Остроумова О.Д. Статины и сахарный диабет: взгляд кардиолога. Consilium Medicum. 2018; 20 (1): 38–44. DOI: 10.26442/2075-1753_2018.1.38-44
________________________________________________
Ostroumova O.D. Statins and diabetes mellitus: cardiologist’s point of view. Consilium Medicum. 2018; 20 (1): 38–44. DOI: 10.26442/2075-1753_2018.1.38-44
Статины и сахарный диабет: взгляд кардиолога
Остроумова О.Д. Статины и сахарный диабет: взгляд кардиолога. Consilium Medicum. 2018; 20 (1): 38–44. DOI: 10.26442/2075-1753_2018.1.38-44
________________________________________________
Ostroumova O.D. Statins and diabetes mellitus: cardiologist’s point of view. Consilium Medicum. 2018; 20 (1): 38–44. DOI: 10.26442/2075-1753_2018.1.38-44
В статье рассмотрены вопросы назначения статинов больным сахарным диабетом для снижения сердечно-сосудистого риска в рамках первичной и вторичной профилактики. Приведены данные о целевых уровнях липопротеидов низкой плотности в разных подгруппах пациентов с сахарным диабетом, получающих терапию статинами. Также обсуждаются результаты рандомизированных клинических исследований и метаанализов, свидетельствующих о повышении риска развития новых случаев сахарного диабета, ассоциированного с приемом статинов. В статье представлены данные о распространенности этого нежелательного явления, зависимости от дозы и длительности приема статина, соотношении «польза/риск», перечисляются популяции пациентов с наибольшим риском развития сахарного диабета, ассоциированного с терапией статинами.
The article concerns statin use in patients with diabetes mellitus for cardiovascular risk reduction in primary and secondary prevention. Data on target levels of low-density lipoprotein in various subgroups of patients with diabetes mellitus receiving therapy with statins is presented. Also results of randomized clinical trials and meta-analyses that indicate the increase of risk for new events of diabetes mellitus associated with statins use are discussed. The article also presents data on the prevalence of this adverse event, its dependence on the dosage and duration of statin use, and benefit-risk profile. The populations of patients with the highest risk for diabetes mellitus associated with statins use are listed.
1. Zimmet PZ, Magliano DJ, Herman WH, Shaw JE. Diabetes: a 21st century challenge. Lancet Diabetes Endocrin 2014; 2: 56–64.
2. Seshasai SR, Kaptoge S, Thompson A et al. Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med 2011; 364: 829–41.
3. Sattar N. Revisiting the links between glycaemia, diabetes and cardiovascular disease. Diabetologia 2013; 56: 686–95.
4. Liu J, Grundy SM, Wang W et al. Ten-year risk of cardiovascular incidence related to diabetes, prediabetes, and the metabolic syndrome. Am Heart J 2007; 153: 552–8.
5. Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation 2012; 126: 1301–13.
6. Donahoe SM, Stewart GC, McCabe CH et al. Diabetes and mortality following acute coronary syndromes. JAMA 2007; 298: 765–75.
7. Catapano AL, Graham I, De Backer G et al; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37 (39): 2999–3058. DOI: 10.1093/eurheartj/ehw272
8. Scott R, O’Brien R, Fulcher G et al. Effects of fenofibrate treatment on cardiovascular disease risk in 9.795 individuals with type 2 diabetes and various components of the metabolic syndrome: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetes Care 2009; 32: 493–8.
9. Adiels M, Olofsson SO, Taskinen MR, Borén J. Overproduction of very lowdensity lipoproteins is the hallmark of the dyslipidemia in the metabolic syndrome. Arterioscler Thromb Vasc Biol 2008; 28: 1225–36.
10. Taskinen MR, Boren J. New insights into the pathophysiology of dyslipidemia in type 2 diabetes. Atherosclerosis 2015; 239: 483–95.
11. Kearney PM, Blackwell L, Collins R et al; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy of cholesterol-lowering therapy in 18.686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 2008; 371 (9607): 117–25. DOI: 10.1016/S0140-6736(08)60104-X
12. Rydén L, Standl E, Bartnik M et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007; 28 (1): 88–136.
13. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J Am Coll Cardiol 2005; 46 (7): 1225–8.
14. LaRosa JC, Grundy SM, Waters DD et al; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352 (14): 1425–35.
15. Shepherd J, Cobbe SM, Ford I et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995; 333 (20): 1301–7.
16. Downs JR, Clearfield M, Weis S et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998; 279 (20): 1615–22.
17. 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 (21): 2195–207. DOI: 10.1056/NEJMoa0807646
18. De Vries FM, Denig P, Pouwels KB et al. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs 2012; 72 (18): 2365–73. DOI: 10.2165/11638240-000000000-00000
19. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации, VI пересмотр. Атеросклероз и дислипидемии. 2017; 3: 5–22. / Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemii. 2017; 3: 5–22. [in Russian]
20. Betteridge DJ, Gibson JM, Sager PT. Comparison of Effectiveness of Rosuvastatin Versus Atorvastatin on the Achievement of Combined C-Reactive Protein (<2 mg/L) and Low-Density Lipoprotein Cholesterol (<70 mg/dl) Targets in Patients With Type 2 Diabetes Mellitus (from the ANDROMEDA Study). Am J Cardiol 2007; 100: 1245–8.
