Nonparametric Expectation Maximisation (NPEM) Population Pharmacokinetic Analysis of Caffeine Disposition from Sparse Data in Adult Caucasians: Systemic Caffeine Clearance as a Biomarker for Cytochrome P450 1A2 Activity

Clinical Pharmacokinetics

Volumn 42, Issue 15, 2003, Pages 1393-1409

  Terziivanov, Dimiter ^a   Bozhinova, Kristina ^a   Dimitrova, Velislava ^a   Atanasova, Ivanka ^b  

^a UNIVERSITY HOSPITAL ALEXANDROVSKA   (Bulgaria)

^b Ministry of Health Sofia   (Bulgaria)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; CAFFEINE; CYTOCHROME P450 1A2; PARAXANTHINE;

ABSORPTION; ADULT; ADULTHOOD; ARTICLE; BIOLOGICAL MONITORING; BLOOD SAMPLING; BULGARIA; CALCULATION; CAUCASIAN; CLEARANCE; CLINICAL PROTOCOL; CONCENTRATION (PARAMETERS); CONCENTRATION RESPONSE; CONTROLLED STUDY; CORRELATION ANALYSIS; CORRELATION COEFFICIENT; DRINKING BEHAVIOR; ENZYME ACTIVITY; EVALUATION; FEMALE; HUMAN; HUMAN EXPERIMENT; KIDNEY FUNCTION; MALE; NONPARAMETRIC TEST; PLASMA CLEARANCE; POPULATION RESEARCH; PRIORITY JOURNAL; SEX DIFFERENCE; SMOKING; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

ADULT; CAFFEINE; CENTRAL NERVOUS SYSTEM STIMULANTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CYTOCHROME P-450 CYP1A2; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; INTESTINAL ABSORPTION; LIVER; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED;

EID: 0347990348     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-200342150-00006     Document Type: Article

References (67)

