A multi-centre, randomised, double-blind 14-week extension study examining the long-term safety and efficacy profile of the ezetimibe/simvastatin combination tablet

International Journal of Clinical Practice

Volumn 61, Issue 9, 2007, Pages 1469-1480

  Ose, L ^a   Johnson Levonas, A ^b   Reyes, R ^b   Lin, J ^b   Shah, A ^b   Tribble, D ^b   Musliner, T ^b  

^a OSLO UNIVERSITY HOSPITAL   (Norway)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; SIMVASTATIN;

ADULT; AGED; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERCHOLESTEROLEMIA; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TABLET; TREATMENT DURATION;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTICHOLESTEREMIC AGENTS; AZETIDINES; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; HYPERCHOLESTEROLEMIA; MALE; MIDDLE AGED; SIMVASTATIN; TABLETS; TREATMENT OUTCOME;

EID: 34547808818     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2007.01402.x     Document Type: Article

References (40)

1. Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA 1986 256 : 2823 8.
2. Gaziano JM, Hebert PR, Hennekens CH. Cholesterol reduction: weighing the benefits and risks. Ann Intern Med 1996 124 : 914 8.
3. Knopp RH. Drug treatment of lipid disorders. N Engl J Med 1999 341 : 498 511.
4. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994 344 : 1383 9.
5. Sacks FM, Pfeffer MA, Moye LA et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med 1996 335 : 1001 9.
6. The Long-Term Intervention with Pravastatin in Ischaemic 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 57.
7. 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 : 1301 7.
8. 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 : 1615 22.
9. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993 269 : 3015 23.
10. 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). JAMA 2001 285 : 2486 97.
11. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Expert Panel. Arch Intern Med 1988 148 : 36 69.
12. Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med 2000 160 : 459 67.
13. Stein EA, Davidson MH, Dobs AS et al. Efficacy and safety of simvastatin 80 mg/day in hypercholesterolemic patients. The Expanded Dose Simvastatin U.S. Study Group. Am J Cardiol 1998 82 : 311 6.
14. Pedersen TR, Tobert JA. Simvastatin: a review. Expert Opin Pharmacother 2004 5 : 2583 96.
15. Davidson MH, Stein EA, Hunninghake DB et al. Lipid-altering efficacy and safety of simvastatin 80 mg/day: worldwide long-term experience in patients with hypercholesterolemia. Nutr Metab Cardiovasc Dis 2000 10 : 253 62.
16. Ose L, Davidson MH, Stein EA 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 : 39 46.
17. 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.
18. Dujovne CA, Chremos AN, Pool JL et al. Expanded clinical evaluation of lovastatin (EXCEL) study results: IV. Additional perspectives on the tolerability of lovastatin. Am J Med 1991 91 : 25S 30.
19. Black DM, Bakker-Arkema RG, Nawrocki JW. An overview of the clinical safety profile of atorvastatin (lipitor), a new HMG-CoA reductase inhibitor. Arch Intern Med 1998 158 : 577 84.
20. Farmer JA, Torre-Amione G. Comparative tolerability of the HMG-CoA reductase inhibitors. Drug Saf 2000 23 : 197 213.
21. Ballantyne CM, Houri J, Notarbartolo A et al. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation 2003 107 : 2409 15.
22. Melani L, Mills R, Hassman D 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 28.
23. Kerzner B, Corbelli J, Sharp S et al. Efficacy and safety of ezetimibe coadministered with lovastatin in primary hypercholesterolemia. Am J Cardiol 2003 91 : 418 24.
24. Davidson MH, McGarry T, Bettis R et al. Ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia. J Am Coll Cardiol 2002 40 : 2125 34.
25. Knopp RH, Dujovne CA, Le Beaut A, Lipka LJ, Suresh R, Veltri EP. Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: a pooled analysis from two controlled phase III clinical studies. Int J Clin Pract 2003 57 : 363 8.
26. Dujovne CA, Ettinger MP, McNeer JF et al. Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe, in patients with primary hypercholesterolemia. Am J Cardiol 2002 90 : 1092 7.
27. Goldberg AC, Sapre A, Liu J, Capece R, Mitchel YB. Efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc 2004 79 : 620 9.
28. Gagne C, Bays HE, Weiss SR et al. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol 2002 90 : 1084 91.
29. Pearson TA, Denke MA, McBride PE, Battisti WP, Brady WE, Palmisano J. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEP ATP III goals for LDL cholesterol in hypercholesterolemic patients: the ezetimibe add-on to statin for effectiveness (EASE) trial. Mayo Clin Proc 2005 80 : 587 95.
30. Knopp RH, Gitter H, Truitt T et al. Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia. Eur Heart J 2003 24 : 729 41.
31. Bays HE, Moore PB, Drehobl MA et al. Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies. Clin Ther 2001 23 : 1209 30.
32. Masana L, Mata P, Gagne C et al. Long-term safety and, tolerability profiles and lipid-modifying efficacy of ezetimibe coadministered with ongoing simvastatin treatment: a multicenter, randomized, double-blind, placebo-controlled, 48-week extension study. Clin Ther 2005 27 : 174 84.
33. Bays HE, Ose L, Fraser N et al. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther 2004 26 : 1758 73.
34. Karpe F, Boquist S, Tang R, Bond GM, de Faire U, Hamsten A. Remnant lipoproteins are related to intima-media thickness of the carotid artery independently of LDL cholesterol and plasma triglycerides. J Lipid Res 2001 42 : 17 21.
35. Kugiyama K, Doi H, Takazoe K et al. Remnant lipoprotein levels in fasting serum predict coronary events in patients with coronary artery disease. Circulation 1999 99 : 2858 60.
36. Koenig W, Sund M, Frohlich M et al. C-Reactive protein, a sensitive marker of inflammation, predicts future risk of coronary heart disease in initially healthy middle-aged men: results from the MONICA (Monitoring Trends and Determinants in Cardiovascular Disease) Augsburg Cohort Study, 1984 to 1992. Circulation 1999 99 : 237 42.
37. Pearson TA, Mensah GA, Alexander RW et al. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation 2003 107 : 499 511.
38. McNamara JR, Shah PK, Nakajima K et al. Remnant-like particle (RLP) cholesterol is an independent cardiovascular disease risk factor in women: results from the Framingham Heart Study. Atherosclerosis 2001 154 : 229 36.
39. Molgaard J, von Schenck H, Olsson AG. Comparative effects of simvastatin and cholestyramine in treatment of patients with hypercholesterolaemia. Eur J Clin Pharmacol 1989 36 : 455 60.
40. Yee HS, Fong NT. Atorvastatin in the treatment of primary hypercholesterolemia and mixed dyslipidemias. Ann Pharmacother 1998 32 : 1030 43.