Clinical considerations in study designs that use cotinine as a biomarker

Biomarkers

Volumn 8, Issue 4/3, 2003, Pages 187-203

  Bramer, Steven L ^a   Kallungal, Beatrice A ^a  

^a OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC   (United States)

Author keywords

Assays; Biomarker; Clinical study designs; Cotinine; Questionnaire; Screening

Indexed keywords

AMITRIPTYLINE; BIOLOGICAL MARKER; CARVEDILOL; CILOSTAZOL; CINNARIZINE; CLOMIPRAMINE; CLOZAPINE; COTININE; CYCLOBENZAPRINE; CYTOCHROME P450 1A2; CYTOCHROME P450 2A6; FLUNARIZINE; FLUVOXAMINE; HALOPERIDOL; IMIPRAMINE; LIDOCAINE; MEXILETINE; MIANSERIN; MIRTAZAPINE; NAPROXEN; NICOTINE; OLANZAPINE; PROPAFENONE; PROPRANOLOL; RILUZOLE; ROPINIROLE; ROPIVACAINE; TACRINE; THEOPHYLLINE; UNINDEXED DRUG;

BLOOD LEVEL; CIGARETTE SMOKING; CONCENTRATION (PARAMETERS); DRUG CLEARANCE; DRUG METABOLISM; HAIR ANALYSIS; HUMAN; HUNGER; METABOLIC PARAMETERS; REVIEW; SALIVA ANALYSIS; SCREENING TEST; SENSITIVITY ANALYSIS; SMOKING CESSATION; SMOKING HABIT; URINALYSIS; WEIGHT GAIN; WITHDRAWAL SYNDROME;

BIOLOGICAL MARKERS; COTININE; DRUG INTERACTIONS; HUMANS; NICOTINE; SMOKING;

NICOTIANA TABACUM;

EID: 0141615686     PISSN: 1354750X     EISSN: None     Source Type: Journal    
DOI: 10.1080/13547500310012545     Document Type: Review

References (69)

