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

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.