Preview

Евразийский кардиологический журнал

Расширенный поиск

ВРЕМЕННЫЕ ФАКТОРЫ, ВЛИЯЮЩИЕ НА ЭФФЕКТИВНОСТЬ И ПЕРЕНОСИМОСТЬ ПРИМЕНЕНИЯ СТАТИНОВ: НАУЧНЫЕ И ПРАКТИЧЕСКИЕ АСПЕКТЫ

Полный текст:

Аннотация

В статье рассматриваются современные подходы к анализу эффективности вмешательств в зависимости от времени, т.е. от продолжительности периода после начала их применения. Обсуждается роль анализа кривых Каплана-Мейера для оценки эффектов сравниваемых вмешательств в зависимости от времени. Рассматриваются различные варианты взаимного расположения кривых Каплана-Мейера в ходе выполнения исследования. Приводятся результаты недавно выполненного анализа, посвященного оценке продолжительности периода между началом приема статинов и развитием клинических преимуществ терапии. В том числе обсуждается возможность использования показателя продолжительности периода до развития преимуществ (ППРП) вмешательства и показателя продолжительности периода до развития вреда (ППРВ), обусловленного вмешательством, при принятии клинического решения об обоснованности выбора определенного метода лечения, в частности показателя ЧБНЛ. Приводятся мнения, подчеркивающие важность оценки эффективности вмешательств с помощью абсолютного, а не относительного риска развития неблагоприятных клинических исходов. Рассматриваются клинические ситуации, в которых имеет особое значение продолжительность периода до развития клинического эффекта, в частности у больных с очень высоким риском развития осложнений сердечно-сосудистых заболеваний (например, после острого коронарного синдрома) и у больных, у которых в большинстве случаев ограничена продолжительность жизни. Подчеркивается роль применения аторвастатина в клинических ситуациях, при которых имеет значение более раннее достижение клинических преимуществ гиполипидемической терапии. Приводятся данные о роли применения статинов, в частности аторвастатина, в ранние сроки после развития острого коронарного синдрома.

Об авторе

С. Р. Гиляревский
Федеральное государственное бюджетное образовательное учреждение дополнительного профессионального образования Российская медицинская академия непрерывного профессионального образования Минздрава России
Россия

д.м.н., профессор кафедры клинической фармакологии и терапии

тел. +7(495)945-70-90



Список литературы

1. Malkin C.J., Channer K.S. Life-saving or life-prolonging? Interpreting trial data and survival curves for patients with congestive heart failure. Eur J Heart Fail 2005;7:143-148.

2. Swedberg K., Kjekshus J., Snapinn S. Long-term survival in severe heart failure in patients treated with enalapril. Ten year follow-up of CONSENSUS I. Eur Heart J 1999;20:136-139.

3. Kaplan E.L., Meier P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association. 1958;53:457-481.

4. Holmes H.M., Min L.C., Yee M., et al. Rationalizing prescribing for older patients with multimorbidity: considering time to benefit. Drugs Aging 2013;30:655-666. doi: 10.1007/ s40266-013-0095-7.

5. Barter P.J., Waters D.D. Variations in time to benefit among clinical trials of cholesterol-lowering drugs. J Clin Lipidol 2018 Apr 21. doi: 10.1016/j.jacl.2018.04.006. [Epub ahead of print]

6. Ray K.K., Cannon C.P., McCabe C.H., et al. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI22 trial. J Am Coll Cardiol 2005;46:1405-1410.

7. Hart R.G., Sharma M., Mundl H., et al. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med 2018;378:2191-2201. doi: 10.1056/ NEJMoa1802686].

8. Sacks F.M., Pfeffer M.A., Moye L.A., et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Trial investigators. N Engl J Med 1996;335:1001-1009.

9. Rubins H.B., Robins S.J., Collins D., et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. N Engl J Med 1999;341:410-418.

10. Yusuf S., Lonn E., Pais P., et al. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease. N Engl J Med 2016;374:2032-2043. doi: 10.1056/NEJMoa1600177.

11. Bibbins-Domingo K.; U.S. Preventive Services Task Force. Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2016;164:836-845. doi: 10.7326/M16-0577.

12. Holmes H.M., Hayley D.C., Alexander G.C., Sachs G.A. Reconsidering medication appropriateness for patients late in life. Archives of internal medicine. 2006;166:605-609.

