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Политаблетка в профилактике сердечно-сосудистых заболеваний: доказательная база, ограничения и перспективы (по материалам доклада Европейского общества по артериальной гипертензии)
Морозова Т.Е., Юдина И.Ю., Карноух К.И., Шацкий Д.А. Политаблетка в профилактике сердечно-сосудистых заболеваний: доказательная база, ограничения и перспективы (по материалам доклада Европейского общества по артериальной гипертензии). Consilium Medicum. 2017; 19 (10): 8–12. DOI: 10.26442/2075-1753_19.10.8-12
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Morozova T.E., Yudina I.Yu., Karnoukh K.I., Shatskiy D.A. Polypill in the prevention of cardiovascular diseases: evidence base, limitations and prospects (based on the report of the European Society for Hypertension). Consilium Medicum. 2017; 19 (10): 8–12. DOI: 10.26442/2075-1753_19.10.8-12
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Аннотация
В статье обсуждаются доказательная база, ограничения и перспективы использования комбинированных многокомпонентных препаратов в профилактике сердечно-сосудистых заболеваний. Комплексная антигипертензивная, липидснижающая, сахароснижающая и антиагрегантная терапия существенно снижает риск сердечно-сосудистых осложнений и фатальных событий. Однако в реальной клинической практике полноценная реализация всех этих подходов не всегда проводится, что снижает эффективность профилактики сердечно-сосудистых заболеваний.
Ключевые слова: политаблетка, полипилюля, приверженность, факторы риска, артериальная гипертензия, профилактика, комбинированная терапия.
Ключевые слова: политаблетка, полипилюля, приверженность, факторы риска, артериальная гипертензия, профилактика, комбинированная терапия.
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The article discusses the evidence base, limitations and prospects for the use of combined multicomponent drugs in the prevention of cardiovascular diseases. Complex of antihypertensive, lipid-lowering, hypoglycemic and antiplatelet therapy significantly reduces the risk of cardiovascular complications and fatal events. However, in real clinical practice, a full implementation of all these approaches is not always carried out, which reduces the effectiveness of preventing cardiovascular diseases.
Key words: poly-drug, polypill, adherence, risk factors, arterial hypertension, prevention, combined therapy.
Полный текст
Список литературы
1. World Health Organization. Secondary prevention of noncommunicable disease in low and middle income countries through communitybased and health service interventions. WHO – Wellcome Trust Meeting report 1–3. Geneva: World Health Organization; 2002.
2. Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002; 360: 2–3.
3. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419.
4. Chapman RH, Benner JS, Petrilla AA et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165: 1147–52.
5. Corrao G, Conti V, Merlino L et al. Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy. Clin Ther 2010; 32: 300–10.
6. DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 2004; 42: 200–9.
7. Wang TD, Chen YH, Huang CH et al. Bidirectional adherence changes and associated factors in patients switched from free combinations to equivalent single-pill combinations of antihypertensive drugs. Hypertension 2014; 63: 958–67.
8. Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents. Am J Health Syst Pharm 2007; 64: 1279–83.
9. Brambilla G, Bombelli M, Seravalle G et al. Prevalence and clinical characteristics of patients with true resistant hypertension in central and Eastern Europe: data from the BPCARE study. J Hypertens 2013; 31: 2018–24.
10. Kotseva K, Wood D, De Backer G et al, EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil 2009; 16: 121–37.
11. Volpe M, Tocci G, Trimarco B et al. Blood pressure control in Italy: results of recent surveys on hypertension. J Hypertens 2007; 25: 1491–8.
12. 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 Hypertens 2013; 31: 1281–357.
13. Zanchetti A. Bottom blood pressure or bottom cardiovascular risk? How far can cardiovascular risk be reduced? J Hypertens 2009; 27: 1509–20.
14. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation 2009; 119: 3028–35.
15. Hughes D, McGuire A. The direct costs to the NHS of discontinuing and switching prescriptions for hypertension. J Hum Hypertens 1998; 12: 533–7.
16. McCombs JS, Nichol MB, Newman CM, Sclar DA. The costs of interrupting antihypertensive drug therapy in a Medicaid population. Med Care 1994; 32: 214–26.
17. Corrao G, Parodi A, Nicotra F et al. Better compliance to antihypertensive medications reduces cardiovascular risk. J Hypertens 2011; 29: 610–8.
18. Corrao G, Rea F, Ghirardi A et al. Adherence with antihypertensive drug therapy and the risk of heart failure in clinical practice. Hypertension 2015; 66: 742–9.
19. Corrao G, Ibrahim B, Nicotra F et al. Long-term use of statins reduces the risk of hospitalization for dementia. Atherosclerosis 2013; 230: 171–6.
