В статье приведены данные об особенностях фармакокинетики и фармакодинамики дигидропиридиновых антагонистов кальция. Рассмотрена доказательная база амлодипина в лечении артериальной гипертонии, ишемической болезни сердца, хронической сердечной недостаточности. Проведено сравнение эффективности, безопасности и особенностей применения в особых клинических ситуациях отдельных представителей класса дигидропиридиновых антагонистов кальция.
This article contains information concerning the aspects of pharmacokinetics and pharmacodynamics of dihydropyridine calcium antagonists. The authors have discussed the evidence-based amlodipine treatment of arterial hypertension, ischemic heart disease and chronic heart failure. The authors present the comparison of the efficacy, safety and application characteristics of the different dihydropyridine calcium antagonists that can be used in specific clinical cases.
1. Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertension 2013, 31: 1281–357.
2. Клинические рекомендации. Диагностика и лечение артериальной гипертонии. Кардиолог. вестн. 2015; 1: 3–30. / Klinicheskie rekomendatsii. Diagnostika i lechenie arterial'noi gipertonii. Kardiolog. vestn. 2015; 1: 3–30. [in Russian]
3. Task Force Members, Montalescot G, Sechtem U, Achenbach S et al; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H et al; Document Reviewers, Knuuti J, Valgimigli M, Bueno H et al. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J 2013; 34 (38): 2949–3003.
4. Кукес В.Г., Остроумова О.Д., Стародубцев А.К. Антагонисты кальция: современные аспекты применения в кардиологии. Consilium Medicum. 2006; 8 (11): 113–7. / Kukes V.G., Ostroumova O.D., Starodubtsev A.K. Antagonisty kal'tsiia: sovremennye aspekty primeneniia v kardiologii. Consilium Medicum. 2006; 8 (11): 113–7. [in Russian]
5. Toyo-Oka T, Nayler WG. Third generation calcium entry blockers. Blood Press 1996; 5: 206–8.
6. Преображенский Д.В., Носенко Н.С., Некрасова Н.И. и др. Антагонист кальция третьего поколения амлодипин: особенности клинической фармакологии и спектр терапевтического применения. Рус. мед. журн. 2011; 14: 884–90. / Preobrazhenskii D.V., Nosenko N.S., Nekrasova N.I. i dr. Antagonist kal'tsiia tret'ego pokoleniia amlodipin: osobennosti klinicheskoi farmakologii i spektr terapevticheskogo primeneniia. Rus. med. zhurn. 2011; 14: 884–90. [in Russian]
7. Neaton JD, Grimm RH Jr, Prineas RJ et al. Treatment of Mild Hypertension Study. Final results. Treatment of Mild Hypertension Study Research Group. JAMA 1993; 270 (6): 713–24.
8. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2988–97.
9. Dahlöf B, Sever PS, Poulter NR et al; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentrerandomised controlled trial. Lancet 2005; 366: 895–906.
10. Julius S, Kjeldsen SE, Weber M et al; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363 (9426): 2022–31.
11. Jamerson K, Weber MA, Bakris GL et al, for the Accomplish trial investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med 2008; 359: 2417–28.
12. Jamerson K, Bakris GL, Dahlöf B et al; ACCOMPLISH Investigators. Exceptional early blood pressure control rates: the ACCOMPLISH trial. Blood Press 2007; 16: 80–6.
13. Weber MA, Bakris GL, Jamerson K et al; ACCOMPLISH Investigators. Cardiovascular events during differing hypertension therapies in patients with diabetes. JACC 2010; 56 (1): 77–85.
14. Rothwell PM, Howard SC, Dolan E et al. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet 2010; 375: 895–905.
15. Webb AJS, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in BP and risk of stroke: a systematic review and meta-analysis. Lancet 2010; 375: 906–15.
16. Rothwell PM, Webb AJS. Effect of Dose and Combination of Antihypertensives on Interindividual Blood Pressure Variability: A Systematic Review. Stroke 2011; 42: 2860–5.
17. Verdecchia P, Angeli F, Gattobigio R et al. Impact of Blood Pressure Variability on Cardiac and Cerebrovascular Complications in Hypertension. Am J Hypertens 2007; 20: 154–61.
18. London G, Asmar R, Schmieder R, Calvo C. Antihypertensive efficacy of Indapamide SR vs candesartan and amlodipine in hypertensive patients in isolated hypertensive patients. Am J Hypertens 2004; 17 (5): 183А.
19. Peixoto AJ, White WB. Circadian blood pressure: clinical implications based on the pathophysiology of its variability. Kidney Int 2007; 71 (9): 855–60.
20. Willich SN. Circadian variation and triggering of cardiovascular events. Vasc Med 1999; 4: 41–9.
21. Willich SN, Goldberg RJ, Maclure M et al. Increased onset of sudden cardiac death in the first three hours after awakening. Am J Cardiol 1992; 70: 65–8.
