Clinical efficacy and tolerability of levofloxacin in patients with liver disease: a prospective, non comparative, observational study.

The aim of this open, non comparative, observational study was to assess the clinical and bacteriological efficacy, the tolerability and safety of levofloxacin for treatment of concurrent bacterial infections in patients with chronic liver disease. Overall, 40 patients (inpatients or outpatients) were recruited to the study (28 with UTI, 6 with pneumonia, and 6 with spontaneous bacterial peritonitis (SBP)). Patients affected by UTI received 250 mg oral levofloxacin once daily for five days; patients with pneumonia or SBP underwent a 10/14-day therapeutic oral regimen with 500 mg b.i.d. Clinical evaluation and possible side effects were monitored daily both in out- and in-patients. For all patients, laboratory tests were performed at baseline and 3-4 days after the end of therapy in order to evaluate levofloxacin tolerability. Statistical analysis was performed by means of Student's t test to show differences between cases; all values are reported as means and standard deviations and p values were considered as significant when p<0.05. After treatment, clinical cure and bacteriological eradication were achieved in all patients (40/40; 100%). Adverse events, mainly gastrointestinal disturbances (e.g. nausea), were observed in 5 out of 40 patients (12.5%) and no neurotoxic effects were registered (e.g. anxiety, hallucinations, convulsions, mental confusion). No significant variation in laboratory tests due to hematic crasis and/or hepatic and renal disorders was observed. Levofloxacin proved to be highly efficacious and safe in the treatment of bacterial infections in patients affected by liver disease.