Safety and effectiveness of the association ezetimibe-statin (E-S) versus high dose rosuvastatin after acute coronary syndrome: The SAFE-ES study

Annales de Cardiologie et d'Angeiologie

Volumn 63, Issue 4, 2014, Pages 222-227

  Deharo, P ^a,b,c   Pankert, M ^a,b,c   Quilici, J ^a,b,c   Grosdidier, C ^a,b,c   Verdier, V ^d   Bonnet, G ^a,b,c   Morange, P ^a,b,c   Alessi, M C ^a,b,c   Bonnet, J L ^a,b,c   Cuisset, T ^a,b,c  

^a TIMONE HOSPITAL   (France)

^b INSERM   (France)

^c AIX MARSEILLE UNIVERSITY   (France)

^d ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE   (France)

Author keywords

Acute coronary syndrome; Ezetimibe; Muscular pain

Indexed keywords

CREATINE KINASE; EZETIMIBE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; SIMVASTATIN; AZETIDINE DERIVATIVE; FLUOROBENZENE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ACUTE CORONARY SYNDROME; ADULT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL EXAMINATION; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERANCE; DYSLIPIDEMIA; ENZYME BLOOD LEVEL; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN; COMPARATIVE STUDY; DRUG COMBINATION; MIDDLE AGED;

ACUTE CORONARY SYNDROME; ANTICHOLESTEREMIC AGENTS; AZETIDINES; DRUG THERAPY, COMBINATION; FEMALE; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PYRIMIDINES; SULFONAMIDES;

EID: 84908027252     PISSN: 00033928     EISSN: 17683181     Source Type: Journal    
DOI: 10.1016/j.ancard.2014.04.018     Document Type: Article

References (31)

1. Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), Steg P.G., James S.K., et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). Eur Heart J 2012, 33:2569-2619.
2. Yusuf S., Hawken S., Ounpuu S., INTERHEART Study Investigators, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52countries (the INTERHEART study): case-control study. Lancet 2004, 364:937-952.
3. Verschuren W.M., Jacobs D.R., Bloemberg B.P., et al. Serum total cholesterol and long-term coronary heart disease mortality in different cultures. Twenty-five years follow-up of the seven countries study. JAMA 1995, 274:131-136.
4. Chen Z., Peto R., Collins R., MacMahon S., Lu J., Li W. Serum cholesterol concentration and coronary heart disease in population with low cholesterol concentrations. BMJ 1991, 303:276-282.
5. O'Keefe J.H., Cordain L., Harris W.H., Moe R.M., Vogel R. Optimal low-density lipoprotein is 50 to 70mg/dL. Lower is better and physiologically normal. J Am Coll Cardiol 2004, 43:2142-2146.
6. Grundy S.M., Cleeman J.I., Merz C.N., National Heart, Lung, and Blood Institute, American College of Cardiology Foundation, American Heart Association, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004, 110:227-239.
7. Jankowski P., Loster M., Kawecka-Jaszcz K. Ezetimibe: new perspectives in lipid lowering treatment. Cardiol J 2007, 14:232-237.
8. Davis H.R., Veltri E.P. Zetia: inhibition of Niemann-Pick C1 Like 1 (NPC1L1) to reduce intestinal cholesterol absorption and treathyperlipidemia. J Atheroscler Thromb 2007, 14:99-108.
9. Kashani A., Sallam T., Bheemreddy S., Mann D.L., Wang Y., Foody J.M. Review of side-effect profile of combination ezetimibe and statin therapy in randomized clinical trials. Am J Cardiol 2008, 101:1606-1613.
10. Stein E., Stender S., Mata P., Ezetimibe Study Group, et al. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe coadministered with atorvastatin. Am Heart J 2004, 148:447-455.
11. Bissonnette S., Habib R., Sampalis F., Boukas S., Sampalis J.S., Ezetrol Add-On Investigators, et al. Efficacy and tolerability of ezetimibe 10mg/day coadministered with statins in patients with primary hypercholesterolemeia who do not achieve target LDL-C while on statin monotherapy: a Canadian, multicentre, prospective study-the Ezetrol Add-On Study. Can J Cardiol 2006, 22:1035-1044.
12. Mikhailidis D.P., Sibbring G.C., Ballantyne C.M., Davies G.M., Catapano A.L. Meta-analysis of the cholesterol- lowering effect of ezetimibe added to ongoing statin therapy. Curr Med ResOpin 2007, 23:2009-2026.
13. Hamm C.W., Bassand J.P., Agewall S., et al. ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation The Task Force for the management of acute coronary syndromes(ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011, 32:2999-3054.
14. McKenney J.M., Davidson M.H., Jacobson T.A., et al. Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force. Am J Cardiol 2006, 97:89C-94C.
15. Melani L., Mills R., Hassman D., Ezetimibe Study Group, et al. Efficacy and safety of ezetimibe coadministered with pravastatin in patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Eur Heart J 2003, 24:717-728.
16. Ballantyne C.M., Weiss R., Moccetti T., EXPLORER Study Investigators, et al. Efficacy and safety of rosuvastatin 40mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007, 99:673-680.
17. Davidson M.H., Ballantyne C.M., Kerzner B., Ezetimibe Study Group, et al. Efficacy and safety of ezetimibe coadministered with statins: randomised, placebo-controlled, blinded experience in 2382patients with primary hypercholesterolemia. Int J Clin Pract 2004, 58:746-755.
18. Fleg J.L., Mete M., Howard B.V., et al. Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial. J Am Coll Cardiol 2008, 52:2198-2205.
19. Mikhailidis D.P., Lawson R.W., McCormick A.L., et al. Comparative efficacy of the addition of ezetimibe to statin vs. statin titration in patients with hypercholesterolaemia: systematic review and meta-analysis. Curr Med Res Opin 2011, 27:1191-1210.
20. Commission de transparence de la Haute Autorité de santé. Available at: http://www.has-sante.fr/portail/jcms/c_997109/crestor-ct-8369. Accessed October 1, 2010.
21. Cannon C.P., Braunwald E., McCabe C.H., et al. Intensive versus moderate lipid lowering withstatins after acute coronary syndromes. N Engl J Med 2004, 350:1495-1504.
22. Davidson M.H., Clark J.A., Glass L.M., Kanumalla A. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol 2006, 97:32C-43C.
23. Kastelein J.J., Akdim F., Stroes E.S., ENHANCE Investigators, et al. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008, 358:1431-1443.
24. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) 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) final report. Circulation 2002, 106:3143-3421.
25. Roy P., Bonello L., Torguson R., et al. Impact of "nuisance" bleeding on clopidogrel compliance in patients undergoing intracoronary drug-eluting stent implantation. Am J Cardiol 2008, 102:1614-1617.
26. Jernberg T., Johanson P., Held C., Svennblad B., Lindbäck J., Wallentin L., et al. Association between adoption of evidence-based treatment and survival for patients with ST-elevation myocardial infarction. JAMA 2011, 305:1677-1684.
27. Stein E.A., Ballantyne C.M., Windler E., et al. Efficacy and tolerability of fluvastatin XL 80mg alone, ezetimibe alone, and the combination of fluvastatin XL 80mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol 2008, 101:490-496.
28. Shek A., Ferrill M.J. Statin-fibrate combination therapy. Ann Pharmacother 2001, 35:908-917.
29. De Lemos J.A., Blazing M.A., Wiviott S.D., Lewis E.F., Fox K.A., White H.D., et al. Early intensive vs. a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004, 292:1307-1316.
30. European Association for Cardiovascular Prevention & Rehabilitation, Reiner Z., Catapano A.L., De Backer G., Graham I., Taskinen M.R., 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, 32:1769-1818.
31. Cannon C.P., Giugliano R.P., Blazing M.A., IMPROVE-IT Investigators, et al. Rationale and design of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial): comparison of ezetimbe/simvastatin versus simvastatin monotherapy on cardiovascular outcomes in patients with acute coronary syndromes. Am Heart J 2008, 156:826-832.