Vol.68 No.S-1 November 2020
Phase III double-blind comparative study of lascufloxacin versus levofloxacin in patients with sinusitis
1)Department of Otolaryngology, Head and Neck Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, Japan
2)Department of Otorhinolaryngology, Shimane University Faculty of Medicine
3)Department of Infecion Control, Jikei University Hospital
4)Department of Microbiology and Infectious Disease, Toho University School of Medicine
5)Department of Internal Medicine, Kita-tama Hospital
6)Clinical Development Center, Kyorin Pharmaceutical
7)Department of Otolaryngology, Yonaha General Hospital
Abstract
To investigate the efficacy and safety of lascufloxacin (LSFX), we conducted a phase III randomized double-blind comparative study, with levofloxacin (LVFX) as the control drug, in patients with acute sinusitis or acute exacerbation of chronic sinusitis. Subjects in the LSFX group received oral LSFX 75 mg once daily, and subjects in the LVFX group received oral LVFX 500 mg once daily. Both drugs were administered for 7 days.
The clinical efficacy rate at end of treatment (EOT), as the primary endpoint, was 84.8% [117/138 (95% CI: 77.9% to 89.8%)] in the LSFX group and 84.6% [110/130 (95% CI: 77.4% to 89.8%)] in the LVFX group. Non-inferiority of LSFX 75 mg to LVFX 500 mg was demonstrated. The recurrence rate on the 7th day after end of treatment was 4.5% (5/112) in the LSFX group and 5.6% (6/107) in the LVFX group. The microbiological efficacy by at the end of treatment was 92.3% (60/65) in the LSFX group and 95.5% (64/67) in the LVFX group. The microbiological efficacies (eradication rates) by the causative microorganisms were as follows: gram-positive bacteria: 100.0% (37/37) in the LSFX group and 97.2% (35/36) in the LVFX group; gram-negative bacteria: 91.4% (32/35) in the LSFX group and 93.8% (30/32) in the LVFX group; anaerobic bacteria: 83.3% (15/18) in the LSFX group and 100.0% (21/21) in the LVFX group. The incidences of adverse events and adverse drug reactions (ADRs) were 20.0% (28/140) and 5.7% (8/140) in the LSFX group, and 22.3% (31/139) and 10.1% (14/139) in the LVFX group, respectively. Among them, the incidences of gastrointestinal disorder as an ADR were 1 case with 1 event (0.7%) in the LSFX group, and 8 cases with 9 events (5.8%) in the LVFX group. There were no deaths or serious adverse events in either group.
LSFX was considered as a highly efficacious novel antimicrobial agent, with efficacy comparable to that of LVFX, for the treatment of patients with acute sinusitis or acute exacerbation of chronic sinusitis, and as probably a safer agent than LVFX in terms of the incidence of drug-induced gastrointestinal disorders.
Key word
lascufloxacin, sinusitis, controlled study, levofloxacin
Received
October 30, 2019
Accepted
February 25, 2020
Jpn. J. Chemother. 68 (S-1): 68-80, 2020
