Efficacy and safety of fluvastatin-extended release in hypercholesterolemic patients: Morning administration is equivalent to evening administration

Cardiology

Volumn 106, Issue 4, 2006, Pages 241-248

  Scharnagl, Hubert ^a   Vogel, Monika ^b   Abletshauser, Claudia ^c   Freisinger, Franz ^a   Stojakovic, Tatjana ^a   März, Winfried ^a  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

^b Astellas Pharma GmbH   (Germany)

^c NOVARTIS PHARMA GMBH   (Germany)

Author keywords

Administration; Evening; Fluvastatin; Morning

Indexed keywords

ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; CREATININE; FLUINDOSTATIN; GAMMA GLUTAMYLTRANSFERASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DELAYED DRUG RELEASE; DOSE TIME EFFECT RELATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; HUMAN; HYPERCHOLESTEROLEMIA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; STATISTICAL SIGNIFICANCE; TREATMENT DURATION;

ADULT; AGED; AGED, 80 AND OVER; ANTICHOLESTEREMIC AGENTS; APOLIPOPROTEINS B; C-REACTIVE PROTEIN; CHOLESTEROL, HDL; CHOLESTEROL, LDL; CIRCADIAN RHYTHM; DELAYED-ACTION PREPARATIONS; FATTY ACIDS, MONOUNSATURATED; FEMALE; HOMOCYSTEINE; HUMANS; HYPERCHOLESTEROLEMIA; INDOLES; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 33751096494     PISSN: 00086312     EISSN: None     Source Type: Journal    
DOI: 10.1159/000093200     Document Type: Article

References (27)

1. Cheung BM, Lauder IJ, Lau CP, Kumana CR: Meta-analysis of large randomized controlled trials to evaluate the impact of statins on cardiovascular outcomes. Br J Clin Pharmacol 2004;57:640-651.
2. Parker TS, McNamara DJ, Brown CD, Kolb R, Ahrens EH Jr, Alberts AW, Tobert J, Chen J, De Schepper PJ: Plasma mevalonate as a measure of cholesterol synthesis in man. J Clin Invest 1984;74:795-804.
3. Jones PJ, Schoeller DA: Evidence for diurnal periodicity in human cholesterol synthesis. J Lipid Res 1990;31:667-673.
4. Parker TS, McNamara DJ, Brown C, Garrigan O, Kolb R, Batwin H, Ahrens EH Jr: Mevalonic acid in human plasma: relationship of concentration and circadian rhythm to cholesterol synthesis rates in man. Proc Natl Acad Sci USA 1982;79:3037-3041.
5. Illingworth DR: Comparative efficacy of once versus twice daily mevinolin in the therapy of familial hypercholesterolemia. Clin Pharmacol Ther 1986;40:338-343.
6. Saito Y, Yoshida S, Nakaya N, Hata Y, Goto Y: Comparison between morning and evening doses of simvastatin in hyperlipidemic subjects. A double-blind comparative study. Arterioscler Thromb 1991;11:816-826.
7. Hunninghake DB, Mellies MJ, Goldberg AC, Kuo PT, Kostis JB, Schrott HG, Insull W Jr, Pan HY: Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing. Atherosclerosis 1990;85:219-227.
8. Wallace A, Chinn D, Rubin G: Taking simvastatin in the morning compared with in the evening: randomised controlled trial. BMJ 2003;327:788.
9. Cilla DD Jr, Gibson DM, Whitfield LR, Sedman AJ: Pharmacodynamic effects and pharmacokinetics of atorvastatin after administration to normocholesterolemic subjects in the morning and evening. J Clin Pharmacol 1996;36:604-609.
10. 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.
11. De Angelis G: The influence of statin characteristics on their safety and tolerability. Int J Clin Pract 2004;58:945-955.
12. Levy RI, Troendle AJ, Fattu JM: A quarter century of drug treatment of dyslipoproteinemia, with a focus on the new HMG-CoA reductase inhibitor fluvastatin. Circulation 1993;87:III45-III53.
13. Barilla D, Prasad P, Hubert M, Gumbhir-Shah K: Steady-state pharmacokinetics of fluvastatin in healthy subjects following a new extended release fluvastatin tablet, Lescol XL. Biopharm Drug Dispos 2004;25:51-59.
14. Ballantyne CM, Pazzucconi F, Pinto X, Reckless JP, Stein E, McKenney J, Bortolini M, Chiang YT: Efficacy and tolerability of fluvastatin extended-release delivery system: a pooled analysis. Clin Ther 2001;23:177-192.
15. Fauler G, März W, Abletshauser C, Erwa W, Löser R: Fluvastatin ER formulation reduces cholesterol synthesis independent of daytime of administration. Abstract M.510. Atherosclerosis 2004;5(suppl):117-118.
16. Kiortsis DN, Giral P, Bruckert E, Turpin G: Factors associated with low compliance with lipid-lowering drugs in hyperlipidemic patients. J Clin Pharm Ther 2000;25:445-451.
17. Corsini A: The safety of HMG-CoA reductase inhibitors in special populations at high cardiovascular risk. Cardiovasc Drugs Ther 2003;17:265-285.
18. Milionis HJ, Papakostas J, Kakafika A, Chasiotis G, Seferiadis K, Elisaf MS: Comparative effects of atorvastatin, simvastatin, and fenofibrate on serum homocysteine levels in patients with primary hyperlipidemia. J Clin Pharmacol 2003;43:825-830.
19. Balk EM, Lau J, Goudas LC, Jordan HS, Kupelnick B, Kim LU, Karas RH: Effects of statins on nonlipid serum markers associated with cardiovascular disease: a systematic review. Ann Intern Med 2003;139:670-682.
20. Isaacsohn JL, LaSalle J, Chao G, Gonasun L: Comparison of treatment with fluvastatin extended-release 80-mg tablets and immediaterelease 40-mg capsules in patients with primary hypercholesterolemia. Clin Ther 2003;25:904-918.
21. Ichihara A, Hayashi M, Ryuzaki M, Handa M, Furukawa T, Saruta T: Fluvastatin prevents development of arterial stiffness in haemodialysis patients with type 2 diabetes mellitus. Nephrol Dial Transplant 2002;17:1513-1517.
22. van Haelst PL, van Doormaal JJ, May JF, Gans RO, Crijns HJ, Cohen Tervaert JW: Secondary prevention with fluvastatin decreases levels of adhesion molecules, neopterin and Creactive protein. Eur J Intern Med 2001;12:503-509.
23. Lund TM, Torsvik H, Falch D, Christophersen B, Skardal 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;90:784-786.
24. Triscari J, Rossi L, Pan HY: Chronokinetics of pravastatin administered in the PM compared with AM dosing. Am J Ther 1995;2:265-268.
25. Benghozi R, Bortolini M, Jia Y, Isaacsohn JL, Troendle AJ, Gonasun L: Frequency of creatine kinase elevation during treatment with fluvastatin. Am J Cardiol 2002;89:231-233.
26. Claxton AJ, Cramer J, Pierce C: A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-1310.
27. Ryan AA: Medication compliance and older people: a review of the literature. Int J Nurs Stud 1999;36:153-162.