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Место розувастатина в липидснижающей терапии у пациентов с разным уровнем сердечно-сосудистого риска: клиническая и фармакоэкономическая эффективность
Место розувастатина в липидснижающей терапии у пациентов с разным уровнем сердечно-сосудистого риска: клиническая и фармакоэкономическая эффективность
Сергиенко И.В., Рудакова А.В., Карпова Е.В. Место розувастатина в липидснижающей терапии у пациентов с разным уровнем сердечно-сосудистого риска: клиническая и фармакоэкономическая эффективность. Consilium Medicum. 2017; 19 (12): 66–73. DOI: 10.26442/2075-1753_19.12.66-73
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Аннотация
Розувастатин является ингибитором редуктазы гидроксиметил-глютарового кофермента А IV поколения, хорошо изученным в рамках программы клинических исследований GALAXY. Его высокая эффективность и безопасность наряду с практически отсутствующим взаимодействием с системой цитохрома P450 являются очевидными преимуществами в терапии гиперхолестеринемии, одного из основных факторов развития сердечно-сосудистых заболеваний. В статье обсуждается место статинов в целом и розувастатина в частности в липидснижающей терапии в свете последних рекомендаций, а также проводится оценка эффективности затрат на генерический препарат розувастатина (Розарт) у пациентов с разным уровнем сердечно-сосудистого риска. Исследование проводилось с позиции системы здравоохранения с помощью марковского моделирования на период 10 лет. Результаты проведенного анализа данных показали, что при первичной профилактике ишемической болезни сердца экономическая эффективность розувастатина (Розарт) возрастает с увеличением уровня кардиоваскулярного риска, при этом назначение препарата с целью замедления прогрессирования атеросклероза для вторичной профилактики ишемической болезни сердца является экономически более эффективным, чем первичная профилактика.
Ключевые слова: розувастатин, Розарт, фармакоэкономика.
Key words: rosuvastatin, Rozart, pharmacoeconomics.
Ключевые слова: розувастатин, Розарт, фармакоэкономика.
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Key words: rosuvastatin, Rozart, pharmacoeconomics.
Полный текст
Список литературы
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2. Yusuf S et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004; 364: 937–52.
3. Cooney MT, Dudina AL, Graham IM. Value and Limitations of Existing Scores for the Assessment of Cardiovascular Risk. J Am Coll Cardiol 2009; 54: 1209–27.
4. Risk Functions. Framingham Heart Study. Available at: https://www.framinghamheartstudy.org/risk-functions/
5. D’Agostino RB et al. General Cardiovascular Risk Profile for Use in Primary Care: The Framingham Heart Study. Circulation 2008; 117: 743–53.
6. SCORE Risk Charts. Available at: https://www.escardio.org/Education/Practice-Tools/CVD-prevention-toolbox/SCORE-Risk-Charts.
7. Goff DC et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129: S49–73.
8. Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study. Circulation 2002; 105: 310–5.
9. WHO | Cardiovascular risk prediction charts. WHO. 2014.
10. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), Dudina MT, D’Agostino RB, Graham IM. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002; 106: 3143–421.
11. Conroy RM et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003; 24: 987–1003.
12. Sergienko I.V., Ezhov M.V., Kukharchuk V.V. i dr. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Ateroskleroz i dislipidemii. 2017; 3: 5–23. [in Russian]
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14. Pereira T. In Dyslipidemia – From Prevention to Treatment (InTech, 2012). DOI: 10.5772/27378.
15. Catapano AL et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37: 2999–3058.
16. Cholesterol Treatment Trialists’ (CTT) Collaboration, C. T. T. (CTT) et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010; 376: 1670–81.
17. Rosenson RS. Statins: Actions, side effects, and administration. Available at: https://www.uptodate.com/ contents/statins-actions- side-effects-and-administration (2017).
18. Crouse JR et al. Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis. JAMA 2007; 297: 1344.
19. Hu M, Tomlinson B. Current Perspectives on rosuvastatin. Integr. Blood Press Control 2013; 6: 15–25.
20. Schuster H. The GALAXY Program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev. Cardiovasc Ther 2007; 5: 177–93.
