Preventive effect of TAK-751S on complications of hemorrhagic colitis (results of clinical study of TAK-751S).
BACKGROUND
The effective therapy for hemolytic uremic syndrome and encephalopathy caused by enterohemorrhagic Escherichia coli have not been established. Great attention has been drawn to the results of the clinical study of TAK-751S, performed in Canada. In Japan, a nationwide clinical study of TAK-751S had been performed since 1997 to investigate the preventive effect on the onset of HUS and the safety.


METHODS
TAK-751S was administered in daily doses of 500 mg/kg for one week to 128 pediatric patients with colitis who were suspected of enterohemorrhagic Escherichia coli (EHEC) infection.


RESULTS
1. TAK-751S was confirmed to absorb Shiga toxin (Stx) existing inside the human intestine and to excrete Stx out of the body. 2. The incidence of HUS is 5.9% (4/68) and a tendency to inhibit the onset of HUS was observed as compared with the historical control. The complications of central neuropathy such as encephalopathy were observed in 3 of these patients with HUS. 3. Mild "sweating" and "nausea" were observed. There were 13 mild non-specific abnormalities of laboratory test values in 8 patients.


CONCLUSIONS
From these results, it was clarified that TAK-751S absorbed and removed free Stx in the intestinal tract of pediatric patients with EHEC infection. The test drug could not inhibit the onset of HUS completely, but since HUS occurred within 48 hours after the start of administration in 3 of the 4 patients with onset of HUS, TAK-751S is a safe drug for pediatric patients with EHEC infection in which the preventive effect on HUS and encephalopathy are expected when it can be given from an early stage of the diseases. Furthermore, these results suggest that importance of rapid diagnosis of HUS.
Ito
Hiroshi
H
Kiyose Children's Hospital.
Takeda
Tae
T
Honda
Masataka
M
Igarashi
Takashi
T
Joh
Kosuke
K
Hashizume
Takao
T
Yamaoka
Kanji
K
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003092:Colitis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology*; D004927:Escherichia coli Infections; D019453:Escherichia coli O157; D005260:Female; D006463:Hemolytic-Uremic Syndrome / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007223:Infant; D008297:Male; D020258:Neurotoxicity Syndromes / Q000209:etiology / Q000517:prevention & control; D017646:Organosilicon Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome; D014312:Trisaccharides / Q000627:therapeutic use*
D017646:Organosilicon Compounds; C119238:SYNSORB Pk; D014312:Trisaccharides