Comparative study of efficacy and safety of garenoxacin and moxifloxacin in acute exacerbation of chronic bronchitis in COPD patients

Ajay Kumar Sinha; Bhavana Srivastava; Dinesh Chand Punera; Renu Khanchandani

doi:10.18203/2319-2003.ijbcp20180651

Authors

Ajay Kumar Sinha Department of Anaesthesiology, Govt. Medical College and Sushila Tiwari Hospital, Haldwani, Uttarakhand, India
Bhavana Srivastava Department of Pharmacology, Govt. Medical College and Sushila Tiwari Hospital, Haldwani, Uttarakhand, India
Dinesh Chand Punera Department of TB & Chest, Govt. Medical College and Sushila Tiwari Hospital, Haldwani, Uttarakhand, India
Renu Khanchandani Department of Pharmacology, Govt. Medical College and Sushila Tiwari Hospital, Haldwani, Uttarakhand, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20180651

Keywords:

COPD, Exacerbation, Garenoxacin, Moxifloxacin

Abstract

Background: Acute exacerbation of chronic bronchitis in COPD (AECB) is the major cause of morbidity, mortality and marked reduction in quality of life and imposes significant burden on both patients and healthcare systems. Bacterial infections causing AECB frequently require antibacterial treatment, so more evidences are needed to guide better antibiotic choice. Objective of the study was planned to compare efficacy and safety of Garenoxacin, a new fluoroquinolone versus moxifloxacin for treatment of Acute exacerbation of Chronic bronchitis in COPD patient.

Methods: This was a prospective open label comparative study done in department of pharmacology and T.B & Chest of Government Medical College attached Dr Shusila Tiwari Hospital, Haldwani. 60 subjects with clinical symptoms suggestive of Anthonisen type II AECOPD (any two of following criteria: Increased dyspnea, cough, sputum purulence) were enrolled and randomized to receive either Moxifloxacin 400 mg once daily for 7 days or Garenoxacin 400mg once daily for 7 days. The primary outcome measure was clinical success rate at day 7 visit. Secondary outcome measures were changes in clinical global impression (CGI) scales and incidence of adverse events.

Results: The mean age of patient was 60.98±9.9 years and 57.9±9.3 years in the Moxifloxacin and Garenoxacin groups. The clinical success rates were comparable with 86.2% in moxifloxacin group 84.6% and in garenoxacin group. Adverse effects were mild and self limiting. We observed two adverse effects in garenoxacin and three in moxifloxacin group.

Conclusions: The result of study showed that garenoxacin is comparable to moxifloxacin in terms of efficacy and safety.

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References

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary Disease (Revised 2011) [accessed on September 16, 2012]. Available at: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21

Celli BR, Vestibo J. The EXACT-Pro: measuring exacerbations of COPD. Am J Respir Crit Care Med. 2011;183:287-8.

Jindal SK, Aggarwal AN, Gupta D, Agarval R, Kumar R, Kaur T, et al. Indian study on epidemiology of asthma, respiratory symptoms and chronic bronchitis in adults (INSEARCH) Int J Tuberc Lung Dis. 2012;16:1270-7.

Barnes PJ. Chronic obstructive pulmonary disease. N Engl J Med. 2000;343:269-80.

Reilly JJ, Silverman EK, Shapiro SD. Chronic obstructive pulmonary disease. In: Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL, editors. Harrison’s principles of internal medicine. 17th Ed. Vol. New York: MacGraw-Hill; 2008:1653-1643.

Jivcu C, Gotfried M. Gemifloxacin use in the treatment of acute bacterial exacerbation of chronic bronchitis. Int J Chron Obstruct Pulmon Dis. 2009;4:291-300.

Massimo G, Francesco B, Ido I, Antonino M, Francesco S, Cecilia P, et al. Prulifloxacin vs Levofloxacin for Exacerbation of COPD after Failure of Other Antibiotics. Journal of Chronic Obstructive Pulmonary Disease. 2016.

Wilson R, Allegra L, Huchon G, Izquierdo JL, Jones P, Schaberg T, et al. MOSAIC Study Group: Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis. Chest. 2004;125:953-64.

Miravitlles M, Marin A, Monso E, Vilà S, de la Roza C, Hervás R, et al. Efficacy of moxifloxacin in the treatment of bronchial colonization in COPD. Eur Respir J. 2009;34:1066-71.

Takagi H, Tanakab K, Tsuda H, Kobayashid H. Clinical studies of garenoxacin. International Journal of Antimicrobial Agents. 2008;32(6):468-74.

Anthonisen NR, Manfreda J, Warren CPW, Hershfield ES, Harding GKM, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106:196-204.

Edwards R, Aronson JK. Adverse Drug Reactions: Definitions, diagnosis and management. Lancet. 2000;356:1255-9.

Dimopoulos G, Siempos II, Korbila IP, Manta KG, Falagas ME. Comparison of first-line with second-line antibiotics for acute exacerbations of chronic bronchitis: a metanalysis of randomized controlled trials. Chest. 2007;132:447-55.

Sachs APE, Koeter GH, Groenier KH, Waaij van der D, Schiphuis J, Jong BMD. Changes in symptoms, peak expiratory flow, and sputum flora during treatment with antibiotics of exacerbations in patients with chronic obstructive pulmonary disease in general practice. Thorax. 1995;50:758-63.

Jorgensen AF, Coolidge J, Pedersen PA, Petersen KP, Waldorff S, Widding E. Amoxicillin in treatment of acute uncomplicated exacerbations of chronic bronchitis. A double-blind, placebo-controlled multicentre study in general practice. Scand J Prim Health Care. 1992;10:7-11.

Wilson R, Schentag JJ, Ball P, Mandell L. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes. Clin Ther. 2002;24:639-52.

Wilson R, Allegra L, Huchon G, Izquierdo JL, Jones P, Schaberg T, et al. Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis. Chest. 2004;125:953-64.

Comparative activity of quinolones (ciprofloxacin, levofloxacin, moxifloxacin and garenoxacin) against extracellular and intracellular infection by Listeria monocytogenes and Staphylococcus aureus in J774 macrophages. C. Seral†, M. Barcia-Macay, M. P. Mingeot-Leclercq, P. M. Tulkens and F. Van Bambeke. Journal of Antimicrobial Chemotherapy. 2005;55:511-7.

Rodriguez-Cerrato V, McCoig CC, Saavedra J, Barton T. Garenoxacin (BMS-284756) and Moxifloxacin in Experimental Meningitis Caused by Vancomycin-Tolerant Pneumococci Antimicrob. Agents Chemother. January 2003;47(1):211-5.

Urueta-Robledo J, Ariza H, Jardim JR. Moxifloxacin versus levofloxacin against acute exacerbations of chronic bronchitis: the Latin American Cohort. Respir Med. 2006;100(9):1504-11.