1. Ahn, H. C., Yang, J. H., Lee, H. B., Rhee, Y. K. and Lee, Y. C. 2000, Effect of combined therapy of oral anti-tubercular agents on theophylline pharmacokinetics. International Journal of Tuberculosis and Lung Disease, 4 (8), 784-787.
2. Al-Delaimy, W. K. 2002, Hair as a biomarker for exposure to tobacco smoke. Tobacco Control, 11, 176-182.
3. Apseloff, G., Ashton, H., Friedman, H. and Gerber, N. 1994, The importance of measuring cotinine levels to identify smokers in clinical trials. Clinical Pharmacology and Therapeutics, 56 (4), 460-462.
4. Baselt, R. C. 1995, Disposition of Toxic Drugs and Chemicals in Man, 4th edition (Chicago: Year Book Medical Publishers), pp. 543-547.
5. Benowitz, N. L. 1988, Pharmacologic aspects of cigarette smoking and nicotine addiction. New England Journal of Medicine, 319 (20), 1318-1330.
6. Benowitz, N. L. 1996, Cotinine as a biomaker of environmental tobacco smoke exposure. Epidemiologic Reviews, 18 (2), 188-204.
7. Benowitz, N. L. and Jacob, P. 1993, Nicotine and cotinine elimination pharmacokinetics in smokers and nonsmokers. Clinical Pharmacology and Therapeutics, 53 (3), 316-323.
8. Benowitz, N. L. and Jacob, P. 2001, Trans-3′-hydroxycotinine: disposition kinetics, effects and plasma levels during cigarette smoking. British Journal of Clinical Pharmacology, 51, 53-59.
9. Benowitz, N. L., Jacob, P., Jones, R. T. and Rosenberg, J. 1982, Interindividual variability in the metabolism and cardiovascular effects of nicotine in man. Journal of Pharmacology and Experimental Therapeutics, 221 (2), 368-372.
10. Benowitz, N. L., Kuyt, F., Jacob, P., Jones, R. T. and Osman, A. 1983, Cotinine disposition and effects. Clinical Pharmacology and Therapeutics, 34 (5), 604-611.
11. Benowitz, N. L., Hall, S. M., Herning, R. I., Jacob, P., Jones, R. T. and Osman, A. 1983, Smokers of low-yield cigarettes do not consume less nicotine. New England Journal of Medicine, 309 (3), 139-142.
12. Benowitz, N. L., Lee, B. L. and Jacob, P. 1989, Nicotine gum and theophylline metabolism. Biomedicine and Pharmacotherapy, 43, 1-3.
13. Benowitz, N. L., Peérez-Stable, E. J., Herrera, B. and Jacob, P. 2002, Slower metabolism and reduced intake of nicotine from cigarette smoking in Chinese-Americans. Journal of the National Cancer Institute, 94 (2), 108-115.
14. Biber, A., Scherer, G., Hoepfner, I., Adlkofer, F., Heller, W., Haddow, J. E. and Knight, G. 1987, Determination of nicotine and cotinine in human serum and urine: an interlaboratory study. Toxicology Letters, 35, 45-52.
15. Butler, M. A., Lang, N. P., Young, J. F., Caporaso, N. E., Vineis, P., Hayes, R. B., Teitel, C. H., Massengill, J. P., Lawsen, M. F. and Kadlubar, F. F. 1992, Determination of CYP1A2 and NAT2 phenotypes in human populations by analysis of caffeine urinary metabolites. Pharmacogenetics, 2, 116-127.
16. Castro, A. and Monji, N. 1986, Dietary nicotine and its significance in studies on tobacco smoking. Biochemical Archives, 2, 91-97.
17. Curvall, M., Vala, E. K., Enzell, C. R. and Wahren, J. 1990, Simulation and evaluation of nicotine intake during passive smoking: cotinine measurements in body fluid of nonsmokers given intravenous infusions of nicotine. Clinical Pharmacology and Therapeutics, 47, 42-49.
18. Davis, R. A., Stiles, M. F., DeBethizy, J. D. and Raynolds, J. H. 1991, Dietary nicotine: a source of urinary cotinine. Food and Chemical Toxicology, 29 (12), 821-827.
19. Ehrlich, R., Kattan, M., Godbold, J., Saltzberg, D. S., Grimm, K. T., Landrigan, P. J. and Lilienfeld, D. E. 1992, Childhood asthma and passive smoking. Urinary cotinine as a biomarker of exposure. American Review of Respiratory Disease, 145 (3), 594-599.
20. Eliopoulos, C., Klein, J., Phan, M. K., Knie, B., Greenwald, M., Chitayat, D. and Koren, G. 1994, Hair concentrations of nicotine and cotinine in women and their newborn infants. JAMA, 271 (8), 621-623.
21. Eliopoulos, C., Klein, J. and Koren, G. 1996, Validation of self-reported smoking by analysis of hair for nicotine and cotinine. Therapeutic Drug Monitoring, 18 (5), 532-536.
22. Eremin, S. A., Coxon, R. E., Colbert, D. L., Landon, J. and Smith, D. S. 1992, Urinary cotinine fluoroimmunoassay for smoking status screening adapted to an automated analyser. Analyst, 117, 697-699.
23. Eskenazi, B., Prehn, A. W. and Christianson, R. E. 1995, Passive and active maternal smoking as measured by serum cotinine: the effect on birthweight. American Journal of Public Health, 85 (3), 395-398.
24. Etzel, R. A. 1990, A review of the use of saliva cotinine as a marker of tobacco smoke exposure. Preventive Medicine, 19, 190-197.