21. Karlson BW, Barter PJ, Palmer MK et al. Comparison of the effects of different statins and doses on lipid levels in patients with diabetes: Results from VOYAGER. Nutr Metab Cardiovasc Dis 2012; 22: 697–703.
22. Rosenson RS, Otvos JD, Hsia J. Effects of rosuvastatin and atorvastatin on LDL and HDL particle concentrations in patients with metabolic syndrome: a randomized, double-blind, controlled study. Diabetes Care 2009; 32: 1087–91.
23. Barter PJ, Brandrup-Wognsen G, Palmer MK, Nicholls SJ. Effect of statins on HDL-C: a complex process unrelated to changes in LDL-C: analysis of the VOYAGER Database.
J Lipid Res 2010; 51: 1546–53.
24. Jones PH et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol 2003; 92: 152–60.
25. Bakker-Arkema RG et al. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA 1996; 275: 128–33.
26. Davidson M et al. Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I. Am J Cardiol 1997; 79: 1475–81.
27. Mulder AB et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001; 70: 546–51.
28. Chasman DI et al. Pharmacogenetic study of statin therapy and cholesterol reduction. JAMA 2004; 291: 2821–7.
29. Bakhai A, Rigney U, Hollis S, Emmas C. Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population. Pharmacoepidemiol Drug Saf 2012; 21: 485–93.
30. White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963–70.
31. Olsson AG, McTaggart F, Raza A. Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor. Cardiovasc Drug Rev 2002; 20: 303–28.
32. Rosenson SR, Baker SK. Statin myopathy (2016). Available at: https://www.uptodate.com/contents/statin-myopathy
33. García-Rodríguez LA, Massó-González EL, Wallander M-A, Johansson S. The safety of rosuvastatin in comparison with other statins in over 100 000 statin users in UK primary care. Pharmacoepidemiol Drug Saf 2008; 17: 943–52.
34. Ridker PM et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195–207.
35. Sattar N et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.
36. Shalnova SA et al. Awareness and treatment specifics of statin therapy in persons with various cardiovasular risk: the study ESSE-RF. Cardiovasc Ther Prev 2016; 15: 29–37.
37. Rawlings R et al. Comparison of effects of rosuvastatin (10 mg) versus atorvastatin (40 mg) on rho kinase activity in caucasian men with a previous atherosclerotic event. Am J Cardiol 2009; 103: 437–41.
38. Durrington PN, Tuomilehto J, Hamann A et al. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidaemia. Diabetes Res Clin Pract 2004; 64: 137–51.
39. Rosenson RS. Rosuvastatin: a new inhibitor of HMG-CoA reductase for the treatment of dyslipidemia. Expert Rev Cardiovasc Ther 2003; 1: 495–505.
40. Teramoto T, Watkins C. Review of efficacy of rosuvastatin 5 mg. Int J Clin Pract 2005; 59: 92–101.
41. Ullah F, Afridi AK, Rahim F et al. Efficacy of 5 mg and 10 mg rosuvastatin in type-2 diabetes mellitus with hypercholesteroalemia. J Ayub Med Coll Abbottabad 2015; 27: 564–8.
42. Meek C et al. Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study. Curr Med Res Opin 2012; 28: 371–8.
43. Olsson AG et al. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J 2002; 144: 1044–51.
44. Clearfield MB et al. Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006; 7: 35.
45. Berne C, Siewert-Delle A, URANUS study investigators, the U. study. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol 2005; 4: 7.
46. Cevc M. Comparison of efficacy and safety of rosuvastatin 15 mg vs. 10 mg: subanalysis of the ROSU-PATH trial (2016). http://congress365.escardio.org/Presentation/140210#.Wf0HX1u0Opp
47. Schuster H et al. Effects of switching statins on achievement of lipid goals: measuring effective reductions in cholesterol using rosuvastatin therapy (MERCURY I) study. Am Heart J 2004; 147: 705–12.
48. Bando Y et al. Switching from atorvastatin to rosuvastatin lowers small, dense low-density lipoprotein cholesterol levels in Japanese hypercholesterolemic patients with type 2 diabetes mellitus. Diabet Res Clin Pract 2016; 111: 66–73.