20. Hameed MA, Dasgupta I, Gill P. Poor adherence to antihypertensive drugs. BMJ 2016; 354: i3268.
21. Mancia G, Zambon A, Soranna D et al. Factors involved in the discontinuation of antihypertensive drug therapy: an analysis from real life data. J Hypertens 2014; 32: 1708–15.
22. Holmes HM, Luo R, Hanlon JT et al. Ethnic disparities in adherence to antihypertensive medications of Medicare part D beneficiaries. J Am Geriatr Soc 2012; 60: 1298–303.
23. Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003; 326: 1427.
24. Sinnott SJ, Buckley C, O’Riordan D et al. The effect of copayments for prescriptions on adherence to prescription medicines in publicly insured populations; a systematic review and meta-analysis. PLoS One 2013; 8:e64914.
25. Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a metaanalysis. Hypertension 2010; 55: 399–407.
26. Zanchetti A, Thomopoulos C, Parati G. Randomized controlled trials of blood pressure lowering in hypertension: a critical reappraisal. Circ Res 2015; 116: 1058–73.
27. Yusuf S, Pais P, Sigamani A et al. Comparison of risk actor reduction and tolerability of a full-dose polypill (with potassium) versus low-dose polypill (Polycap) in individuals at high risk of cardiovascular diseases the Second Indian Polycap Study (TIPS-2) investigators. Circ Cardiovasc Qual Outcomes 2012; 5: 463–71.
28. Thom S, Poulter N, Field J et al. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA 2013; 310: 918–29.
29. Selak V, Elley CR, Bullen C et al. Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomized controlled trial in primary care. BMJ 2014; 348: g3318.
30. Patel A, Cass A, Peiris D et al. A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk. Eur J Prev Cardiol 2015; 22: 920–30.
31. Рolypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol 2014; 64: 2071–82.
32. Tamargo J, Castellano JM, Fuster V. The Fuster-CNIC-Ferrer cardiovascular polypill: a polypill for secondary cardiovascular prevention. Int J Cardiol 2015; 201 (Suppl 1): S15–S22.
33. Kolte D, Aronow WS, Banach M. Polypills for the prevention of cardiovascular diseases. Expert Opin Investig Drugs 2016; 22: 1–10.
34. Guglietta A, Guerrero M. Issues to consider in the pharmaceutical development of a cardiovascular polypill. Nat Clin Pract Cardiovasc Med 2009; 6: 112–9.
35. Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill (PolyIran). Available at: http://clinicaltrials. gov/ct2/show/NCT01271985.
36. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome incidence in hypertension: 3. Effects in patients at different levels of cardiovascular risk – overview and meta-analyses of randomized trials. J Hypertens 2014; 32: 23052314.
37. Huffman MD, Xavier D, Perel P. Uses of polypills for cardiovascular disease and evidence to date. Lancet 2017; 389: 1055–65.
2. Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002; 360: 2–3.
3. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419.
4. Chapman RH, Benner JS, Petrilla AA et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165: 1147–52.
5. Corrao G, Conti V, Merlino L et al. Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy. Clin Ther 2010; 32: 300–10.
6. DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 2004; 42: 200–9.
7. Wang TD, Chen YH, Huang CH et al. Bidirectional adherence changes and associated factors in patients switched from free combinations to equivalent single-pill combinations of antihypertensive drugs. Hypertension 2014; 63: 958–67.
8. Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents. Am J Health Syst Pharm 2007; 64: 1279–83.
9. Brambilla G, Bombelli M, Seravalle G et al. Prevalence and clinical characteristics of patients with true resistant hypertension in central and Eastern Europe: data from the BPCARE study. J Hypertens 2013; 31: 2018–24.
10. Kotseva K, Wood D, De Backer G et al, EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil 2009; 16: 121–37.
11. Volpe M, Tocci G, Trimarco B et al. Blood pressure control in Italy: results of recent surveys on hypertension. J Hypertens 2007; 25: 1491–8.
12. 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 Hypertens 2013; 31: 1281–357.
13. Zanchetti A. Bottom blood pressure or bottom cardiovascular risk? How far can cardiovascular risk be reduced? J Hypertens 2009; 27: 1509–20.
14. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation 2009; 119: 3028–35.
15. Hughes D, McGuire A. The direct costs to the NHS of discontinuing and switching prescriptions for hypertension. J Hum Hypertens 1998; 12: 533–7.
16. McCombs JS, Nichol MB, Newman CM, Sclar DA. The costs of interrupting antihypertensive drug therapy in a Medicaid population. Med Care 1994; 32: 214–26.
17. Corrao G, Parodi A, Nicotra F et al. Better compliance to antihypertensive medications reduces cardiovascular risk. J Hypertens 2011; 29: 610–8.
18. Corrao G, Rea F, Ghirardi A et al. Adherence with antihypertensive drug therapy and the risk of heart failure in clinical practice. Hypertension 2015; 66: 742–9.
19. Corrao G, Ibrahim B, Nicotra F et al. Long-term use of statins reduces the risk of hospitalization for dementia. Atherosclerosis 2013; 230: 171–6.
20. Hameed MA, Dasgupta I, Gill P. Poor adherence to antihypertensive drugs. BMJ 2016; 354: i3268.
21. Mancia G, Zambon A, Soranna D et al. Factors involved in the discontinuation of antihypertensive drug therapy: an analysis from real life data. J Hypertens 2014; 32: 1708–15.
22. Holmes HM, Luo R, Hanlon JT et al. Ethnic disparities in adherence to antihypertensive medications of Medicare part D beneficiaries. J Am Geriatr Soc 2012; 60: 1298–303.
23. Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003; 326: 1427.
24. Sinnott SJ, Buckley C, O’Riordan D et al. The effect of copayments for prescriptions on adherence to prescription medicines in publicly insured populations; a systematic review and meta-analysis. PLoS One 2013; 8:e64914.
25. Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a metaanalysis. Hypertension 2010; 55: 399–407.
26. Zanchetti A, Thomopoulos C, Parati G. Randomized controlled trials of blood pressure lowering in hypertension: a critical reappraisal. Circ Res 2015; 116: 1058–73.
27. Yusuf S, Pais P, Sigamani A et al. Comparison of risk actor reduction and tolerability of a full-dose polypill (with potassium) versus low-dose polypill (Polycap) in individuals at high risk of cardiovascular diseases the Second Indian Polycap Study (TIPS-2) investigators. Circ Cardiovasc Qual Outcomes 2012; 5: 463–71.
28. Thom S, Poulter N, Field J et al. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA 2013; 310: 918–29.
29. Selak V, Elley CR, Bullen C et al. Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomized controlled trial in primary care. BMJ 2014; 348: g3318.
30. Patel A, Cass A, Peiris D et al. A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk. Eur J Prev Cardiol 2015; 22: 920–30.
31. Рolypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol 2014; 64: 2071–82.
32. Tamargo J, Castellano JM, Fuster V. The Fuster-CNIC-Ferrer cardiovascular polypill: a polypill for secondary cardiovascular prevention. Int J Cardiol 2015; 201 (Suppl 1): S15–S22.
33. Kolte D, Aronow WS, Banach M. Polypills for the prevention of cardiovascular diseases. Expert Opin Investig Drugs 2016; 22: 1–10.
34. Guglietta A, Guerrero M. Issues to consider in the pharmaceutical development of a cardiovascular polypill. Nat Clin Pract Cardiovasc Med 2009; 6: 112–9.
35. Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill (PolyIran). Available at: http://clinicaltrials. gov/ct2/show/NCT01271985.
36. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome incidence in hypertension: 3. Effects in patients at different levels of cardiovascular risk – overview and meta-analyses of randomized trials. J Hypertens 2014; 32: 23052314.
37. Huffman MD, Xavier D, Perel P. Uses of polypills for cardiovascular disease and evidence to date. Lancet 2017; 389: 1055–65.
________________________________________________
1. World Health Organization. Secondary prevention of noncommunicable disease in low and middle income countries through communitybased and health service interventions. WHO – Wellcome Trust Meeting report 1–3. Geneva: World Health Organization; 2002.
2. Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002; 360: 2–3.
3. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419.
4. Chapman RH, Benner JS, Petrilla AA et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165: 1147–52.
5. Corrao G, Conti V, Merlino L et al. Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy. Clin Ther 2010; 32: 300–10.
6. DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 2004; 42: 200–9.
7. Wang TD, Chen YH, Huang CH et al. Bidirectional adherence changes and associated factors in patients switched from free combinations to equivalent single-pill combinations of antihypertensive drugs. Hypertension 2014; 63: 958–67.
8. Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents. Am J Health Syst Pharm 2007; 64: 1279–83.
9. Brambilla G, Bombelli M, Seravalle G et al. Prevalence and clinical characteristics of patients with true resistant hypertension in central and Eastern Europe: data from the BPCARE study. J Hypertens 2013; 31: 2018–24.
10. Kotseva K, Wood D, De Backer G et al, EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil 2009; 16: 121–37.
11. Volpe M, Tocci G, Trimarco B et al. Blood pressure control in Italy: results of recent surveys on hypertension. J Hypertens 2007; 25: 1491–8.
12. 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 Hypertens 2013; 31: 1281–357.
13. Zanchetti A. Bottom blood pressure or bottom cardiovascular risk? How far can cardiovascular risk be reduced? J Hypertens 2009; 27: 1509–20.
14. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation 2009; 119: 3028–35.
15. Hughes D, McGuire A. The direct costs to the NHS of discontinuing and switching prescriptions for hypertension. J Hum Hypertens 1998; 12: 533–7.
16. McCombs JS, Nichol MB, Newman CM, Sclar DA. The costs of interrupting antihypertensive drug therapy in a Medicaid population. Med Care 1994; 32: 214–26.
17. Corrao G, Parodi A, Nicotra F et al. Better compliance to antihypertensive medications reduces cardiovascular risk. J Hypertens 2011; 29: 610–8.
18. Corrao G, Rea F, Ghirardi A et al. Adherence with antihypertensive drug therapy and the risk of heart failure in clinical practice. Hypertension 2015; 66: 742–9.
19. Corrao G, Ibrahim B, Nicotra F et al. Long-term use of statins reduces the risk of hospitalization for dementia. Atherosclerosis 2013; 230: 171–6.
20. Hameed MA, Dasgupta I, Gill P. Poor adherence to antihypertensive drugs. BMJ 2016; 354: i3268.
21. Mancia G, Zambon A, Soranna D et al. Factors involved in the discontinuation of antihypertensive drug therapy: an analysis from real life data. J Hypertens 2014; 32: 1708–15.
22. Holmes HM, Luo R, Hanlon JT et al. Ethnic disparities in adherence to antihypertensive medications of Medicare part D beneficiaries. J Am Geriatr Soc 2012; 60: 1298–303.
23. Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003; 326: 1427.
24. Sinnott SJ, Buckley C, O’Riordan D et al. The effect of copayments for prescriptions on adherence to prescription medicines in publicly insured populations; a systematic review and meta-analysis. PLoS One 2013; 8:e64914.
25. Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a metaanalysis. Hypertension 2010; 55: 399–407.
26. Zanchetti A, Thomopoulos C, Parati G. Randomized controlled trials of blood pressure lowering in hypertension: a critical reappraisal. Circ Res 2015; 116: 1058–73.
27. Yusuf S, Pais P, Sigamani A et al. Comparison of risk actor reduction and tolerability of a full-dose polypill (with potassium) versus low-dose polypill (Polycap) in individuals at high risk of cardiovascular diseases the Second Indian Polycap Study (TIPS-2) investigators. Circ Cardiovasc Qual Outcomes 2012; 5: 463–71.
28. Thom S, Poulter N, Field J et al. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA 2013; 310: 918–29.
29. Selak V, Elley CR, Bullen C et al. Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomized controlled trial in primary care. BMJ 2014; 348: g3318.
30. Patel A, Cass A, Peiris D et al. A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk. Eur J Prev Cardiol 2015; 22: 920–30.
31. Рolypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol 2014; 64: 2071–82.
32. Tamargo J, Castellano JM, Fuster V. The Fuster-CNIC-Ferrer cardiovascular polypill: a polypill for secondary cardiovascular prevention. Int J Cardiol 2015; 201 (Suppl 1): S15–S22.
33. Kolte D, Aronow WS, Banach M. Polypills for the prevention of cardiovascular diseases. Expert Opin Investig Drugs 2016; 22: 1–10.
34. Guglietta A, Guerrero M. Issues to consider in the pharmaceutical development of a cardiovascular polypill. Nat Clin Pract Cardiovasc Med 2009; 6: 112–9.
35. Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill (PolyIran). Available at: http://clinicaltrials. gov/ct2/show/NCT01271985.
36. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome incidence in hypertension: 3. Effects in patients at different levels of cardiovascular risk – overview and meta-analyses of randomized trials. J Hypertens 2014; 32: 23052314.
37. Huffman MD, Xavier D, Perel P. Uses of polypills for cardiovascular disease and evidence to date. Lancet 2017; 389: 1055–65.
Авторы
Т.Е.Морозова*, И.Ю.Юдина, К.И.Карноух, Д.А.Шацкий
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М.Сеченова» Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2
*temorozova@gmail.com
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М.Сеченова» Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2
*temorozova@gmail.com
________________________________________________
T.E.Morozova*, I.Yu.Yudina, K.I.Karnoukh, D.A.Shatskiy
I.M.Sechenov First Moscow Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2
*temorozova@gmail.com
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