[Early phase II study of FUT-187 (sepimostat mesilate) on reflux esophagitis--mainly on postgastrectomy reflux esophagitis].
An early phase II clinical study with the proteolysis inhibitor FUT-187 was carried out on patients with reflux esophagitis. FUT-187 was administered orally at the dose of 300 mg/day or 400 mg/day four times daily, after meals and at bedtime, for 4 consecutive weeks. The total number of patients admitted to this study was 40, of whom 9 were assigned to 300 mg/day group and 31 to 400 mg/day group. The rate of effectiveness on postgastrectomy reflux esophagitis was 88% (7/8) in 300 mg/day group and 85%(22/26) in 400 mg/day group when "improved" or better final general improvement ratings were taken into consideration, and 75% (6/8) in 300 mg/day group and 69% (9/13) in 400 mg/day group when "improved" or better endoscopic general improvement ratings were used. The overall safety rating "no problem as to the drug safety" was 89% (8/9) in 300 mg/day group and 71% (22/31) in 400 mg/day group. The main side effect was diarrhea, which was experienced in 6 patients in 400 mg/day group. However, it was resolved by discontinuation of the drug treatment. Other symptoms of gastrointestinal upsets, such as nausea and anorexia, were also induced. Based on these results, it may be concluded that FUT-187 can be a drug with clinical utility that benefits postgastrectomy reflux esophagitis at the dose level of 300 mg/day or less.
Abe
O
O
Dept. of Surgery, School of Medicine, Keio University.
Yoshino
K
K
Kimura
K
K
Suzuki
H
H
Aoki
T
T
Hiki
Y
Y
Mitomi
T
T
Makuuchi
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
D007093:Imidazoles; C058875:sepimostate mesilate