Effect of multiple doses of montelukast on the pharmacokinetics of rosiglitazone, a CYP2C8 substrate, in humans

British Journal of Clinical Pharmacology

Volumn 63, Issue 3, 2007, Pages 339-345

  Kim, Kyoung Ah ^a   Park, Pil Whan ^b   Kim, Kyong Rae ^c   Park, Ji Young ^a  

^a Korea University College of Medicine   (South Korea)

^b Gachon University   (South Korea)

^c Konkuk University   (South Korea)

Author keywords

CYP2C8; Drug drug interaction (DDI); Montelukast; Rosiglitazone

Indexed keywords

CYTOCHROME P450 2C8; DRUG METABOLITE; LEUKOTRIENE RECEPTOR BLOCKING AGENT; MONTELUKAST; N NORROSIGLITAZONE; PLACEBO; ROSIGLITAZONE; SINGULAR; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG CLEARANCE; DRUG EFFECT; DRUG METABOLISM; FLUORESCENCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE;

ACETATES; ADULT; CROSS-OVER STUDIES; DRUG INTERACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; LEUKOTRIENE ANTAGONISTS; MALE; QUINOLINES; RANDOMIZED CONTROLLED TRIALS; THIAZOLIDINEDIONES;

EID: 33846995662     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02764.x     Document Type: Article

References (37)

