Vol.59 No.6 November 2011

Clinical response of levofloxacin 500 mg qd to urogenital infection (in compliance with the new guidelines) and examination of penetration into the prostatic tissues

Mitsuru Yasuda¹⁾, Soichi Arakawa²⁾, Satoshi Ishihara³⁾, Shin Ito⁴⁾, Koji Hikosaka⁵⁾, Kenji Minayoshi⁶⁾, Shoji Hara⁷⁾, Kenji Ito⁸⁾, Shuichi Kawai⁹⁾, Hirofumi Nishimura¹⁰⁾, Sadaaki Sakamoto¹¹⁾, Koichi Takahashi¹²⁾, Masato Fujisawa²⁾, Takashi Deguchi¹⁾ and Tetsuro Matsumoto¹³⁾

¹⁾Department of Urology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Japan
²⁾Division of Urology, Department of Surgery Related, Kobe University Graduate School of Medicine
³⁾Department of Urology, Kizawa Memorial Hospital
⁴⁾Ai Clinic
⁵⁾Department of Urology, Hikosaka Hospital
⁶⁾Department of Urology, Shakaihoken Kobe Central Hospital
⁷⁾Hara Genitourinary Hospital
⁸⁾Ito Urology Clinic
⁹⁾Kawai Urology Clinic
¹⁰⁾Nishimura Urology Clinic
¹¹⁾Department of Urology, Keiaikai Nakamura Hospital
¹²⁾Department of Urology, Fukuoka Shin Mizumaki Hospital
¹³⁾Department of Urology, University of Occupational and Environmental Health

Abstract

We conducted a post-marketing clinical study to evaluate the clinical efficacy and safety of 500 mg of levofloxacin (LVFX, Cravit^®) once daily (qd) in patients with urogenital infection, as well as another post-marketing clinical study to examine the penetration into prostatic tissues when a single 500 mg dose of LVFX was administered.
The clinical study on urogenital infection was conducted in patients with acute uncomplicated cystitis, complicated cystitis, non-gonococcal urethritis (chlamydial), acute bacteriological prostatitis or acute epididymitis (bacteriological or chlamydial). The dosage of LVFX was 500 mg once daily, and the treatment duration was 3 days, 7 days or 14 days, depending on the disease. The clinical efficacy was evaluated in accordance with Guidelines of conducting clinical studies concerning urogenital infection. In order to examine the penetration of LVFX into prostatic tissues, we selected specific patients who had been scheduled for trans-urethral resection of the prostrate due to benign prostatic hypertrophy. They received a single 500 mg dose of LVFX orally before the surgery, and the concentration of LVFX in prostatic tissues and plasma was measured.
In the clinical study on urogenital infection, the primary endpoint was set as the efficacy rate at 5 to 9 days (bacteriological disease) or 2 to 4 weeks (chlamydial disease) after completion of treatment. The efficacy rate of each disease was as follows: acute uncomplicated cystitis, 97.4% (37/38); complicated cystitis, 82.9% (29/35); and non-gonococcal urethritis (chlamydial), 84.8% (28/33). Efficacy was shown in both of the two patients with acute bacteriological prostatitis and four out of five patients with acute epididymitis, including the patient with chlamydial epididymitis. The incidence of adverse drug reactions was 14.2% (20/141). No serious or severe adverse drug reactions were observed.
In the clinical study to examine the penetration of LVFX into the prostatic tissues, the ratio of LVFX concentration in prostatic tissues against that in plasma (mean±SD) was 1.16±0.26.
These results suggest that the administration of levofloxacin at a dose of 500 mg qd is useful in the treatment of urogenital infection and penetrates well into prostatic tissues.

Key word

levofloxacin, once daily dosing, urogenital infection, penetration, prostatic tissue

Received

August 23, 2011

Accepted

September 21, 2011

Jpn. J. Chemother. 59 (6): 585-596, 2011