Evaluation of therapeutic similarity of generic levofloxacin in lower respiratory tract infections
https://doi.org/10.18093/0869-0189-2008-0-1-93-100
Abstract
This study was aimed to compare clinical and bacteriological efficacy and tolerability of generic levofloxacin (Levoxin®, Shreya Life Sciences) and original levofloxacin (Tavanic®, sanofi-aventis) in patients admitted for communityacquired pneumonia (CAP) or exacerbation of COPD. This open comparative nonrandomized prospective study involved 40 patients with CAP (mean age, 44 ± 13 yrs) and 40 patients with exacerbation of COPD (mean age, 63 ± 7 yrs, smoking history, 38 ± 10 packyrs). Both levofloxacin (L) medications were given 500 mg daily for 7 days or 750 mg daily for 10 days if P. aeruginosa was isolated. Clinical and microbiological efficacy and tolerability were assessed in 3, 7 and 10 days of the antibac terial therapy. To the end of the therapy, clinical efficacy in CAP patients was 95 % for both drugs. Bacteriological efficacy was 91.6 % in generic L group and 90.9 % in original L group. Tolerability of L was good or excellent in 90 % of pneumonia patients. In COPD patients, clinical efficacy was 95 % in both the groups to the end of the study. Bacteriological efficacy in COPD exacerbations was 75 % for generic L and 81.8 % for original L. Complete eradication of S. pneumoniae was reached in 100 % of cases. Generic L was welltolerated or excellently tolerated in 95 % of COPD patients and original L was welltolerated or excellently tolerated in 100 % of COPD patients. Adverse events were rare, mild and transitional.
About the Authors
A. G. Chuchalin
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
S. N. Avdeev
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
N. A. Tsareva
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
G. E. Baymakanova
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
P. A. Zubairova
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
References
1. Tremolieres F. Epidemiologie microbienne des infections respiratoires basses actualites. Medecine et maladies infectieuses 2006; 36: 546–554.
2. Huchon G., Woodhead M. Management of adult community-acquired lower respiratory tract infections. Eur. Respir. Rev. 1998; 8: 391–426.
3. Чучалин А.Г., Синопальников А.И., Страчунский Л.С. и др. Внебольничная пневмония у взрослых: практические рекомендации по диагностике, лечению и профилактике. М.: издательский дом "М-Вести"; 2006.
4. Mandell L.A., Wunderink R.G., 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: S27–S72.
5. Woodhead M. Community acquired pneumonia in Europe: causative pathogens and resistance patterns. Eur. Respir. J. 2002; 20: 20s–27s.
6. Global initiative for chronic obstructive lung disease (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO workshop report. Last updated 2007. www.goldcopd.org/.
7. Seemungal T.A.R., Donaldson G.C., Paul E.A. et al. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med.1998; 151: 1418–1422.
8. Donaldson G.C., Seemungal T.A.R., Bhowmik A., Wedzicha J.A. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57: 847–852.
9. Zielinski J., MacNee W., Wedzicha J. et al. Causes of death in patients with COPD and chronic respiratory failure. Monaldi Arch. Chest Dis. 1997; 52: 43–47.
10. Ewig S., Rodriguez)Roisin R., Torres A. Indications for and choice of antibiotics in COPD. In: Similowski T., Whitelaw W.A., Derenne J.-P., eds. Clinical management of chronic obstructive pulmonary disease. New York: Marcel Dekker Inc, 2002. 427–449.
11. Soler N., Torres A., Ewig S. et al. Bronchial microbial patterns in severe exacerbations of chronic obstructive pulmonary disease requiring mechanical ventilation. Am. J. Respir. Crit. Care Med. 1998; 157: 1498–1505.
12. Авдеев С.Н., Шанина А.Г., Чучалин А.Г. Бактериальная инфекция у больных ХОБЛ с острой дыхательной недостаточностью. Клин. микробиол. антимикр. химиотер. 2005; 7 (3): 245–254.
13. Ortqvist A. Treatment of community-acquired lower respiratory tract infections in adults. Eur. Respir. J. 2002; 20 (suppl. 36): 40s–53s.
14. O'Donnell J.A., Gelone S.P. The newer fluoroquinolones.
15. Infect. Dis. Clin. N. Am. 2004; 18: 691–716.
16. Greenberg R.N. Overview of patient compliance with medication dosing: a literature review. Clin. Ther. 1994; 6: 592–599.
17. Чучалин А.Г., Синопальников А.И., Фесенко О.В. Результаты открытого нерандомизированного несравнительного исследования эффективности и безопасности левофлоксацина при внебольничной пневмонии и обострении хронического бронхита. Пульмонология 2002; 4: 71–78.
18. The rules governing medicinal products in the European Union. Investigation of Bioavailability and Bioequivalence, 3C; 1998: 231–244.
19. Anthonisen N.R., Manfreda J., Warren C.P.W. et al. Antibiotic therapy in acute exacerbations of chronic obstructive pulmonary disease. Ann. Intern. Med. 1987; 106: 196–204.
20. Beam T.R. Jr., Gilbert D.N., Kunin C.M., eds. European gudelines for clinical evalution of anti-infective drug products, 1993. Пер. с англ. Смоленск: Амипресс; 1996; cc. 320.
21. Murray P.R., Washington J.A. Microscopic and bacteriologic analysis of expectorated sputum. Mayo Clin. Proc. 1975; 50: 339–344.
22. Miravitlles M., Espinosa C., Fernandez)Laso E. et al. Relationship between bacterial flora in sputum and functional impairment in patients with acute exacerbations of COPD. Study Group of Bacterial Infection in COPD. Chest 1999; 116: 40–46.
23. National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing (Vol 17). Philadelphia, PA: NCCLS, 1997; 1: M57–M100.
24. Fine M.J., Auble T.E., Yealy D.M. et al. A prediction rule to identify low-risk patients with community-acquired pneumonia. N. Engl. J. Med. 1997; 336: 243–250.
Review
For citations:
Chuchalin A.G., Avdeev S.N., Tsareva N.A., Baymakanova G.E., Zubairova P.A. Evaluation of therapeutic similarity of generic levofloxacin in lower respiratory tract infections. PULMONOLOGIYA. 2008;(1):93-100. (In Russ.) https://doi.org/10.18093/0869-0189-2008-0-1-93-100
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