22. Kaplan NM. Morning surge in blood pressure. Circulation 2003; 107: 1347.
23. Chalmers J, Arima H, Woodward M et al. Effects of combination of perindopril, indapamide, and calcium channel blockers in patients with type 2 diabetes mellitus: results from the Action In Diabetes and Vascular Disease: Preterax and Diamicron Controlled Evaluation (ADVANCE) trial. Hypertension 2014; 63: 259–64.
24. Bakris GL, Sarafidis PA, Weir MR et al; ACCOMPLISH Trial investigators. Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of randomised controlled trial. Lancet 2010; 375: 1173–81.
25. Nissen SE, Tuzcu EM, Libby P et al, for the CAMELOT Investigators. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure. The CAMELOT study: a randomized controlled trial. JAMA 2004; 292: 2217–26.
26. Pitt B, Byington RP, Furberg CD et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation 2000; 102 (13): 1503–10.
27. Jorgensen B, Simonsen S, Endresen K et al. Restenosis and Clinical Outcome in Patients Treated With Amlodipine After Angioplasty: Results From the Coronary Angio Plasty Amlodipine REStenosis Study (CAPARES). J Am Coll Cardiol 2000; 35 (3): 592–9.
28. Deanfield JE, Jean-Marie RG, Detry J-MRG et al. For the CAPE study group. Amlodipine reduces transient myocardial ischemia in patients with coronary artery disease: double-blind Circadian Anti-Ischemia Program in Europe (CAPE Trial). J Am Coll Cardiol 1994; 24 (6): 1460–7.
29. Packer M, O’Connor CM, Ghali JK et al. For the Prospective Randomized Amlodipine Survival Evaluation Study Group. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. N Engl J Med 1996; 335: 1107–14.
30. Kloner RA, Vetrovec GW, Materson BJ, Levenstein M. Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients. Am J Cardiol 1998; 81 (2): 163–9.
31. Hansson L. The Hypertension Optimal Treatment study and the importance of lowering blood pressure. J Hypertens Suppl 1999; 17 (1): S9–13.
32. Liu L, Zhang Y, Liu G; FEVER Study Group. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens 2005; 23 (12): 2157–72.
33. Zhang Y, Zhang X, Liu L, Zanchetti A; FEVER Study Group. Effects of individual risk factors on the residual risk of cardiovascular events in a population of treated Chinese patients with hypertension: data from the Felodipine Event Reduction (FEVER) study. J Hypertens 2010; 28 (10): 2016–25.
34. Wong ND, Teng W, Abrahamson D et al. Noninvasive tracking of coronary atherosclerosis by electron beam computed tomography: Rationale and design of the Felodipine Atherosclerosis Prevention Study (FAPS). Am J Cardiol 1995; 76 (17): 1239–42.
35. Кукес В.Г., Стародубцев А.К. Клиническая фармакология и фармакотерапия. М.: ГЭОТАР-Медиа, 2012; с. 181–92. / Kukes V.G., Starodubtsev A.K. Klinicheskaia farmakologiia i farmakoterapiia. M.: GEOTAR-Media, 2012; s. 181–92. [in Russian]
36. Schaefer RM, Aldons PM, Burgess ED et al. Improved tolerability of felodipine compared with amlodipine in elderly hypertensives: a randomised, double-blind study in 535 patients, focusing on vasodilatory adverse events. The International Study Group. Int J Clin Pract 1998; 52 (6): 381–6.
37. Cheung BMY, Lau Сh-P, Wu B-Zh. Amlodipine, Felodipine, and Isradipine in the Treatment of Chinese Patients with Mild-to-Moderate Hypertension. Clin Ther 1998; 20 (6): 1159–69.
38. Vestra MD, Pozza G, Mosca A et al. Effect of lercanidipine compared with ramipril on albumin excretion rate in hypertensive Type 2 diabetic patients with microalbuminuria: DIAL study (Diabete, Ipertensione, Albuminuria, Lercanidipina). Diab Nutr Metab 2004; 17: 259–66.
39. Robles NR, Ocon J, Gomez CF et al. Lercanidipine in patients with chronic renal failure: the ZAFRA study. Ren Fail 2005; 27 (1): 73–80.
40. Borghi С, Prandin MG, Dormi A et al. The use of lercanidipine can improve the individual tolerability in dihydropyridine calcium blockers in hypertensive patients. J Hypertension 2000; 18 (Suppl. 2): S155–S156 (abstract).
41. Leonetti G, Magnani B, Pessina AC et al; COHORT Study Group. Tolerability of long-term treatment with lercanidipine versus amlodipine and lacidipine in elderly hypertensives. Am J Hypertens 2002; 15 (11): 932–40.
42. Lund-Johansena P, Strandenb E, Helbergc S et al. Quantification of leg oedema in postmenopausal hypertensive patients treated with lercanidipine or amlodipine. J Hypertension 2003; 21: 1003–10.
43. De Giorgio LA, Orlandini F, Malasoma P, Zappa A. Double-blind, crossover study of lercanidipine versus amlodipine in the treatment of mild-to-moderate essential hypertension. Cur Ther Res 1999; 60 (10): 511–20.
________________________________________________
1. Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertension 2013, 31: 1281–357.
2. Klinicheskie rekomendatsii. Diagnostika i lechenie arterial'noi gipertonii. Kardiolog. vestn. 2015; 1: 3–30. [in Russian]
3. Task Force Members, Montalescot G, Sechtem U, Achenbach S et al; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H et al; Document Reviewers, Knuuti J, Valgimigli M, Bueno H et al. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J 2013; 34 (38): 2949–3003.
4. Kukes V.G., Ostroumova O.D., Starodubtsev A.K. Antagonisty kal'tsiia: sovremennye aspekty primeneniia v kardiologii. Consilium Medicum. 2006; 8 (11): 113–7. [in Russian]
5. Toyo-Oka T, Nayler WG. Third generation calcium entry blockers. Blood Press 1996; 5: 206–8.
6. Preobrazhenskii D.V., Nosenko N.S., Nekrasova N.I. i dr. Antagonist kal'tsiia tret'ego pokoleniia amlodipin: osobennosti klinicheskoi farmakologii i spektr terapevticheskogo primeneniia. Rus. med. zhurn. 2011; 14: 884–90. [in Russian]
7. Neaton JD, Grimm RH Jr, Prineas RJ et al. Treatment of Mild Hypertension Study. Final results. Treatment of Mild Hypertension Study Research Group. JAMA 1993; 270 (6): 713–24.
8. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2988–97.
9. Dahlöf B, Sever PS, Poulter NR et al; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentrerandomised controlled trial. Lancet 2005; 366: 895–906.
10. Julius S, Kjeldsen SE, Weber M et al; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363 (9426): 2022–31.
11. Jamerson K, Weber MA, Bakris GL et al, for the Accomplish trial investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med 2008; 359: 2417–28.
12. Jamerson K, Bakris GL, Dahlöf B et al; ACCOMPLISH Investigators. Exceptional early blood pressure control rates: the ACCOMPLISH trial. Blood Press 2007; 16: 80–6.
13. Weber MA, Bakris GL, Jamerson K et al; ACCOMPLISH Investigators. Cardiovascular events during differing hypertension therapies in patients with diabetes. JACC 2010; 56 (1): 77–85.
14. Rothwell PM, Howard SC, Dolan E et al. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet 2010; 375: 895–905.
15. Webb AJS, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in BP and risk of stroke: a systematic review and meta-analysis. Lancet 2010; 375: 906–15.
16. Rothwell PM, Webb AJS. Effect of Dose and Combination of Antihypertensives on Interindividual Blood Pressure Variability: A Systematic Review. Stroke 2011; 42: 2860–5.
17. Verdecchia P, Angeli F, Gattobigio R et al. Impact of Blood Pressure Variability on Cardiac and Cerebrovascular Complications in Hypertension. Am J Hypertens 2007; 20: 154–61.
18. London G, Asmar R, Schmieder R, Calvo C. Antihypertensive efficacy of Indapamide SR vs candesartan and amlodipine in hypertensive patients in isolated hypertensive patients. Am J Hypertens 2004; 17 (5): 183А.
19. Peixoto AJ, White WB. Circadian blood pressure: clinical implications based on the pathophysiology of its variability. Kidney Int 2007; 71 (9): 855–60.
20. Willich SN. Circadian variation and triggering of cardiovascular events. Vasc Med 1999; 4: 41–9.
21. Willich SN, Goldberg RJ, Maclure M et al. Increased onset of sudden cardiac death in the first three hours after awakening. Am J Cardiol 1992; 70: 65–8.
22. Kaplan NM. Morning surge in blood pressure. Circulation 2003; 107: 1347.
23. Chalmers J, Arima H, Woodward M et al. Effects of combination of perindopril, indapamide, and calcium channel blockers in patients with type 2 diabetes mellitus: results from the Action In Diabetes and Vascular Disease: Preterax and Diamicron Controlled Evaluation (ADVANCE) trial. Hypertension 2014; 63: 259–64.
24. Bakris GL, Sarafidis PA, Weir MR et al; ACCOMPLISH Trial investigators. Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of randomised controlled trial. Lancet 2010; 375: 1173–81.
25. Nissen SE, Tuzcu EM, Libby P et al, for the CAMELOT Investigators. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure. The CAMELOT study: a randomized controlled trial. JAMA 2004; 292: 2217–26.
