Evaluation of initial and steady-state gatifloxacin pharmacokinetics and dose in pulmonary tuberculosis patients by using Monte Carlo simulations

Antimicrobial Agents and Chemotherapy

Volumn 57, Issue 9, 2013, Pages 4164-4171

  Smythe, Wynand ^a   Merle, Corinne S ^b   Rustomjee, Roxana ^c   Gninafon, Martin ^d   Lo, Mame Bocar ^e   Bah Sow, Oumou ^f   Olliaro, Piero L ^g   Lienhardt, Christian ^h   Horton, John ⁱ   Smith, Peter ^a   McIlleron, Helen ^a   Simonsson, Ulrika S H ^j  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^d Programme National de Lutte Contre la Tuberculose   (Benin)

^e Programme National de Lutte contre la Tuberculose   (Senegal)

^f CHU Ignace Deen   (Guinea)

^g WORLD HEALTH ORGANIZATION   (Switzerland)

^h INSTITUT DE RECHERCHE POUR LE DÉVELOPPEMENT   (France)

ⁱ Tropical Projects   (United Kingdom)

^j UPPSALA UNIVERSITY   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GATIFLOXACIN; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN;

ADULT; ALLOMETRY; AREA UNDER THE CURVE; ARTICLE; DRUG ABSORPTION; FEMALE; HUMAN; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SOUTH AFRICA; STEADY STATE;

ADULT; ANTITUBERCULAR AGENTS; AREA UNDER CURVE; COINFECTION; DRUG ADMINISTRATION SCHEDULE; DRUG DOSAGE CALCULATIONS; DRUG SYNERGISM; DRUG THERAPY, COMBINATION; FEMALE; FLUOROQUINOLONES; HIV INFECTIONS; HUMANS; ISONIAZID; MALE; MONTE CARLO METHOD; PYRAZINAMIDE; RIFAMPIN; TUBERCULOSIS, PULMONARY;

EID: 84882396767     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00479-13     Document Type: Article

References (46)

