NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: A randomized controlled trial for pharmacogenetics-based therapy

European Journal of Clinical Pharmacology

Volumn 69, Issue 5, 2013, Pages 1091-1101

  Azuma, Junichi ^a,b   Ohno, Masako ^a,b   Kubota, Ryuji ^b   Yokota, Soichiro ^c   Nagai, Takayuki ^d   Tsuyuguchi, Kazunari ^e   Okuda, Yasuhisa ^f   Takashima, Tetsuya ^d   Kamimura, Sayaka ^b   Fujio, Yasushi ^b   Kawase, Ichiro ^d  

^a HYOGO COLLEGE OF MEDICINE   (Japan)

^b OSAKA UNIVERSITY   (Japan)

^c TONEYAMA NATIONAL HOSPITAL   (Japan)

^d OSAKA PREFECTURAL MEDICAL CENTER FOR RESPIRATORY AND ALLERGIC DISEASES   (Japan)

^e NATIONAL HOSPITAL ORGANIZATION KINKI CHUO CHEST MEDICAL CENTER   (Japan)

^f FUKUJUJI HOSPITAL   (Japan)

Author keywords

Arylamine N acetyltransferase 2 (NAT2); Isoniazid; Pharmacogenomics; Pulmonary tuberculosis; Randomized clinical trial

Indexed keywords

ARYLAMINE ACETYLTRANSFERASE; ETHAMBUTOL; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN; STREPTOMYCIN;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; FEMALE; GASTROINTESTINAL DISEASE; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; INTENTION TO TREAT ANALYSIS; JAPANESE; LIVER INJURY; LUNG TUBERCULOSIS; MALE; N ACETYLTRANSFERASE 2 GENE; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; PHARMACOGENETICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN DISEASE; THORAX RADIOGRAPHY; TREATMENT DURATION; VISUAL IMPAIRMENT;

ADULT; ANIMALS; ANTITUBERCULAR AGENTS; ARYLAMINE N-ACETYLTRANSFERASE; ASIAN CONTINENTAL ANCESTRY GROUP; DRUG-INDUCED LIVER INJURY; GENETIC PREDISPOSITION TO DISEASE; GENOTYPE; HUMANS; INDIVIDUALIZED MEDICINE; ISONIAZID; MALE; MIDDLE AGED; TREATMENT FAILURE; TUBERCULOSIS;

EID: 84879461332     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1429-9     Document Type: Article

References (36)