1. De Lepeleire I, Reiss TF, Rochette F, Botto A, Zhang J, Kundu S, Decramer M. Montelukast causes prolonged, potent leukotriene D4-receptor antagonism in the airways of patients with asthma. Clin Pharmacol Ther 1997; 61: 83-92.
2. Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB. Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: a multicenter, randomized, double-blind trial. Montelukast Clinical Research Study Group. Arch Intern Med 1998; 158: 1213-20.
3. Horwitz RJ, McGill KA, Busse WW. The role of leukotriene modifiers in the treatment of asthma. Am J Respir Crit Care Med 1998; 157: 1363-71.
4. Laitinen LA, Laitinen A, Haahtela T, Vilkka V, Spur BW, Lee TH. Leukotriene E4 and granulocytic infiltration into asthmatic airways. Lancet 1993; 341: 989-90.
5. Bronsky EA, Kemp JP, Zhang J, Guerreiro D, Reiss TF. Dose-related protection of exercise bronchoconstriction by montelukast, a cysteinyl leukotriene-receptor antagonist, at the end of a once-daily dosing interval. Clin Pharmacol Ther 1997; 62: 556-61.
6. Dockhorn RJ, Baumgartner RA, Leff JA, Noonan M, Vandormael K, Stricker W. Weinland DE, Reiss TF. Comparison of the effects of intravenous and oral montelukast on airway function: a double blind, placebo controlled, three period, crossover study in asthmatic patients. Thorax 2000; 55: 260-5.
7. Noonan MJ, Chervinsky P, Brandon M, Zhang J, Kundu S, McBurney J, Reiss TF. Montelukast, a potent leukotriene receptor antagonist, causes dose-related improvements in chronic asthma. Montelukast Asthma Study Group. Eur Respir J 1998; 11: 1232-9.
8. Depre M, Van Hecken A, Verbesselt R, Wynants K, De Lepeleire I, Freeman A, Holland S, Shahane A, Gertz B, De Schepper PJ. Effect of multiple doses of montelukast, a CysLT1 receptor antagonist, on digoxin pharmacokinetics in healthy volunteers. J Clin Pharmacol 1999; 39: 941-4.
9. Malmstrom K, Schwartz J, Reiss TF, Sullivan TJ, Reese JH, Jauregui L, Miller K, Scott M, Shingo S, Peszek I, Larson P, Ebel D, Hunt TL, Huhn RD, Bachmann K. Effect of montelukast on single-dose theophylline pharmacokinetics. Am J Ther 1998; 5: 189-95.
10. Van Hecken A, Depre M, Verbesselt R, Wynants K, De Lepeleire I, Arnout J, Wong PH, Freeman A, Holland S, Gertz B, De Schepper PJ. Effect of montelukast on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol 1999; 39: 495-500.
11. Chiba M, Xu X, Nishime JA, Balani SK, Lin JH. Hepatic microsomal metabolism of montelukast, a potent leukotriene D4 receptor antagonist, in humans. Drug Metab Dispos 1997; 25: 1022-31.
12. Rettie AE, Korzekwa KR, Kunze KL, Lawrence RF, Eddy AC, Aoyama T, Gelboin HV, Gonzalez FJ, Trager WF. Hydroxylation of warfarin by human cDNA-expressed cytochrome P-450. a role for P-4502C9 in the etiology of (S)-warfarin-drug interactions. Chem Res Toxicol 1992; 5: 54-9.
13. Wen X, Wang JS, Backman JT, Kivisto KT, Neuvonen PJ. Gemfibrozil is a potent inhibitor of human cytochrome P450 2C9. Drug Metab Dispos 2001; 29: 1359-61.
14. Kim KA, Park JY. Inhibitory effect of glyburide on human cytochrome p450 isoforms in human liver microsomes. Drug Metab Dispos 2003; 31: 1090-2.
15. Walsky RL, Gaman EA, Obach RS. Examination of 209 drugs for inhibition of cytochrome P450 2C8. J Clin Pharmacol 2005; 45: 68-78.
16. Walsky RL, Obach RS, Gaman EA, Gleeson JP, Proctor WR. Selective inhibition of human cytochrome P4502C8 by montelukast. Drug Metab Dispos 2005; 33: 413-8.
17. Malinowski JM, Bolesta S. Rosiglitazone in the treatment of type 2 diabetes mellitus: a critical review. Clin Ther 2000; 22: 1151-68;discussion 1149-50.
18. Baldwin SJ, Clarke SE, Chenery RJ. Characterization of the cytochrome P450 enzymes involved in the in vitro metabolism of rosiglitazone. Br J Clin Pharmacol 1999; 48: 424-32.
19. Niemi M, Backman JT, Granfors M, Laitila J, Neuvonen M, Neuvonen PJ. Gemfibrozil considerably increases the plasma concentrations of rosiglitazone. Diabetologia 2003; 46: 1319-23.
20. Niemi M, Backman JT, Neuvonen PJ. Effects of trimethoprim and rifampin on the pharmacokinetics of the cytochrome P450 2C8 substrate rosiglitazone. Clin Pharmacol Ther 2004; 76: 239-49.
21. Park JY, Kim KA, Kang MH, Kim SL, Shin JG. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther 2004; 75: 157-62.
22. Park JY, Kim KA, Shin JG, Lee KY. Effect of ketoconazole on the pharmacokinetics of rosiglitazone in healthy subjects. Br J Clin Pharmacol 2004; 58: 397-402.
23. Kim KA, Park JY. Simple and extractionless high-performance liquid chromatographic determination of rosiglitazone in human plasma and application to pharmacokinetics in humans. Biomed Chromatogr 2004; 18: 613-5.
24. Wang JS, Neuvonen M, Wen X, Backman JT, Neuvonen PJ. Gemfibrozil inhibits CYP2C8-mediated cerivastatin metabolism in human liver microsomes. Drug Metab Dispos 2002; 30: 1352-6.
25. Ong CE, Coulter S, Birkett DJ, Bhasker CR, Miners JO. The xenobiotic inhibitor profile of cytochrome P4502C8. Br J Clin Pharmacol 2000; 50: 573-80.
26. Wen X, Wang JS, Backman JT, Laitila J, Neuvonen PJ. Trimethoprim and sulfamethoxazole are selective inhibitors of CYP2C8 and CYP2C9, respectively. Drug Metab Dispos 2002; 30: 631-5.
27. Lasker JM, Wester MR, Aramsombatdee E, Raucy JL. Characterization of CYP2C19 and CYP2C9 from human liver: respective roles in microsomal tolbutamide, S-mephenytoin, and omeprazole hydroxylations. Arch Biochem Biophys 1998; 353: 16-28.
28. Hruska MW, Amico JA, Langaee TY, Ferrell RE, Fitzgerald SM, Frye RF. The effect of trimethoprim on CYP2C8 mediated rosiglitazone metabolism in human liver microsomes and healthy subjects. Br J Clin Pharmacol 2005; 59: 70-9.
29. Ito K, Brown HS, Houston JB. Database analyses for the prediction of in vivo drug-drug interactions from in vitro data. Br J Clin Pharmacol 2004; 57: 473-86.
30. Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach RS, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA., Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism/Clinical Pharmacology Technical Working Group, FDA Center for Drug Evaluation and Research (CDER). The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. Drug Metab Dispos 2003; 31: 815-32.
31. Zhao JJ, Rogers JD, Holland SD, Larson P, Amin RD, Haesen R, Freeman A, Seiberling M, Merz M, Cheng H. Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in healthy young and elderly volunteers. Biopharm Drug Dispos 1997; 18: 769-77.
32. Schoch GA, Yano JK, Wester MR, Griffin KJ, Stout CD, Johnson EF. Structure of human microsomal cytochrome P450 2C8. Evidence for a peripheral fatty acid binding site. J Biol Chem 2004; 279: 9497-503.
33. von Moltke LL, Greenblatt DJ, Schmider J, Duan SX, Wright CE, Harmatz JS, Shader RI. Midazolam hydroxylation by human liver microsomes in vitro: inhibition by fluoxetine, norfluoxetine, and by azole antifungal agents. J Clin Pharmacol 1996; 36: 783-91.
34. Drazen JM, Israel E, O'Byrne PM. Treatment of asthma with drugs modifying the leukotriene pathway. N Engl J Med 1999; 340: 197-206.
35. Nozawa T, Sugiura S, Nakajima M, Goto A, Yokoi T, Nezu J, Tsuji A, Tamai I. Involvement of organic anion transporting polypeptides in the transport of troglitazone sulfate: implications for understanding troglitazone hepatotoxicity. Drug Metab Dispos 2004; 32: 291-4.
36. Kim KA, Park PW, Kim HK, Ha JM, Park JY. Effect of quercetin on the pharmacokinetics of rosiglitazone, a CYP2C8 substrate, in healthy subjects. J Clin Pharmacol 2005; 45: 941-6.
37. Williamson G, Barron D, Shimoi K, Terao J. In vitro biological properties of flavonoid conjugates found in vivo. Free Radic Res 2005; 39: 457-69.