Safety and Efficacy of Balofox (Balofloxacin) in the Treatment of Uncomplicated Urinary Tract Infections in Adults (BUTA Study).
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Date
2012-04
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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.
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Keywords
balofloxacin, urinary tract infections, efficacy, safety
Citation
Naik Manoj, Khandeparkar Prashant, Nair Saritha. Safety and Efficacy of Balofox (Balofloxacin) in the Treatment of Uncomplicated Urinary Tract Infections in Adults (BUTA Study). Indian Medical Gazette. 2012 Apr ; 145 (4): 156-158.