49. Stein EA et al. Long-Term Efficacy and Safety of Rosuvastatin 40 mg in Patients With Severe Hypercholesterolemia. Am J Cardiol 2007; 100: 1387–96.
50. Leiter LA et al. Efficacy and safety of rosuvastatin 40mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolemia: Results of the POLARIS study. Atherosclerosis 2007; 194: e154–e164.
51. Lipid-modifying drugs. 2015. Available at: https://www.nice.org. uk/guidance/ktt3/resources/ lipidmodifying-drugs-pdf-1632168482245
52. Hirsch M, O’Donnell JC, Jones P. Rosuvastatin is cost-effective in treating patients to low-density lipoprotein-cholesterol goals compared with atorvastatin, pravastatin and simvastatin: analysis of the STELLAR trial. Eur J Cardiovasc Prev Rehabil 2005; 12: 18–28.
53. Gandhi S et al. Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events. Clin Outcomes Res 2012; 4: 1.
54. Hlatky M. The Cost-Effectiveness of Rosuvastatin Therapy. J Am Coll Cardiol 2011; 57: 792–3.
55. Costa-Scharplatz M, Ramanathan K, Frial T et al. Cost-effectiveness analysis of rosuvastatin versus atorvastatin, simvastatin, and pravastatin from a Canadian health system perspective. Clin Ther 2008; 30: 1345–57.
56. Gofman E.A. i dr. Pervye rezul'taty issledovaniia “Prognoz IBS”. Klinitsist. 2012; 1: 56–62. [in Russian]
57. Montalescot G 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: 2949–3003.
58. Ginzburg M.L. Izuchenie otdalennykh rezul'tatov lecheniia bol'nykh, perenesshikh ostryi infarkt miokarda, i otsenka faktorov riska, opredeliaiushchikh prognoz ikh zhizni. Avtoref. dis. … d-ra med. nauk. М.: Gosudarstvennyi nauchno-issledovatel'skii tsentr profilakticheskoi meditsiny Minzdrava Rossii, 2013. [in Russian]
59. Ward S et al. A systematic review and economic evaluation of statins for the prevention of coronary events. NIHR Heal Technol Assess Program Exec Summ 2007; 11: 1–160.
60. Dzhaiani N.A., Il'ina E.V., Tereshchenko S.N. Sovremennye aspekty primeneniia statinov pri ostrom infarkte miokarda. Serdtse. 2007; 6: 85. [in Russian]
61. McConnachie A et al. Long-term impact on healthcare resource utilization of statin treatment, and its cost effectiveness in the primary prevention of cardiovascular disease: a record linkage study. Eur Heart J 2013; 35: 290–8.
62. Neyt M, Laet C, Brabandt H et al. Cost-effectiveness of statins in the primary prevention of cardiovascular disease: a systematic review and economic analysis for Belgium. Acta Cardiol 2009; 64: 1–10.
63. Peura P, Martikainen J, Soini E et al. Cost-effectiveness of statins in the prevention of coronary heart disease events in middle-aged Finnish men. Curr Med Res Opin 2008; 24: 1823–32.
64. Ito MK et al. Statins for Cardiovascular Prevention According to Different Strategies. Am J Cardiovasc drugs 2011; 11: 33–44.
65. Mal' G.S., Zheludkov I.S., Meshkov A.I. K voprosu o farmakoekonomike statinov pri lechenii IBS. Sovr. naukoemkie tekhnologii. 2004; 6. [in Russian]
66. Rudakova A.V. Statiny v terapii ishemicheskoi bolezni serdtsa: farmakoekonomicheskie aspekty. Serdtse. 2008; 7: 227–33. [in Russian]
67. Brugts JJ, Yetgin T, Hoeks SE et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ 2009; 338: b2376. DOI: 10.1136/bmj.b2376
2. Yusuf S et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004; 364: 937–52.
3. Cooney MT, Dudina AL, Graham IM. Value and Limitations of Existing Scores for the Assessment of Cardiovascular Risk. J Am Coll Cardiol 2009; 54: 1209–27.
