Safety and Efficacy of Balofox (Balofloxacin) in the Treatment of Uncomplicated Urinary Tract Infections in Adults (BUTA Study).

ABSTRACT

Objective: To evaluate the safety and efficacy of Balofox (Balofloxacin) in the treatment of Uncomplicated Urinary Tract Infections in Adults. Design: Open, prospective, noncomparative, observational, multi-center, post-marketing study. Setting: 248 physicians across India in clinical and hospital settings. Patients A total of 3511 patients of either sex above 18 years of age with laboratory and/or clinical diagnosis of urinary tract infection were administered Balofox (Balofloxacin) orally two times daily for 5-7 days. Respiratory system abnormalities, cardiovascular abnormalities, nervous system abnormalities and abdominal symptoms were seen in 554 patients. Body temperature, abdominal pain and burning during micturation were recorded at baseline and then on days 2, 3, 4, 5 and 6. Global assessment was done by physician independently at the end of therapy on a 4-point Likert scale. Results: Of the 8063 patients enrolled in the study with, 6977 patients had urinary tract infection, but data of 3466 patients was excluded from analysis due to insufficient data and an intention-to-treat analysis done for efficacy on 3511 patients. The body temperature reduced from 102.12°F at baseline to 99.03°F on day 3 (p<0.0001), and upto 97.72 on day 6 (p<0.0001). The scores for abdominal pain and burning during micturation also significantly (p<0.05) reduced on days 2, 3, 5, & 6 from baseline. The commonly reported adverse events were nausea (5.95%), headache (1.85%), vomiting (1.77%), vertigo and giddiness (1.62%), hyperacidity (1.05%). For global assessment of response to therapy, more than 95% doctors reported the response to therapy as good. More than 90% of doctors reported the tolerability of the drug to be good. Conclusion: Balofox is safe and effective in the management of uncomplicated urinary tract infection in adults.