1. Nebert DW, Nelson DR, Coon MJ, et al. The P450 superfamily: update on new sequences, gene mapping, and recommended nomenclature. DNA 1991; 10: 1-4
2. Ioannides C, Parke DV. The cytochrome P450 1 gene family of microsomal hemoproteins and their role in the metabolic activation of chemicals. Drug Metab Rev 1990; 22: 1-85
3. Shimada T, Iwasaki M, Martin MV, et al. Human liver microsomal cytochrome P-450 enzymes involved in the bioactivation of procarcinogens detected by umu gene response in Salmonella typhimurium TA 1535/pSK1002. Cancer Res 1989; 49: 3218-28
4. Eaton DL, Gallagher EP, Bammler TK, et al. Role of cytochrome P4501A2 in chemical carcinogenesis: implications for human variability in expression and enzyme activity. Pharmacogenetics 1995; 5: 259-74
5. Gonzalez FJ, Gelboin HV. Role of human cytochromes P450 in the metabolic activation of chemical carcinogens and toxins. Drug Metab Rev 1994; 26: 165-83
6. Carrillo JA, Benitez J. Clinically significant pharmacokinetic interactions between dietary caffeine and medications. Clin Pharmacokinet 2000; 39: 127-53
7. Schweikl H, Taylor JA, Kitareewan S, et al. Expression of CYP1A1 and CYP1A2 genes in human liver. Pharmacogenetics 1993; 3: 239-49
8. Shimada T, Yamazaki H, Mimura M, et al. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. J Pharmacol Exp Ther 1994; 270: 414-23
9. Denaro CP, Jacob III P, Benowitz NL. Evaluation of pharmacokinetic methods used to estimate caffeine clearance and comparison with a Bayesian forecasting method. Ther Drug Monit 1998; 20: 78-87
10. Bechtel YC, Haffen E, Lelouët H, et al. Relationship between the severity of alcoholic liver cirrhosis and the metabolism of caffeine in 226 patients. Int J Clin Pharmacol Ther 2000; 38: 467-75
11. Lelouët H, Bechtel YC, Paintaud G, et al. Caffeine metabolism in a group of 67 patients with primary biliary cirrhosis. Int J Clin Pharmacol Ther 2001; 39: 25-32
12. Bechtel YC, Lelouët H, Hrusovsky S, et al. Caffeine metabolism before and after liver transplantation. Int J Clin Pharmacol Ther 2001; 39: 53-60
13. Lelo A, Miners JO, Robson RA, et al. Quantitative assessment of caffeine partial clearances in man. Br J Clin Pharmacol 1986; 22: 183-6
14. Gu L, Gonzalez FJ, Kalow W, et al. Biotransformation of caffeine, paraxanthine, theobromine and theophylline by cDNA-expressed human CYP1A2 and CYP2E1. Pharmacogenetics 1992; 2: 73-7
15. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69: 89-95
16. Jost G, Wahllander A, Von Mandach U, et al. Overnight salivary caffeine clearance: a liver function test suitable for routine use. Hepatology 1987; 7: 338-44
17. Nagel RA, Dirix LY, Hayllar KM, et al. Use of quantitative liver function tests: caffeine clearance and galactose elimination capacity: after orthotopic liver transplantation. J Hepatol 1990; 10: 149-57
18. Tanaka E, Ishikawa A, Yamamoto Y, et al. A simple useful method for the determination of hepatic function in patients with liver cirrhosis using caffeine and its three major dimethylmetabolites. Int J Clin Pharmacol Ther Toxicol 1992; 30: 336-41
19. Tang BK, Zhou Y, Kadar D, et al. Caffeine as a probe for CYP1A2 activity: potential influence of renal factors on urinary phenotypic trait measurements. Pharmacogenetics 1994; 4: 117-24
20. Denaro C, Brown CR, Wilson M, et al. Dose-dependency of caffeine metabolism with repeated dosing. Clin Pharmacol Ther 1990; 48: 277-85
21. Carrillo JA, Christensen M, Ramos SI, et al. Evaluation of caffeine as an in vivo probe for CYP1A2 using measurements in plasma, saliva, and urine. Ther Drug Monit 2000; 22: 409-17
22. Fuhr U, Rost KL. Simple and reliable CYP1A2 phenotyping by the paraxanthine/caffeine ratio in plasma and in saliva. Pharmacogenetics 1994; 4: 109-16
23. Butler MA, Lang NP, Young JF, et al. Determination of CYP1A2 and NAT2 phenotypes in human populations by analysis of caffeine urinary metabolites. Pharmacogenetics 1992; 2: 116-27
24. Lang NP, Butler MA, Massengill J, et al. Rapid metabolic phenotypes for acetyltransferase and cytochrome P4501A2 and putative exposure to food-borne heterocyclic amines increase risk for colorectal cancer or polyps. Cancer Epidemiol Biomark Prevent 1994; 3: 675-82
25. Nakajima M, Yokoi T, Mizutani M, et al. Phenotyping of CYP1A2 in Japanese population by analysis of caffeine urinary metabolites: absence of mutation prescribing the phenotype in the CYP1A2 gene. Cancer Epidemiol Biomarkers Prev 1994; 3: 415-21
26. Rostami-Hodjegam A, Nurminen S, Jackson PR, et al. Caffeine urinary metabolite ratios as markers of enzyme activity: a theoretical assessment. Pharmacogenetics 1996; 6: 121-49
27. Schrenk D, Brockmeier D, Mörike K, et al. A distribution study of CYP1A2 phenotypes among smokers and non-smokers in a cohort of healthy Caucasian volunteers. Eur J Clin Pharmacol 1998; 53: 361-7
28. Jelliffe RW, Schumitzky A, Bayard D, et al. Model-based, goal-oriented, individualised drug therapy. Clin Pharmacokinet 1998; 34: 57-77
29. Mallet A. A maximum likelihood estimation method for random coefficient regression models. Biometrika 1986; 73: 645-56
30. Schumitzky A. Nonparametric EM algorithms for estimating prior distributions. Appl Math Comput 1991; 45: 143-57
31. Jerling M, Merlé Y, Mentré F, et al. Population pharmacokinetics of nortriptyline during monotherapy and during concomitant treatment with drugs that inhibit CYP2D6: an evaluation with the nonparametric maximum likelihood method. Br J Clin Pharmacol 1994; 38: 453-62
32. Preston SL, Drusano GL. Nonparametric expectation maximization population modeling of ganciclovir. J Clin Pharmacol 1996; 36: 301-10
33. Terziivanov D, Atanasova I, Dimitrova V. Population pharmacokinetics of ciprofloxacin in patients with liver impairments analyzed by NPEM2 algorithm: a retrospective study. Int J Clin Pharmacol Ther 1998; 36: 376-82
34. Terziivanov D, Atanasova I, Dimitrova V, et al. Pharmacokinetic variability of nimodipine disposition after single and multiple oral dosing to hypertensive renal failure patients: parametric and nonparametric population analysis. Int J Clin Pharmacol Ther 1999; 37: 404-12
35. Jelliffe RW, Schumitzky A, Van Guilder M. User manual for version 10.6 of the USC*PACK collection of PC programs. Los Angeles (CA): Laboratory of Applied Pharmacokinetics, University of Southern California. School of Medicine, 1995
36. Jeliffe RW, Jeliffe SM. A computer program for estimation of creatinine clearance from unstable serum creatinine levels, age, sex and weight. Math Biosci 1972; 14: 17-24
37. Bonati M, Latini R, Galetti F, et al. Caffeine disposition after oral doses. Clin Pharmacol Ther 1982; 32: 98-106
38. Blanchard J, Sawers SJA. The absolute bioavailability of caffeine in man. Eur J Clin Pharmacol 1983; 24: 93-7
39. Grant DM, Tang BK, Kalow W. Variability in caffeine metabolism. Clin Pharmacol Ther 1983; 33: 591-602
40. Bojinova C, Terziivanov D. Measurement of drug concentrations in biological fluids for the purposes of population pharmacokinetic analysis: I. validation of HPLC assay for simultaneous determination of caffeine and its primary metabolites in blood and urine [in Bulgarian]. Anal Lab 1997; 6: 142-8
41. Ette EI. Stability and performance of a population pharmacokinetic model. J Clin Pharmacol 1997; 37: 486-95
42. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503-12
43. Afifi AA, Azen SP. Statistical analysis: a computer oriented approach [in Russian]. Moscow: Mir, 1982
44. Tantcheva-Poór I, Zaigler M, Rietbrock S, et al. Estimation of cytochrome P-450 CYP1A2 activity in 863 healthy Caucasians using a saliva-based caffeine test. Pharmacogenetics 1999; 9: 131-44
45. Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika 1965; 52: 591-611
46. PA (P4501A2), the phenacetin O-deethylase, is primarily responsible for the hepatic 3-demethylation of caffeine and N-oxidation of carcinogenic arylamines. Proc Natl Acad Sci U S A 1989; 86: 7696-700
47. Kalow W, Tang BK. The use of caffeine for enzyme assays: a critical appraisal. Clin Pharmacol Ther 1993; 53: 503-14
48. Guengerich FP. Human cytochrome P450 enzymes. In: Ortiz de Montellano PR, editor. Cytochrome P450. 2nd ed. New York: Plenum, 1995: 473-535
49. Kadlubar FF. Biochemical individuality and its implications for drug and carcinogen metabolism. Recent insights from acetyltransferase and cytochrome P4501A2 phenotyping and genotyping in humans. Drug Metab Dispos 1994; 26: 37-46
50. Guengerich FP, Parikh A, Turesky RJ, et al. Inter-individual differences in the metabolism of environmental toxicants: cytochrome P450 1A2 as a prototype. Mutat Res 1999; 428: 115-24
51. Campbell ME, Spielberg SP, Kalow W. A urinary metabolite ratio that reflects systemic caffeine clearance. Clin Pharmacol Ther 1987; 42: 157-65
52. Ullrich D, Compagnone D, Münch B, et al. Urinary caffeine metabolites in man: age-dependent changes and pattern in various clinical situations. Eur J Clin Pharmacol 1992; 43: 167-72
53. Relling MV, Lin J-S, Ayers G, et al. Racial and gender differences in N-acetyltransferase, xanthine oxidase, and CYP1A2* activities. Clin Pharmacol Ther 1992; 52: 643-58
54. Kalow W, Tang BK. Use of caffeine metabolite ratios to explore CYP1A2 and xanthine oxidase activities. Clin Pharmacol Ther 1991; 50: 508-19
55. Kashuba ADM, Bertino JS, Kearns GL, et al. Quantitation of three-month intraindividual variability and influence of sex and menstrual cycle phase on CYP1A2, N-acetyltransferase-2, and xanthine oxidase activity determined with caffeine phenotyping. Clin Pharmacol Ther 1998; 63: 540-51
56. Zaigler M, Rietbrock S, Szymanski J, et al. Variation of CYP1A2-dependent caffeine metabolism during menstrual cycle in healthy women. Int J Clin Pharmacol Ther 2000; 38: 235-44
57. Kalow W, Tang BK. Caffeine as a metabolic probe: exploration of the enzyme-inducing effect of cigarette smoking. Clin Pharmacol Ther 1991; 49: 44-8
58. Harder S, Staib AH, Beer C, et al. 4-Quinolones inhibit biotransformation of caffeine. Eur J Clin Pharmacol 1988; 35: 651-6
59. Healy PD, Polk RE, Kanawati L, et al. Interaction between oral ciprofloxacin and caffeine in normal volunteers. Antimicrob Agents Chemother 1989; 33: 474-8
60. Kadlubar FF, Talaska G, Butler MA, et al. Determination of carcinogenic arylamine N-oxidation phenotype in humans by analysis of caffeine urinary metabolites. In: Mendelsohn ML, Albertini RJ, editors. Mutation and the environment. Part B: metabolism, testing methods, and chromosomes. New York: Wily-Liss, 1990: 107-14
61. Vesell ES, Gaylor DW. Limitations of probit plots in pharmacogenetics: requirement of genetic analyses to test hypotheses based on graphical methods. Pharmacogenetics 1995; 5: 18-23
62. Jackson PR, Tucker GT, Woods HF. Testing for bimodality in frequency distributions of data suggesting polymorphisms of drug metabolism: histograms and probit plots. Br J Clin Pharmacol 1989; 28: 647-53
63. Jackson PR, Tucker GT, Woods HF. Testing for bimodality in frequency distributions of data suggesting polymorphisms of drug metabolism: hypothesis testing. Br J Clin Pharmacol 1989; 28: 655-62
64. Endrenyi L, Patel M. A new, sensitive graphical method for detecting deviations from the normal distribution of drug response: the NTV plot. Br J Clin Pharmacol 1991; 32: 159-66
65. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21: 735-50
66. Schmider J, Brockmöller J, Arold G, et al. Simultaneous assessment of CYP3A4 and CYP1A2 activity in vivo with alprazolam and caffeine. Pharmacogenetics 1999; 9: 725-34
67. Spigset O, Hägg S, Söderström E, et al. The paraxanthine:caffeine ratio in serum or in saliva as a measure of CYP1A2 activity: when should the sample be obtained? Pharmacogenetics 1999; 9: 409-12