Vol.60 No.2 March 2012

Safety and efficacy of levofloxacin 500 mg once a day in patients with otological infections

Kazuhiro Uchino¹⁾, Hiroki Yamaguchi¹⁾, Takuyuki Matsumoto¹⁾, Kyoko Kuroyanagi¹⁾, Sanae Yoshida¹⁾, Megumi Takahashi¹⁾, Hiroko Kodama¹⁾, Satoko Hamajima¹⁾, Rie Yonemochi²⁾, Fumiaki Kobayashi³⁾, Naoki Yamanouchi³⁾, Tadamichi Suzuki²⁾, Tomoo Shiozawa¹⁾ and Fumie Yamaguchi¹⁾

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

We performed a subgroup analysis to evaluate the efficacy and safety of oral levofloxacin (LVFX) in patients with otological infections (otitis media, otitis externa, sinusitis, and suppurative sialadenitis)(n=2,679), who were extracted from subjects (n=52,200) of a postmarketing surveillance of LVFX 500 mg once daily conducted from October 2009 to September 2010.
The incidence of adverse reactions in overall patients with otological infections was 1.87% (46/2,454 patients). The most commonly-reported adverse reaction was gastrointestinal disorders (e.g., diarrhea and nausea) reported in 23 patients (0.94%), followed by skin and subcutaneous tissue discords (e.g. skin rashes and pruritus) in 8 patients (0.33%) and psychiatric disorder (e.g., insomnia) in 5 patients (0.20%). No serious adverse reaction was observed.
Stratified analysis by the type of infections showed the incidence of adverse reactions to be 0% (0/123) for patients with otitis externa, 1.23% (6/486) for patients with otitis media, 2.03% (36/1,770) for patients with sinusitis, and 5.33% (4/75) for patients with suppurative sialadenitis.
The clinical efficacy rate for overall otological infections was 94.7% (2,305/2,435 patients). Stratified analysis by the type of infections showed the clinical efficacy rate to be 96.7% (119/123) for patients with otitis externa, 92.3% (445/482) for patients with otitis media, 95.1% (1,669/1,755) for patients with sinusitis, and 96.0% (72/75) for patients with suppurative sialadenitis.
The most common bacterial species among the pathogenic isolates was Staphylococcus sp. (49.0%), followed by Streptococcus pneumoniae(14.7%), Pseudomonas aeruginosa(11.7%), and Haemophilus influenzae(9.0%). The eradication rate for the overall clinical isolates was 94.0% (282/300 isolates). Analysis by the bacterial species (among the common pathogenic isolates) showed the eradication rate to be 92.5% (136/147 isolates) for Staphylococcus sp., 95.5% (42/44 isolates) for S. pneumoniae, and 100% (27/27 isolates) for H. influenzae. These bacterial eradication rates were consistent with the clinical efficacy rates stratified by the species of pathogenic microorganisms detected.
The above results indicate that oral 500-mg once-daily dosage of LVFX can be safely used also for the treatment of otological infections and achieved clinical efficacy rates of more than 90% for all otitis externa, otitis media, sinusitis, and suppurative sialadenitis cases. Thus, based on the excellent bacterial eradication rates and clinical efficacy rates by the species of pathogenic isolates, the oral 500-mg once-daily dosage of LVFX was confirmed to be a useful regimen of antimicrobial medication for patients with otological infections.

Key word

levofloxacin, safety, efficacy, postmarketing surveillance, otological infections

Received

January 17, 2012

Accepted

January 23, 2012

Jpn. J. Chemother. 60 (2): 175-187, 2012