Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI)

Alexander Chuchalin, Maryna Zakharova, Dejan Dokic, Mahir Tokić, Hans-Peter Marschall, Thomas Petri, Alexander Chuchalin, Maryna Zakharova, Dejan Dokic, Mahir Tokić, Hans-Peter Marschall, Thomas Petri

Abstract

Background: Acute exacerbations of chronic bronchitis (AECB), including chronic obstructive pulmonary disease (AECOPD), represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®), although moxifloxacin is widely approved in this region based on evidence from international clinical studies.

Methods: AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs) was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected.

Results: In the efficacy population (N = 2536), chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily) was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I) was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672), 57 (2.3%) patients had treatment-emergent adverse events (TEAEs) and 4 (0.15%) had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin.

Conclusions: A significant number of patients in this observational study had risk factors for poor outcome, justifying use of moxifloxacin. The safety profile of moxifloxacin and its value as an antibiotic treatment were confirmed. Physicians complied with the recommended 400 mg once-daily dose in a large proportion of patients, confirming the advantages of this simple dosing regimen.

Trial registration: ClinicalTrials.gov identifier: NCT00846911.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Cumulative increase in proportion of symptom-free patients during moxifloxacin treatment.

References

    1. Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008;178(4):332–338. doi: 10.1164/rccm.200712-1869OC.
    1. Doll H, Miravitlles M. Health-related QOL in acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease: a review of the literature. PharmacoEconomics. 2005;23(4):345–363. doi: 10.2165/00019053-200523040-00005.
    1. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57(10):847–852. doi: 10.1136/thorax.57.10.847.
    1. Kanner RE, Anthonisen NR, Connett JE. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med. 2001;164(3):358–364.
    1. Nicolson P, Anderson P. The patient’s burden: physical and psychological effects of acute exacerbations of chronic bronchitis. J Antimicrob Chemother. 2000;45:25–32. doi: 10.1093/jac/45.suppl_2.25.
    1. Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;157(5 Pt 1):1418–1422.
    1. Soler-Cataluna JJ, Martinez-Garcia MA, Roman SP, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60(11):925–931. doi: 10.1136/thx.2005.040527.
    1. Spencer S, Jones PW. Time course of recovery of health status following an infective exacerbation of chronic bronchitis. Thorax. 2003;58(7):589–593. doi: 10.1136/thorax.58.7.589.
    1. Sethi S. Infectious etiology of acute exacerbations of chronic bronchitis. Chest. 2000;117(5 Suppl 2):380S–385S.
    1. Global Initative for Chronic Obstructive Lung Disease (GOLD) Global Strategy for the Diagnosis, Management and Prevention of COPD. 2010. Available at: . Accessed November 1, 2011.
    1. O’Donnell DE, Hernandez P, Kaplan A, Aaron S, Bourbeau J, Marciniuk D, Balter M, Ford G, Gervais A, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care. Can Respir J. 2008;15(Suppl A):1A–8A.
    1. Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ. Guidelines for the management of adult lower respiratory tract infections–full version. Clin Microbiol Infect. 2011;17(Suppl 6):E1–E59.
    1. Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106(2):196–204.
    1. Burkhardt O, Welte T. 10 years’ experience with the pneumococcal quinolone moxifloxacin. Expert Rev Anti Infect Ther. 2009;7(6):645–668. doi: 10.1586/eri.09.46.
    1. Chodosh S, DeAbate CA, Haverstock D, Aneiro L, Church D. Short-course moxifloxacin therapy for treatment of acute bacterial exacerbations of chronic bronchitis.The bronchitis study group. Respir Med. 2000;94(1):18–27. doi: 10.1053/rmed.1999.0708.
    1. Miravitlles M, Molina J, Brosa M. Clinical efficacy of moxifloxacin in the treatment of exacerbations of chronic bronchitis: a systematic review and meta-analysis [in Spanish] Arch Bronconeumol. 2007;43(1):22–28.
    1. Wilson R, Kubin R, Ballin I, Deppermann KM, Bassaris HP, Leophonte P, Schreurs AJ, Torres A, Sommerauer B. Five day moxifloxacin therapy compared with 7 day clarithromycin therapy for the treatment of acute exacerbations of chronic bronchitis. J Antimicrob Chemother. 1999;44(4):501–513. doi: 10.1093/jac/44.4.501.
    1. Miravitlles M. Moxifloxacin: an antibiotic designed for use in the community. Eur Respir Rev. 2000;10:161–169.
