Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis

Abstract

Objective:

To compare the safety and efficacy of levofloxacin 750 mg QD for 2 weeks or levofloxacin 750 mg QD for 3 weeks to levofloxacin 500 mg QD for 4 weeks in treating chronic bacterial prostatitis (CBP).

Research design and methods:

This was a randomized, multicenter, double-blind, noninferiority study. The primary efficacy end point was investigator assessment of clinical success in the modified intent-to-treat (mITT) population at post-therapy. National Institutes of Health–Chronic Prostatitis Symptom Index (NIH-CPSI) scores were utilized to evaluate subject-reported responses post-therapy.

Results:

A total of 241 subjects were enrolled. At post-therapy (test of cure [TOC]), clinical success rates for levofloxacin-treated subjects (750 mg QD for 3 weeks [64.9%, 48/74]) were noninferior to 500 mg QD for 4 weeks (69.3%, 52/75: 95% CI, –19.5%, 10.6%). Success rates with levofloxacin 750 mg QD for 2 weeks (63.0%, 46/73) were not noninferior to therapy with levofloxacin 500 mg QD for 4 weeks (95% CI, −21.5%, 8.9%) at TOC. At 3 and 6 months post-therapy, clinical success rates were clinically higher for the 500-mg, 4-week treatment group, and statistical analysis demonstrated both groups were not noninferior to standard therapy with levofloxacin 500 mg (95% CI, −32.5%, −0.6% for both 750-mg groups at 6 months). NIH-CPSI scores showed similar trends. Overall, adverse event (AE) rates were similar for the three treatment groups; however, discontinuation of therapy due to AEs was higher with the 750-mg dose (p = 0.02, and p = 0.13 for 750 mg, 2 weeks and 750 mg, 3 weeks versus 500 mg for 4 weeks, respectively). The main limitation of this study was that no bacterial cultures were required.

Conclusions:

Higher doses for shorter durations were determined to be no worse than standard therapy with levofloxacin 500 mg for a longer duration at the TOC visit. However, at the 6-month follow-up visit, the levofloxacin 750-mg dose administered for either 2 weeks or 3 weeks was inferior to the standard therapy, suggesting that a longer duration of treatment may help extend the relapse-free interval in patients with CBP.

Clinical Trial Registration:

clinicaltrials.gov, nct00402688

Key words::

• Chronic bacterial prostatitis
• Fluoroquinolone
• Infection
• Levofloxacin

Transparency

Declaration of funding

Ortho-McNeil Janssen Scientific Affairs, LLC provided the financial support for this study.

Declaration of financial/other relationships

All coauthors have disclosed that they are employees of Ortho-McNeil Janssen Scientific Affairs, that they had access to study data, and that they participated in development of this manuscript. J.B.K. has disclosed that he is an employee of JBK Strategic Consultations, LLC, Philadelphia, PA, USA and has done consulting work for Ortho-McNeil Janssen Scientific Affairs.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors acknowledge writing and editorial assistance from Ira Mills, PhD and Craig Ornstein, PhD, of Embryon, LLC, A Division of Advanced Health Media, LLC (formerly Medesta Publications Group, A Business of Advogent).