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Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data.
Am J Gastroenterol. 2006 May; 101(5):1069-79.AJ

Abstract

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+Show Affiliations

Center for Neurovisceral Sciences & Women's Health, Department of Medicine, UCLA and VA Greater Los Angeles Healthcare Center, California, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review
Systematic Review

Language

eng

PubMed ID

16606352

Citation

Chang, Lin, et al. "Incidence of Ischemic Colitis and Serious Complications of Constipation Among Patients Using Alosetron: Systematic Review of Clinical Trials and Post-marketing Surveillance Data." The American Journal of Gastroenterology, vol. 101, no. 5, 2006, pp. 1069-79.
Chang L, Chey WD, Harris L, et al. Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. Am J Gastroenterol. 2006;101(5):1069-79.
Chang, L., Chey, W. D., Harris, L., Olden, K., Surawicz, C., & Schoenfeld, P. (2006). Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. The American Journal of Gastroenterology, 101(5), 1069-79.
Chang L, et al. Incidence of Ischemic Colitis and Serious Complications of Constipation Among Patients Using Alosetron: Systematic Review of Clinical Trials and Post-marketing Surveillance Data. Am J Gastroenterol. 2006;101(5):1069-79. PubMed PMID: 16606352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. AU - Chang,Lin, AU - Chey,William D, AU - Harris,Lucinda, AU - Olden,Kevin, AU - Surawicz,Christina, AU - Schoenfeld,Philip, PY - 2006/4/12/pubmed PY - 2006/6/7/medline PY - 2006/4/12/entrez SP - 1069 EP - 79 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 101 IS - 5 N2 - 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. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/16606352/Incidence_of_ischemic_colitis_and_serious_complications_of_constipation_among_patients_using_alosetron:_systematic_review_of_clinical_trials_and_post_marketing_surveillance_data_ L2 - http://Insights.ovid.com/pubmed?pmid=16606352 DB - PRIME DP - Unbound Medicine ER -