    1. 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 fibre-optic bronchoscopy. J Antimicrob Chemother. 1999;44(6):835–838. doi: 10.1093/jac/44.6.835.
    1. Krasemann C, Meyer J, Springsklee M. Moxifloxacin (MFX) in acute exacerbations of chronic bronchitis (AECB): a bacteriological and clinical meta-analysis [abstract] Program and abstracts of the 9th European Congress of Clinical Microbiology and Infectious Diseases; 1999. Abstract P203.
    1. Miravitlles M. Moxifloxacin in respiratory tract infections. Expert Opin Pharmacother. 2005;6(2):283–293. doi: 10.1517/14656566.6.2.283.
    1. Wilson R, Allegra L, Huchon G, Izquierdo JL, Jones P, Schaberg T, Sagnier PP. Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis. Chest. 2004;125(3):953–964. doi: 10.1378/chest.125.3.953.
    1. Miravitlles M. Moxifloxacin in the management of exacerbations of chronic bronchitis and COPD. Int J Chron Obstruct Pulmon Dis. 2007;2(3):191–204.
    1. Wilson R, Jones P, Schaberg T, Arvis P, Duprat-Lomon I, Sagnier PP. Antibiotic treatment and factors influencing short and long term outcomes of acute exacerbations of chronic bronchitis. Thorax. 2006;61(4):337–342. doi: 10.1136/thx.2005.045930.
    1. Wilson R, Anzueto A, Miravitlles M, Arvis P, Alder J, Haverstock D, Trajanovic M, Sethi S. Moxifloxacin vs amoxicillin/clavulanic acid in outpatient AECOPD: MAESTRAL results. Eur Respir J. 2012. Epub ahead of print.
    1. Miravitlles M, Llor C, Molina J, Naberan K, Cots JM, Ros F. Antibiotic treatment of exacerbations of COPD in general practice: long-term impact on health-related quality of life. Int J Chron Obstruct Pulmon Dis. 2010;5:11–19.
    1. Llor C, Sierra N, Hernandez S, Moragas A, Hernandez M, Bayona C, Miravitlles M. The higher the number of daily doses of antibiotic treatment in lower respiratory tract infection the worse the compliance. J Antimicrob Chemother. 2009;63(2):396–399.
    1. Simoens S, Decramer M. A pharmacoeconomic review of the management of respiratory tract infections with moxifloxacin. Expert Opin Pharmacother. 2008;9(10):1735–1744. doi: 10.1517/14656566.9.10.1735.
    1. Miravitlles M, Anzueto A, Ewig S, Legnani D, Stauch K. Characterisation of exacerbations of chronic bronchitis and COPD in Europe: the GIANT study. Ther Adv Respir Dis. 2009;3(6):267–277. doi: 10.1177/1753465809352791.
    1. Merck. AVELOX® (moxifloxacin hydrochloride) US prescribing information. 2011. Available at: .Accessed January 25, 2012.
    1. Miravitlles M, Zalacain R, Murio C, Ferrer M, Alvarez-Sala JL, Masa JF, Verea H, Ros F, Vidal R. Speed of recovery from acute exacerbations of chronic obstructive pulmonary disease after treatment with antimicrobials: results of a two-year study. Clin Drug Investig. 2003;23(7):439–450. doi: 10.2165/00044011-200323070-00003.
    1. Miravitlles M, Torres A. Antibiotics in exacerbations of COPD: lessons from the past. Eur Respir J. 2004;24(6):896–897. doi: 10.1183/09031936.04.00099004.
    1. Kreis SR, Herrera N, Golzar N. A comparison of moxifloxacin and azithromycin in the treatment of acute exacerbations of chronic bronchitis. J Clin Outcomes Manage. 2000;7(12):33–37.
    1. Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010;11:10. doi: 10.1186/1465-9921-11-10.
    1. Ball P, Stahlmann R, Kubin R, Choudhri S, Owens R. Safety profile of oral and intravenous moxifloxacin: cumulative data from clinical trials and postmarketing studies. Clin Ther. 2004;26(7):940–950. doi: 10.1016/S0149-2918(04)90170-1.
    1. Van Bambeke F, Tulkens PM. Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes. Drug Saf. 2009;32(5):359–378. doi: 10.2165/00002018-200932050-00001.
    1. Behrendt CE. Mild and moderate-to-severe COPD in nonsmokers: distinct demographic profiles. Chest. 2005;128(3):1239–1244. doi: 10.1378/chest.128.3.1239.
    1. Birring SS, Brightling CE, Bradding P, Entwisle JJ, Vara DD, Grigg J, Wardlaw AJ, Pavord ID. Clinical, radiologic, and induced sputum features of chronic obstructive pulmonary disease in nonsmokers: a descriptive study. Am J Respir Crit Care Med. 2002;166(8):1078–1083. doi: 10.1164/rccm.200203-245OC.
    1. Pena VS, Miravitlles M, Gabriel R, Jimenez-Ruiz CA, Villasante C, Masa JF, Viejo JL, Fernandez-Fau L. Geographic variations in prevalence and underdiagnosis of COPD: results of the IBERPOC multicentre epidemiological study. Chest. 2000;118(4):981–989. doi: 10.1378/chest.118.4.981.
    1. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007;370(9589):765–773. doi: 10.1016/S0140-6736(07)61380-4.
    1. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312(7040):1215–1218. doi: 10.1136/bmj.312.7040.1215.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel