Document Detail


Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data.
MedLine Citation:
PMID:  16606352     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Ischemic colitis and serious complications of constipation have been reported in association with the use of alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies. This systematic review calculated the incidence of these adverse events in alosetron-using patients in clinical trials and post-marketing surveillance. METHODS: A panel of experts in epidemiology and functional bowel disorders reviewed clinical trial report forms and FDA MedWatch forms of each reported case of ischemic colitis or serious complications of constipation. Experts were blinded about whether patients used alosetron or placebo. Using pre-specified criteria, experts rated the likelihood of an accurate diagnosis and an association between medication use and adverse events. Cases that were not consistent with the reported diagnosis or not possibly associated with medication use were eliminated from calculation of incidence rates of adverse events. RESULTS: Pooled data from clinical trials indicate an increased rate of ischemic colitis among alosetron-using patients compared to placebo-using patients (0.15%vs 0.0%, respectively, p = 0.03), but there was no significant difference in the rate of serious complications of constipation. All (19/19) alosetron-using patients with ischemic colitis had reversible colitis without long-term sequelae. Based on post-marketing surveillance data, the post-adjudication rate of ischemic colitis is 1.1 per 1,000 patient-years of alosetron use and the rate of serious complications of constipation is 0.66 per 1,000 patient-years of alosetron use. CONCLUSION: The incidence of ischemic colitis and serious complications of constipation is very low and is rarely associated with long-term sequelae or serious morbidity.
Authors:
Lin Chang; William D Chey; Lucinda Harris; Kevin Olden; Christina Surawicz; Philip Schoenfeld
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  101     ISSN:  0002-9270     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-22     Completed Date:  2006-06-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1069-79     Citation Subset:  IM    
Affiliation:
Center for Neurovisceral Sciences & Women's Health, Department of Medicine, UCLA and VA Greater Los Angeles Healthcare Center, California, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Carbolines / adverse effects*
Clinical Trials as Topic
Colitis, Ischemic / chemically induced*
Constipation / chemically induced*,  complications*
Diarrhea / drug therapy
Female
Gastrointestinal Agents / adverse effects*
Humans
Irritable Bowel Syndrome / drug therapy*
Male
Middle Aged
Product Surveillance, Postmarketing
Chemical
Reg. No./Substance:
0/Carbolines; 0/Gastrointestinal Agents; 122852-42-0/alosetron
Comments/Corrections
Comment In:
Am J Gastroenterol. 2006 May;101(5):1080-3   [PMID:  16696787 ]

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


Previous Document:  Factors associated with the development of intestinal strictures or obstructions in patients with Cr...
Next Document:  Oligodendrocyte excitotoxicity determined by local glutamate accumulation and mitochondrial function...