4. Risk Functions. Framingham Heart Study. Available at: https://www.framinghamheartstudy.org/risk-functions/
5. D’Agostino RB et al. General Cardiovascular Risk Profile for Use in Primary Care: The Framingham Heart Study. Circulation 2008; 117: 743–53.
6. SCORE Risk Charts. Available at: https://www.escardio.org/Education/Practice-Tools/CVD-prevention-toolbox/SCORE-Risk-Charts.
7. Goff DC et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129: S49–73.
8. Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study. Circulation 2002; 105: 310–5.
9. WHO | Cardiovascular risk prediction charts. WHO. 2014.
10. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), Dudina MT, D’Agostino RB, Graham IM. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002; 106: 3143–421.
11. Conroy RM et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003; 24: 987–1003.
12. Сергиенко И.В., Ежов М.В., Кухарчук В.В. и др. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Атеросклероз и дислипидемии. 2017; 3: 5–23. / Sergienko I.V., Ezhov M.V., Kukharchuk V.V. i dr. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Ateroskleroz i dislipidemii. 2017; 3: 5–23. [in Russian]
13. Рабочая группа Европейского общества кардиологов (ЕОК) и Европейского общества атеросклероза (ЕОА) по лечению дислипидемий. Рекомендации Европейского общества кардиологов и Европейского общества атеросклероза по лечению дислипидемий. Рациональная фармакотерапия в кардиологии (Прил.). 2012; 1–3. / Rabochaia gruppa Evropeiskogo obshchestva kardiologov (EOK) i Evropeiskogo obshchestva ateroskleroza (EOA) po lecheniiu dislipidemii. Rekomendatsii Evropeiskogo obshchestva kardiologov i Evropeiskogo obshchestva ateroskleroza po lecheniiu dislipidemii. Ratsional'naia farmakoterapiia v kardiologii (Pril.). 2012; 1–3. [in Russian]
14. Pereira T. In Dyslipidemia – From Prevention to Treatment (InTech, 2012). DOI: 10.5772/27378.
15. Catapano AL et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37: 2999–3058.
16. Cholesterol Treatment Trialists’ (CTT) Collaboration, C. T. T. (CTT) et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010; 376: 1670–81.
17. Rosenson RS. Statins: Actions, side effects, and administration. Available at: https://www.uptodate.com/ contents/statins-actions- side-effects-and-administration (2017).
18. Crouse JR et al. Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis. JAMA 2007; 297: 1344.
19. Hu M, Tomlinson B. Current Perspectives on rosuvastatin. Integr. Blood Press Control 2013; 6: 15–25.
20. Schuster H. The GALAXY Program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev. Cardiovasc Ther 2007; 5: 177–93.
21. Karlson BW, Barter PJ, Palmer MK et al. Comparison of the effects of different statins and doses on lipid levels in patients with diabetes: Results from VOYAGER. Nutr Metab Cardiovasc Dis 2012; 22: 697–703.
22. Rosenson RS, Otvos JD, Hsia J. Effects of rosuvastatin and atorvastatin on LDL and HDL particle concentrations in patients with metabolic syndrome: a randomized, double-blind, controlled study. Diabetes Care 2009; 32: 1087–91.
23. Barter PJ, Brandrup-Wognsen G, Palmer MK, Nicholls SJ. Effect of statins on HDL-C: a complex process unrelated to changes in LDL-C: analysis of the VOYAGER Database.
J Lipid Res 2010; 51: 1546–53.
24. Jones PH et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol 2003; 92: 152–60.
25. Bakker-Arkema RG et al. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA 1996; 275: 128–33.
26. Davidson M et al. Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I. Am J Cardiol 1997; 79: 1475–81.
27. Mulder AB et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001; 70: 546–51.
28. Chasman DI et al. Pharmacogenetic study of statin therapy and cholesterol reduction. JAMA 2004; 291: 2821–7.
29. Bakhai A, Rigney U, Hollis S, Emmas C. Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population. Pharmacoepidemiol Drug Saf 2012; 21: 485–93.