21. Wolffenbuttel BHR, Franken AAM, Vincent HH on behalf of the DUTCH CORALL study group. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study. J In Med 2005; 257: 531–9.
22. Sorof J, Berne Ch, Siewert-Delle A et al on behalf of the URANUS study investigators. Effect of rosuvastatin or atorvastatin on urinary albumin excretion and renal function in type 2 diabetic patients. Diab Res Clin Practice 2006; 72: 81–7.
23. Karlson BW, Palmer MK, Nicholls SJ et al. A VOYAGER Meta-Analysis of the Impact of Statin Therapy on Low-Density Lipoprotein Cholesterol and Triglyceride Levels in Patients With Hypertriglyceridemia. Am J Cardiol 2016; 117 (9): 1444–8. DOI: 10.1016/j.amjcard.2016.02.011
24. Food and Drug Administration. FDA drug safety communication: important safety label changes to cholesterol lowering statin drugs. Available at: www.fda.gov/drugs/drugsafety/ucm293101.htm
25. Zhou Y, Yuan Y, Cai RR et al. Statin therapy on glycaemic control in type 2 diabetes: a meta-analysis. Expert Opin Pharmacother 2013; 14 (12): 1575–84.
26. Astra Zeneca. Clinical briefing document – Endocrine and Metabolic Drugs Advisory Committee meeting for rosuvastatin (Crestor). Available at: www.fda.gov/downloads/advisorycommittees/committe esmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisory committee/ucm193831.pdf
27. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 75: 735–42.
28. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011; 305 (24): 2556–64.
29. Кобалава Ж.Д., Виллевальде С.В. Терапия статинами и риск развития сахарного диабета. Эффективная фармакотер. Эндокринология. Спецвып. 2015; 11: 33–9. / Kobalava Zh.D., Villeval'de S.V. Terapiia statinami i risk razvitiia sakharnogo diabeta. Effektivnaia farmakoter. Endokrinologiia. Spetsvyp. 2015; 11: 33–9. [in Russian]
30. 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 (14): 1535–45. DOI: 10.1016/j.jacc.2010.10.047
31. Ruscica M, Macchi C, Morlotti B et al. Statin therapy and related risk of new-onset type 2 diabetes mellitus. Eur J Intern Med 2014; 25 (5): 401–6.
32. Mora S, Glynn RJ, Hsia J et al. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation 2010; 121 (9): 1069–77.
33. Puurunen J, Piltonen T, Puukka K et al. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab 2013; 98 (12): 4798–807.
34. Culver AL, Ockene IS, Balasubramanian R et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med 2012; 172 (2): 144–52.
35. Ridker PM, Pradhan A, MacFadyen JG et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet 2012; 380 (9841): 565–71.
36. Yoon JS, Lee HW. Diabetogenic effect of statins: a double-edged sword? Diabetes Metab J 2013; 37 (6): 415–22.
________________________________________________
1. Zimmet PZ, Magliano DJ, Herman WH, Shaw JE. Diabetes: a 21st century challenge. Lancet Diabetes Endocrin 2014; 2: 56–64.
2. Seshasai SR, Kaptoge S, Thompson A et al. Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med 2011; 364: 829–41.
3. Sattar N. Revisiting the links between glycaemia, diabetes and cardiovascular disease. Diabetologia 2013; 56: 686–95.
4. Liu J, Grundy SM, Wang W et al. Ten-year risk of cardiovascular incidence related to diabetes, prediabetes, and the metabolic syndrome. Am Heart J 2007; 153: 552–8.
5. Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation 2012; 126: 1301–13.
6. Donahoe SM, Stewart GC, McCabe CH et al. Diabetes and mortality following acute coronary syndromes. JAMA 2007; 298: 765–75.
7. Catapano AL, Graham I, De Backer G et al; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J 2016; 37 (39): 2999–3058. DOI: 10.1093/eurheartj/ehw272
8. Scott R, O’Brien R, Fulcher G et al. Effects of fenofibrate treatment on cardiovascular disease risk in 9.795 individuals with type 2 diabetes and various components of the metabolic syndrome: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetes Care 2009; 32: 493–8.
9. Adiels M, Olofsson SO, Taskinen MR, Borén J. Overproduction of very lowdensity lipoproteins is the hallmark of the dyslipidemia in the metabolic syndrome. Arterioscler Thromb Vasc Biol 2008; 28: 1225–36.
