Vol.60 No.5 September 2012

Efficacy and safety of levofloxacin 500 mg once a day in patients with urogenital infection

Kazuhiro Uchino¹⁾, Hiroki Yamaguchi¹⁾, Takuyuki Matsumoto¹⁾, Kyoko Kuroyanagi¹⁾, Megumi Takahashi¹⁾, Hiroko Kodama¹⁾, Satoko Hamajima¹⁾, Rie Yonemochi²⁾, Fumiaki Kobayashi³⁾, Naoki Yamanouchi³⁾, Tomoo Shiozawa¹⁾ and Yukihiro Okutani¹⁾

¹⁾Post Marketing Studies Management Department, Daiichi Sankyo Company, Limited, 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
²⁾Pharmacovigilance Department, Daiichi Sankyo Company, Limited
³⁾Clinical Data and Biostatistics Department, Daiichi Sankyo Company, Limited

Abstract

A use-result survey of the oral administration of levofloxacin (LVFX) 500 mg once-daily was conducted between October 2009 and September 2010 on 32,200 patients. Among these patients, we studied the efficacy and safety of LVFX in 9,049 patients with urinary tract and sexually transmitted infections (cystitis, pyelonephritis, prostatitis, epididymitis and urethritis).
The efficacy rate in total urinary tract and sexually transmitted infections was 95.7% (8,026/8,386 patients). The efficacy rates by the type of infection were: cystitis, 96.4% (6,080/6,309 patients); pyelonephritis, 95.2% (750/788 patients); prostatitis, 94.3% (617/654 patients); epididymitis, 94.6% (141/149 patients); and urethritis, 90.1% (438/486 patients).
The bacterial eradication rate was 94.2% (1,884/2,001 isolates). The eradication rates of major bacteria by pathogen type were; Escherichia coli 95.7% (1,099/1,148 isolates), Enterococcus faecalis 89.6% (95/106 isolates), Klebsiella pneumoniae 100% (71/71 isolates), and Chlamydia trachomatis 92.0% (46/50 isolates).
The overall incidence of side effects was 1.56% with a range of 0.66-2.75% dependent on the type of infection. Major side effects were gastrointestinal disorders including nausea and vomiting (61 patients, 0.72%), neurological disorders including dizziness and somnolence (19 patients, 0.22%) and abnormal laboratory values such as increased AST or ALT (17 patients, 0.20%).
In conclusion, it was confirmed that the oral administration of levofloxacin 500 mg once-daily was highly useful for urinary tract and sexually transmitted infections due to demonstrably excellent therapeutic effects on both types of infections and lack of safety profile issues.

Key word

levofloxacin, postmarketing surveillance, urinary tract infection, genitals infection

Received

June 18, 2012

Accepted

July 18, 2012

Jpn. J. Chemother. 60 (5): 580-591, 2012