Evidence-based grounds of the efficacy of simvastatin (zocor): 15 years later


Cite item

Full Text

Abstract

The review describes the history of hypolipidemic therapy with statins. It gives the results of studies of the primary prevention of atherosclerosis and the treatment of hyperlipidemias with lovastatin, pravastatin, and fluvastatin. Emphasis is laid on trial data on the efficacy, tolerability, and safety of simvastatin (zocor). The results of studies, including regression ones, of this drug in different doses, controlled by biochemical, clinical, magnet resonance imaging, and ultrasonic data are summarized. There is a significant reduction in the risk of cardiovascular, coronary, and overall deaths and in that of stroke. There is evidence for the successful use of simvastatin (zocor) in combined therapy with fibrates, nicotinic acid, and ezetrol.

About the authors

Andrey Vladimirovich Susekov

Email: asus99@mail.ru

Natal'ya Badrievna Gornyakova

Email: gornyakova@bk.ru

Marina Yur'evna Zubareva

Email: mzubareva06@mail.ru

A V Susekov

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

N B Gornyakova

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

M Yu Zubareva

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

Russian Cardiology Research-and-Production Complex, Russian Agency for Medical Technologies

References

  1. Heron M. P. et al. National Vital Statistics Report, CDC 2008; 56(16); 1-52.
  2. Explaining the decline in heart disease mortality. Am. J. Epidemiol. 2005; 162: 764-773.
  3. Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383-1389.
  4. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk patients: a randomized placebo-controlled trial. Lancet 2002; 360: 7-22.
  5. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). J. A. M. A. 2001; 285(19): 2486-2497.
  6. Grundy S. M., Cleeman J. I., Bairey C. N. et al. Implication of recent clinical trials for the national cholesterol education programm adult. Treatment Panel III Guidelines. Circulation 2004; 110: 227-239.
  7. Conroy R. M., Pyorala K., Fitzgerald A. P. et al. SCORE project group. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur. Heart J. 2003; 24(11): 987-1003.
  8. Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts. European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Eur. Heart J. 2007; 28(19): 2375-2414.
  9. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации (IV пересмотр). Кардиоваск. тер. и профилакт. 2009; 6(прил. 3): 3-58.
  10. Downs J. R., Clearfield M., Weis S. et al. for the AFCAPS/ TexCAPS Research Group. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels. J. A. M. A. 1998; 279: 1615-1622.
  11. Blankenhorn D. H., Azen S. P., Dramsch D. M. et al. Coronary angiographic changes with lovastatin therapy. The Monitored Atherosclerosis Regression Study (MARS). Ann. Intern. Med. 1993; 119(10); 969-976.
  12. Effects of simvastatin on coronary atheroma: The Multicenter Anti-Atheroma Study (MAAS). Lancet 1994; 344: 633-638.
  13. Waters D., Higginson L., Gladstone P. et al. Effects of monotherapy with an HMG- Co-A reductase inhibitor on the progression of coronary atherosclerosis as assessed by serial quantitative arteriography. The Canadian Coronary Atherosclerosis Interventional Trial. Circulation 1994; 89(3): 959-968.
  14. Groot E., Jukema J. W., Bruschke A. V. et al. Effects of lipid-lowering by pravastatin on progression and regression of coronary artery disease in symptomatic men with normal to moderate elevated serum cholesterol levels. The Regression Growth Evaluation Statin Study (REGRESS). Circulation 1995; 91: 2528-2540.
  15. Herd J. A., Ballantyne C. M., Farmer J. A. et al. Effects of fluvastatin on coronary atherosclerosis in patients with mild to moderate cholesterol elevations (Lipoprotein and coronary atherosclerosis study ([LCAS]). Am. J. Cardiol. 1997; 80: 278-286.
  16. Bestehorn H.-P., Rensing U. F. E., Roskamm H. et al. The effect of simvastatin on progression of coronary artery disease. The Multicentre Coronary Intervention Study (CIS). Eur. Heart J. 1997; 18(2): 226-234.
  17. Pitt B., Mancini G. B., Ellis S. G. et al. Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC-I): reduction in atherosclerosis progression and clinical events. J. Am. Coll. Cardiol. 1995; 26: 1113-1120.
  18. Thompson G. R., Maher V. M., Mattews S. et al. Familial Hypercholesterolemia Regression Study: a randomized taril of low-density lipoprotein apheresis. Lancet 1995; 345: 811-816.
  19. Thompson G. R. Angiographic trials of lipid-lowering therapy: end of an era? Br. Heat J. 1995; 74: 343-347.
  20. Waters D. Stabilization of coronary atherosclerosis. London: Science Press Ltd; 1994.
  21. Thompson G. R., Holyer J., Waters D. Percentage change rather than plasma level of LDL-cholesterol determines therapeutic response in coronary heart disease. Curr. Opin. Lipidol. 1995; 6: 386-388.
  22. Thompson G. R. What targets should lipid-modulating therapy achieve to optimise the prevention of coronary heart disease? Atherosclerosis 1997; 131: 1-5.
  23. Corti R., Fuster V., Fayad Z. A. et al. Effects of aggressive versus conventional lipid-lowering therapy by simvastatin on human atherosclerosis lesions: a prospective, randomized, double blind trial with high-resolution magnetic resonance imaging. J. Am. Coll. Cardiol. 2005; 46(1): 106-112.
  24. Lima J., Desai M. Y., Steen H. et al. Statin-induced cholesterol lowering and plaque regression after 6 months of magnetic resonance imaging-monitored therapy. Circulation 2004; 110: 2336-2341.
  25. Jensen L., Thayssen P., Pedersen K. E. et al. Regression of coronary atherosclerosis by Simvastatin: a serial intravascular ultrasound study. Circulation 2004; 110: 265-270.
  26. Сусеков А. В. Обоснование увеличения доз статинов в клинической практике. Тер. арх. 2001; 4: 76-80.
  27. Davidson M. H., Stein E. A., Dujovne C. A. et al. The efficacy and six week tolerability of Simvastatin 80 and l60 mg/day. Am. J. Cardiol. 1997; 79: 38-42.
  28. Crouse J. R. III, Frohlich J., Ose L. et al. Effects of high doses of Simvastatin and atorvastatin on high density lipoprotein cholesterol and apolipoprotein. Am. J. Cardiol. 1999; 83(10): 1476-1477.
  29. Wierzbicki A. S., Lumb P. J., Chick G., Crook M. A. Comparison of therapy with simvastatin 80 mg and atorvastatin 80 mg in patients with familial hypercholesterolaemia. Int. J. Clin. Pract. 1999; 53(8): 609-611.
  30. Ose L., Davidson M. H., Stein E. A. et al. Lipid-altering efficacy and safety of simvastatin 80 mg/day: long-term experience in a large group of patients with hypercholesterolemia. World Wide Expanded Dose Simvastatin Study Group. Clin. Cardiol. 2000; 23(1): 39-46.
  31. Illingworth D. R.,Crouse J. R. 3-rd, Hunninghake D. B. et al. A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. Curr. Med. Res. Opin. 2001; 17(1): 43-50.
  32. Davidson M. H., Stein E. A., Hunninghake D. B. et al. for the Worldwide Expanded Dose Simvastatin Study Group. Lipid-altering efficacy and safety of simvastatin 80 mg/day: worldwide long-term experience in patients with hypercholesterolemia. Nutr. Metab. Cardiovasc. Dis. 2000; 10(5): 253-262.
  33. De Sauvage Nolting P. R., Buirma R. J., Hutten B. A. et al. Two year efficacy and safety of simvastatin 80 mg in familial hypercholesterolaemia (the Examination of Probands and Relatives in Statin Studies with Familial Hypercholesterolemia [ExPRESS FH]. Am. J. Cardiol. 2002; 90(2): 181-184.
  34. Pedersen T. R., Faergeman O., Kastelein J. J. et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDLEAL study: a randomized controlled trial. Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. J. A. M. A. 2005; 294(19): 2437-2445.
  35. Brown B. G., Zhao X. Q., Chait A. et al. Simvastatin and niacin, antioxidant vitamins or the combination for the prevention of coronary heart disease. N. Engl. J. Med. 2001; 345(22): 1583-1592.
  36. Grundy S. M., Vega G. L., Tomassini J. E., Tershakovec A. M. Correlation of non-high density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). Am. J. Cardiol. 2009; 104(4): 548-553.
  37. Grundy S., Vega G. L., Yuan Z. et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). An. J. Cardiol. 2005; 15(4): 462- 468.
  38. Kastelein J. J. P., Akdim F., Stroes E. et al. for the ENHANCE investigators. Simvastatin with or without ezetimibe in familial hypercholesterolaemia. N. Engl. J. Med. 2008; 358: 1431- 1443.
  39. Canon C. P., Giugliano R. P., Blazing M. A. et al. Rationale and design of IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial): comparison of ezetimibe/simvastatin versus simvastatin monotherapy and cardiovascular outcomes in patients with acute coronary syndromes. Am. Heart J. 2008; 156: 826-832.
  40. Califf R., Lokhnygina Y., Cannon C. P. et al. An update on the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) design. Am. J. Cardiol. 2010; in press.
  41. Gitt A. K. Trial data suggest wider more intensive statin use. DYSIS (Dislipidemia International Study). Pharm. Ther. 2009; 34(5): 258-260.

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2010 Consilium Medicum

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
 

Address of the Editorial Office:

  • Novij Zykovskij proezd, 3, 40, Moscow, 125167

Correspondence address:

  • Alabyan Street, 13/1, Moscow, 127055, Russian Federation

Managing Editor:

  • Tel.: +7 (926) 905-41-26
  • E-mail: e.gorbacheva@ter-arkhiv.ru

 

© 2018-2021 "Consilium Medicum" Publishing house


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies