Influence of drugs interacting with CYP3A4 on the pharmacokinetics, pharmacodynamics, and safety of the prandial glucose regulator repaglinide

Journal of Clinical Pharmacology

Volumn 43, Issue 6, 2003, Pages 649-660

  Hatorp, Vibeke ^b   Hansen, Kristian T ^b   Thomsen, Mikael S ^a  

^a NOVO NORDISK A S   (Denmark)

^b NONE

Author keywords

Blood glucose concentrations; CYP3A4; Drug interactions; Pharmacokinetics; Repaglinide

Indexed keywords

CYTOCHROME P450 3A4; ETHINYLESTRADIOL; ETHINYLESTRADIOL PLUS LEVONORGESTREL; GLUCOSE; INSULIN; KETOCONAZOLE; LEVONORGESTREL; NIFEDIPINE; REPAGLINIDE; RIFAMPICIN; SIMVASTATIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG CROSS REACTIVITY; DRUG DOSE REGIMEN; DRUG MECHANISM; DRUG POTENCY; DRUG SAFETY; ENZYME BINDING; ENZYME SUBSTRATE; FEMALE; GLUCOSE BLOOD LEVEL; GLUCOSE TOLERANCE; HUMAN; HUMAN EXPERIMENT; HYPOGLYCEMIA; INCIDENCE; INSULIN RELEASE; MALE; METABOLIC REGULATION; NORMAL HUMAN; PATIENT MONITORING; RANDOMIZED CONTROLLED TRIAL;

EID: 0037566974     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270003253704     Document Type: Article

References (28)

1. Owens DR: Repaglinide: a new short-acting insulinotropic agent for the treatment of type 2 diabetes. Eur J Clin Invest 1999;29(Suppl. 2):30-37.
2. Hatorp V, Oliver S, Su C-APF: Bioavailability of repaglinide, a novel antidiabetic agent, administered orally in tablet or solution form or intravenously in healthy male volunteers. Int J Clin Pharmacol Ther 1998;36:636-641.
3. Hatorp V, Walther K, Christensen MS, Haug-Pihale G: Single-dose pharmacokinetics of repaglinide in subjects with chronic liver disease. J Clin Pharmacol 2000;40(2):142-152.
4. Plum A, Muller LK, Jansen JA: The effects of selected drugs on the in vitro protein binding of repaglinide in human plasma. Meth Find Exp Clin Pharmacol 2000;22(3):139-143.
5. 14C] repaglinide in human, cynomolgus monkey, dog, rabbit, rat and mouse. Diabetologia 1997;40(Suppl. 1):A326.
6. 14C-repaglinide during repaglinide multiple dosing. Eur J Clin Pharmacol 1999;55:521-525.
7. Martucci CP, Fishman J: P450 enzymes of estrogen metabolism. Pharmacol Ther 1993;57:237-257.
8. Prueksaritanont T, Gorham LM, Ma B, Liu L, Yu X, Zhao JJ, et al: In vitro metabolism of simvastatin in humans [SBT] identification of metabolizing enzymes and effect of the drug on hepatic P450s. Drug Metab Dispos 1997;25(10):1191-1199.
9. Li AP, Kaminski DL, Rasmussen A: Substrates of human hepatic cytochrome P450 3A4. Toxicology 1995;104(1-3):1-8.
10. Commission of the European Community CPMP Working Party on Efficacy of Medical Products: Good clinical practice for trials on medical products in the European Community, Brussels 1990. Document IIII3976/8, final approval by CPMP 11.07.1990. Pharmacol Toxicol 1990;67:361-372.
11. World Medical Association: Declaration of Helsinki: recommendations guiding physicians in biomedical research involving human patients. Amended by the 41st World Medical Assembly, Hong Kong. September 1989. Nord Med 1992;107:25.
12. Carlucci G, Mazzeo P, Biordi L, Bologna M: Simultaneous determination of simvastatin and its hydroxy acid form in human plasma by high performance liquid chromatography with UV detection. J Pharm Biomed Anal 1992;10(9):693-697.
13. Maurice M, Pichard L, Daujat M, Fabre I, Joyeux H, Domergue J, et al: Effects of imidazole derivatives on cytochromes P450 from human hepatocytes in primary culture. FASEB J 1992;6(2):752-758.
14. Wrighton SA, Ring BJ: Inhibition of human CYP3A catalyzed 1′-hydroxy midazolam formation by ketoconazole, nifedipine, erythromycin, cimetidine, and nizatidine. Pharm Res 1994;11:921-924.
15. Spina E, Avenoso A, Campo GM, Scordo MG, Caputi AP, Perucca E: Effect of ketoconazole on the pharmacokinetics of imipramine and desipramine in healthy subjects. Br J Clin Pharmacol 1997;43:315-318.
16. Honig PK, Wortham DC, Zamani KJ, Conner DP, Mullin JC, Cantilena LR: Terfenadine-ketoconazole interaction: pharmacokinetic and electrocardiographic consequences. JAMA 1993;269:1513-1518.
17. Varhe A, Olkkola KT, Neuvonen PJ: Oral triazolam is potentially hazardous to patients receiving systemic antimycotics ketoconazole or itraconazole. Clin Pharmacol Ther 1994;56:601-607.
18. Hatorp V, Thomsen M: Drug interaction studies with repaglinide: repaglinide on digoxin or theophylline pharmacokinetics and cimetidine on repaglinide pharmacokinetics. J Clin Pharm 2000;40(2):184-192.
19. Niemi M, Neuvonen PJ, Kivistö KT: The cytochrome P4503A4 inhibitor clarithromycin increases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther 2001;70:58-65.
20. Bidstrup TB, Bjørnsdottir I, Thomsen MS, Hansen KT: CYP2C8 and CYP3A4 are the principle enzymes involved in the in vitro biotransformation of the insulin secretagogue repaglinide. Pharmacol Toxicol 2001;89(Suppl. I):65.
21. Venkatesan K: Pharmacokinetic drug interactions with rifampicin. Clin Pharmacokinet 1992;22:47-65.
22. Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivistö KT: Rifampicin decreases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther 2000;68:495-500.
23. Ball SE, Forrester LM, Wolf CR, Back DJ: Differences in the cytochrome P-450 isoenzymes involved in the 2-hydroxylation of estradiol and 17β-ethinylestradiol. Biochem J 1990;267:221-226.
24. Kerlan V, Dreano Y, Bercovici JP, Beaune PH, Floch HH, Berthou F: Nature of cytochromes P450 involved in the 2/4 hydroxylations of estradiol in hurhan liver microsomes. Biochem Pharmacol 1992;44:1745-1756.
25. Back D, Orme MLE: Pharmacokinetic drug interactions with oral contraceptives. Clin Pharmacokinet 1990;18:472-484.
26. Neuvonen PJ, Kantola T, Kivistö KT: Simvastatin but not pravastatin is very susceptible to interaction with the CYP3A4 inhibitor itraconazole. Clin Pharmacol Ther 1998;63:332-341.
27. Amiel SA, Maran A, Powrie JK, Umpleby AM, Macdonald IA: Gender differences in counterregulation to hypoglycaemia. Diabetologia 1993;36:460-464.
28. Fanelli C, Pampanelli S, Epifano L, Rambotti AM, Ciofetta M, Modarelli F, et al: Relative roles of insulin and hypoglycaemia on induction of neuroendocrine responses to, symptoms of, and deterioration of cognitive function in hypoglycaemia in male and female humans. Diabetologia 1994;37:797-807.