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Нежелательные эффекты терапии статинами: реальные доказательства
Нежелательные эффекты терапии статинами: реальные доказательства
Бубнова М.Г. Нежелательные эффекты терапии статинами: реальные доказательства. CardioСоматика. 2019; 10 (1): 51–61. DOI: 10.26442/22217185.2019.1.190264
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Аннотация
Цель. Осветить современные представления о переносимости и безопасности терапии статинами.
Материалы и методы. Рассмотрены данные 73 научных источников, опубликованных в российской и зарубежной печати в 1996–2018 гг.
Результаты. Общепризнанно, что статины – препараты 1-й линии терапии для лечения гиперхолестеринемии и комбинированной гиперлипидемии. К настоящему времени накоплено достаточно доказательств, подтверждающих, что снижение уровня холестерина липопротеидов низкой плотности предотвращает появление атеросклеротических заболеваний, уменьшает риск сердечно-сосудистой и общей смертности. Основные проблемы современной терапии статинами связаны с назначением их в неадекватных дозах для профилактики атеросклеротических заболеваний, низкой приверженностью и непереносимостью. Проблема непереносимости статинов стала актуальной в последние годы. Предложены критерии ее определения, рядом экспертов предлагается заменить понятие «непереносимость статинов» термином «статин-ассоциированные побочные эффекты». Наиболее часто обсуждаемыми нежелательными эффектами статинов являются мышечные симптомы (миалгии/миопатии), гепатотоксичность (печеночная гиперферментемия), развитие новых случаев сахарного диабета и деменции, когнитивные нарушения. Механизмы развития этих нежелательных эффектов до сих пор неясны. Выделяют определенные факторы и состояния, способные спровоцировать появление тех или иных нежелательных эффектов, а также абсолютные противопоказания к терапии статинами. Возникновение нежелательных эффектов на терапии статинами зависит от дозы статина, возраста пациента, пола, коморбидности и сопутствующей терапии. Многие нежелательные эффекты статинов носят класс-эффект. В то же время каждый из статинов имеет особенности структуры и метаболизма, взаимодействия с другими лекарственными препаратами, разные фармакокинетические характеристики. Питавастатин – статин последнего поколения с отличительными фармакологическими особенностями, нейтральным диабетогенным эффектом и т.д. Развитие нежелательных эффектов на статинах часто преувеличено, а польза от их приема в предупреждении атеросклеротических заболеваний превышает возможные риски. Истинное появление некоторых нежелательных эффектов на терапии статинами требует дополнительных доказательств.
Заключение. В целом статины имеют хороший профиль переносимости и разрешены к назначению большинству пациентов, нуждающихся в гиполипидемической терапии.
Ключевые слова: статины, мышечные симптомы, печеночная дисфункция, сахарный диабет, питавастатин.
Materials and methods. The data of 73 scientific sources from Russian and foreign literature published within 1996–2018 are considered.
Results. It is generally accepted that statins are first-line therapeutic agents for hypercholesterolemia and combined hyperlipidemia. Today there in growing evidence that lowering of low-density lipoprotein cholesterol levels prevents atherosclerotic diseases and reduces a risk of cardiovascular and overall mortality. Main issues of current statin therapy include a use of inadequate dosage for atherosclerotic diseases prevention, low treatment compliance and drug intolerance. In recent years the issue of statin intolerance has become of great importance. Criteria were proposed for determining an inability to tolerate statins, some experts suggest replacing definition of “statin intolerance” with the term “statin-associated side-effects”. Most discussed adverse effects due to statins include muscle-related symptoms (myalgia/myopathy), hepatotoxicity (hepatic hyperenzymemia) new-onset diabetes, dementia and cognitive impairment. Mechanisms of development of these adverse effects are still unclear. Certain factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were established. Some factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were identified. Occurrence of statin-associated side-effects depends on statin dose, a patient's age, gender, comorbidity and concomitant therapy. Many adverse effects of statins are drug class effect. At the same time each of statins has specific features of its structure, metabolism, drug interactions and pharmacokinetics. Pitavastatin belongs to the last generation of statins and it has distinct pharmacological features and neutral diabetogenic effects, etc. Risk of adverse effects due to statins is often exaggerated while benefit from the use of statins for preventing atherosclerotic diseases outweighs potential risks. Real occurrence of some adverse effects due to statin therapy requires additional evidence.
Conclusion. Overall, statins have a good tolerability profile and are approved for use in the vast majority of patients who required lipid-lowering therapy.
Key words: statins, muscle symptoms, hepatic dysfunction, diabetes mellitus, pitavastatin.
Материалы и методы. Рассмотрены данные 73 научных источников, опубликованных в российской и зарубежной печати в 1996–2018 гг.