1. Nakashima M, Uematsu T, Kosuge K, Kusajima H, Ooie T, Masuda Y, Ishida R, Uchida H. 1995. Single-and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob. Agents Chemother. 39:2635-2640.
2. Alvirez-Freites EJ, Carter JL, Cynamon MH. 2002. In vitro and in vivo activities of gatifloxacin against Mycobacterium tuberculosis. Antimicrob. Agents Chemother. 46:1022-1025.
3. Rodriguez JC, Ruiz M, Lopez M, Royo G. 2002. In vitro activity of moxifloxacin, levofloxacin, gatifloxacin and linezolid against Mycobacterium tuberculosis. Int. J. Antimicrob. Agents 20:464-467.
4. Singh M, Chauhan DS, Gupta P, Das R, Srivastava RK, Singh PUP, Srivastava K, Faujdar J, Jaudaun GPS, Yadav VS, Sharma VD, Venkatesan K, Sachan S, Sachan P, Katoch K, Katoch VM. 2009. In vitro effect of fluoroquinolones against Mycobacterium tuberculosis isolates from Agra & Kanpur region of north India. Indian J. Med. Res. 129:542-547.
5. Cynamon MH, Sklaney MR, Shoen C. 2007. Gatifloxacin in combination with rifampicin in a murine tuberculosis model. J. Antimicrob. Agents Chemother. 60:429-432.
6. Johnson JL, Hadad DJ, Boom WH, Daley CL, Peloquin CA, Eisenach KD, Jankus DD, Debanne SM, Charlebois ED, Maciel E, Palaci M, Dietze R. 2006. Early and extended bactericidal activity of levofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis. Int. J. Tuberc. Lung Dis. 10:605-612.
7. Rustomjee R, Lienhardt C, Kanyok T, Davies GR, Levin J, Mthiyane T, Reddy C, Sturm AW, Sirgel FA, Allen J, Coleman DJ, Fourie B, Mitchison DA. 2008. A Phase II study of the sterilising activities of ofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis. Int. J. Tuberc. Lung Dis. 12:128-138.
8. McIlleron H, Norman J, Kanyok TP, Fourie PB, Horton J, Smith PJ. 2007. Elevated gatifloxacin and reduced rifampicin concentrations in a single-dose interaction study amongst healthy volunteers. J. Antimicrob. Agents Chemother. 60:1398-1401.
9. Ambrose PG, Bhavnani SM, Cirincione BB, Piedmonte M, Grasela TH. 2003. Gatifloxacin and the elderly: pharmacokinetic-pharmacodynamic rationale for a potential age-related dose reduction. J. Antimicrob. Chemother. 52:435-440.
10. Park-Wyllie LY, Juurlink DN, Kopp A, Shah BR, Stukel TA, Stumpo C, Dresser L, Low DE, Mamdani MM. 2006. Outpatient gatifloxacin therapy and dysglycemia in older adults. N. Engl. J. Med. 354:1352-1361.
11. Mehlhorn AJ, Brown DA. 2007. Safety concerns with fluoroquinolones. Ann. Pharmacother. 41:1859-1866.
12. LaPlante KL, Mersfelder TL, Ward KE, Quilliam BJ. 2008. Prevalence of and risk factors for dysglycemia in patients receiving gatifloxacin and levofloxacin in an outpatient setting. Pharmacotherapy 28:82-89.
13. Forrest A, Nix DE, Ballow CH, Goss TF, Birmingham MC, Schentag JJ. 1993. Pharmacodynamics of intravenous ciprofloxacin in seriously ill patients. Antimicrob. Agents Chemother. 37:1073-1081.
14. Schentag JJ, Gilliland KK, Paladino JA. 2001. What have we learned from pharmacokinetic and pharmacodynamic theories? Clin. Infect. Dis. 32: S39-S46.
15. Mouton JW, Dudley MN, Cars O, Derendorf H, Drusano GL. 2005. Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: an update. J. Antimicrob. Chemother. 55:601-607.
16. Merle CS, Sismanidis C, Bah Sow O, Gninafon M, Horton J, Lapujade O, Lo MB, Mitchinson DA, Perronne C, Portaels F, Odhiambo J, Olliaro P, Rustomjee R, Lienhardt C, Fielding K. 2012. A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project. Trials 13:61.
17. Beal S, Sheiner LB, Boeckmann A, Bauer RJ. 2009. NONMEM user's guides 1989-2009. Icon Development Solutions, Ellicott City, MD.
18. The R Foundation for Statistical Computing. 2 June 2011. R. A language and environment for statistical computing. http://www.R-project.org.
19. Jonsson EN, Karlsson MO. 1999. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput. Methods Programs Biomed. 58:51-64. http://xpose.sourceforge .net/. Accessed 9 June 2011.
20. Lindbom L, Ribbing J, Jonsson EN. 2004. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput. Methods Programs Biomed. 75:85-94. http://psn.sourceforge.net/. Accessed 9 June 2011.
21. Lindbom L, Pihlgren P, Jonsson EN. 2005. PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput. Methods Programs Biomed. 79:241-257. http://psn. sourceforge.net/. Accessed 9 June 2011.
22. Jonsson EN, Karlsson MO. 1998. Automated covariate model building within NONMEM. Pharm. Res. 15:1463-1468.
23. Holford NHG. 2005. PAGE 14. Abstract 738. http:www.page-meeting.org/? abstr-738.
24. Holford NHG, Karlsson MO. 2008. PAGE 17. Abstract 1434. http:www .page-meeting.org/?abstr-1434.
25. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. 2011. Predictioncorrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 13:143-151.
26. Savic RM, Jonker DM, Kerbusch T, Karlsson MO. 2007. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J. Pharmacokinet. Pharmacodyn. 34:711-726.
27. Wilkins JJ, Savic RM, Karlsson MO, Langdon G, McIlleron H, Pillai G, Smith PJ, Simonsson USH. 2008. Population pharmacokinetics of rifampin in pulmonary tuberculosis patients, including a semimechanistic model to describe variable absorption. Antimicrob. Agents Chemother. 52:2138-2148.
28. Cockcroft DW, Gault MH. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
29. Holford NHG. 1996. A size standard for pharmacokinetics. Clin. Pharmacokinet. 30:329-332.
30. West GB, Brown JH, Enquist BJ. 1997. A general model for the origin of allometric scaling laws in biology. Science 276:122-126.
31. West GB, Brown JH, Enquist BJ. 1999. The fourth dimension of life: fractal geometry and allometric scaling of organisms. Science 284:1677-1679.
32. Anderson BJ, Holford NH. 2008. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu. Rev. Pharmacol. Toxicol. 48:303-332.
33. Anderson BJ, Holford NH. 2009. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab. Pharmacokinet. 24:25-36.
34. Karlsson MO, Sheiner LB. 1993. The importance of modelling interoccasion variability in population pharmacokinetic analyses. J. Pharmacokinet. Biopharm. 21:735-750.
35. Pasipanodya J, Gumbo T. 2011. An oracle: antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation, and clinical trial simulations to predict the future. Antimicrob. Agents Chemother. 55: 24-34.
36. Mouton JW, Punt N, Vinks AA. 2005. A retrospective analysis using Monte Carlo simulation to evaluate recommended ceftazidime dosing regimens in healthy volunteers, patients with cystic fibrosis, and patients in the intensive care unit. Clin. Ther. 27:762-772.
37. Gajjar DA, LaCreta FP, Uderman HD, Kollia GD, Duncan G, Birkhofer MJ, Grasela DM. 2000. A dose-escalation study of the safety, tolerability, and pharmacokinetics of intravenous gatifloxacin in healthy adult men. Pharmacotherapy 20:49S-58S.
38. Peloquin CA, Hadad DJ, Molino LP, Palaci M, Boom WH, Dietze R, Johnson JL. 2008. Population pharmacokinetics of levofloxacin, gatifloxacin, and moxifloxacin in adults with pulmonary tuberculosis. Antimicrob. Agents Chemother. 52:852-857.
39. Mignot A, Guillaume M, Brault M, Gualano V, Millérioux L, Göhler K, Stahlberg HJ. 2002. Multiple-dose pharmacokinetics and excretion balance of gatifloxacin, a new fluoroquinolone antibiotic, following oral administration to healthy Caucasian volunteers. Chemotherapy 48:116-121.
40. Kwatra D, Vadlapatla RK, Vadlapudi AD, Pal D, Mitra AK. 2010. Interaction of gatifloxacin with efflux transporters: a possible mechanism for drug resistance. Int. J. Pharm. 395:114-121.
41. Schuetz EG, Schinkel AH, Relling MV, Schuetz JD. 1996. P-glycoprotein: a major determinant of rifampicin-inducible expression of cytochrome P4503A in mice and humans. Proc. Natl. Acad. Sci. U. S. A. 93: 4001-4005.
42. Crawford B. 1948. Depression of the exogenous creatinine/inulin or thiosulphate clearance ratios in man by diodrast and p-aminohippuric acid. J. Clin. Invest. 27:171-175.
43. Ginsburg AS, Grosset JH, Bishai WR. 2003. Fluoroquinolones, tuberculosis, and resistance. Lancet Infect. Dis. 3:432-442.
44. Thwaites GE, Bhavnani SM, Chau TTH, Hammel JP, Török ME, Van Wart SA, Mai PP, Reynolds DK, Caws M, Dung NT, Hien TT, Kulawy R, Farrar J, Ambrose PG. 2011. Randomized pharmacokinetic and pharmacodynamic comparison of fluoroquinolones for tuberculous meningitis. Antimicrob. Agents Chemother. 55:3244-3253.
45. Honeybourne D, Banerjee D, Andrews J, Wise R. 2001. Concentrations of gatifloxacin in plasma and pulmonary compartments following a single 400 mg oral dose in patients undergoing fibre-optic bronchoscopy. J. Antimicrob. Chemother. 48:63-68.
46. Fung-Tomc J, Minassian B, Kolek B, Washo T, Huczko E, Bonner D. 2000. In vitro antibacterial spectrum of a new broad-spectrum 8-methoxy fluoroquinolone, gatifloxacin. J. Antimicrob. Chemother. 45: 437-446.