10. Taskinen MR, Boren J. New insights into the pathophysiology of dyslipidemia in type 2 diabetes. Atherosclerosis 2015; 239: 483–95.
11. Kearney PM, Blackwell L, Collins R et al; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy of cholesterol-lowering therapy in 18.686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 2008; 371 (9607): 117–25. DOI: 10.1016/S0140-6736(08)60104-X
12. Rydén L, Standl E, Bartnik M et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007; 28 (1): 88–136.
13. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J Am Coll Cardiol 2005; 46 (7): 1225–8.
14. LaRosa JC, Grundy SM, Waters DD et al; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352 (14): 1425–35.
15. Shepherd J, Cobbe SM, Ford I et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995; 333 (20): 1301–7.
16. Downs JR, Clearfield M, Weis S et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998; 279 (20): 1615–22.
17. 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 (21): 2195–207. DOI: 10.1056/NEJMoa0807646
18. De Vries FM, Denig P, Pouwels KB et al. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs 2012; 72 (18): 2365–73. DOI: 10.2165/11638240-000000000-00000
19. Diagnostika i korrektsiia narushenii lipidnogo obmena s tsel'iu profilaktiki i lecheniia ateroskleroza. Rossiiskie rekomendatsii, VI peresmotr. Ateroskleroz i dislipidemii. 2017; 3: 5–22. [in Russian]
20. Betteridge DJ, Gibson JM, Sager PT. Comparison of Effectiveness of Rosuvastatin Versus Atorvastatin on the Achievement of Combined C-Reactive Protein (<2 mg/L) and Low-Density Lipoprotein Cholesterol (<70 mg/dl) Targets in Patients With Type 2 Diabetes Mellitus (from the ANDROMEDA Study). Am J Cardiol 2007; 100: 1245–8.
21. Wolffenbuttel BHR, Franken AAM, Vincent HH on behalf of the DUTCH CORALL study group. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study. J In Med 2005; 257: 531–9.
22. Sorof J, Berne Ch, Siewert-Delle A et al on behalf of the URANUS study investigators. Effect of rosuvastatin or atorvastatin on urinary albumin excretion and renal function in type 2 diabetic patients. Diab Res Clin Practice 2006; 72: 81–7.
23. Karlson BW, Palmer MK, Nicholls SJ et al. A VOYAGER Meta-Analysis of the Impact of Statin Therapy on Low-Density Lipoprotein Cholesterol and Triglyceride Levels in Patients With Hypertriglyceridemia. Am J Cardiol 2016; 117 (9): 1444–8. DOI: 10.1016/j.amjcard.2016.02.011
24. Food and Drug Administration. FDA drug safety communication: important safety label changes to cholesterol lowering statin drugs. Available at: www.fda.gov/drugs/drugsafety/ucm293101.htm
25. Zhou Y, Yuan Y, Cai RR et al. Statin therapy on glycaemic control in type 2 diabetes: a meta-analysis. Expert Opin Pharmacother 2013; 14 (12): 1575–84.
26. Astra Zeneca. Clinical briefing document – Endocrine and Metabolic Drugs Advisory Committee meeting for rosuvastatin (Crestor). Available at: www.fda.gov/downloads/advisorycommittees/committe esmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisory committee/ucm193831.pdf
27. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 75: 735–42.
28. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011; 305 (24): 2556–64.
29. Kobalava Zh.D., Villeval'de S.V. Terapiia statinami i risk razvitiia sakharnogo diabeta. Effektivnaia farmakoter. Endokrinologiia. Spetsvyp. 2015; 11: 33–9. [in Russian]
30. 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 (14): 1535–45. DOI: 10.1016/j.jacc.2010.10.047
31. Ruscica M, Macchi C, Morlotti B et al. Statin therapy and related risk of new-onset type 2 diabetes mellitus. Eur J Intern Med 2014; 25 (5): 401–6.
32. Mora S, Glynn RJ, Hsia J et al. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation 2010; 121 (9): 1069–77.
33. Puurunen J, Piltonen T, Puukka K et al. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab 2013; 98 (12): 4798–807.
34. Culver AL, Ockene IS, Balasubramanian R et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med 2012; 172 (2): 144–52.
35. Ridker PM, Pradhan A, MacFadyen JG et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet 2012; 380 (9841): 565–71.
36. Yoon JS, Lee HW. Diabetogenic effect of statins: a double-edged sword? Diabetes Metab J 2013; 37 (6): 415–22.
Авторы
О.Д.Остроумова
ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И.Евдокимова» Минздрава России. 127473, Россия, Москва, ул. Делегатская, д. 20, стр. 1;
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М.Сеченова» Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2 ostroumova.olga@mail.ru
________________________________________________
O.D.Ostroumova
A.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian Federation. 127473, Russian Federation, Moscow, ul. Delegatskaia, d. 20, str. 1;
I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubet-skaia, d. 8, str. 2 ostroumova.olga@mail.ru