Результаты. Общепризнанно, что статины – препараты 1-й линии терапии для лечения гиперхолестеринемии и комбинированной гиперлипидемии. К настоящему времени накоплено достаточно доказательств, подтверждающих, что снижение уровня холестерина липопротеидов низкой плотности предотвращает появление атеросклеротических заболеваний, уменьшает риск сердечно-сосудистой и общей смертности. Основные проблемы современной терапии статинами связаны с назначением их в неадекватных дозах для профилактики атеросклеротических заболеваний, низкой приверженностью и непереносимостью. Проблема непереносимости статинов стала актуальной в последние годы. Предложены критерии ее определения, рядом экспертов предлагается заменить понятие «непереносимость статинов» термином «статин-ассоциированные побочные эффекты». Наиболее часто обсуждаемыми нежелательными эффектами статинов являются мышечные симптомы (миалгии/миопатии), гепатотоксичность (печеночная гиперферментемия), развитие новых случаев сахарного диабета и деменции, когнитивные нарушения. Механизмы развития этих нежелательных эффектов до сих пор неясны. Выделяют определенные факторы и состояния, способные спровоцировать появление тех или иных нежелательных эффектов, а также абсолютные противопоказания к терапии статинами. Возникновение нежелательных эффектов на терапии статинами зависит от дозы статина, возраста пациента, пола, коморбидности и сопутствующей терапии. Многие нежелательные эффекты статинов носят класс-эффект. В то же время каждый из статинов имеет особенности структуры и метаболизма, взаимодействия с другими лекарственными препаратами, разные фармакокинетические характеристики. Питавастатин – статин последнего поколения с отличительными фармакологическими особенностями, нейтральным диабетогенным эффектом и т.д. Развитие нежелательных эффектов на статинах часто преувеличено, а польза от их приема в предупреждении атеросклеротических заболеваний превышает возможные риски. Истинное появление некоторых нежелательных эффектов на терапии статинами требует дополнительных доказательств.
Заключение. В целом статины имеют хороший профиль переносимости и разрешены к назначению большинству пациентов, нуждающихся в гиполипидемической терапии.
Ключевые слова: статины, мышечные симптомы, печеночная дисфункция, сахарный диабет, питавастатин.
________________________________________________
Materials and methods. The data of 73 scientific sources from Russian and foreign literature published within 1996–2018 are considered.
Results. It is generally accepted that statins are first-line therapeutic agents for hypercholesterolemia and combined hyperlipidemia. Today there in growing evidence that lowering of low-density lipoprotein cholesterol levels prevents atherosclerotic diseases and reduces a risk of cardiovascular and overall mortality. Main issues of current statin therapy include a use of inadequate dosage for atherosclerotic diseases prevention, low treatment compliance and drug intolerance. In recent years the issue of statin intolerance has become of great importance. Criteria were proposed for determining an inability to tolerate statins, some experts suggest replacing definition of “statin intolerance” with the term “statin-associated side-effects”. Most discussed adverse effects due to statins include muscle-related symptoms (myalgia/myopathy), hepatotoxicity (hepatic hyperenzymemia) new-onset diabetes, dementia and cognitive impairment. Mechanisms of development of these adverse effects are still unclear. Certain factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were established. Some factors and conditions capable of triggering some adverse effects as well as absolute contraindications to statin therapy were identified. Occurrence of statin-associated side-effects depends on statin dose, a patient's age, gender, comorbidity and concomitant therapy. Many adverse effects of statins are drug class effect. At the same time each of statins has specific features of its structure, metabolism, drug interactions and pharmacokinetics. Pitavastatin belongs to the last generation of statins and it has distinct pharmacological features and neutral diabetogenic effects, etc. Risk of adverse effects due to statins is often exaggerated while benefit from the use of statins for preventing atherosclerotic diseases outweighs potential risks. Real occurrence of some adverse effects due to statin therapy requires additional evidence.
Conclusion. Overall, statins have a good tolerability profile and are approved for use in the vast majority of patients who required lipid-lowering therapy.
Key words: statins, muscle symptoms, hepatic dysfunction, diabetes mellitus, pitavastatin.
Полный текст
Список литературы
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70. Drew BG, Rye KA, Duffy SJ et al. The emerging role of HDL in glucose metabolism. Nat Rev Endocrinol 2012; 8: 237–45.
71. Wu X, Yu Z, Su W et al. Low levels of ApoA1 improve risk prediction of type 2 diabetes mellitus. J Clinic Lipidol 2017. http://creativecommons.org/licenses/by-nc-nd/4.0/
72. Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA 2009; 302: 179–88.
73. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy [published correction appears in Lancet. 2017; 389: 602]. Lancet 2016; 388: 2532–61. DOI: 10.1016/S0140-6736(16)31357-5
2. Baigent C, Blackwell L, Emberson J et al. Cholesterol Treatment Trialists’ (CTT) Collaboration, 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. DOI: 10.1016/S0140-6736(10)61350-5
3. Buhaescu I, Izzedine H. Mevalonate pathway: a review of clinical and therapeutical implications. Clin Biochem 2007; 40: 575–84. DOI: 10.1016/j.clinbiochem
4. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J 2016; 37: 2999–3058. DOI: 10.1093/eurheartj/ ehw272.