30. White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963–70.
31. Olsson AG, McTaggart F, Raza A. Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor. Cardiovasc Drug Rev 2002; 20: 303–28.
32. Rosenson SR, Baker SK. Statin myopathy (2016). Available at: https://www.uptodate.com/contents/statin-myopathy
33. García-Rodríguez LA, Massó-González EL, Wallander M-A, Johansson S. The safety of rosuvastatin in comparison with other statins in over 100 000 statin users in UK primary care. Pharmacoepidemiol Drug Saf 2008; 17: 943–52.
34. Ridker PM et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195–207.
35. Sattar N et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.
36. Shalnova SA et al. Awareness and treatment specifics of statin therapy in persons with various cardiovasular risk: the study ESSE-RF. Cardiovasc Ther Prev 2016; 15: 29–37.
37. Rawlings R et al. Comparison of effects of rosuvastatin (10 mg) versus atorvastatin (40 mg) on rho kinase activity in caucasian men with a previous atherosclerotic event. Am J Cardiol 2009; 103: 437–41.
38. Durrington PN, Tuomilehto J, Hamann A et al. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidaemia. Diabetes Res Clin Pract 2004; 64: 137–51.
39. Rosenson RS. Rosuvastatin: a new inhibitor of HMG-CoA reductase for the treatment of dyslipidemia. Expert Rev Cardiovasc Ther 2003; 1: 495–505.
40. Teramoto T, Watkins C. Review of efficacy of rosuvastatin 5 mg. Int J Clin Pract 2005; 59: 92–101.
41. Ullah F, Afridi AK, Rahim F et al. Efficacy of 5 mg and 10 mg rosuvastatin in type-2 diabetes mellitus with hypercholesteroalemia. J Ayub Med Coll Abbottabad 2015; 27: 564–8.
42. Meek C et al. Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study. Curr Med Res Opin 2012; 28: 371–8.
43. Olsson AG et al. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J 2002; 144: 1044–51.
44. Clearfield MB et al. Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006; 7: 35.
45. Berne C, Siewert-Delle A, URANUS study investigators, the U. study. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol 2005; 4: 7.
46. Cevc M. Comparison of efficacy and safety of rosuvastatin 15 mg vs. 10 mg: subanalysis of the ROSU-PATH trial (2016). http://congress365.escardio.org/Presentation/140210#.Wf0HX1u0Opp
47. Schuster H et al. Effects of switching statins on achievement of lipid goals: measuring effective reductions in cholesterol using rosuvastatin therapy (MERCURY I) study. Am Heart J 2004; 147: 705–12.
48. Bando Y et al. Switching from atorvastatin to rosuvastatin lowers small, dense low-density lipoprotein cholesterol levels in Japanese hypercholesterolemic patients with type 2 diabetes mellitus. Diabet Res Clin Pract 2016; 111: 66–73.
49. Stein EA et al. Long-Term Efficacy and Safety of Rosuvastatin 40 mg in Patients With Severe Hypercholesterolemia. Am J Cardiol 2007; 100: 1387–96.
50. Leiter LA et al. Efficacy and safety of rosuvastatin 40mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolemia: Results of the POLARIS study. Atherosclerosis 2007; 194: e154–e164.
51. Lipid-modifying drugs. 2015. Available at: https://www.nice.org. uk/guidance/ktt3/resources/ lipidmodifying-drugs-pdf-1632168482245
52. Hirsch M, O’Donnell JC, Jones P. Rosuvastatin is cost-effective in treating patients to low-density lipoprotein-cholesterol goals compared with atorvastatin, pravastatin and simvastatin: analysis of the STELLAR trial. Eur J Cardiovasc Prev Rehabil 2005; 12: 18–28.
53. Gandhi S et al. Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events. Clin Outcomes Res 2012; 4: 1.
54. Hlatky M. The Cost-Effectiveness of Rosuvastatin Therapy. J Am Coll Cardiol 2011; 57: 792–3.
55. Costa-Scharplatz M, Ramanathan K, Frial T et al. Cost-effectiveness analysis of rosuvastatin versus atorvastatin, simvastatin, and pravastatin from a Canadian health system perspective. Clin Ther 2008; 30: 1345–57.
