A COMPARATIVE STUDY TO EVALUATE EFFICACY, SAFETY AND COST EFFECTIVENESS BETWEEN ORAL BALOFLOXACIN VS. ORAL LEVOFLOXACIN IN PATIENTS OF ACUTE, UNCOMPLICATED URINARY TRACT INFECTION ATTENDING C. U. SHAH MEDICAL COLLEGE, SURENDRANAGAR

Objectives: To compare the efficacy, safety and cost effectiveness between oral Balofloxacin and oral Levofloxacin in acute uncomplicated urinary tract infections. Methods: Total 130 patients were enrolled for the study, out of them 119 patients completed the study. Patients were divided into two groups randomly; 63 patients received Balofloxacin 100 mg BID orally and 56 patients received Levofloxacin 500 mg orally OD for 5 days. Baseline evaluation of clinical features and urine culture was performed for isolation of causative organism. After 5 days on completion of therapy above parameters were repeated and compared. Analysis of reported adverse drug reactions (ADRs) and cost effectiveness was carried out. Results: After completion of treatment clinical evaluation showed Cure rate was 82.54% and 85.71%, while Effective rate was 96.83% and 98.21% for Balofloxacin and Levofloxacin group patients respectively. Bacteriological evaluation revealed that bacteriological clearance rate for Balofloxacin and Levofloxacin was 94.91% and 98.11% respectively. There was no statistical difference between both drugs for clinical and bacteriological cure (p > 0.05). ADRs reported were nausea, vomiting, abdominal distension, skin rashes and QT prolongation, with incidence rate of 3.17% and 16.07% for Balofloxacin and Levofloxacin respectively, which was statistically significant (p < 0.05). Cost effective analysis revealed that incremental Cost (ΔC) was Rs 30 and incremental effectiveness (ΔE) was -1%, which indicates that Levofloxacin is more cost effective as compared to Balofloxacin. Conclusion: Balofloxacin is as efficacious as and safer than Levofloxacin, while Levofloxacin is more cost effective for the treatment of acute uncomplicated urinary tract infections.