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Levofloxacin prophylaxis reduces the rate of infection compared with placebo and is well tolerated in elderly patients receiving docetaxel plus carboplatin.

The aim of this prospective observational study was to present relevant data on the efficacy and safety of levofloxacin in the treatment of chronic bacterial prostatitis (NIH-II) in the daily clinical routine of urologists in their practices. In total, 243 patients were treated, including 62 patients with a microbiologically confirmed diagnosis -based on expressed prostatic secretion (EPS). The current evaluation is based on these patients. Their median age was 53 years. The patients were treated with levofloxacin 500 mg / day for 29 days (median) which is in accordance to the -registered recommendation for this indication. Clinical symptoms were assessed using a standardised questionnaire. The clinical symptoms dysuria, painful ejaculation, perineal pain, urinary obstruction, increased urgency, prostate pain during palpation as well as CRP and number of leukocytes showed statistically significant improvements at the end of therapy with levofloxacin as compared to baseline. At the end of treatment 93.5 % (n = 58 / 62, 95 % confidence interval: 84.5 %-97.8 %) of the patients were cured or improved. The patients were able to resume their regular activities after 10 days (median). 93.5 % (n = 58 / 62) of the patients and 95.2 % (n = 59 / 62) of the doctors were satisfied or very satisfied with this treatment. In all 62 patients the diagnosis was microbiologically confirmed based on EPS. In 39 patients (62.9 %) E. coli was identified. At the end of therapy microbiological testing was performed in 62.9 % (n = 39 / 62) of the patients, in 29 cases including EPS. In 37 of these 39 patients (94.9 %) no pathogen was identified. In 2 cases (5.1 %) a pathogen was identified (Proteus mirabilis and Staphylococcus species). In 181 patients without microbiological confirmation -based on EPS comparable clinical results were found. In the total population of 243 patients 5 adverse drug reactions were reported in 3 patients (incidence 1.2 %, n = 3 / 243), The results of this study confirm the efficacy and safety of levofloxacin in the treatment of chronic bacterial prostatitis in daily clinical practice.

No abstract

Bioequivalence could be demonstrated in terms of rate and extent of absorption after administration of test and reference products under naltrexone protection. Concerning the safety evaluation, no negative implications on the possible use of the test formulation could be determined.