Pharmacodynamic interaction between ezetimibe and rosuvastatin

Current Medical Research and Opinion

Volumn 20, Issue 8, 2004, Pages 1185-1195

  Kosoglou, Teddy ^a   Statkevich, Paul ^a   Yang, Bo ^a   Suresh, Ramachandran ^a   Zhu, Yali ^a   Boutros, Tanya ^a   Maxwell, Stephen E ^a   Tiessen, Renger ^b   Cutler, David L ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b PRA International USA   (Netherlands)

Author keywords

Cholesterol absorption inhibitor; Drug interaction; Ezetimibe; Hypercholesterolemia; Pharmacodynamics; Pharmacokinetics; Rosuvastatin

Indexed keywords

EZETIMIBE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; ROSUVASTATIN; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ADULT; ARTICLE; BACKACHE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLATULENCE; HEADACHE; HOSPITAL PATIENT; HUMAN; HYPERCHOLESTEROLEMIA; LABORATORY TEST; LIPID BLOOD LEVEL; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MUSCULOSKELETAL DISEASE; MYALGIA; PHARMACODYNAMICS; PHARYNGITIS; PHYSICAL ACTIVITY; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SIDE EFFECT; SINGLE BLIND PROCEDURE; STATISTICAL SIGNIFICANCE;

EID: 4344630867     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079904125004213     Document Type: Article

References (47)

1. Rosamond WD, Chambless LE, Folsom AR, et al. Trends in the incidence of myocardial infarction and in mortality due to coronary heart disease, 1987 to 1994. New Engl J Med 1998;339:861-7
2. Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet 1997;349:1269-76
3. 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 Am Med Assoc 2001;285:2486-97
4. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-89
5. Downs JR, Clearfield M, Weis S, PA, 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. J Am Med Assoc 1998;279:1615-22
6. 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]. New Engl J Med 1996;335:1001-9
7. 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. New Engl J Med 1998;339:1349-57
8. 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]. New Engl J Med 1995;333:1301-7
9. Beisiegel U. Lipoprotein metabolism. Eur Heart J 1998;19 (Suppl A):A20-A23
10. Moghadasian MH. Clinical pharmacology of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. Life Sci 1999;65:1329-37
11. Jones P, Kafonek S, Laurora I, Hunninghake D. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol 1998;81:582-7
12. Erhardt L. Are we treating to target? Atheroscler Suppl 2000;1:9-14
13. Tikkanen MJ. Statins: within-group comparisons, statin escape and combination therapy. Curr Opin Lipidol 1996;7:385-8
14. Wood D, De Backer G, Faergeman O, Graham I, Mancia G, Pyorala K. Prevention of coronary heart disease in clinical practice: recommendations of the Second Joint Task Force of European and other Societies on Coronary Prevention. Atherosclerosis 1998;140:199-270
15. Wierzbicki AS, Mikhailidis DP, Wray R, et al. Statin-fibrate combination therapy for hyperlipidaemia: a review. Curr Med Res Opin 2003;19:155-68
16. Schectman G, Hiatt J. Drug therapy for hypercholesterolemia in patients with cardiovascular disease: factors limiting achievement of lipid goals. Am J Med 1996;100:197-204
17. Altmann SW, Davis HR, Zhu LJ, et al. Niemann-Pick C1 Like 1 protein is critical for intestinal cholesterol absorption. Science 2004;303:1201-4
18. Van Heek M, Compton DS, Davis HR. The cholesterol absorption inhibitor, ezetimibe, decreases diet-induced hypercholesterolemia in monkeys. Eur J Pharmacol 2001;415:79-84
19. 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
20. 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
21. Sudhop T, Lütjohann D, Kodal A, et al. Inhibition of intestinal cholesterol absorption by ezetimibe in humans. Circulation 2002;106:1943-8
22. Patrick JE, Kosoglou T, Stauber KL, et al. Disposition of the selective cholesterol absorption inhibitor ezetimibe in healthy male subjects. Drug Metabol Dispos 2002;30:430-7
23. Ezzet F, Krishna G, Wexler DB, Statkevich P, Kosoglou T, Batra VK. A population pharmacokinetic model that describes multiple peaks due to enterohepatic recirculation of ezetimibe. Clin Ther 2001;23:871-85
24. Bays HE, Moore PB, Drehobl MA, Rosenblatt S, Toth PD, Dujovne CA 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
25. 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
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. 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
28. 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
29. 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
30. 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
31. Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol 2001;88:504-8
32. Ernst ND, Cleeman J, Mullis R, Sooter-Bochenek J, Van Horn L. The National Cholesterol Education Program: implications for dietetic practitioners from the Adult Treatment Panel recommendations. J Am Diet Assoc 1988;88:1401-8, 1411
33. Martin PD, Mitchell PD, Schneck DW. Pharmacodynamic effects and pharmacokinetics of a new HMG-CoA reductase inhibitor, rosuvastatin, after morning or evening administration in healthy volunteers. Br J Clin Pharmacol 2002;54:472-7
34. Gibaldi M, Perrier D. Pharmacokinetics, 2nd ed. New York: Marcel Dekker Inc; 1982. p. 409-17
35. Blasetto JW, Stein EA, Brown WV, Chitra R, Raza A. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups. Am J Cardiol 2003;91:3C-10C
36. Paoletti R, Fahmy M, Mahla G, Mizan J, Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. J Cardiovasc Risk 2001;8:383-90
37. Roberts WC. The rule of 5 and the rule of 7 in lipid-lowering by statin drugs. Am J Cardiol 1997;80:106-7
38. Kosoglou T, Meyer I, Veltri EP, et al. Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and simvastatin. Br J Clin Pharmacol 2002;54:309-19
39. Kosoglou T, Seiberling M, Statkevich P, et al. Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and atorvastatin. J Am Coll Cardiol 2001;37(Suppl A):229A [abstract]
40. Kosoglou T, Meyer I, Musiol B, et al. Pharmacodynamic interaction between fluvastatin and ezetimibe has favorable clinical implications. Atherosclerosis Suppl 2001;2:89 [abstract]
41. Knopp RH, Retzlaff B, Walden C, Fish B, Buck B, McCann B. One-year effects of increasingly fat-restricted, carbohydrate-enriched diets on lipoprotein levels in free-living subjects (44564E). Proc Soc Exp Biol Med 2000;225:191-9
42. Chapman MJ, McTaggart F. Optimizing the pharmacology of statins: characteristics of rosuvastatin. Atheroscler Suppl 2002;2:33-6
43. McTaggart F, Buckett L, Davidson R, et al. Preclinical and clinical pharmacology of Rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001;87:28B-32B
44. Zhu Y, Statkevich P, Kosoglou T. Effect of ezetimibe (SCH 58235) on the activity of drug metabolizing enzymes in vivo. Clin Pharmacol Ther 2000;67:152 [Abstract]
45. Zhu Y, Statkevich P, Maxwell SE, et al. The effect of gender on the pharmacokinetics of SCH 58235, a cholesterol absorption inhibitor. AAPS PharmSci Suppl 1999;1(4):S-24 [abstract 1076]
46. SN 01483. Influence of subject demographics on ezetimibe plasma concentration following multiple dosing in healthy subjects: meta analysis. Schering-Plough Research Institute, Kenilworth, NJ, USA [data on file]
47. Schering-Plough Research Institute, Kenilworth, NJ, USA [data on file]