Efficacy and safety of ezetimibe coadministered with pravastatin in patients with primary hypercholesterolemia: A prospective, randomized, double-blind trial

European Heart Journal

Volumn 24, Issue 8, 2003, Pages 717-728

  Melani, Lorenzo ^a   Mills, Richard ^b   Hassman, David ^c   Lipetz, Robert ^d   Lipka, Leslie ^a   LeBeaut, Alexandre ^a   Suresh, Ramachandran ^a   Mukhopadhyay, Pabak ^a   Veltri, Enrico ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Coastal Carolina Research Center ^*  (United States)

^c Comprehensive Clinical Research ^*  (United States)

^d Encompass Clinical Research   (United States)

Author keywords

Cholesterol absorption inhibitor; Coadministration; Ezetimibe; Hyperchotesterotemia; LDL cholesterol; Pravastatin

Indexed keywords

CHOLESTEROL; EZETIMIBE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PRAVASTATIN;

ADULT; AGED; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERANCE; FEMALE; HUMAN; HYPERCHOLESTEROLEMIA; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME;

ADULT; AGED; ANTICHOLESTEREMIC AGENTS; AZETIDINES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERCHOLESTEROLEMIA; LIPIDS; MALE; MIDDLE AGED; PRAVASTATIN; TREATMENT OUTCOME; VITAMINS;

EID: 0344490262     PISSN: 0195668X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0195-668X(02)00803-5     Document Type: Article

References (19)

1. Wood D, De Backer G, Faergeman O et al. Prevention of coronary heart disease in clinical practice: recommendations of the Second Joint Task Force of European and other Societies on Coronary Prevention. Eur Heart J 1998; 19:1434-503.
2. 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.
3. Knopp RH. Drug treatment of lipid disorders. N Engl J Med 1999;341:498-511.
4. Fruchart J-C, Brewer HB Jr, Leitersdorf E. Consensus for the use of fibrates in the treatment of dyslipoproteinemia and coronary heart disease. Am J Cardiot 1998;81:912-7.
5. Backman JT, Kyrklund C, Kivistö KT et al. Plasma concentrations of active simvastatin acid are increased by gemfibrozil. Clin Pharmacol Ther 2000;68:122-9.
6. Federman DG, Hussain F, Walters AB. Fatal rhabdomyolysis caused by lipid-lowering therapy. South Med J 2001; 94:1023-6.
7. Bays HE, Dujovne CA. Drug interactions of lipid-altering drugs. Drug Safety 1998;19:355-71.
8. van Heek M, France CF, Compton DS et al. In vivo metabolism-based discovery of a potent cholesterol absorption inhibitor, SCH58235, in the rat and rhesus monkey through the identification of the active metabolites of SCH48461. J Pharmacol Exp Ther 1997;283:157-63.
9. van Heek M, Farley C, Compton DS et al. Comparison of the activity and disposition of the novel cholesterol absorption inhibitor, SCH58235, and its glucuronide, SCH60663. Br J Pharmacol 2000;129:1748-54.
10. Knopp RH, Bays H, Manion CV et al. Effect of ezetimibe on serum concentrations of lipid-soluble vitamins. Atherosclerosis 2001;2(Suppl):90.
11. Miettinen TA. Cholesterol absorption inhibition: a strategy for cholesterol-lowering therapy. Drug Focus 2001; 55:710-6.
12. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972;18:499-502.
13. New York Heart Association. Disease of the heart and blood vessels. Nomenclature and criteria for diagnosis. 6th ed. Boston, MA: Little Brown, 1964. p. 114.
14. 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.
15. 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.
16. Ballantyne C, Houri J, Notarbartolo A et al. Ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia. J Am Coll Cardiol 2002; 39:227A.
17. 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.
18. Bradford RH, Shear CL, Chremos AN et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med 1991;151:43-9.
19. Tolman KG. Defining patient risks from expanded preventive therapies. Am J Cardiol 2000;85:9E-15E.