5. Sirtori CR. The pharmacology of statins. Pharmacol Res 2014; 88: 3–11.
6. Catapano AL. Pitavastatin: a different pharmacological profile. Clin Lipidol 2012; 7 (3): 3–9.
7. Banach M, Stulc T, Dent R et al. Statin non-adherence and residual cardiovascular risk: there is need for substantial improvement. Int J Cardiol 2016; 225: 184–96.
8. Bubnova M.G., Aronov D.M., Deev A.D. Terapiia statinami v real'noi klinicheskoi praktike u pozhilykh patsientov s giperlipidemiei i koronarnoi bolezn'iu serdtsa. Rossiiskaia programma EFFORT. Ateroskleroz i dislipidemii. 2018; 1: 5–16 (in Russian).
9. Ward NC, Watts GF, Eckel RH. Statin Toxicity Mechanistic Insights and Clinical Implications. Сirc Res 2019; 124: 328–50. DOI: 10.1161/CIRCRESAHA.118.312782
10. Toth PP, Patti AM, Giglio RV et al. Management of Statin Intolerance in 2018: Still More Questions Than Answers. Am J Cardiovasc Drugs https://doi.org/10.1007/s40256-017-0259-7
11. Tobert JA, Newman CB. Statin tolerability: in defence of placebocontrolled trials. Eur J Prev Cardiol 2016; 23: 891–6. DOI: 10.1177/2047487315602861
12. Banach M, Rizzo M, Toth PP et al. Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci 2015; 11: 1–23. DOI: 10.5114/aoms.2015.49807
13. Tobert JA, Newman CB. The nocebo effect in the context of statin intolerance. J Clin Lipidol 2016; 10: 739–47.
14. Gupta A, Thompson D, Whitehouse A et al. ASCOT Investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017; 389: 2473–81. DOI: 10.1016/S0140-6736(17)31075-9
15. Nissen SE. Statin denial: an internet-driven cult with deadly consequences. Ann Intern Med 2017; 167: 281–2.
16. Khan S, Holbrook A, Shah BR. Does Googling lead to statin intolerance? Int J of Cardiol 2018; 25: 25–7. DOI: 10.1016/j.ijcard.2018.02.085
17. Penson PE, Mancini GBJ, Toth PP et al. Lipid and Blood Pressure Meta-Analysis Collaboration (LBPMC) Group & International Lipid Expert Panel (ILEP). Introducing the ‘Drucebo’ effect in statin therapy: a systematic review of studies comparing reported rates of statin-associated muscle symptoms, under blinded and open-label conditions. J Cachexia Sarcopenia Muscle 2018; 9: 1023–33. DOI: 10.1002/jcsm.12344
18. Guyton JR, Bays HE, Grundy SM, Jacobson TA. The national lipid association statin intolerance panel. An assessment by thestatin intolerance panel: 2014 update. J Clin Lipidol 2014; 8 (Suppl. 3): S72-81.
19. Grundy SM, Stone NJ, Bailey AL et al. 2018 AHA/ACC/AACVPR/ AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol: а report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2018. DOI: 10.1161/CIR.0000000000000625
20. Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol 2012; 6: 208–15.
21. Chodick G, Shalev V, Gerber Y et al. Longterm persistence with statin treatment in a not-for-profit health maintenance organization: a population-based retrospective cohort study in Israel. Clin Ther 2008; 30: 2167–79.
22. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97: 52C–60C.
23. Rosenson RS, Baker SK, Jacobson TA et al. The National Lipid Association’s Muscle Safety Expert P. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol 2014; 8: S58–S71.
24. Stroes ES, Thompson PD, Corsini A et al. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, A etiology and Management. Eur Heart J 2015; 36: 1012–22.
25. Newman CB, Preiss D, Tobert JА et al. Statin Safety and Associated Adverse Events A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol 2018; 38: e00-e00. DOI: 10.1161/ATV.0000000000000073
26. Rosenson RS, Miller K, Bayliss M et al. The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): revision for clinical use, content validation, and interrater reliability. Cardiovasc Drugs Ther 2017; 31: 179–86.
27. Muntean DM, Thompson PD, Catapano AL et al. Statin-associated myopathy and the quest for biomarkers: can we effectively predict statin-associated muscle symptoms? Drug Discov Today 2017; 22: 85–96. DOI: 10.1016/j.drudis.2016.09.001
28. Elam MB, Majumdar G, Mozhui K et al. Patients experiencing statin induced myalgia exhibit a unique program of skeletal muscle gene expression following statin re-challenge. PLoS One 2017; 12: e0181308. DOI: 10.1371/journal.pone.0181308
29. Brunham LR, Baker S, Mammen A et al. Role of genetics in the prediction of statin-associatedmuscle symptoms and optimization of statin use and adherence. Cardiovasc Res 2018; 114: 1073–81. DOI: 10.1093/cvr/cvy119
30. De Pinieux G, Chariot P, Ammi-Sand M et al. Lipid-lowering drugs and mitochondrial function: effects of HMG-CoA reductase inhibitors on serum ubiquinone and blood lactate/pyruvate ratio. Br J Clin Pharmacol 1996; 42: 333–7.
31. Calvano J, Achanzar W, Murphy B et al. Evaluation of micro-RNAs-208 and 133a/b as differential biomarkers of acute cardiac and skeletal muscle toxicity in rats. Toxicol Appl Pharmacol 2016; 312: 53–60.
32. Davidson MH, Robinson JG. Safety of aggressive lipid management. J Am Coll Cardiol 2007; 49: 1753–62.
33. Bays H, Cohen DE, Chalasani N, Harrison SA. The National Lipid Association’s Statin Safety Task Force. An assessment by the Statin Liver Safety Task Force: 2014 update. J Clin Lipidol 2014; 8: S47–S57.
34. Mach F, Ray KK, Wiklund O et al. European Atherosclerosis Society Consensus Panel. Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J 2018; 39: 2526–39. DOI: 10.1093/eurheartj/ehy182
35. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J 2016; 37: 2999–3058.
36. Pastori D, Polimeni L, Baratta F et al. The efficacy and safety of statins for the treatment of non-alcoholic fatty liver disease. Dig Liver Dis 2015; 47: 4–11.
37. Kim RG, Loomba R, Prokop LJ, Singh S. Statin use and risk of cirrhosis and related complications in patients with chronic liver diseases: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2017; 15: 1521–30.
38. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statin trials. Lancet 2010; 375: 735–42.
39. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a metaanalysis. JAMA 2011; 305: 2556–64.
40. Waters DD, Ho JE, DeMicco DA et al. Predictors of new-onset diabetes in patients treated with atorvastatin: results from 3 large randomized clinical trials. J Am Coll Cardiol 2011; 57: 1535–45.
41. Cederberg H, Stanca´kova A, Yaluri N et al. Increased risk of diabetes with statin treatment is associated with impaired insulin sensitivity and insulin secretion: a 6 year follow-up study of the METSIM cohort. Diabetologia 2015; 58: 1109–17.
42. Nielsen SF, Nordestgaard BG. Statin use before diabetes diagnosis and risk of microvascular disease: a nationwide nested matched study. Lancet Diabetes Endocrinol 2014; 2: 894–900.
43. Betteridge DJ, Carmena R. The diabetogenic action of statins–mechanisms and clinical implications. Nat Rev Endocrinol 2016; 12: 90–110.
44. Swerdlow DI, Preiss D, Kuchenbaecker KB et al. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials. Lancet 2015; 385: 351–61.
45. Vallejo-Vaz AJ, Kondapally Seshasai SR, Kurogi K et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis 2015; 241: 409–18. DOI: 10.1016/j.atherosclerosis. 2015.06.001
46. Simons M, Keller P, Dichgans J, Schulz JB. Cholesterol and Alzheimer’s disease: is there a link? Neurology 2001; 57: 1089–93.
47. U.S. Food and Drug Administration. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 https://www.fda.gov/drugs/ drugsafety/ucm293101.htm (14 September 2017).
48. Richardson K, Schoen M, French B et al. Statins and cognitive function: a systematic review. Ann Intern Med 2013; 159: 688–97.
49. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo controlled trial. Lancet 2002; 360: 7–22.
50. Trompet S, van Vliet P, de Craen AJ et al. Pravastatin and cognitive function in the elderly. Results of the PROSPER study. J Neurol 2010; 257: 85–90.
51. Ott BR, Daiello LA, Dahabreh IJ et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med 2015; 30: 348–58.
52. Song Y, Nie H, Xu Y et al. Association of statin use with risk of dementia: a meta-analysis of prospective cohort studies. Ger Gerontol Int 2013; 13: 817–24.
53. Wolozin B, Kellman W, Ruosseau P et al. Decreased prevalence of Alzheimer disease associated with 3-hydroxy-3-methyglutaryl coenzyme A reductase inhibitors. Arch Neurol 2000; 57: 1439–43.
54. Giugliano RP, Wiviott SD, Blazing MA et al. Long-term safety and efficacy of achieving very low levels of low-density lipoprotein cholesterol a prespecified analysis of the IMPROVE-IT trial. JAMA Cardiol 2017; 2: 547–55.
55. Giugliano RP, Pedersen TR, Park JG et al. FOURIER Investigators. Clinical efficacy and safety of achieving very low LDLcholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390: 1962–71.
56. Giugliano RP, Mach F, Zavitz K et al. EBBINGHAUS Investigators. Cognitive function in a randomized trial of evolocumab. N Engl J Med 2017; 377: 633–43.
57. Kastelein JJ, Braamskamp M. Pitavastatin: an overview of the LIVES study. Clin Lipidol 2012; 7 (3 Suppl. 1): 25–31.
58. Teramoto T. Pitavastatin: clinical effects from the LIVES Study. Atheroscler Suppl. 2011; 12: 285–8.
59. Kurihara Y, Douzono T, Kawakita K, Nagasaka Y. A large-scale, long-term, prospective postmarketing surveillance of pitavastatin (LIVALO Tablet) – LIVALO Effectiveness and Safety (LIVES) Study. Jpn Pharmacol Ther 2008; 36: 709–31.
60. Taguchi I, Iimuro S, Iwata H et al. High dose versus low-dose pitavastatin in Japanese patients with stable coronary artery disease (REAL-CAD): a randomized superiority trial. Circulation 2018; 137: 1997–2009. DOI: 10.1161/circulationaha.117.032615
61. Takano H, Mizuma H, Kuwabara Y et al. Оn behalf of the PEARL Study Investigators Effects of Pitavastatin in Japanese Patients With Chronic Heart Failure. The Pitavastatin Heart Failure Study (PEARL Study). Circ J 2013; 77: 917–25.
62. Hiro T, Kimura T, Morimoto T et al. for the JAPAN-ACS Investigators. Effect of Intensive Statin Therapy on Regression of Coronary Atherosclerosis in Patients With Acute Coronary Syndrome A Multicenter Randomized Trial Evaluated by Volumetric Intravascular Ultrasound Using Pitavastatin Versus Atorvastatin (JAPAN-ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study). J Am Coll Cardiol 2009; 54: 293–302.
63. Hyogo H, Ikegami T, Tokushige K et al. Efficacy of pitavastatin for the treatment of non-alcoholic steatohepatitis with dyslipidemia: an open-label, pilot study. Hepatol Res 2011; 41: 1057–65.
64. Vallejo-Vaz AJ, Kondapally Seshasai SR, Kurogi K et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis 2015; 241: 409–18. DOI: 10.1016/j.atherosclerosis. 2015.06.001
65. Teramoto T, Shimano H, Yokote K, Urashima M. New evidence on pitavastatin: efficacy and safety in clinical studies. Exp Opin Pharmacother 2010; 11: 817–28.
66. J-PREDICT Study Group: Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (J-PREDICT) http://clinicaltrials.gov/ct2/show/NCT00301392.
67. Chapman MJ, Orsoni A, Robillard P et al. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin 2014; 1–10.
68. Huang C, Huang Y, Hsu B. Pitavastatin improves glycated hemoglobin in patients with poorly controlled type 2 diabetes. Diabetes Invest 2016; 7: 769–76.
69. Wang Y, Fu X, Gu X, et al. Effects of intensive pitavastatin therapy on glucose control in patients with non-ST elevation acute coronary syndrome. Am J Cardiovasc Dis 2017; 7(4): 89–96.
70. Drew BG, Rye KA, Duffy SJ et al. The emerging role of HDL in glucose metabolism. Nat Rev Endocrinol 2012; 8: 237–45.
71. Wu X, Yu Z, Su W et al. Low levels of ApoA1 improve risk prediction of type 2 diabetes mellitus. J Clinic Lipidol 2017. http://creativecommons.org/licenses/by-nc-nd/4.0/
72. Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA 2009; 302: 179–88.
73. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy [published correction appears in Lancet. 2017; 389: 602]. Lancet 2016; 388: 2532–61. DOI: 10.1016/S0140-6736(16)31357-5
2. Baigent C, Blackwell L, Emberson J et al. Cholesterol Treatment Trialists’ (CTT) Collaboration, 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. DOI: 10.1016/S0140-6736(10)61350-5
3. Buhaescu I, Izzedine H. Mevalonate pathway: a review of clinical and therapeutical implications. Clin Biochem 2007; 40: 575–84. DOI: 10.1016/j.clinbiochem
4. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J 2016; 37: 2999–3058. DOI: 10.1093/eurheartj/ ehw272.
5. Sirtori CR. The pharmacology of statins. Pharmacol Res 2014; 88: 3–11.
6. Catapano AL. Pitavastatin: a different pharmacological profile. Clin Lipidol 2012; 7 (3): 3–9.
7. Banach M, Stulc T, Dent R et al. Statin non-adherence and residual cardiovascular risk: there is need for substantial improvement. Int J Cardiol 2016; 225: 184–96.
8. Бубнова М.Г., Аронов Д.М., Деев А.Д. Терапия статинами в реальной клинической практике у пожилых пациентов с гиперлипидемией и коронарной болезнью сердца. Российская программа ЭФФОРТ. Атеросклероз и дислипидемии. 2018; 1: 5–16.
[Bubnova M.G., Aronov D.M., Deev A.D. Terapiia statinami v real'noi klinicheskoi praktike u pozhilykh patsientov s giperlipidemiei i koronarnoi bolezn'iu serdtsa. Rossiiskaia programma EFFORT. Ateroskleroz i dislipidemii. 2018; 1: 5–16 (in Russian).]
9. Ward NC, Watts GF, Eckel RH. Statin Toxicity Mechanistic Insights and Clinical Implications. Сirc Res 2019; 124: 328–50. DOI: 10.1161/CIRCRESAHA.118.312782
10. Toth PP, Patti AM, Giglio RV et al. Management of Statin Intolerance in 2018: Still More Questions Than Answers. Am J Cardiovasc Drugs https://doi.org/10.1007/s40256-017-0259-7
11. Tobert JA, Newman CB. Statin tolerability: in defence of placebocontrolled trials. Eur J Prev Cardiol 2016; 23: 891–6. DOI: 10.1177/2047487315602861
12. Banach M, Rizzo M, Toth PP et al. Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci 2015; 11: 1–23. DOI: 10.5114/aoms.2015.49807
13. Tobert JA, Newman CB. The nocebo effect in the context of statin intolerance. J Clin Lipidol 2016; 10: 739–47.
14. Gupta A, Thompson D, Whitehouse A et al. ASCOT Investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017; 389: 2473–81. DOI: 10.1016/S0140-6736(17)31075-9
15. Nissen SE. Statin denial: an internet-driven cult with deadly consequences. Ann Intern Med 2017; 167: 281–2.
16. Khan S, Holbrook A, Shah BR. Does Googling lead to statin intolerance? Int J of Cardiol 2018; 25: 25–7. DOI: 10.1016/j.ijcard.2018.02.085
17. Penson PE, Mancini GBJ, Toth PP et al. Lipid and Blood Pressure Meta-Analysis Collaboration (LBPMC) Group & International Lipid Expert Panel (ILEP). Introducing the ‘Drucebo’ effect in statin therapy: a systematic review of studies comparing reported rates of statin-associated muscle symptoms, under blinded and open-label conditions. J Cachexia Sarcopenia Muscle 2018; 9: 1023–33. DOI: 10.1002/jcsm.12344
18. Guyton JR, Bays HE, Grundy SM, Jacobson TA. The national lipid association statin intolerance panel. An assessment by thestatin intolerance panel: 2014 update. J Clin Lipidol 2014; 8 (Suppl. 3): S72-81.
19. Grundy SM, Stone NJ, Bailey AL et al. 2018 AHA/ACC/AACVPR/ AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol: а report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2018. DOI: 10.1161/CIR.0000000000000625
20. Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol 2012; 6: 208–15.
21. Chodick G, Shalev V, Gerber Y et al. Longterm persistence with statin treatment in a not-for-profit health maintenance organization: a population-based retrospective cohort study in Israel. Clin Ther 2008; 30: 2167–79.
22. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97: 52C–60C.
23. Rosenson RS, Baker SK, Jacobson TA et al. The National Lipid Association’s Muscle Safety Expert P. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol 2014; 8: S58–S71.
24. Stroes ES, Thompson PD, Corsini A et al. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, A etiology and Management. Eur Heart J 2015; 36: 1012–22.
25. Newman CB, Preiss D, Tobert JА et al. Statin Safety and Associated Adverse Events A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol 2018; 38: e00-e00. DOI: 10.1161/ATV.0000000000000073
26. Rosenson RS, Miller K, Bayliss M et al. The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): revision for clinical use, content validation, and interrater reliability. Cardiovasc Drugs Ther 2017; 31: 179–86.
27. Muntean DM, Thompson PD, Catapano AL et al. Statin-associated myopathy and the quest for biomarkers: can we effectively predict statin-associated muscle symptoms? Drug Discov Today 2017; 22: 85–96. DOI: 10.1016/j.drudis.2016.09.001
28. Elam MB, Majumdar G, Mozhui K et al. Patients experiencing statin induced myalgia exhibit a unique program of skeletal muscle gene expression following statin re-challenge. PLoS One 2017; 12: e0181308. DOI: 10.1371/journal.pone.0181308
29. Brunham LR, Baker S, Mammen A et al. Role of genetics in the prediction of statin-associatedmuscle symptoms and optimization of statin use and adherence. Cardiovasc Res 2018; 114: 1073–81. DOI: 10.1093/cvr/cvy119
30. De Pinieux G, Chariot P, Ammi-Sand M et al. Lipid-lowering drugs and mitochondrial function: effects of HMG-CoA reductase inhibitors on serum ubiquinone and blood lactate/pyruvate ratio. Br J Clin Pharmacol 1996; 42: 333–7.
31. Calvano J, Achanzar W, Murphy B et al. Evaluation of micro-RNAs-208 and 133a/b as differential biomarkers of acute cardiac and skeletal muscle toxicity in rats. Toxicol Appl Pharmacol 2016; 312: 53–60.
32. Davidson MH, Robinson JG. Safety of aggressive lipid management. J Am Coll Cardiol 2007; 49: 1753–62.
33. Bays H, Cohen DE, Chalasani N, Harrison SA. The National Lipid Association’s Statin Safety Task Force. An assessment by the Statin Liver Safety Task Force: 2014 update. J Clin Lipidol 2014; 8: S47–S57.
34. Mach F, Ray KK, Wiklund O et al. European Atherosclerosis Society Consensus Panel. Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J 2018; 39: 2526–39. DOI: 10.1093/eurheartj/ehy182
35. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J 2016; 37: 2999–3058.
36. Pastori D, Polimeni L, Baratta F et al. The efficacy and safety of statins for the treatment of non-alcoholic fatty liver disease. Dig Liver Dis 2015; 47: 4–11.
37. Kim RG, Loomba R, Prokop LJ, Singh S. Statin use and risk of cirrhosis and related complications in patients with chronic liver diseases: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2017; 15: 1521–30.
38. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statin trials. Lancet 2010; 375: 735–42.
39. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a metaanalysis. JAMA 2011; 305: 2556–64.
40. Waters DD, Ho JE, DeMicco DA et al. Predictors of new-onset diabetes in patients treated with atorvastatin: results from 3 large randomized clinical trials. J Am Coll Cardiol 2011; 57: 1535–45.
41. Cederberg H, Stanca´kova A, Yaluri N et al. Increased risk of diabetes with statin treatment is associated with impaired insulin sensitivity and insulin secretion: a 6 year follow-up study of the METSIM cohort. Diabetologia 2015; 58: 1109–17.
42. Nielsen SF, Nordestgaard BG. Statin use before diabetes diagnosis and risk of microvascular disease: a nationwide nested matched study. Lancet Diabetes Endocrinol 2014; 2: 894–900.
43. Betteridge DJ, Carmena R. The diabetogenic action of statins–mechanisms and clinical implications. Nat Rev Endocrinol 2016; 12: 90–110.
44. Swerdlow DI, Preiss D, Kuchenbaecker KB et al. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials. Lancet 2015; 385: 351–61.
45. Vallejo-Vaz AJ, Kondapally Seshasai SR, Kurogi K et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis 2015; 241: 409–18. DOI: 10.1016/j.atherosclerosis. 2015.06.001
46. Simons M, Keller P, Dichgans J, Schulz JB. Cholesterol and Alzheimer’s disease: is there a link? Neurology 2001; 57: 1089–93.
47. U.S. Food and Drug Administration. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 https://www.fda.gov/drugs/ drugsafety/ucm293101.htm (14 September 2017).
48. Richardson K, Schoen M, French B et al. Statins and cognitive function: a systematic review. Ann Intern Med 2013; 159: 688–97.
49. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo controlled trial. Lancet 2002; 360: 7–22.
50. Trompet S, van Vliet P, de Craen AJ et al. Pravastatin and cognitive function in the elderly. Results of the PROSPER study. J Neurol 2010; 257: 85–90.
51. Ott BR, Daiello LA, Dahabreh IJ et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med 2015; 30: 348–58.
52. Song Y, Nie H, Xu Y et al. Association of statin use with risk of dementia: a meta-analysis of prospective cohort studies. Ger Gerontol Int 2013; 13: 817–24.
53. Wolozin B, Kellman W, Ruosseau P et al. Decreased prevalence of Alzheimer disease associated with 3-hydroxy-3-methyglutaryl coenzyme A reductase inhibitors. Arch Neurol 2000; 57: 1439–43.
54. Giugliano RP, Wiviott SD, Blazing MA et al. Long-term safety and efficacy of achieving very low levels of low-density lipoprotein cholesterol a prespecified analysis of the IMPROVE-IT trial. JAMA Cardiol 2017; 2: 547–55.
55. Giugliano RP, Pedersen TR, Park JG et al. FOURIER Investigators. Clinical efficacy and safety of achieving very low LDLcholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390: 1962–71.
56. Giugliano RP, Mach F, Zavitz K et al. EBBINGHAUS Investigators. Cognitive function in a randomized trial of evolocumab. N Engl J Med 2017; 377: 633–43.
57. Kastelein JJ, Braamskamp M. Pitavastatin: an overview of the LIVES study. Clin Lipidol 2012; 7 (3 Suppl. 1): 25–31.
58. Teramoto T. Pitavastatin: clinical effects from the LIVES Study. Atheroscler Suppl. 2011; 12: 285–8.
59. Kurihara Y, Douzono T, Kawakita K, Nagasaka Y. A large-scale, long-term, prospective postmarketing surveillance of pitavastatin (LIVALO Tablet) – LIVALO Effectiveness and Safety (LIVES) Study. Jpn Pharmacol Ther 2008; 36: 709–31.
60. Taguchi I, Iimuro S, Iwata H et al. High dose versus low-dose pitavastatin in Japanese patients with stable coronary artery disease (REAL-CAD): a randomized superiority trial. Circulation 2018; 137: 1997–2009. DOI: 10.1161/circulationaha.117.032615
61. Takano H, Mizuma H, Kuwabara Y et al. Оn behalf of the PEARL Study Investigators Effects of Pitavastatin in Japanese Patients With Chronic Heart Failure. The Pitavastatin Heart Failure Study (PEARL Study). Circ J 2013; 77: 917–25.
62. Hiro T, Kimura T, Morimoto T et al. for the JAPAN-ACS Investigators. Effect of Intensive Statin Therapy on Regression of Coronary Atherosclerosis in Patients With Acute Coronary Syndrome A Multicenter Randomized Trial Evaluated by Volumetric Intravascular Ultrasound Using Pitavastatin Versus Atorvastatin (JAPAN-ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study). J Am Coll Cardiol 2009; 54: 293–302.
63. Hyogo H, Ikegami T, Tokushige K et al. Efficacy of pitavastatin for the treatment of non-alcoholic steatohepatitis with dyslipidemia: an open-label, pilot study. Hepatol Res 2011; 41: 1057–65.
64. Vallejo-Vaz AJ, Kondapally Seshasai SR, Kurogi K et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis 2015; 241: 409–18. DOI: 10.1016/j.atherosclerosis. 2015.06.001
65. Teramoto T, Shimano H, Yokote K, Urashima M. New evidence on pitavastatin: efficacy and safety in clinical studies. Exp Opin Pharmacother 2010; 11: 817–28.
66. J-PREDICT Study Group: Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (J-PREDICT) http://clinicaltrials.gov/ct2/show/NCT00301392.
67. Chapman MJ, Orsoni A, Robillard P et al. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin 2014; 1–10.
68. Huang C, Huang Y, Hsu B. Pitavastatin improves glycated hemoglobin in patients with poorly controlled type 2 diabetes. Diabetes Invest 2016; 7: 769–76.
69. Wang Y, Fu X, Gu X, et al. Effects of intensive pitavastatin therapy on glucose control in patients with non-ST elevation acute coronary syndrome. Am J Cardiovasc Dis 2017; 7(4): 89–96.
70. Drew BG, Rye KA, Duffy SJ et al. The emerging role of HDL in glucose metabolism. Nat Rev Endocrinol 2012; 8: 237–45.
71. Wu X, Yu Z, Su W et al. Low levels of ApoA1 improve risk prediction of type 2 diabetes mellitus. J Clinic Lipidol 2017. http://creativecommons.org/licenses/by-nc-nd/4.0/
72. Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA 2009; 302: 179–88.
73. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy [published correction appears in Lancet. 2017; 389: 602]. Lancet 2016; 388: 2532–61. DOI: 10.1016/S0140-6736(16)31357-5
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64. Vallejo-Vaz AJ, Kondapally Seshasai SR, Kurogi K et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis 2015; 241: 409–18. DOI: 10.1016/j.atherosclerosis. 2015.06.001
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68. Huang C, Huang Y, Hsu B. Pitavastatin improves glycated hemoglobin in patients with poorly controlled type 2 diabetes. Diabetes Invest 2016; 7: 769–76.
69. Wang Y, Fu X, Gu X, et al. Effects of intensive pitavastatin therapy on glucose control in patients with non-ST elevation acute coronary syndrome. Am J Cardiovasc Dis 2017; 7(4): 89–96.
70. Drew BG, Rye KA, Duffy SJ et al. The emerging role of HDL in glucose metabolism. Nat Rev Endocrinol 2012; 8: 237–45.
71. Wu X, Yu Z, Su W et al. Low levels of ApoA1 improve risk prediction of type 2 diabetes mellitus. J Clinic Lipidol 2017. http://creativecommons.org/licenses/by-nc-nd/4.0/
72. Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA 2009; 302: 179–88.
73. Collins R, Reith C, Emberson J et al. Interpretation of the evidence for the efficacy and safety of statin therapy [published correction appears in Lancet. 2017; 389: 602]. Lancet 2016; 388: 2532–61. DOI: 10.1016/S0140-6736(16)31357-5
Авторы
М.Г.Бубнова
ФГБУ «Национальный медицинский исследовательский центр профилактической медицины» Минздрава России. 101990, Россия, Москва, Петроверигский пер., д. 10, стр. 3
mbubnova@gnicpm.ru
National Medical Research Center for Preventive Medicine of the Ministry of Health of the Russian Federation. 10, 3, Petroverigskii ln., Moscow, 101990, Russian Federation
mbubnova@gnicpm.ru
ФГБУ «Национальный медицинский исследовательский центр профилактической медицины» Минздрава России. 101990, Россия, Москва, Петроверигский пер., д. 10, стр. 3
mbubnova@gnicpm.ru
________________________________________________
National Medical Research Center for Preventive Medicine of the Ministry of Health of the Russian Federation. 10, 3, Petroverigskii ln., Moscow, 101990, Russian Federation
mbubnova@gnicpm.ru
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