Comparison of two dosing regimens of gabexate in the prophylaxis of post-ERCP pancreatitis.
OBJECTIVE
A continuous 13-h infusion of gabexate starting 30-90 min before endoscopic cholangiopancreatography (ERCP) can reduce postprocedural pancreatitis, the onset of which is generally observed within the first 6 h after ERCP. This study was designed to verify whether a 6.5-h infusion of gabexate was as effective as a 13-h infusion, at the same concentration, for reducing the incidence of post-ERCP pancreatitis (primary endpoint) and pancreatic hyperenzymemia and pain (secondary endpoints).


METHODS
A total of 434 patients (201 male and 233 female; mean age 63.9 yr, range 18-96 yr) scheduled for ERCP were prospectively recruited in 25 Italian centers. Patients were randomized double-blind to two treatment groups. All subjects enrolled were first treated with a 500-mg continuous intravenous infusion of gabexate, starting 30 min before the endoscopic maneuvers and continuing up to 6.5 h after it. Over the next 6.5 h, 214 patients (group I) continued the infusion of gabexate (for a total of 1 g over 13 h) and 220 patients (group II) were given placebo (saline solution).


RESULTS
The overall incidence of acute pancreatitis was 1.8% (eight patients), which included 1.4% in group I (three of 214 patients) and 2.2% in group II (five of 220 patients). Serum amylase and lipase values over time, peak levels of the two enzymes, pancreatic pain, and need for analgesics did not significantly differ in the two groups.


CONCLUSIONS
These results suggest that a 6.5-h infusion of gabexate (for a total of 500 mg) is not less effective than a 13 h infusion, with evident savings.
Servizio di Gastroenterologia ed Endoscopia Digestiva, Ospedale S. Raffaele, Università Vita e Salute, Milan, Italy.
Enzo
E
Masci
Giorgio
G
Cavallini
Alberto
A
Mariani
Luca
L
Frulloni
Pier Alberto
PA
Testoni
Simona
S
Curioni
Alberto
A
Tittobello
Generoso
G
Uomo
Guido
G
Costamagna
Sandro
S
Zambelli
Gianpiero
G
Macarri
Paolo
P
Innocenti
Carola
C
Dragonetti
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000175:diagnosis; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D016670:Gabexate / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D007558:Italy; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010182:Pancreatic Diseases / Q000175:diagnosis; D010195:Pancreatitis / Q000209:etiology* / Q000517:prevention & control*; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome
D016670:Gabexate