25. Gehlback, S. H., Perry, L. D., Williams, W. A. and Freeman, J. I. 1975, Nicotine absorption by workers harvesting green tobacco. Lancet, i, 478-480.
26. Gonzalez, Y. M., Nardin, A. D., Grossi, S. D., Machtei, E. E., Genco, R. J. and Nardin, E. D. 1996, Serum cotinine levels, smoking, and periodontal attachment loss. Journal of Dental Research, 75 (2), 796-802.
27. Haley, N. J. and Hoffmann, D. 1985, Analysis for nicotine and cotinine in hair to determine cigarette smoker status. Clinical Chemistry, 31 (10), 1598-1600.
28. Haufroid, V. and Lison, D. 1998, Urinary cotinine as a tobacco-smoke exposure index: a mini review. International Archives of Occupational and Environmental Health, 71, 162-168.
29. Hughes, J. R., Hatsukami, D. K., Pickens, R. W., Krahn, D., Malin, S. and Luknic, A. 1984, Effect of nicotine on the tobacco withdrawal syndrome. Psychopharmacology, 83, 82-87.
30. Hughes, J. R., Higgins, S. T. and Bickel, W. K. 1994, Nicotine withdrawal versus other drug withdrawal syndromes: similarities and dissimilarities. Addiction, 89, 1461-1470.
31. Jarvis, M. J., Tunstall-Pedoe, H., Feyerabend, C., Vesey, C. and Saloojee, Y 1987, Comparison of tests used to distinguish smokers from non-smokers. American Journal of Public Health, 77 (11), 1435-1438.
32. Jarvis, M. J., Russell, M., Benowitz, N. L. and Feyerabend, C. 1988, Elimination of cotinine from body fluids: implications for noninvasive measurement of tobacco smoke exposure. American Journal of Public Health, 78 (6), 696-698.
33. Kintz, P. 1992, Gas chromotagraphic analysis of nicotine and cotinine in hair. Journal of Chromatography, 580, 347-353.
34. Klein, J. and Koren, G. 1999, Hair analysis - a biological marker for passive smoking in pregnancy and childhood. Human and Experimental Toxicology, 18, 279-282.
35. Klein, J., Forman, R., Eliopoulos, C. and Koren, G. 1994, A method for simultaneous measurement of cocaine and nicotine in neonatal hair. Therapeutic Drug Monitoring, 16, 67-70.
36. Knight, J. M., Eliopoulos, C., Klein, J., Greenwald, M. and Koren, G. 1998, Pharmacokinetic predisposition to nicotine from environmental tobacco smoke: a risk factor for pediatric asthma. Journal of Asthma, 35 (1), 113-117.
37. Kolonen, S. A. and Puhakainen, E. V. J. 1991, Assessment of automated colorimetric and the high-performance liquid chromatographic methods for nicotine intake by urine samples of smokers' smoking low- and medium-yield cigarettes. Clinica Chemica Acta, 196, 159-166.
38. Landi, M. T., Sinha, R., Lang, N. P. and Kadlubar, F. F. 1999, Human cytochrome P4501A2. In Metabolic Polymorphisms and Susceptibility to Cancer, edited by P. Vineis, N. Malats, M. Lang, A. d'Errico, N. Caporaso, J. Cuzick and P. Boffetta, IARC Scientific Publications no. 148 (Lyon: IARC), pp. 173-195.
39. Lawson, G. M., Hurt, R. D., Lowell, D. C., Offord, K. P, Croghan, I. T., Schroeder, D. R. and Jiang, N. S. 1998, Application of serum nicotine and plasma cotinine concentrations to assessment of nicotine replacement in light, moderate, and heavy smokers undergoing transdermal therapy. Journal of Clinical Pharmacology, 38, 502-509.
40. Lequang, N. T., Roussel, G., Roche, D., Migueres, M. L., Chretien, J. and Ekindjian, O. G. 1994, Urine collection for nicotine and cotinine measurements in studies on nicotine addicts. Pathologie-Biologie, 42 (2), 191-196.
41. Lode, H. 2001, Evidence of different profiles of side effects and drug-drug interactions among the quinolones - the pharmacokinetic standpoint. Chemotherapy, 47 (3), 24-31.
42. Messina, E. S., Tyndale, R. F. and Sellers, E. M. 1997, A major role for CYP2A6 in nicotine C-oxidation by human liver microsomes. Journal of Pharmacology and Experimental Therapeutics, 282 (3), 1608-1614.
43. Miller, L. G. 1989, Recent developments in the study of the effects of cigarette smoking on clinical pharmacokinetics and clinical pharmacodynamics. Clinical Pharmacokinetics, 17 (2), 90-108.
44. Miller, L. G. 1990, Cigarettes and drug therapy: pharmacokinetic and pharmacodynamic considerations. Clinical Pharmacy, 9, 125-135.
45. Murphy, S. E., Johnson, L. M. and Pullo, D. A. 1999, Characterization of multiple products of cytochrome P450 2A6-catalyzed cotinine metabolism. Chemical Research in Toxicology, 12 (7), 639-645.
46. Nakajima, M., Yamamoto, T., Nunoya, K., Yokoi, T., Nagashima, K., Inoue, K., Funae, Y., Shimada, N., Kamataki, T. and Kuroiwa, Y. 1996, Role of human cytochrome P450 2A6 in C-oxidation of nicotine. Drug Metabolism and Disposition, 24 (11), 1212-1217.
47. Nakajima, M., Yamagishi, S., Yamamoto, H., Yamamoto, T., Kuroiwa, Y. and Yokoi, T. 2000, Deficient cotinine formation from nicotine is attributed to the whole deletion of the CYP2A6 gene in humans. Clinical Pharmacology and Therapeutics, 67, 57-69.
48. Parazzini, F, Davoli, E., Rabaiotti, M., Restelli, S., Stramare, L., Dindelli, M., Vecchia, C. L. and Fanelli, R. 1996, Validity of self-reported smoking habits in pregnancy: a saliva cotinine analysis. Acta Obstetricia et Gynecologica Scandinavica, 75, 352-354.
49. Pelkonen, O., Maenpaa, J., Taavitsainen, P., Rautio, A. and Raunio, H. 1998, Inhibition and induction of human cytochrome P450 (CYP) enzymes. Xenobiotica, 28 (12), 1203-1253.
50. Perez-Stable, E. J., Herrera, B., Jacob, P. and Benowitz, N. L. 1998, Nicotine metabolism and intake in black and white smokers. JAMA, 280 (2), 152-156.
51. Physicians' Desk Reference, 2001, 55th edition (Montvale: Medical Economics), p. 1614.
52. Pirkle, J. L., Flegal, K. M., Bernert, J. T., Brody, D. J., Etzel, R. A. and Maurer, K. R. 1996, Exposure of the US population to environmental tobacco smoke. JAMA, 275 (16), 1233-1240.
53. Pritchard, M. P. and Wolf, C. R. 2000, Other CYP: 2A6, 2B6, 4A. In Metabolic Drug Interactions, edited by R. H. Levy, K. E. Thummel, W. F. Trager, P. D. Hansten and M. Eichelbaum (Philadelphia: Lippincott Williams & Wilkins), pp. 145-150.
54. Quattrochi, L. C., Vu, T. and Tukey, R. H. 1994, The human CYP1A2 gene and induction by 3-methylcholanthrene: a region of DNA that supports Ah-receptor binding and promoter-specific induction. Journal of Biological Chemistry, 269 (9), 6949-6954.
55. Riboli, E., Haley, N. J., Trédaneil, J., Saeacci, R., Preston-Martin, S. and Trichopoulos, D. 1995, Misclassification of smoking status among women in relation to exposure to environmental tobacco smoke. European Respiratory Journal, 8 (2), 285-290.
56. Rosa, M., Pacifici, R., Altieri, I., Pichini, S., Ottaviani, G. and Zuccaro, P. 1992, How the steady-state cotinine concentration in cigarette smokers is directly related to nicotine intake. Clinical Pharmacology and Therapeutics, 52 (3), 324-329.
57. Saitoh, T., Kokue, E. and Schimoda, M. 1999, The suppressive effects of lipopolysaccharide-induced acute phase response on hepatic cytochrome P450-dependent drug metabolism in rabbits. Journal of Veterinary Pharmacology and Therapeutics, 22, 87-95.
58. Schein, J. R. 1995, Cigarette smoking and clinically significant drug interactions. Annals of Pharmacotherapy, 29, 1139-1148.
59. Scherer, G., Jarczyk, L., Heller, W. D., Biber, A., Neurath, G. B. and Adlkofer, F. 1988, Pharmacokinetics of nicotine, cotinine and 3′-hydroxycotinine in cigarette smokers. Klinische Wochenschrift, 66 (11), 5-11.
60. Siegmund, B., Leitner, E. and Pfannhauser, W. 1999, Determination of the nicotine content of various edible nightshades (solanaceae) and their products and estimation of the associated dietary nicotine intake. Journal of Agricultural and Food Chemistry, 47 (8), 3113-3120.
61. SNRT Subcommittee on Biochemical Verification 2002, Biochemical verification of tobacco use and cessation. Nicotine and Tobacco Research, 4, 149-159.
62. Sofowora, G. G., Choo, E. F., Mayo, G., Shyr, Y. and Wilkinson, G. R. 2001, In vivo inhibition of human CYP1A2 activity by oltipraz. Cancer Chemotherapy and Pharmacology, 47, 505-510.
63. Swan, G. E., Habina, K., Means, B., Jobe, J. B. and Esposito, J. L. 1993, Saliva cotinine and recent smoking evidence for a nonlinear relationship. Public Health Reports, 108 (6), 779-783.
64. Uematsu, T. 1993, Utilization of hair analysis for therapeutic drug monitoring with a special reference to ofloxacin and to nicotine. Forensic Science International, 63, 261-268.
65. Vine, M. F., Hulka, B. S., Margolin, B. H., Truong, Y. K., Hu, P., Schramm, M., Griffith, J. D., McCann, M. and Everson, R. B. 1993, Cotinine concentrations in semen, urine, and blood of smokers and nonsmokers. American Journal of Public Health, 83 (9), 1335-1338.
66. Willers, S., Skarping, G., Dalene, M. and Skerfving, S. 1995, Urinary cotinine in children and adults during and after semiexperimental exposure to environmental tobacco smoke. Archives of Environmental Health, 50 (2), 130-138.
67. Yamazaki, H., Inoue, K., Hashimoto, M. and Shimada, T. 1999, Roles of CYP2A6 and CYP2B6 in nicotine C-oxidation by human liver microsomes. Archives of Toxicology, 73, 65-70.
68. Yew, W. W. 2002, Clinically significant interactions with drugs used in the treatment of tuberculosis. Drug Safety, 25 (2), 111-133.
69. Zevin, S. and Benowitz, N. L. 1999, Drug interactions with tobacco smoking. Clinical Pharmacokinetics, 36 (6), 425-438.