26. Pitt B, Byington RP, Furberg CD et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation 2000; 102 (13): 1503–10.
27. Jorgensen B, Simonsen S, Endresen K et al. Restenosis and Clinical Outcome in Patients Treated With Amlodipine After Angioplasty: Results From the Coronary Angio Plasty Amlodipine REStenosis Study (CAPARES). J Am Coll Cardiol 2000; 35 (3): 592–9.
28. Deanfield JE, Jean-Marie RG, Detry J-MRG et al. For the CAPE study group. Amlodipine reduces transient myocardial ischemia in patients with coronary artery disease: double-blind Circadian Anti-Ischemia Program in Europe (CAPE Trial). J Am Coll Cardiol 1994; 24 (6): 1460–7.
29. Packer M, O’Connor CM, Ghali JK et al. For the Prospective Randomized Amlodipine Survival Evaluation Study Group. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. N Engl J Med 1996; 335: 1107–14.
30. Kloner RA, Vetrovec GW, Materson BJ, Levenstein M. Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients. Am J Cardiol 1998; 81 (2): 163–9.
31. Hansson L. The Hypertension Optimal Treatment study and the importance of lowering blood pressure. J Hypertens Suppl 1999; 17 (1): S9–13.
32. Liu L, Zhang Y, Liu G; FEVER Study Group. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens 2005; 23 (12): 2157–72.
33. Zhang Y, Zhang X, Liu L, Zanchetti A; FEVER Study Group. Effects of individual risk factors on the residual risk of cardiovascular events in a population of treated Chinese patients with hypertension: data from the Felodipine Event Reduction (FEVER) study. J Hypertens 2010; 28 (10): 2016–25.
34. Wong ND, Teng W, Abrahamson D et al. Noninvasive tracking of coronary atherosclerosis by electron beam computed tomography: Rationale and design of the Felodipine Atherosclerosis Prevention Study (FAPS). Am J Cardiol 1995; 76 (17): 1239–42.
35. Kukes V.G., Starodubtsev A.K. Klinicheskaia farmakologiia i farmakoterapiia. M.: GEOTAR-Media, 2012; s. 181–92. [in Russian]
36. Schaefer RM, Aldons PM, Burgess ED et al. Improved tolerability of felodipine compared with amlodipine in elderly hypertensives: a randomised, double-blind study in 535 patients, focusing on vasodilatory adverse events. The International Study Group. Int J Clin Pract 1998; 52 (6): 381–6.
37. Cheung BMY, Lau Сh-P, Wu B-Zh. Amlodipine, Felodipine, and Isradipine in the Treatment of Chinese Patients with Mild-to-Moderate Hypertension. Clin Ther 1998; 20 (6): 1159–69.
38. Vestra MD, Pozza G, Mosca A et al. Effect of lercanidipine compared with ramipril on albumin excretion rate in hypertensive Type 2 diabetic patients with microalbuminuria: DIAL study (Diabete, Ipertensione, Albuminuria, Lercanidipina). Diab Nutr Metab 2004; 17: 259–66.
39. Robles NR, Ocon J, Gomez CF et al. Lercanidipine in patients with chronic renal failure: the ZAFRA study. Ren Fail 2005; 27 (1): 73–80.
40. Borghi С, Prandin MG, Dormi A et al. The use of lercanidipine can improve the individual tolerability in dihydropyridine calcium blockers in hypertensive patients. J Hypertension 2000; 18 (Suppl. 2): S155–S156 (abstract).
41. Leonetti G, Magnani B, Pessina AC et al; COHORT Study Group. Tolerability of long-term treatment with lercanidipine versus amlodipine and lacidipine in elderly hypertensives. Am J Hypertens 2002; 15 (11): 932–40.
42. Lund-Johansena P, Strandenb E, Helbergc S et al. Quantification of leg oedema in postmenopausal hypertensive patients treated with lercanidipine or amlodipine. J Hypertension 2003; 21: 1003–10.
43. De Giorgio LA, Orlandini F, Malasoma P, Zappa A. Double-blind, crossover study of lercanidipine versus amlodipine in the treatment of mild-to-moderate essential hypertension. Cur Ther Res 1999; 60 (10): 511–20.
1 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И.Евдокимова» Минздрава России. 127473, Россия, Москва, ул. Делегатская, д. 20, стр. 1;
2 ФГАОУ ВО «Первый Московский государственный университет им. И.М.Сеченова» Минздрава России. 119991, Россия, Москва, ул. Трубецкая, 8, стр. 2
*ostroumova.olga@mail.ru
1 A.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian Federation. 127473, Russian Federation, Moscow, ul. Delegatskaia, d. 20, str. 1;
2 I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubetskaia d. 8, str. 1
*ostroumova.olga@mail.ru