1. Global Health Observatory (GHO); Tuberculosis (TB). World Health Organization Web site. http://www.who.int/gho/tb/en/index.html Accessed Sep 10, 2012.
2. The Global Plan to Stop TB. Stop TB Partnership Web site. http://www.stoptb.org/global/plan/ Accessed Sep 10, 2012.
3. Guidelines for treatment of tuberculosis, 4th ed. World Health Organization Web site. http://www.who.int/tb/publications/2010/9789241547833/en/ Accessed Sep 10, 2012.
4. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA (2003) American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med 167:603-662
5. Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D (2003) Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. Am J Respir Crit Care Med 167:1472-1477 (Pubitemid 37363354)
6. Steele MA, Burk RF, DeaPrez RM (1991) Toxic hepatitis with isoniazid and rifampin. A meta-analysis. Chest 99:465-71
7. Jindani A, Nunn AJ, Enarson DA (2004) Two 8-month regimens of chemotherapy for treatment of newly diagnosed pulmonary tuberculosis: international multicentre randomised trial. Lancet 364:1244-1251 (Pubitemid 39311345)
8. Durand F, Jebrak G, Pessayre D, Fournier M, Bernuau J (1996) Hepatotoxicity of antitubercular treatments. Rationale for monitoring liver status. Drug Saf 15:394-405
9. Evans DA, Manley KA, Mc KV (1960) Genetic control of isoniazid metabolism in man. Br Med J 2:485-491
10. Evans DA, Storey PB, Wittstadt FB, Manley KA (1960) The determination of the isoniazid inactivator phenotype. Am Rev Respir Dis 82:853-861
11. Human NAT2 alleles (Haplotypes) (updated July 22, 2011) http://louisville.edu/medschool/pharmacology/consensus-human-arylamine-n- acetyltransferase-gene-nomenclature/nat-pdf-files/Human-NAT2-alleles.pdf Accessed Sep 10, 2012.
12. Mashimo M, Suzuki T, Abe M, Deguchi T (1992) Molecular genotyping of N-acetylation polymorphism to predict phenotype. Hum Genet 90:139-143
13. Parkin DP, Vandenplas S, Botha FJ, Vandenplas ML, Seifart HI, van Helden PD, van der Walt BJ, Donald PR, van Jaarsveld PP (1997) Trimodality of isoniazid elimination: phenotype and genotype in patients with tuberculosis. Am J Respir Crit Care Med 155:1717-1722 (Pubitemid 27216683)
14. Ellard GA (1976) Variations between individuals and populations in the acetylation of isoniazid and its significance for the treatment of pulmonary tuberculosis. Clin Pharmacol Ther 19:610-625
15. Donald PR, Sirgel FA, Venter A, Parkin DP, Seifart HI, van de Wal BW, Werely C, van Helden PD, Maritz JS (2004) The influence of human N-acetyltransferase genotype on the early bactericidal activity of isoniazid. Clin Infect Dis 39:1425-1430 (Pubitemid 39518202)
16. Kubota R, Ohno M, Yasunaga M, Yokota S, Maekura R, Azuma J (2005) Tentative treatments for tuberculosis based on N-acetyltransferase gene polymorphism. Jpn J Therapeutic Drug Monitoring 22:336-340
17. Evans DA (1989) N-acetyltransferase. Pharmacol Ther 42:157-234 (Pubitemid 19140452)
18. Ohno M, Yamaguchi I, Yamamoto I, Fukuda T, Yokota S, Maekura R, Ito M, Yamamoto Y, Ogura T, Maeda K, et al. (2000) Slow N-acetyltransferase 2 genotype affects the incidence of isoniazid and rifampicin-induced hepatotoxicity. Int J Tuberc Lung Dis 4:256-261 (Pubitemid 30151575)
19. Huang YS, Chern HD, Su WJ, Wu JC, Lai SL, Yang SY, Chang FY, Lee SD (2002) Polymorphism of the N-acetyltransferase 2 gene as a susceptibility risk factor for antituberculosis drug-induced hepatitis. Hepatology 35:883-889 (Pubitemid 34258383)
20. Kinzig-Schippers M, Tomalik-Scharte D, Jetter A, Scheidel B, Jakob V, Rodamer M, Cascorbi I, Doroshyenko O, Sorgel F, Fuhr U (2005) Should we use N-acetyltransferase type 2 genotyping to personalize isoniazid doses? Antimicrob Agents Chemother 49:1733-1738 (Pubitemid 40631582)
21. Kubota R, Ohno M, Hasunuma T, Iijima H, Azuma J (2007) Dose-escalation study of isoniazid in healthy volunteers with the rapid acetylator genotype of arylamine N-acetyltransferase 2. Eur J Clin Pharmacol 63:927-933 (Pubitemid 47387905)
22. http://www.info.pmda.go.jp/juutoku/file/jfm0804002.pdf Accessed Sep 10, 2012.
23. Takikawa H, Onji M (2005) A proposal of the diagnostic criteria of drug-induced liver injury. Hepatol Res 32:250-1 (Pubitemid 41194999)
24. Danan G, Benichou C (1993) Causality assessment of adverse reactions to drugs. A novel method based on the conclusions of international consensus meetings: Application to drug-Induced liver injuries. J Clin Epidemiol 46:1323-30 (Pubitemid 23333873)
25. Tokuda A, Ohno M, Furutsuka M, Kubota R, Nakayama S, Yokota S, Maekura R, Azuma J (2006) GSTs and NAT2 gene polymorphisms and drug induced hepatotoxicity in anti-tuberculosis therapy. Jpn J Clin Pharmacol Ther 37:S224
26. Mitchison DA (1993) Assessment of new sterilizing drugs for treating pulmonary tuberculosis by culture at 2 months. Am Rev Respir Dis 147:1062-1063 (Pubitemid 23093839)
27. Kimerling ME, Phillips P, Patterson P, Hall M, Robinson CA, Dunlap NE (1998) Low serum antimycobacterial drug levels in non-HIV-infected tuberculosis patients. Chest 113:1178-1183 (Pubitemid 28223801)
28. Weiner M, Burman W, Vernon A, Benator D, Peloquin CA, Khan A, Weis S, King B, Shah N, Hodge T (2003) Low isoniazid concentrations and outcome of tuberculosis treatment with once-weekly isoniazid and rifapentine. Am J Respir Crit Care Med 167:1341-1347 (Pubitemid 36609717)
29. Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T (2005) Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis 40:1481-1491 (Pubitemid 40628637)
30. Jayaram R, Shandil RK, Gaonkar S, Kaur P, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharath S, Kantharaj E, Balasubramanian V (2004) Isoniazid pharmacokinetics-pharmacodynamics in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother 48:2951-2957 (Pubitemid 38989160)
31. Jindani A, Aber VR, Edwards EA, and Mitchison DA (1980) The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis 121-939-949.
32. Jindani A, Cj D, Mitchison DA (2003) Bactericidal and sterilizing activities of antituberculosis drugs during the first 14 days. Am J Resp Crit Care Med 167:1348-1354 (Pubitemid 36609718)
33. Gumbo T, Louie A, Liu W, Ambrose PG, Bhavnani SM, Brown D, Drusano GL (2007) Isoniazid's bactericidal activity ceases because of the emergence of resistance, not depletion of Mycobacterium tuberculosis in the log phase of growth. J Infect Dis 195:194-201 (Pubitemid 46080051)
34. Abe C, Hirano K, Wada M, Aoyagi T (2001) Resistance of Mycobacterium tuberculosis of four first-line anti-tuberculosis drugs in Japan, 1997. Int J Tuberc Lung Dis 5:46-52 (Pubitemid 32401875)
35. Sunahara S, Urano M, Ogawa M (1961) Genetical and geographic studies on isoniazid inactivation. Science 134:1530-1531
36. Cascorbi I, Drakoulis N, Brockmoller J, Maurer A, Sperling K, Roots I (1995) Arylamine N-acetyltransferase (NAT2) mutations and their allelic linkage in unrelated Caucasian individuals: correlation with phenotypic activity. Am J Hum Genet 57:581-592