal efficacy of isosorbide dinitrate therapy is maintained during diuretic treatment. Clin Pharmacol Ther 1994; 56: 229-34.
64. Elkayam U, Weber L, McKay C, Rahimtoola S. Spectrum of acute hemodynamic effects of nifedipine in severe congestive heart failure. Am J Cardiol 1985; 56: 560-6.
65. Goldstein RE, Boccuzzi SJ, Cruess D, Nattel S. Diltiazem increases late-onset congestive heart failure in postinfarction patients with early reduction in ejection fraction. The Adverse Experience Committee; and the Multicenter Diltiazem Postinfarction Research Group. Circulation 1991; 83: 52-60.
66. Littler WA, Sheridan DJ. Placebo controlled trial of felodipine in patients with mild to moderate heart failure. UK Study Group. Br Heart J 1995; 73: 428-33.
67. Benatar D, Hall V, Reddy S, Gheorghiade M. Clinical and neurohormonal effects of nicardipine hydrochloride in patients with severe chronic heart failure receiving angiotensin-converting enzyme inhibitor therapy. Am J Ther 1998; 5: 25-32.
68. Gammage M. Treatment of acute pulmonary oedema: diuresis or vasodilatation? Lancet 1998; 351: 382-8.
69. Chatterjee K, Parmley WW, Ganz W, et al. Haemodynamic and metabolic responses to vasodilator therapy in acute myocardial infarction. Circulation 1973; 48: 1183-93.
70. Nelson GIC, Silke B, Ahuja RC, et al. Haemodynamic advantages of isosorbide dinitrate over frusemide in acute heart failure following myocardial infarction. Lancet 1983; 1: 730-2.
71. Cotter G, Metzkor E, Kaluski E, et al. Randomised trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary oedema. Lancet 1998; 351: 389-93.
72. Sharon A, Shpirer I, Kaluski E, et al. High-dose intravenous isosorbide-dinitrate is safer and better than Bi-PAP ventilation combined with conventional treatment for severe pulmonary edema. JACC 2000; 36: 832-7.
73. Sporl-Radun S, Betzein G, Kaufmann B, et al. Effect and pharmacokinetics of isosorbide dinitrate in normal man. Eur Clin J Pharmacol 1980; 18: 237-44.
74. Taylor T, Chasseaud LF, Doyle E. Pharmacokinetics of isosorbide dinitrate after intravenous infusion in human subjects. Biopharm Drugs Dispos 1980; 1: 149-56.
75. Morrison RA, Weigand UW, Jahnchem E, et al. Isosorbide dinitrate kinetics and dynamics after intravenous, sublingual and percutaneous dosing in angina. Clin Pharmacol Ther 1983; 33: 747-56.
76. Gammage MD, Murray RG, Littler WA. Isosorbide-5-mononitrate in the treatment of acute left ventricular failure following acute myocardial infarction. Eur J Clin Pharmacol 1986; 29: 639- 43.
77. Johnson A, Mackway-Jones K. Frusemide or nitrates in acute left ventricular failure. Emerg Med J 2001; 18: 59-60.
78. Лондон Ж. Ремоделирование артерий и артериальное давление у больных с уремией. Нефрология и диализ 2000;2(3). Available at: www.dialysis.ru/magazine/2000-3/
79. Latbam RD, Westerbof N, Sipkema P, et al. Regional wave travel and reflections along the human aorta: a study with six simultaneous micromanometric pressures. Circulation 1985; 72; 1257-69.
80. O’Rourke MF, Kelly RP. Wave reflections in systemic circulation and its implications in ventricular function. J Hypertens 1993; 11; 327-37.
81. Nichols WW, O’Rourke M.E. (1998). Vascular impedance. In McDonald’s blood/low in arteries: theoretical, experimental and clinical principles, (4 ed.), Edward Arnold, London.
82. O’Rourke MF. Arterial function in health and disease. Churchill Livingstone, Edinburgh 1982.
83. Safar ME, London GM. The arterial system in human hypertension. In Textbook of Hypertension, (ed. J.D. Swales), pp. 85-102, Blackwell Scientific, London 1994.
84. O’Rourke ME. Mechanical principles in arterial disease. Hypertension 1995; 26: 2-9.
85. Benetos A, Safar M, Rudnichi A, et al. Pulse pressure; a predictor of long-term cardiovascular mortality in a French male population. Hypertension 1997; 30: 1410-5.
86. Mitcbell GF, Moye LM, Braunwald E, et al. Sphygmomanometrically determined pulse pressure is a powerful independent predictor of recurrent events after myocardial infarction in patients with impaired left ventricular function. Circulation 1997; 96: 4254-60.
