Document Detail


Clinical evaluation of oral administration of a cholecystokinin-A receptor antagonist (loxiglumide) to patients with acute, painful attacks of chronic pancreatitis: a multicenter dose-response study in Japan.
MedLine Citation:
PMID:  12131781     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: Cholecystokinin (CCK)-receptor antagonists have been found to markedly reduce the severity of pancreatitis and improve survival in experimental animal models of acute pancreatitis. CCK appears to play an important role in the development and progression of acute pancreatitis, and the recent development of CCK antagonists has provided a new approach to the treatment of acute pancreatitis in humans. AIMS: The therapeutic efficacy of a CCK-A receptor antagonist, loxiglumide, in patients with painful acute attacks of chronic pancreatitis was evaluated. METHODOLOGY: A multicenter dose-response controlled trial was conducted at 110 institutions in Japan from June 1993 to December 1994. Chronic pancreatitis was diagnosed for all patients on the basis of the Japanese criteria for chronic pancreatitis. Two-hundred seven patients were randomized to oral treatment with loxiglumide (300, 600, and 1,200 mg/d) or placebo for 4 weeks. The efficacy of treatment was evaluated on the basis of clinical symptoms, physical signs, and serum pancreatic enzyme levels. The groups were comparable with respect to age, sex, etiology, complications, and previous treatment. RESULTS: The improvement rate of the abdominal and/or back pain was 46% in the loxiglumide 300-mg group, 59% in the 600-mg group, and 52% in the 1,200-mg group, and it was 36% in the placebo group (600 mg versus placebo: p < 0.05). The physical signs evaluated--abdominal tenderness and resistance--improved in all three loxiglumide groups, and the serum pancreatic amylase and trypsin levels decreased significantly in the 600-mg group (p < 0.05). The overall clinical improvement rate was 46% in the 300-mg loxiglumide group, 58% in the 600-mg group, and 52% in the 1,200-mg group, and it was 34% in the placebo group. CONCLUSION: These results indicate that oral administration of loxiglumide may be useful in the treatment of patients with acute, painful attacks of chronic pancreatitis, and 600 mg/d is recommended as a beneficial dosage.
Authors:
Keiko Shiratori; Tadashi Takeuchi; Katsusuke Satake; Seiki Matsuno;
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Pancreas     Volume:  25     ISSN:  0885-3177     ISO Abbreviation:  Pancreas     Publication Date:  2002 Jul 
Date Detail:
Created Date:  2002-07-19     Completed Date:  2003-01-10     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8608542     Medline TA:  Pancreas     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e1-5     Citation Subset:  IM    
Affiliation:
Department of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan. tskeiko@ige.tmmu.ac.jp
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Administration, Oral
Adult
Amylases / blood
Chronic Disease
Female
Hormone Antagonists / administration & dosage*
Humans
Lipase / blood
Male
Middle Aged
Pain / etiology
Pancreatitis / blood,  complications,  drug therapy*
Proglumide / administration & dosage*,  analogs & derivatives*
Receptor, Cholecystokinin A
Receptors, Cholecystokinin / antagonists & inhibitors
Treatment Outcome
Trypsin / blood
Chemical
Reg. No./Substance:
0/Hormone Antagonists; 0/Receptor, Cholecystokinin A; 0/Receptors, Cholecystokinin; 107097-80-3/loxiglumide; 6620-60-6/Proglumide; EC 3.1.1.3/Lipase; EC 3.2.1.-/Amylases; EC 3.4.21.4/Trypsin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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