Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Соотношение эффективности и безопасности применения статинов с целью первичной и вторичной профилактики: мифы и реальность
________________________________________________
Giliarevskii S.R., Golshmid M.V., Kuz'mina I.M. The correlation of the efficacy and safety of statins with the aim of primary and secondary prevention: myths and reality. Systemic Hypertension. 2015; 12 (2): 96–102.
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Ключевые слова: профилактика, станины, мифы, розувастатин.
________________________________________________
This article deals with the different aspects of statins acceptability. Special attention is paid to the most clinically significant and frequent side-effects of the statins application. In particular, we discuss in detail the problem of toxic effect of statins on muscles and the approaches of the optimum tactics of treatment in patients with the symptoms of muscles damage associated with the use of statins. We show the information concerning the safety use of modern statins, especially rosuvastatin.
Key words: prevention, statins, myths, rosuvastatin.
2. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis [letter]. N Engl J Med 2002; 346: 539–40.
3. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20.536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7–22.
4. Ridker PM, Danielson E, Fonseca FA et al. JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195–207.
5. Kashani A, Phillips CO, Foody JM et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 2006; 114: 2788–97.
6. Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet 2000; 355: 253–9.
7. Dahlöf B, Devereux RB, Kjeldsen SE et al. LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995–1003.
8. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97 (Suppl.): 52C–60C.
9. Bruckert E, Hayem G, Dejager S et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients – the PRIMO study. Cardiovasc Drugs Ther 2005; 19: 403–14.
10. Buettner C, Rippberger MJ, Smith JK et al. Statin use and musculoskeletal pain among adults with and without arthritis. Am J Med 2012; 125: 176–82.
11. 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.
12. Zhang H, Plutzky J, Skentzos S et al. Discontinuation of statins in routine care settings: a cohort study. Ann Int Med 2013; 158: 526–34.
13. El-Salem K, Ababeneh B, Rudnicki S et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve 2011; 44: 877–81.
14. Chodick G, Shalev V, Gerber Y et al. Long-term 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.
15. Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 2002; 288: 462–7.
16. Chowdhury R, Khan H, Heydon E et al. Adherence to cardiovascular therapy: a meta-analysis of prevalence and clinical consequences. Eur Heart J 2013; 34: 2940–8.
17. Rosenson RS, Baker SK, Jacobson TA et al. Anassessment by the statin muscle safety task force: 2014 update. J Clin Lipidol 2014; 8: 558–71.
18. Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J 2014; 168: 6–15.
19. Finegold JA, Manisty CH, Goldacre B et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol 2014; 21: 464–76.
20. Parker BA, Capizzi JA, Grimaldi AS et al. Effect of statins on skeletal muscle function. Circulation 2013; 127: 96–103.
21. Keech A, Collins S, MacMahon S et al. Three-year follow-up of the Oxford Cholesterol Study: assessment of the efficacy and safety of simvastatin in preparation for a large mortality study. Eur Heart J 1994; 15: 255–69.
22. MRC/BHF Heart Protection Study Collaborative Group. Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people. BMC Clin Pharmacol 2009; 9: 6.
23. Mampuya WM, Frid D, Rocco M et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience. Am Heart J 2013; 166: 597–603.
24. Downs JR, Clearfield M, Tyroler HA et al. Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS). Additional perspectives on tolerability of long-term treatment with lovastatin. Am J Cardiol 2001; 87: 1074–9.
25. Armitage J. The safety of statins in clinical practice. Lancet 2007; 370: 1781–90.
26. Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med 2009; 150: 858–68.
27. Mancini GB, Tashakkor AY, Baker S et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Working Group Consensus update. Can J Cardiol 2013; 29: 1553–68.
28. Corsini A. The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. Cardiovasc Drugs Ther 2003; 17: 265–85.
29. Armitage J, Baigent C, Collins R. Misrepresentation of statin safety evidence. Lancet 2014; 384: 1263–4.
30. Ahmad Z. Statin intolerance. Am J Cardiol 2014; 113: 1765–71.
31. Alfirevic A, Neely D, Armitage J et al. Phenotype standardization for statin-induced myotoxicity. Clin Pharmacol Ther 2014; 96: 470–6.
32. Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med 2009; 361: 62–72.
33. Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006; 97 (Suppl.): 77C–81C.
34. Bays H. Statin safety: an overview and assessment of the data – 2005. Am J Cardiol 2006; 97 (Suppl.): 6C–26C.
35. Charles EC, Olson KL, Sandhoff BG et al. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. Am J Med 2005; 118: 618–24.
36. Kjekshus J, Apetrei E, Barrios V et al. Rosuvastatin in Older Patients with Systolic Heart Failure. N Engl J Med 2007; 357: 2248–61.
37. GISSI-HF Investigators, Tavazzi L, Maggioni AP et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008; 372: 1231–9.
38. Preiss D, Campbell RT, Murray HM et al. The effect of statin therapy on heart failure events: a collaborative meta-analysis of unpublished data from major randomized trials. Eur Heart J 2015 Mar 23. [Epub ahead of print].
39. Rogers JK, Jhund PS, Perez AC et al. Effect of rosuvastatin on repeat heart failure hospitalizations: the CORONA Trial (Controlled Rosuvastatin Multinational Trial in Heart Failure). J Am Coll Cardiol HF 2014; 2: 289–97.
40. Álvarez-García J, Ferrero-Gregori A, Puig T et al. A simple validated method for predicting the risk of hospitalization for worsening of heart failure in ambulatory patients: the Redin-SCORE. Eur J Heart Fail 2015 May 23. [Epub ahead of print].
41. Swiger KJ, Manalac RJ, Blumenthal RS et al. Statins and cognition: a systematic review and meta-analysis of short- and long-term cognitive effects. Mayo Clin Proc 2013; 88: 1213–21.
42. Robinson JG, Farnier M, Krempf M et al. Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events. N Engl J Med 2015; 372: 1489–99.
43. Freeman DJ, Norrie J, Sattar N et al. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation 2001; 103: 357–62.
44. Clinical Directions – The JUPITER trial: will you change your practice? http://www.nejm.org/clinical-directions/jupiter-statins-trial/(accessed Nov 26, 2008)
45. Yusuf S, Lonn E, Bosch J. Lipid lowering for primary prevention. Lancet 2009; 373: 1152–5.
46. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.
47. Mansi I, Frei CR, Wang CP, Mortensen EM. Statins and New-Onset Diabetes Mellitus and Diabetic Complications: A Retrospective Cohort Study of US Healthy Adults. J Gen Intern Med 2015. [Epub ahead of print].
48. Cholesterol Treatment Trialists' (CTT) Collaboration. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from
174 000 participants in 27 randomised trials. Lancet 2015; 385 (9976): 1397–405.
49. Amarenco P, Bogousslavsky J, Callahan A 3rd. et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006; 355: 549–59.
50. Rordorf G, McDonald C. Spontaneous intracerebral hemorrhage: pathogenesis, clinical features, and diagnosis. In: S.E.Kasner, J.L.Wilterdink, eds. UpToDate, Version 18.2. Waltham, MA: UpToDate Inc.; 2010.
51. Hackam DG, Woodward M, Newby LK et al. Statins and Intracerebral Hemorrhage. Collaborative Systematic Review and Meta-Analysis. Circulation 2011; 124: 2233–42.
52. 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.
53. Andrade SE, Walker AM, Gottlieb LK et al. Discontinuation of antihyperlipidemic drugs: do rates reported in clinical trials reflect rates in primary care settings? N Engl J Med 1995; 332: 1125–8.
54. Heeschen C, Hamm CW, Laufs U et al. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation 2002; 105: 1446–52.
55. Heeschen C, Hamm CW, Laufs U et al. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation 2003; 107: e27. Letter.
56. Spencer FA, Allegrone J, Goldberg RJ et al. Association of statin therapy with outcomes of acute coronary syndromes: the GRACE Study. Ann Intern Med 2004; 140: 857–66.
57. McGowan MP. Treating to New Target (TNT) Study Group. There is no evidence for an increase in acute coronary syndromes after short-term abrupt discontinuation of statins in stable cardiac patients. Circulation 2004; 110: 2333–5.
58. Kutner JS, Blatchford PJ, Taylor DHJr et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med 2015; 175: 691–700.
59. Cohen SM. Concept Analysis of Adherence in the Context of Cardiovascular Risk Reduction. Nursing Forum 2009; 44 (1): 25–36.
________________________________________________
1. Reiner Z, Catapano AL, De Backer G et al. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J 2011; 32: 1769–818.
2. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis [letter]. N Engl J Med 2002; 346: 539–40.
3. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20.536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7–22.
4. Ridker PM, Danielson E, Fonseca FA et al. JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195–207.
5. Kashani A, Phillips CO, Foody JM et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 2006; 114: 2788–97.
6. Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet 2000; 355: 253–9.
7. Dahlöf B, Devereux RB, Kjeldsen SE et al. LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995–1003.
8. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97 (Suppl.): 52C–60C.
9. Bruckert E, Hayem G, Dejager S et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients – the PRIMO study. Cardiovasc Drugs Ther 2005; 19: 403–14.
10. Buettner C, Rippberger MJ, Smith JK et al. Statin use and musculoskeletal pain among adults with and without arthritis. Am J Med 2012; 125: 176–82.
11. 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.
12. Zhang H, Plutzky J, Skentzos S et al. Discontinuation of statins in routine care settings: a cohort study. Ann Int Med 2013; 158: 526–34.
13. El-Salem K, Ababeneh B, Rudnicki S et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve 2011; 44: 877–81.
14. Chodick G, Shalev V, Gerber Y et al. Long-term 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.
15. Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 2002; 288: 462–7.
16. Chowdhury R, Khan H, Heydon E et al. Adherence to cardiovascular therapy: a meta-analysis of prevalence and clinical consequences. Eur Heart J 2013; 34: 2940–8.
17. Rosenson RS, Baker SK, Jacobson TA et al. Anassessment by the statin muscle safety task force: 2014 update. J Clin Lipidol 2014; 8: 558–71.
18. Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J 2014; 168: 6–15.
19. Finegold JA, Manisty CH, Goldacre B et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol 2014; 21: 464–76.
20. Parker BA, Capizzi JA, Grimaldi AS et al. Effect of statins on skeletal muscle function. Circulation 2013; 127: 96–103.
21. Keech A, Collins S, MacMahon S et al. Three-year follow-up of the Oxford Cholesterol Study: assessment of the efficacy and safety of simvastatin in preparation for a large mortality study. Eur Heart J 1994; 15: 255–69.
22. MRC/BHF Heart Protection Study Collaborative Group. Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people. BMC Clin Pharmacol 2009; 9: 6.
23. Mampuya WM, Frid D, Rocco M et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience. Am Heart J 2013; 166: 597–603.
24. Downs JR, Clearfield M, Tyroler HA et al. Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS). Additional perspectives on tolerability of long-term treatment with lovastatin. Am J Cardiol 2001; 87: 1074–9.
25. Armitage J. The safety of statins in clinical practice. Lancet 2007; 370: 1781–90.
26. Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med 2009; 150: 858–68.
27. Mancini GB, Tashakkor AY, Baker S et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Working Group Consensus update. Can J Cardiol 2013; 29: 1553–68.
28. Corsini A. The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. Cardiovasc Drugs Ther 2003; 17: 265–85.
29. Armitage J, Baigent C, Collins R. Misrepresentation of statin safety evidence. Lancet 2014; 384: 1263–4.
30. Ahmad Z. Statin intolerance. Am J Cardiol 2014; 113: 1765–71.
31. Alfirevic A, Neely D, Armitage J et al. Phenotype standardization for statin-induced myotoxicity. Clin Pharmacol Ther 2014; 96: 470–6.
32. Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med 2009; 361: 62–72.
33. Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006; 97 (Suppl.): 77C–81C.
34. Bays H. Statin safety: an overview and assessment of the data – 2005. Am J Cardiol 2006; 97 (Suppl.): 6C–26C.
35. Charles EC, Olson KL, Sandhoff BG et al. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. Am J Med 2005; 118: 618–24.
36. Kjekshus J, Apetrei E, Barrios V et al. Rosuvastatin in Older Patients with Systolic Heart Failure. N Engl J Med 2007; 357: 2248–61.
37. GISSI-HF Investigators, Tavazzi L, Maggioni AP et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008; 372: 1231–9.
38. Preiss D, Campbell RT, Murray HM et al. The effect of statin therapy on heart failure events: a collaborative meta-analysis of unpublished data from major randomized trials. Eur Heart J 2015 Mar 23. [Epub ahead of print].