87. Stokes GS, Barin ES, Gilfillan KL. Effects of isosorbide mononitrate and AII inhibition on pulse wave reflection in hypertension. Hypertension 2003; 41(2): 297-301.
88. Felizardo A, Maldonado J, Pego M, et al. Role of nitrates in pharmacologic modulation of reflected waves and their significance in the treatment of arterial hypertension in the elderly. Rev Port Cardiol 1997; 16(7-8): 607-11.
89. Stokes GS, Barin ES, Gilfillan KL, Kaesemeyer WH. Interactions of L-arginine, isosorbide mononitrate, and angiotensin II inhibitors on arterial pulse wave. Am J Hypertens 2003; 16(9 Pt 1): 719-24.
90. Lohmann FW. Treatment of Isolated Systolic Hypertension. Clin Drug Invest 1999; 18(3): 173-81.
91. Stokes G.S.Nitrates as adjunct hypertensive treatment. Curr Hypertens Rep 2006; 8: 60-8.
92. Trenk D, Hinder M, Stengele E, et al. Comparison of the initial hemodynamic effects of immediate-release ver-sus sustained-release isosorbide-5-mononitrate following single oral doses. J Clin Pharmacol 2000; 40: 168-76.
93. Cleophas TJ, Niemeyer MG, Zwinderman AH., van der Wall EE. Isosorbide mononitrate 30% immediate-release 70% sustained-release formulation: a review. DUMQOL (DUtch Mononitrate Quality of Life) Study Group. Angiology 2000; 51: 631-8.
94. Chen YH, Ding PY, Wang SP. Anti-ischemic and antianginal effects of controlled-release and conventional isosorbide-5- mononitrate in stable angina pectoris. Zhonghua Yi Xue Za Zhi (Taipei) 1998; 61: 577-83.
95. Zwinderman AH, Cleophas TJ, van der Sluijs H, et al. Comparison of 50-mg and 100-mg sustained-release isosorbide mononitrate in the treatment of stable angina pectoris: effects on quality-of-life indices. Dutch Mononitrate Quality of Life (DUMQOL) Study Group. Angiology 1999; 50: 963-9.
96. Niemeyer MG, Kleinjans HA, de Ree R, et al. Comparison of multiple-dose and once-daily nitrate therapy in 1212 patients with stable angina pectoris: effects on quality of life indices. Dutch Mononitrate Quality of Life (DUMQOL) Study Group. Angiology 1997; 48: 855-62.
97. Jansen R, Cleophas TJ, Zwinderman AH, Niemeijer MG. Chronic nitrate therapy in patients with angina with comorbidity. Am J Ther 2006; 13: 188-91.
98. Brown RE, Kendall MJ, Halpern MT. Cost analysis of once-daily ISMN versus twice-daily ISMN or transdermal patch for nitrate prophylaxis. J Clin Pharm Ther 1997; 22: 67-76.
99. Kosoglou T, Kazierad DJ, Schentag JJ, et al. Effect of food on the oral bioavailability of isosorbide-5-mononitrate administered as an extended-release tablet. J Clin Pharmacol 1995; 35: 151-8.
100. Hider JD, Shehab Z, Courteney-Harris R. Effectiveness of modified release isosorbide mononitrate affected by incorrect use. BMJ 2000; 320: 483.
101. Rejnmark L, Vestergaard P, Mosekilde L. Decreased fracture risk in users of organic nitrates: a nationwide case-control study. J Bone Miner Res 2006; 21: 1811-7.
102. Nabhan AF. A randomized clinical trial of the effects of isosorbide mononitrate on bone formation and resorption in post-menopausal women: a pilot study. Hum Reprod 2006; 21: 1320-4.
103. Cleophas TJ, Niemeyer MC, van der Wall EE, van der Meulen J. Nitrate-induced head-ache in patients with stable angina pectoris: beneficial effect of starting on a low dosage. 5-ISMN headache study group. Angiology 1996; 47: 679-85.
104. Food and Drug Administration Approvals. Medscape Pharmacists 2003; 4(1). Available at: www.medscape.com.
105. Cheitlin MD, Hutter AMJr, Brindis RG, et al. ACC/AHA expert consensus document. Use of sildenafil (Viagra) in patients with cardiovascular disease. JACC 1999; 33: 273-82.
106. Ishikura F, Beppu S, Hamada T, et al. Effects of sildenafil citrate (Viagra) combined with nitrate on the heart. Circulation 2000; 102(20): 2516-21.
107. Darius H. Role of nitrates for the therapy of coronary artery disease patients in the years be-yond 2000. J Cardiovasc Pharmacol 1999; 34(Suppl 2): S15-20; discussion S29-31.