Levofloxacin in the treatment of community-acquired infections of the lower respiratory tract: a look through a quarter of a century

Cover Page

Cite item

Full Text

Abstract

This review is devoted to the 25th anniversary of the beginning of the widespread use of the prototype of "respiratory" fluoroquinolones levofloxacin in clinical practice. The article presents the evidence of clinical and microbiological efficacy, as well as good tolerability of levofloxacin obtained during numerous clinical studies, as well as evidence of long-term successful use of the antibiotic in real clinical practice, which determines its unique place in modern schemes of antibacterial therapy of adult patients with community-acquired lower respiratory tract infections.

About the authors

Alexander I. Sinopalnikov

Russian Medical Academy of Continuous Professional Education

Email: aisyn@list.ru
д-р мед. наук, проф., зав. каф. Moscow, Russia

References

  1. New FDA requirements for post-marketing studies and clinical trials: patient strategy. Q2. MemorANDA. 2009; p. 1-10.
  2. Adriaenssens N, Coenen S, Versporten A, et al. European Surveillance of Antimicrobial Consumption (ESAC): outpatient quinolone uses in Europe (1997-2009). J Antimicrob Chemother. 2011;66(Suppl. 6):vi47-56.
  3. Lesher GY, Froelich ED, Gruett MD, et al. 1,8-Naphthyridine derivatives. A new class of chemotherapeutic agents. J Med Pharm Chem. 1962;91:1063-5.
  4. Naber K, Adam D. Expertengruppe der PEG. Einteilung der Fluorchinolone. Chemother J. 1998;7: 66-8.
  5. Nareddin AM, Elkhatib WF, Cunnion KM, Zhanel GG. Cumulative clinical experience from over a decade of use of levofloxacin in community-acquired pneumonia: critical appraisal and role in therapy. Drug Healthc PatientSaf. 2011;3:59-68.
  6. Anderson VR, Perry CM. Levofloxacin. A review of its use as a high-dose, short-course treatment for bacterial infection. Drugs. 2008;68(4):535-56.
  7. Schito GC, Varaldo PE, Nicoletti G. Activity of Levofloxacin on Respiratory Pathogens: Results of the SEMPRE Italian Study (2000-2002). Chicago: ICAAC, 2003.
  8. Odenholt I, Cars O. Pharmacodynamics of moxifloxacin and levofloxacin against Streptococcus pneumoniae, Staphylococcus aureus, Klebsiella pneumoniae and Escherichia coli: simulation of human plasma concentrations after intravenous dosage in an in vitro model. JAC. 2006;58:960-5.
  9. Nareddin AM, Marras TK, Sanders K, et al. Pharmacodynamic target attainment analysis against Streptococcus pneumoniae using levofloxacin 500 mg, 750 mg and 1000 mg once daily in plasma and epithelial lining fluid of hospitalized patients with community-acquired pneumonia. Int J AntimicrobAgents. 2004;24:479-84.
  10. Drusano GL, Preston SL, Gotfried MH, et al. Levofloxacin penetration into epithelial lining fluid as determined by population pharmacokinetic modeling and Monte Carlo simulation. Antimicrob Agents Chemother. 2002;46:586-9.
  11. Capitano B, Mattoes HM, Shore E, et al. Steady-state intrapulmonary concentrations of moxifloxacin, levofloxacin, and azithromycin in older adults. Chest. 2004;125(3):965-97.
  12. Langtry HD, Lamb HM. Levofloxacin: Its use in infections of respiratory tract, skin, soft tissues, and urinary tract. Drugs. 1998;56:487-515.
  13. Norrby SR. Levofloxacin. Exp Opin Pharmacother. 1999;1:109-19.
  14. European Committee on Antimicrobial Susceptibility testing (EUCAST). Breakpoint tables for interpretation of MICs and zone diameters. Ver. 9.0, 2019. Available at: www.eucast.org/fileadmin/ src/media/PDFs/EUCAST_files/Breakpoint_tables/v9.0. Accessed: 25.08.2021.
  15. Lynch JP, File TM, Zhanel GG. Levofloxacin for the treatment of community-acquired pneumonia. Expert Rev Anti Infect Ther. 2006;4:725-42.
  16. Davis R, Bryson HM. Levofloxacin. A review of its antibacterial activity, pharmacokinetics and therapeutic efficacy. Drugs. 1994;47(4):677-700.
  17. Zanel GG, Fontaine S, Adam H, et al. A review of new fluoroquinolones. Focus on their use in respirator tract infections. Treat Respir Med. 2006;5:437-65.
  18. Иванчик Н.В., Чагарян А.Н., Сухорукова М.В., и др. Антибиотикорезистентность клинических штаммов Streptococcus pneumoniae в России: результаты многоцентрового эпидемиологического исследования «ПеГАС 2014-2017». Клиническая микробиология и антимикробная химиотерапия. 2019;21(3):230-7
  19. Doern GV, Richter SS, Miller A, et al. Antimicrobial resistance among Streptococcus pneumoniae in the United States: have we begun to turn the corner on resistnce to certain antimicrobial classes? Clin Infect Dis. 2005;41:139-48.
  20. Doern GV, Brown SD. Antimicrobial susceptibility among community-acquired respiratory tract pathogens in the USA: data from PROTEKT US 2000-2001. J Infect 2004;48:56-65.
  21. Noreddin AM, Elkhatib WF. Levofloxacin in the treatment of community-acquired pneumonia. Expert Rev Anti Infect Ther. 2010;8:505-14.
  22. Felmingham D, Feldman C, Hryniewicz W, et al. Surveillance of resistance in bacteria causing community-acquired respiratory tract infections. Clin Microbiol Infect. 2002;8(Suppl. 2):12-42.
  23. Baquero F, Baquero-Artigao G, Canton R, Garcia-Rey C. Antibiotic consumption and resistance selection in Streptococcus pneumoniae. J Antimicrob Chemother. 2002;50(Suppl. S2): 27-37.
  24. Drlica K. A strategy for fighting antibiotic resistance. Am Soc Microbiol News. 2001;67:27-33.
  25. Boselli E, Breilh D, Rimmele T, et al. Pharmacokinetics and intrapulmonary diffusion of levofloxacin in critically ill patients with severe community-acquired pneumonia. Crit Care Med. 2005;33(1):104-9.
  26. Gotfried MH, Danziger LH, Rodvold KA. Steady-state plasma and intrapulmonary concentrations of levofloxacin and ciprofloxacin in healthy adult subjects. Chest. 2001;119(4):1114-22.
  27. Hermsen ED, Hovde LB, Konstantinides GN, Rotschafer JC. Mutant prevention concentrations of ABT-492, levofloxacin, moxifloxacin, and gatifloxacin against three common respiratory pathogens. Antimicrob Agents Chemother. 2005;49(4):1633-5.
  28. Soman A, Honeybourne D, Andrews J, et al. Concentrations of gatifloxacin in plasma and pulmonary compartments following a single 400 mg oral dose in patients undergoing fibre-optic bronchoscopy. J Antimicrob Chemother. 2001;48:63-6.
  29. Soman A, Honeybourne D, Andrews J, Jevons G, Wise R. Concentrations of moxifloxacin in serum and pulmonary compartments following a single 400 mg oral dose in patients undergoing fibreoptic bronchoscopy. J Antimicrob Chemother. 1999;44:835-8.
  30. Canton R, Lode H, Graninger W, Milkovich G. Respiratory tract infections: at-risk patients, who are they? Implications for their management with levofloxacin. Int J Antimicrob Agents. 2006;28(Suppl. 2):S115-27.
  31. Практическое руководство по антиинфекционной химиотерапии. Под ред. Л.С. Страчунского, Ю.Б. Белоусова, С.Н. Козлова. НИИАХ СГМА, 2007. Режим доступа: http://antibiotics.ru/ab. Ссылка активна на 25.08.2021
  32. Синопальников А.И., Козлов Р.С. Внебольничные инфекции дыхательных путей. Руководство для врачей. М.: Премьер МТ, Наш Город, 2007
  33. Thiem U, Heppner HJ, Pientka L. Elderly patients with community-acquired pneumonia. Optimal treatment strategies. Drug Aging. 2011;28(7):519-37.
  34. Vardakas KZ, Siempos II, Grammatikos A, et al. Respiratory fluoroquinolones for the treatment of community-acquired pneumonia: a meta-analysis of randomized controlled trials. CMAJ. 2008;179(12):1269-77.
  35. Ye X, Sikirica V, Schein JR, et al. Treatment failure rates and health care utilization and costs among patients with community-acquired pneumonia treated with levofloxacin or macrolides in an outpatient setting: a retrospective claims database analysis. Clin Ther. 2008;30(2):358-71.
  36. Hess G, Hill JW, Raut MK, et al. Comparative antibiotic failure rates in the treatment of community-acquired pneumonia: results from a claims analysis. Adv Ther. 2010;27(10):743-55.
  37. Simonetti AF, Garcia-Vidal C, Viasus D, et al. Declining mortality among hospitalized patients with community-acquired pneumonia. Clin Microbiol Infect. 2016;22(6):e1-567.
  38. Raz-Pasteur A, Shasha D, Pual M. Fluoroquinolones or macrolides alone versus combined with 0-lactams for adults with community-acquired pneumonia: Systematic review and meta-analysis. Int J Antimicrob Agents. 2015;46:242-8.
  39. Wang CC, Lin CH, Lin KY, et al. Comparative outcome analysis of penicillin-based versus fluoroquinolone-based antibiotic therapy for community-acquired pneumonia. A nationwide population-based cohort study. Medicine (Baltimore). 2016;95(6):e2763.
  40. Belforti RK, Lagu T, Haessler S, et al. Association between initial route of fluoroquinolone administration and outcomes in patients hospitalized for community-acquired pneumonia. Clin Infect Dis. 2016;63(1):1-9.
  41. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45-e67.
  42. Внебольничная пневмония. Клинические рекомендации Российского респираторного общества и Межрегиональной ассоциации по клинической микробиологии и антимикробной химиотерапии (проект), 2021. Режим доступа: www.antibiotic.ru. Ссылка активна на 25.08.2021
  43. Santos S, Marin A, Serra-Batlles J, et al. Treatment of patients with COPD and recurrent exacerbations: the role of infection and inflammation. Int J Chron Obstruct Pulmon Dis. 2016;11:515-25.
  44. Bafadhel M, McKenna S, Terry S, et al. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011;184(6):662-71.
  45. Miravitlles M, Espinosa C, Fernandez-Laso E, et al; Study Group of Bacterial Infection in COPD. Relationship between bacterial flora in sputum and functional impairment in patients with acute exacerbations of COPD. Chest. 1999;116(1):40-6.
  46. Miravitlles M, Anzueto A. Antibiotics for acute and chronic respiratory infection in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013;188(9):1052-7.
  47. Shah PM, Maesen FP, Dolmann A, et al. Levofloxacin versus cefuroxime axetil in the treatment of acute exacerbations of chronic bronchitis: results of a randomized, double-blind study. J Antimicrob Chemother. 1999;43(4):529-39.
  48. Masterton RG, Burley CJ. Randomized, double-blind study comparing 5- and 7-day regimens of oral levofloxacin in patients with acute exacerbations of chronic bronchitis. Int J Antimicrob Agents. 2001;18(6):503-12.
  49. Weis LR. Open-label, randomized comparison of the efficacy and tolerability of clarithromycin, levofloxacin, and cefuroxime axetil in the treatment of adults with acute bacterial exacebations of chronic bronchitis. Clin Ther. 2002;24(9):1414-25.