56. Гофман Е.А. и др. Первые результаты исследования «Прогноз ИБС». Клиницист. 2012; 1: 56–62. / Gofman E.A. i dr. Pervye rezul'taty issledovaniia “Prognoz IBS”. Klinitsist. 2012; 1: 56–62. [in Russian]
57. Montalescot G 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: 2949–3003.
58. Гинзбург М.Л. Изучение отдаленных результатов лечения больных, перенесших острый инфаркт миокарда, и оценка факторов риска, определяющих прогноз их жизни. Автореф. дис. … д-ра мед. наук. М.: Государственный научно-исследовательский центр профилактической медицины Минздрава России, 2013. / Ginzburg M.L. Izuchenie otdalennykh rezul'tatov lecheniia bol'nykh, perenesshikh ostryi infarkt miokarda, i otsenka faktorov riska, opredeliaiushchikh prognoz ikh zhizni. Avtoref. dis. … d-ra med. nauk. М.: Gosudarstvennyi nauchno-issledovatel'skii tsentr profilakticheskoi meditsiny Minzdrava Rossii, 2013. [in Russian]
59. Ward S et al. A systematic review and economic evaluation of statins for the prevention of coronary events. NIHR Heal Technol Assess Program Exec Summ 2007; 11: 1–160.
60. Джаиани Н.А., Ильина Е.В., Терещенко С.Н. Современные аспекты применения статинов при остром инфаркте миокарда. Сердце. 2007; 6: 85. / Dzhaiani N.A., Il'ina E.V., Tereshchenko S.N. Sovremennye aspekty primeneniia statinov pri ostrom infarkte miokarda. Serdtse. 2007; 6: 85. [in Russian]
61. McConnachie A et al. Long-term impact on healthcare resource utilization of statin treatment, and its cost effectiveness in the primary prevention of cardiovascular disease: a record linkage study. Eur Heart J 2013; 35: 290–8.
62. Neyt M, Laet C, Brabandt H et al. Cost-effectiveness of statins in the primary prevention of cardiovascular disease: a systematic review and economic analysis for Belgium. Acta Cardiol 2009; 64: 1–10.
63. Peura P, Martikainen J, Soini E et al. Cost-effectiveness of statins in the prevention of coronary heart disease events in middle-aged Finnish men. Curr Med Res Opin 2008; 24: 1823–32.
64. Ito MK et al. Statins for Cardiovascular Prevention According to Different Strategies. Am J Cardiovasc drugs 2011; 11: 33–44.
65. Маль Г.С., Желудков И.С., Мешков А.И. К вопросу о фармакоэкономике статинов при лечении ИБС. Совр. наукоемкие технологии. 2004; 6. / Mal' G.S., Zheludkov I.S., Meshkov A.I. K voprosu o farmakoekonomike statinov pri lechenii IBS. Sovr. naukoemkie tekhnologii. 2004; 6. [in Russian]
66. Рудакова А.В. Статины в терапии ишемической болезни сердца: фармакоэкономические аспекты. Сердце. 2008; 7: 227–33. / Rudakova A.V. Statiny v terapii ishemicheskoi bolezni serdtsa: farmakoekonomicheskie aspekty. Serdtse. 2008; 7: 227–33. [in Russian]
67. Brugts JJ, Yetgin T, Hoeks SE et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ 2009; 338: b2376. DOI: 10.1136/bmj.b2376
________________________________________________
2. Yusuf S et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004; 364: 937–52.
3. Cooney MT, Dudina AL, Graham IM. Value and Limitations of Existing Scores for the Assessment of Cardiovascular Risk. J Am Coll Cardiol 2009; 54: 1209–27.
4. Risk Functions. Framingham Heart Study. Available at: https://www.framinghamheartstudy.org/risk-functions/
5. D’Agostino RB et al. General Cardiovascular Risk Profile for Use in Primary Care: The Framingham Heart Study. Circulation 2008; 117: 743–53.
6. SCORE Risk Charts. Available at: https://www.escardio.org/Education/Practice-Tools/CVD-prevention-toolbox/SCORE-Risk-Charts.
