Comparison of effects of morning versus evening administration of ezetimibe/simvastatin on serum cholesterol in patients with primary hypercholesterolemia;Efecto en los Niveles en Suero de Colesterol Cuando se Compara la Administración de por la Mañana Contra la Administración por la Tarde de Ezetimibe/Simvastatina en Pacientes con Hipercolesterolemia Primaria

Annals of Pharmacotherapy

Volumn 45, Issue 7-8, 2011, Pages 841-849

  Yoon, Hyung Sik ^a   Kim, Sung Ho ^a   Kim, Jeong Kyung ^a   Ko, Sang Hun ^a   Ko, Jae Ee ^a   Park, Soo Jin ^a   Park, Moon Gi ^a   Lee, Jae Hwan ^b,c   Hyon, Min Soo ^d  

^a Sun General Hospital   (South Korea)

^b Chungnam National University   (South Korea)

^c Cardiovascular Center   (South Korea)

^d Soonchunhyang University   (South Korea)

Author keywords

Chronobiologic variation; Ezetimibe; High sensitivity C reactive protein; Hypercholesterolemia; Simvastatin

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; APOLIPOPROTEIN B; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CALCIUM CHANNEL BLOCKING AGENT; CHOLESTEROL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NITRATE; SIMVASTATIN; TRIACYLGLYCEROL;

ADULT; ARTICLE; BLOOD SAMPLING; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CROSSOVER PROCEDURE; DIARRHEA; DISEASE MARKER; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; HUMAN; HYPERCHOLESTEROLEMIA; INDIGESTION; ISCHEMIC HEART DISEASE; LABORATORY TEST; LIPID ANALYSIS; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; MYALGIA; OPEN STUDY; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL;

AGED; ANTICHOLESTEREMIC AGENTS; AZETIDINES; C-REACTIVE PROTEIN; CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; CROSS-OVER STUDIES; DRUG CHRONOTHERAPY; DRUG COMBINATIONS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL COA REDUCTASES; HYPERCHOLESTEROLEMIA; INTENTION TO TREAT ANALYSIS; LIPIDS; MALE; MEDICATION ADHERENCE; MIDDLE AGED; PATIENT DROPOUTS; REPUBLIC OF KOREA; RISK FACTORS; SIMVASTATIN;

EID: 79960752475     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1P511     Document Type: Article

References (40)

1. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-1389.
2. Shepherd J, Cobbe SM, Ford I, et al.; The West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med 1995;333: 1301-1307.
3. Libby P, Aikawa M. Mechanisms of plaque stabilization with statins. Am J Cardiol 2003;91(suppl):4-8.
4. van Heek M, Farley C, Compton DS, Hoos LM, Smith-Torhan A, Davis HR. Ezetimibe potently inhibits cholesterol absorption but does not affect acute hepatic or intestinal cholesterol synthesis in rats. Br J Pharmacol 2003;138:1459-1464.
5. Altmann SW, Davis HR Jr, Zhu LJ, et al. Niemann-Pick C1 like 1 protein is critical for intestinal cholesterol absorption. Science 2004;303: 1201-1204.
6. Darkes MJ, Poole RM, Goa KL. Ezetimibe. Am J Cardiovasc Drugs 2003;3:67-76.
7. 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;54:309-319.
8. Ose L, Shah A, Davis MJ, et al. Consistency of lipid-altering effects of ezetimibe/simvastatin across gender, race, age, baseline low density lipoprotein cholesterol levels, and coronary heart disease status: results of a pooled retrospective analysis. Curr Med Res Opin 2006;22:823-835.
9. Kalogirou M, Tsimihodimos V, Saougos V, Lagos K, Tselepis AD, Elisaf M. Effect of ezetimibe on lipoprotein subfraction concentrations: the role of atorvastatin pretreatment. Arch Med Sci 2007;3:344-350.
10. Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol 2007;99:1706-1713.
11. 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). JAMA 2001;285:2486-97.
12. Package insert. Zocor (simvastatin) tablets. Whitehouse Station, NJ: Merck Pharmaceuticals, November 2009.
13. Package insert. Mevacor (lovastatin) tablets. Whitehouse Station, NJ: Merck Pharmaceuticals, November 2009.
14. Package insert. Lescol (fluvastatin) tablets. East Hanover, NJ: Novartis Pharmaceuticals, May 2009.
15. Parker TS, McNamara DJ, Brown C, et al. Mevalonic acid in human plasma: relationship of concentration and circadian rhythm to cholesterol synthesis rates in man. Proc Natl Acad Sci U S A 1982;79:3037-3034.
16. Package insert. Lipitor (atorvastatin calcium) tablets. Morris Plains, NJ: Pfizer Pharmaceuticals, July 2009.
17. Package insert. Pravachol (pravastatin) tablets. Princeton, NJ: Bristol-Myers Squibb, November 2009.
18. Package insert. Crestor (rosuvastatin) tablets. Wilmington, DE: Astra-Zeneca, March 2009.
19. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004;110:227-239.
20. Bairaktari E, Hatzidimou K, Tzallas C, et al. Estimation of LDL cholesterol based on the Friedewald formula and on apo B levels. Clin Biochem 2000;33:549-555. DOI 10.1016/S0009-9120(00)00162-4
21. Lund TM, Torsvik H, Falch D, Christophersen B, Skårdal R, Gullestad L. Effect of morning versus evening intake of simvastatin on the serum cholesterol level in patients with coronary artery disease. Am J Cardiol 2002;90:784-6.
22. Kaul S, Diamond GA. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials. Prog Cardiovasc Dis 2007;49:284-99.
23. Lewis JA. Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Statist Med 1999;18:1903-1942.
24. Chow S-C, Liu J-P. Design and analysis of bioavailability and bioequiva-lence studies. 2nd ed. New York, NY: Marcel Dekker, Inc., 1999:73-77.
25. Chow S-C, Shao J, Wang H. Sample size calculations in clinical research. 1st ed. New York, NY: Marcel Dekker, Inc., 2003:63-68.
26. Koenig W, Sund M, Frölich 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- 242.
27. 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.
28. Ballantyne CM, Hoogeveen RC, Bang H, et al. Lipoprotein associated phospholipase A2, high-sensitivity C-reactive protein, and risk for incident coronary heart disease in middle-aged men and women in the Atherosclerosis Risk in Communities (ARIC) study. Circulation 2004; 109:837-842.
29. Sabatine MS, Morrow DA, Jablonski KA, et al. Prognostic significance of the Centers for Disease Control/American Heart Association high-sensitivity C-reactive protein cut points for cardiovascular and other outcomes in patients with stable coronary artery disease. Circulation 2007; 115:1528-1536.
30. Ridker PM, Rifai N, Clearfield M, et al. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med 2001;344:1959-1965.
31. Gagné C, Bays HE, Weiss SR, et al.; Ezetimibe Study Group. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol 2002;90: 1084-1091.
32. Gagné C, Gaudet D, Bruckert E, for the Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simva-statin in patients with homozygous familial hypercholesterolemia. Circulation 2002;105:2469-2475.
33. Stein EA. An investigative look: selective cholesterol absorption inhibitors-embarking on a new standard care. Am J Manag Care 2002; 8(2 suppl):S36-S39;discussion S45-7.
34. Wallace A, Chinn D, Rubin G. Taking simvastatin in the morning compared with in the evening: randomised controlled trial. BMJ 2003;327: 788.
35. Illingworth RD. Comparative efficacy of once versus twice daily mevi-nolin in the therapy of familial hypercholesterolemia. Clin Pharmacol Ther 1986;40:338-343.
36. Hunninghake DB, Mellies MJ, Goldberg AC, et al. Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing. Atherosclerosis 1990;85:219-227.
37. 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;54:472-477.
38. Cilla DD Jr, Gibson DM, Whitfield LR, Sedman AJ. Pharmacodynamic effects and pharmacokinetics of atorvastatin after administration to nor-mo-cholesterolemic subjects in the morning and evening. J Clin Pharmacol 1996;36:604-609.
39. Scharnagl H, Vogel M, Abletshauser C, Freisinger F, Stojakovic T, März W. Efficacy and safety of fluvastatin-extended release in hypercholes-terolemic patients: morning administration is equivalent to evening administration. Cardiology 2006;106:241-248.
40. Sharp Collaborative Group. Study of Heart and Renal Protection (SHARP): randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease. Am Heart J 2010;160:785-794.e10.