13. Scott I.A., Gray L.C., Martin J.H., Mitchell C.A. Minimizing inappropriate medications in older populations: a 10-step conceptual framework. Am J Medicine 2012;125:529-537. e4.

14. Stevenson J., Abernethy A.P., Miller C., Currow D.C. Managing comorbidities in patients at the end of life. BMJ (Clinical research ed) 2004;329:909-912.

15. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA 1994;272:1926-1931.

16. Schulz K.F., Altman D.G., MoherD. CONSORT2010 statement: updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine 2010;152:726-732.

17. Fuster V. Changing demographics: a new approach to global health care due to the aging population. J Am Coll Cardiol 2017;69:3002-3005.

18. Kontis V., Bennett J.E., Mathers C.D., et al. Future life expectancy in 35 industrialised countries: projections with a Bayesian model ensemble. Lancet 2017;389:1323-1335.

19. Odden M.C., Coxson P.G., Moran A, et al. The impact of the aging population on coronary heart disease in the United States. Am J Med 2011;124:827-833.e5.

20. Heidenreich P.A., Trogdon J.G., Khavjou O.A., et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation 2011;123:933-944.

21. Stone N.J., Robinson J.G., Lichtenstein A.H., et al. 2013 ACC/ AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults. J Am Coll Cardiol 2014;63:2889-2934.

22. National Clinical Guideline Centre. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. National Institute for Health and Care Excellence (NICE) July 2014.

23. Anderson T.J., Gre goire J., Pearson G.J., et al. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol 2016;32:1263-1282.

24. Bibbins-Domingo K., Grossman D.C., Curry S.J., et al. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force Recommendation Statement. JAMA 2016; 316:1997-2007.

25. Catapano A.L., Graham I., De Backer G., et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 2016;37:2999-3058.

26. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-1389.

27. Ridker P.M., Danielson E., Fonseca F.A.H., et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-2207.

28. Schwartz G.G., Olsson A.G., Ezekowitz M.D., et al. Effect of atorvastatin on early recurrent ischemic events in acute coronary syndromes. The MIRACL study: a randomized controlled trial. JAMA 2001;285:1711-1718.

29. Shepherd J., Cobbe S.M., Ford I., et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med 1995;333:1711-1718.

30. Colhoun H.M., Betteridge D.J., Durrington P.N., et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicenter randomised placebo-controlled trial. Lancet 2004;364:685-696.

31. 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.

32. Downs J.R., Clearfield M., Weiss S., et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels. Results of AFCAPS/TexCAPS. JAMA 1998;279:1615-1622.

33. Sever P.S., Dalho F.B., Poulter N.R., et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial - Lipid Lowering Arm (ASCOT-LLA): a multicenter randomised controlled trial. Lancet 2003;361:1149-1158.

34. The Long-Term Intervention with Pravastatin in Ischaemic Heart Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998;339:1349-1357.

35. Yusuf S., Bosch J., Dagenais G., et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med 2016;374:2021-2031.

36. Shepherd J., Blauw G.J., Murphy M.B., et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomized controlled trial. Lancet 2002;360:1623-1630.

37. Nakamura H., Arakawa K., Itakura H., et al. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Lancet 2006;368:1155-1163.

38. Baigent C., Landray M.J., Reith C., et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomized placebo-controlled trial. Lancet 2011;377:2181-2192.

39. Cannon C.P., Braunwald E., McCabe C.H., et al. Intensive versus moderate lipid lowering with statins in acute coronary syndromes. N Engl J Med 2004;350:1495-1504.

40. LaRosa J.C., Grundy S.M., Waters D.D., et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-1435.

41. Pedersen T.R., Faergeman O., Kastelein J.J.P., et al. Highdose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction. The IDEAL study: a randomized controlled trial. JAMA 2005;294:2437-2445.

42. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results. JAMA 1984;251:35-64.

43. Frick M.H., Elo O., Haapa K., et al. Helsinki Heart Study: Primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med 1987;317:1237-1245.

44. Cannon C.P., Blazing MA, Giugliano R.P., et al. Ezetimibe added to statin therapy for acute coronary syndromes. N Engl J Med 2015;372:2387-2397.

45. Sabatine M.S., Giugliano R.P., Keech A.C., et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med 2017;376:1713-1722.

46. Steg P.G. ODYSSEY Outcomes trial, presented March 10, 2018, at the American College of Cardiology Annual Scientific Sessions, http://www.acc.org/latest-in-cardiology/ articles/2018/03/05/15/53/sat-9am-odyssey-outcomes-cv-outcomes-with- alirocumab-after-acs-acc-2018, accessed April 6,2018.

47. The HPS3/TIMI55-REVEAL Collaborative Group. Effects of anacetrapib in patients with atherosclerotic vascular disease. N Engl J Med 2017;377:1217-1227.

48. Collins R., Reith C., Emberson J., et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016;388:2532-2561.

49. Waters D.D. Cholesterol lowering: should it continue to be the last thing we do? Circulation 1999;99:3215-3217.

50. Mason R.P., Walter M.F., Day C.A., et al. Active metabolite of atorvastatin inhibits membrane cholesterol domain formation by an antioxidant mechanism. J Biol Chem 2006;281:9337- 9345.

51. Jacob R.F., Walter M.F., Self-Medlin Y., et al. Atorvastatin active metabolite inhibits oxidative modification of small dense low-density lipoprotein. J Cardiovasc Pharmacol 2013;62:160-166.

52. Mason R.P., Sherratt S.C.R, Jacob R.F. Eicosapentaenoic acid inhibits oxidation of apoB-containing lipoprotein particles of different size in vitro when administered alone or in combination with atorvastatin active metabolite compared with other triglyceride-lowering agents. J Cardiovasc Pharmacol 2016;68:33-40.

53. Ford I., Murray H., McCowan C., Packard C.J. Long-term safety and efficacy of lowering low- density lipoprotein cholesterol with statin therapy. 20-year follow-up of West of Scotland coronary prevention study. Circulation 2016;133:1073-1080.

54. Waters D.D., Bangalore S. The evolution of myocardial infarction: when the truths we hold to be self-evident no longer have evidence. Can J Cardiol 2017;33:1209-1211.

55. Komukai K., Kubo T., Kitabata H., et al. Effect of atorvastatin therapy on fibrous cap thickness in coronary atherosclerotic plaque as assessed by optical coherence tomography: the EASY-FIT study. J Am Coll Cardiol 2014;64:2207-2217. doi: 10.1016/j.jacc.2014.08.045.

56. Nishiguchi T., Kubo T., Tanimoto T., et al. Effect of Early Pitavastatin Therapy on Coronary Fibrous-Cap Thickness Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome: The ESCORT Study. JACC Cardiovasc Imaging 2018;11:829-838. doi: 10.1016/j. jcmg.2017.07.011.

57. Ogita M., Miyauchi K., Morimoto T., et al. Association between circulating matrix metalloproteinase levels and coronary plaque regression after acute coronary syndrome--subanalysis of the JAPAN-ACS study. Atherosclerosis 2013;226:275-280. doi: 10.1016/j.atherosclerosis.2012.10.063.

58. Ylä-Herttuala S., Bentzon J.F., Daemen M., et al. Stabilisation of atherosclerotic plaques. Position paper of the European Society of Cardiology (ESC) Working Group on atherosclerosis and vascular biology. Thromb Haemost 2011;106:1-19. doi: 10.1160/TH10-12-0784.

59. Uzui H., Nakano A, Mitsuke Y,et al. Comparison of lipophilic and hydrophilic statins on atheroma stabilizing effects in hypercholesterolemic patients. Presented at: European Society of Cardiology Congress 2010. August 28-September 1,2010; Stockholm, Sweden. Abstract P5565.

60. Berwanger O., Santucci E.V., de Barros e Silva P.G.M., et al. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial. JAMA 2018;319:1331-1340. doi: 10.1001/jama.2018.2444.


Для цитирования:


Гиляревский С.Р. ВРЕМЕННЫЕ ФАКТОРЫ, ВЛИЯЮЩИЕ НА ЭФФЕКТИВНОСТЬ И ПЕРЕНОСИМОСТЬ ПРИМЕНЕНИЯ СТАТИНОВ: НАУЧНЫЕ И ПРАКТИЧЕСКИЕ АСПЕКТЫ. Евразийский кардиологический журнал. 2018;(3):62-75.

For citation:


Giliarevskii S.R. TIME-DEPENDENT FACTORS OF EFFECTIVENESS AND TOLERABILITY OF STATINS: SCIENTIFIC AND PRACTICAL ASPECTS. Eurasian heart journal. 2018;(3):62-75.

Просмотров: 9


Creative Commons License
Контент доступен под лицензией BY NC ND.


ISSN 2225-1685 (Print)
ISSN 2305-0748 (Online)