7. Goff DC et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129: S49–73.
8. Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study. Circulation 2002; 105: 310–5.
9. WHO | Cardiovascular risk prediction charts. WHO. 2014.
10. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), Dudina MT, D’Agostino RB, Graham IM. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002; 106: 3143–421.
11. Conroy RM et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003; 24: 987–1003.
12. Sergienko I.V., Ezhov M.V., Kukharchuk V.V. i dr. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Ateroskleroz i dislipidemii. 2017; 3: 5–23. [in Russian]
13. Rabochaia gruppa Evropeiskogo obshchestva kardiologov (EOK) i Evropeiskogo obshchestva ateroskleroza (EOA) po lecheniiu dislipidemii. Rekomendatsii Evropeiskogo obshchestva kardiologov i Evropeiskogo obshchestva ateroskleroza po lecheniiu dislipidemii. Ratsional'naia farmakoterapiia v kardiologii (Pril.). 2012; 1–3. [in Russian]
14. Pereira T. In Dyslipidemia – From Prevention to Treatment (InTech, 2012). DOI: 10.5772/27378.
15. Catapano AL et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37: 2999–3058.
16. Cholesterol Treatment Trialists’ (CTT) Collaboration, C. T. T. (CTT) et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010; 376: 1670–81.
17. Rosenson RS. Statins: Actions, side effects, and administration. Available at: https://www.uptodate.com/ contents/statins-actions- side-effects-and-administration (2017).
18. Crouse JR et al. Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis. JAMA 2007; 297: 1344.
19. Hu M, Tomlinson B. Current Perspectives on rosuvastatin. Integr. Blood Press Control 2013; 6: 15–25.
20. Schuster H. The GALAXY Program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev. Cardiovasc Ther 2007; 5: 177–93.
21. Karlson BW, Barter PJ, Palmer MK et al. Comparison of the effects of different statins and doses on lipid levels in patients with diabetes: Results from VOYAGER. Nutr Metab Cardiovasc Dis 2012; 22: 697–703.
22. Rosenson RS, Otvos JD, Hsia J. Effects of rosuvastatin and atorvastatin on LDL and HDL particle concentrations in patients with metabolic syndrome: a randomized, double-blind, controlled study. Diabetes Care 2009; 32: 1087–91.
23. Barter PJ, Brandrup-Wognsen G, Palmer MK, Nicholls SJ. Effect of statins on HDL-C: a complex process unrelated to changes in LDL-C: analysis of the VOYAGER Database.
J Lipid Res 2010; 51: 1546–53.
24. Jones PH et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol 2003; 92: 152–60.
25. Bakker-Arkema RG et al. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA 1996; 275: 128–33.
26. Davidson M et al. Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I. Am J Cardiol 1997; 79: 1475–81.
27. Mulder AB et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001; 70: 546–51.
28. Chasman DI et al. Pharmacogenetic study of statin therapy and cholesterol reduction. JAMA 2004; 291: 2821–7.
29. Bakhai A, Rigney U, Hollis S, Emmas C. Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population. Pharmacoepidemiol Drug Saf 2012; 21: 485–93.
30. White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963–70.
31. Olsson AG, McTaggart F, Raza A. Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor. Cardiovasc Drug Rev 2002; 20: 303–28.
32. Rosenson SR, Baker SK. Statin myopathy (2016). Available at: https://www.uptodate.com/contents/statin-myopathy
33. García-Rodríguez LA, Massó-González EL, Wallander M-A, Johansson S. The safety of rosuvastatin in comparison with other statins in over 100 000 statin users in UK primary care. Pharmacoepidemiol Drug Saf 2008; 17: 943–52.
34. Ridker PM et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195–207.
35. Sattar N et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.
36. Shalnova SA et al. Awareness and treatment specifics of statin therapy in persons with various cardiovasular risk: the study ESSE-RF. Cardiovasc Ther Prev 2016; 15: 29–37.
37. Rawlings R et al. Comparison of effects of rosuvastatin (10 mg) versus atorvastatin (40 mg) on rho kinase activity in caucasian men with a previous atherosclerotic event. Am J Cardiol 2009; 103: 437–41.
38. Durrington PN, Tuomilehto J, Hamann A et al. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidaemia. Diabetes Res Clin Pract 2004; 64: 137–51.
39. Rosenson RS. Rosuvastatin: a new inhibitor of HMG-CoA reductase for the treatment of dyslipidemia. Expert Rev Cardiovasc Ther 2003; 1: 495–505.
40. Teramoto T, Watkins C. Review of efficacy of rosuvastatin 5 mg. Int J Clin Pract 2005; 59: 92–101.
41. Ullah F, Afridi AK, Rahim F et al. Efficacy of 5 mg and 10 mg rosuvastatin in type-2 diabetes mellitus with hypercholesteroalemia. J Ayub Med Coll Abbottabad 2015; 27: 564–8.
42. Meek C et al. Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study. Curr Med Res Opin 2012; 28: 371–8.
43. Olsson AG et al. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J 2002; 144: 1044–51.
44. Clearfield MB et al. Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006; 7: 35.
45. Berne C, Siewert-Delle A, URANUS study investigators, the U. study. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol 2005; 4: 7.
46. Cevc M. Comparison of efficacy and safety of rosuvastatin 15 mg vs. 10 mg: subanalysis of the ROSU-PATH trial (2016). http://congress365.escardio.org/Presentation/140210#.Wf0HX1u0Opp
47. Schuster H et al. Effects of switching statins on achievement of lipid goals: measuring effective reductions in cholesterol using rosuvastatin therapy (MERCURY I) study. Am Heart J 2004; 147: 705–12.
48. Bando Y et al. Switching from atorvastatin to rosuvastatin lowers small, dense low-density lipoprotein cholesterol levels in Japanese hypercholesterolemic patients with type 2 diabetes mellitus. Diabet Res Clin Pract 2016; 111: 66–73.
49. Stein EA et al. Long-Term Efficacy and Safety of Rosuvastatin 40 mg in Patients With Severe Hypercholesterolemia. Am J Cardiol 2007; 100: 1387–96.
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Авторы
И.В.Сергиенко1, А.В.Рудакова2, Е.В.Карпова*3
1 ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России. 121552, Россия, Москва, ул. 3-я Черепковская, д. 15а;
2 ФГБОУ ВО «Санкт-Петербургская государственная химико-фармацевтическая академия» Минздрава России. 197376, Россия, Санкт-Петербург, ул. Профессора Попова, д. 14, лит. А;
3 ООО «Тева». 115093, Россия, Москва, ул. Валовая, д. 35
*Ekaterina.Karpova03@teva.ru
1 National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation. 121552, Russian Federation, Moscow, ul. 3-ia Cherepkovskaia, d. 15a;
2 Saint Petersburg State Chemical Pharmaceutical Academy of the Ministry of Health of the Russian Federation. 197376, Russian Federation, Saint Petersburg, ul. Professora Popova, d. 14, lit. A;
3 Teva Pharmaceutical Industries Ltd. 115093, Russian Federation, Moscow, ul. Valovaia, d. 35
*Ekaterina.Karpova03@teva.ru
1 ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России. 121552, Россия, Москва, ул. 3-я Черепковская, д. 15а;
2 ФГБОУ ВО «Санкт-Петербургская государственная химико-фармацевтическая академия» Минздрава России. 197376, Россия, Санкт-Петербург, ул. Профессора Попова, д. 14, лит. А;
3 ООО «Тева». 115093, Россия, Москва, ул. Валовая, д. 35
*Ekaterina.Karpova03@teva.ru
________________________________________________
1 National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation. 121552, Russian Federation, Moscow, ul. 3-ia Cherepkovskaia, d. 15a;
2 Saint Petersburg State Chemical Pharmaceutical Academy of the Ministry of Health of the Russian Federation. 197376, Russian Federation, Saint Petersburg, ul. Professora Popova, d. 14, lit. A;
3 Teva Pharmaceutical Industries Ltd. 115093, Russian Federation, Moscow, ul. Valovaia, d. 35
*Ekaterina.Karpova03@teva.ru
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