  50. Canut A, Martin-Herrero JE, Labora A, Maortua H. What are the most appropriate antibiotics for the treatment of acute exacerbations of chronic obstructive pulmonary disease? A therapeutic outcomes model. J Antimicrob Chemother. 2007;60(3):605-12.
  51. Дворецкий Л.И., Дубровская Н.В., Грудинина С.А., и др. Левофлоксацин и макролиды при обострении хронического бронхита: сравнительный анализ эффективности лечения и длительности безрецидивного периода. Антибиотики и химиотерапия. 2007;52(7):21-31.
  52. Ruiz-Gonzalez A, Gimenez A, Gomez-Arbones X, et al. Open-label, randomized comparison trial of long-term outcomes of levofloxacin versus standard antibiotic therapy in acute exacerbations of chronic obstructive pulmonary disease. Respirology. 2007;12(1):117-21.
  53. Holland M, Chien S, Corrado M, et al. The pharmacokinetic profile of levofloxacin following once-or twice-daily 500 mg administration. Proceedings of Fifth International Symposium on New Quinolones. Singapore, 1994; p. 25-7.
  54. Chow AT, Fowler CL, Williams RR, et al. Safety and pharmacokinetics of multiple 750-milligram doses of intravenous levofloxacin in healthy volunteers. Antimicrob Agents Chemother. 2001;45(7):2122-5.
  55. Chien SC, Wong FA, Fowler CL, et al. Double-blind evaluation of the safety and pharmacokinetics of multiple oral once-daily 750-milligram and 1-gram doses of levofloxacin in healthy volunteers. Antimicrob Agents Chemother. 1998;42(4):885-8.
  56. Lister P.D. Pharmacodynamics of 750 mg and 500 mg doses of levofloxacin against ciprofloxacin-resistant strains of Streptococcus pneumoniae. Diagn Microbiol Infect Dis. 2002;44(1):43-9.
  57. Gotfried MH, Danziger LH, Rodvold KA. Steady-state plasma and intrapulmonary concentrations of levofloxacin and ciprofloxacin in healthy adult subjects. Chest. 2001;119(4):1114-22.
  58. Frei CR, Jaso TC, Mortensen EM, et al. Medical resource utilization among community-acquired pneumonia patients initially treated with levofloxacin 750 mg daily versus ceftriaxone 1000 mg plus azithromycin 500 mg daily: a US-based study. Curr Med Res Opin. 2009;25(4):859-68.
  59. File TM Jr. Duration and cessation of antimicrobial treatment. J Hosp Med. 2012;7(Suppl. 1):S22-33.
  60. Tansarli GS, Mylonakis EE. Efficacy of short-course antibiotic treatments for community-acquired pneumonia in adults: A systematic review and meta-analysis. AntimicrobAgents Chemother. 2018; 62(9):AAC.e00635-18.
  61. Bronzawear S, Cars O, Buchholz U, et al. A European study on the relationship between antimicrobial use and antimicrobial resistance. Emerg Infect Dis. 2002;8(3):278-82.
  62. Goossens H, Ferech M, Vander Stichele R, Elseviers M; ESAC Project Group. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005;365(9459):579-87.
  63. Esposito S, Esposito I, Leone S. Considerations of antibiotic therapy duration in community- and hospital-acquired bacterial infections. J Antimicrob Chemother. 2012;67(11):2570-5.
  64. Navarta AC, Peyrani P, Wiemken TL, et al. Short duration of antibiotic therapy in hospitalized patients with community-acquired pneumonia: results from the CAPO international cohort study. ULJRI. 2017;1(3):21-6.
  65. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44 Suppl. 2(Suppl. 2):S27-72.
  66. Woodhead M, Blasi F, Ewig S, et al. Guidelines for the management of adult lower respiratory tract infections. Clin Microbiol Infect. 2011;17 Suppl. 6(Suppl. 6):E1-59.
  67. Lim WS, Baudouin SV, George RC, et al. BTS guidelines for the management of community-acquired pneumonia in adults: update 2009. Thorax. 2009;64 Suppl. 3:iii1-55.
  68. Dunbar LM, Wunderink RG, Habib MP, et al. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003;37(6):752-60.
  69. Dunbar LM, Khashab MM, Kahn JB, et al. Efficacy of 750 mg, 5 days levofloxacin in the treatment of community-acquired pneumonia caused by atypical pathogens. Curr Med Res Opin. 2004;20(4):555-63.
  70. Shorr AF, Khashab MM, Xiang JX, et al. Levofloxacin 750 mg for 5 days for the treatment of hospitalized fine risk class III/IV community-acquired pneumonia patients. Respir Med. 2006;100(12):2129-36.
  71. Shorr AF, Zadeikis N, Xiang JX, et al. A multicenter, randomized, double-blind, retrospective comparison of 5- and 10-day regimens of levofloxacin in a subgroup of patients aged >65 years with community-acquired pneumonia. Clin Ther. 2005;27(8):1251-9.
  72. Zhao X, Wu JF, Xiu QY, et al. A randomized controlled clinical trial of levofloxacin 750 mg versus 500 mg intravenous infusion in the treatment of community-acquired pneumonia. Diagn Microbiol Infect Dis. 2014;80(2):141-7.
  73. Zhao T, Chen LA, Wang P, et al. A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for the treatment of community-acquired pneumonia. J Thorac Dis. 2016;8(9):2473-84.
  74. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2021 Report). Available at: https://goldcopd.org. Accessed: 25.08.2021
  75. Masterton RG, Burley CJ. Randomized, double-blind study comparing 5- and 7-day regimens of oral levofloxacin in patients with acute exacerbation of chronic bronchitis. Int J Antimicrob Agents. 2001;18(6):503-12.
  76. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Available at: www.fda.gov/Drugs/DrugSafety/ucm511530. htm. Accessed: 25.08.2021.
  77. Stahlmann R, Lode HM. Risks associated with the therapeutic use of fluoroquinolones. Expert Opin Drug Saf. 2013;12(4):497-505.
  78. Lu ZK, Yuan J, Li M, et al. Cardiac risks associated with antibiotics: azithromycin and levofloxacin. Expert Opin Drug Saf. 2015;14(2):295-303.
  79. Ball P. Role of levofloxacin in the treatment of lower respiratory tract infections. Penetration: New challenges for levofloxacin in the fight against infectious diseases. Tokyo: BIOMEDIS, 2003; p. 22-32.
  80. Khashab MM, Xiang J, Kahn JB. Comparison of the adverse event profiles of levofloxacin 500 mg and 750 mg in clinical trials for the treatment of respiratory infections. Curr Med Res Opin. 2006;22(10):1997-2006.
  81. Medication guide Levaquin. Available at: www.fda.gov/safety/medwatch/safetyinformation/ ucm303865.htm. Accessed: 25.08.2021.
  82. Tillotson G, Ball P Fluoroquinolone safety profiles - A review. Today's Therapeutic Trends. 2002;20(4):419-35.
  83. Lipsky BA, Baker CA. Fluoroquinolone toxicity profiles: a review focusing on new agents. Clin Infect Dis. 1999;28(2):352-64.
  84. Highlights of prescribing information. Available at: www.accessdata.fda.gov/drugsatfda_docs/lab el/2016/020634s067,020635s073,021721s034lbl.pdf. Accessed: 25.08.2021.
  85. Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19). Версия 11 (07.05.2021). Временные методические рекомендации. Режим доступа: www.minzdrav.gov.ru. Ссылка активна на 25.08.2021

Copyright (c) 2021 Consilium Medicum

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies