Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

• Published in: Japanese Journal of Chemotherapy Vol. 45; no. 6; pp. 425 - 441
• Main Author: Kobayashi, Hiroyuki
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 1997; 公益社団法人 日本化学療法学会
• Subjects: grepanoxadn; ofloxacin; OPC-17116; 慢性気道感染症; 用量比較試験
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.45.425

A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200mg q. d.(Group L) were compared with GPFX 300mg q. d.(Group H) by the double-blindmethod, and each dose of GPFX was compared with open-label treatment with OFLX 200mg t. i. d.(Group O). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group O) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2%(33/37), 97.6%(40/41), and 88.4%(38/43) in Groups L, H, and O, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0%(15/20), 93.3%(14/15), and 85.7%(18/21) in Groups L, H, and O, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and O, the incidence of adverse reactions was 2.6%(1/39), 7.3%(3/41) and 9.1%(4/44), respectively, and the incidence of abnormal laboratory findings was 5.1%(2/39), 5.1%(2/39), and 4.9%(2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5%(32/37), 94.9%(37/39), and 85.4%(35/41) in Groups L, H, and O, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.