To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Once-Daily Oral Levofloxacin Effective and Safe in Patients With Chronic Bacterial Prostatitis: Presented at ECCMID URL: http://www.pslgroup.com/dg/22003E.htm Doctor's Guide April 24, 2008
By Chris Berrie BARCELONA, Spain -- April 24, 2008 -- Once-daily oral dosing of the fluoroquinolone levofloxacin is well tolerated and clinically and microbiologically effective for patients with chronic bacterial prostatitis (CBP), according to findings from an international, multicentre, open, noncomparative study. The study was presented here on April 21 at the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Chronic prostatitis is one of the most common urological conditions in men aged >50 years, and although a causative organism is generally identified in a small proportion of cases, a link to bacterial infection has been suggested. Levofloxacin is active against a relatively wide spectrum of Gram-negative and Gram-positive bacteria and has demonstrated efficacy in the treatment of complicated urinary tract infections. Kurt G. Naber, MD, PhD, Professor in Urology, Technical University of Munich, Straubing, Germany, and colleagues conducted their study to provide further data on the safety and efficacy of levofloxacin in the treatment of CBP. The study enrolled men aged 18 years or older with clinical diagnosis of current prostatitis, along with leucocyturia, and laboratory evidence of prostatitis. Clinical evaluations were carried out at baseline (1-7 days pretreatment), during treatment, and 6 months post-treatment. Microbiological evaluations were carried out at baseline, at 1 month, and at 6 months post-treatment. The primary analysis variable was microbial eradication in the microbiologically evaluable per-protocol (PP) patient population at 1 month post-treatment. The secondary endpoints included microbiological eradication at 6 months post-treatment in the PP and clinical success or relapse during the post-treatment period in the intention-to-treat (ITT) patient population. All patients received treatment with oral levofloxacin 500 mg once daily for 28 days. General patient characteristics at baseline were mean height of 1.77 m, weight of 81.5 kg, and body mass index of 26.0 kg/m2. In the evaluation of the eradication rate, microbiological data were divided according to 4 classification schemes, using the same cut-off levels as in previous similar studies. At the end of treatment, the clinical success rate (cured and improved patients, with 95% confidence intervals) in the ITT patient population was 92%, with a gradual decline to 62% at the 6-month post-treatment evaluation. Over the 6 months post-treatment, the microbiological eradication rates across the 4 analysis schemes were high (80% or greater) and were maintained. Microbiological analyses over the first month post-treatment saw up to a 40% increase in new pathogens, although these were lost by 6 months post-treatment. Dr. Naber stressed, "What is unique is that we have a correlation between [minimum inhibitory concentrations] MIC and eradication of bacteria." There also were no significant differences between MIC distributions for eradicated and persistent/early recurrent bacteria (P = .142), while isolates from reinfections/superinfections did have a significant shift of MIC distribution (P = .005). Safety analysis showed a range of low-frequency adverse events (AEs) across the patient population, with 12.8% of patients reporting at least 1 AE, and 3.4% discontinuing treatment due to AEs. One patient experienced a serious AE (intestinal bleeding), but this was judged not judged to be caused by the study medication. "So for chronic bacterial prostatitis, levofloxacin 500 mg for 4 weeks is a good option, and it also has some advantages for dosage and for tolerance," Dr. Naber concluded. Funding for this study was provided by sanofi-aventis. [Presentation title: Levofloxacin 500 mg Once Daily Oral in the Treatment of Chronic Bacterial Prostatitis (CBP). Abstract P1540] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.