39. Rogers JK, Jhund PS, Perez AC et al. Effect of rosuvastatin on repeat heart failure hospitalizations: the CORONA Trial (Controlled Rosuvastatin Multinational Trial in Heart Failure). J Am Coll Cardiol HF 2014; 2: 289–97.
40. Álvarez-García J, Ferrero-Gregori A, Puig T et al. A simple validated method for predicting the risk of hospitalization for worsening of heart failure in ambulatory patients: the Redin-SCORE. Eur J Heart Fail 2015 May 23. [Epub ahead of print].
41. Swiger KJ, Manalac RJ, Blumenthal RS et al. Statins and cognition: a systematic review and meta-analysis of short- and long-term cognitive effects. Mayo Clin Proc 2013; 88: 1213–21.
42. Robinson JG, Farnier M, Krempf M et al. Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events. N Engl J Med 2015; 372: 1489–99.
43. Freeman DJ, Norrie J, Sattar N et al. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation 2001; 103: 357–62.
44. Clinical Directions – The JUPITER trial: will you change your practice? http://www.nejm.org/clinical-directions/jupiter-statins-trial/(accessed Nov 26, 2008)
45. Yusuf S, Lonn E, Bosch J. Lipid lowering for primary prevention. Lancet 2009; 373: 1152–5.
46. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.
47. Mansi I, Frei CR, Wang CP, Mortensen EM. Statins and New-Onset Diabetes Mellitus and Diabetic Complications: A Retrospective Cohort Study of US Healthy Adults. J Gen Intern Med 2015. [Epub ahead of print].
48. Cholesterol Treatment Trialists' (CTT) Collaboration. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from
174 000 participants in 27 randomised trials. Lancet 2015; 385 (9976): 1397–405.
49. Amarenco P, Bogousslavsky J, Callahan A 3rd. et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006; 355: 549–59.
50. Rordorf G, McDonald C. Spontaneous intracerebral hemorrhage: pathogenesis, clinical features, and diagnosis. In: S.E.Kasner, J.L.Wilterdink, eds. UpToDate, Version 18.2. Waltham, MA: UpToDate Inc.; 2010.
51. Hackam DG, Woodward M, Newby LK et al. Statins and Intracerebral Hemorrhage. Collaborative Systematic Review and Meta-Analysis. Circulation 2011; 124: 2233–42.
52. 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.
53. Andrade SE, Walker AM, Gottlieb LK et al. Discontinuation of antihyperlipidemic drugs: do rates reported in clinical trials reflect rates in primary care settings? N Engl J Med 1995; 332: 1125–8.
54. Heeschen C, Hamm CW, Laufs U et al. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation 2002; 105: 1446–52.
55. Heeschen C, Hamm CW, Laufs U et al. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation 2003; 107: e27. Letter.
56. Spencer FA, Allegrone J, Goldberg RJ et al. Association of statin therapy with outcomes of acute coronary syndromes: the GRACE Study. Ann Intern Med 2004; 140: 857–66.
57. McGowan MP. Treating to New Target (TNT) Study Group. There is no evidence for an increase in acute coronary syndromes after short-term abrupt discontinuation of statins in stable cardiac patients. Circulation 2004; 110: 2333–5.
58. Kutner JS, Blatchford PJ, Taylor DHJr et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med 2015; 175: 691–700.
59. Cohen SM. Concept Analysis of Adherence in the Context of Cardiovascular Risk Reduction. Nursing Forum 2009; 44 (1): 25–36.
1 ГБОУ ДПО Российская медицинская академия последипломного образования Минздрава России. 123995, Россия, Москва, ул. Баррикадная, д. 2/1;
2 ГБУЗ НИИ скорой помощи им. Н.В.Склифосовского Департамента здравоохранения г. Москвы. 129090, Россия, Москва, Большая Сухаревская пл., д. 3
*sgilarevsky@rambler.ru
________________________________________________
S.R.Gilyarevsky*1, M.V.Golshmid1, I.M.Kuzmina2
1 Russian Medical Academy of Postgraduate Education of the Ministry of Health of the Russian Federation. 123995, Russian Federation, Moscow, ul. Barrikadnaia, d. 2/1;
2 N.V.Sklifosovsky Research Institute of Emergency Medicine of the Department of Health of Moscow. 129090, Russian Federation, Mosсow, B. Sukharevskaia pl., d. 3
*sgilarevsky@rambler.ru