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A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program.
Therap Adv Gastroenterol. 2013 Sep; 6(5):344-57.TA

Abstract

OBJECTIVES

Adverse events (AEs) of ischemic colitis (IC) and complications of constipation (CoC) associated with alosetron are rare and have been adjudicated during the first 5.5 years of the risk management program (RMP); however, changes in incidence rates relative to reductions in AE reports and increases in alosetron prescriptions over the 9-year RMP have not been evaluated. The authors aim to evaluate temporal trends in alosetron postmarketing safety over the 9-year RMP.

METHODS

The alosetron safety database was searched to identify cases of IC, CoC, and related AEs from 20 November 2002 to 31 December 2011. Adjudication of IC and CoC cases were based on US Food and Drug Administration-defined criteria. Incidence rates were calculated using the number of AEs and alosetron prescriptions (expressed as cases/1000 patient-years exposure).

RESULTS

A total of 29 cases were adjudicated as probable/possible IC and 7 cases were adjudicated as CoC. Cumulative adjudicated incidence rate of IC (1.03 cases/1000 patient-years) is low and stable, while that of CoC (0.25 cases/1000 patient-years) is low, declining progressively over time. Decreases in the incidence rates of potential symptoms of IC (abdominal pain with bloody diarrhea/hematochezia) and CoC (constipation) were also observed.

CONCLUSIONS

Over the 9-year RMP period, incidence rates of IC and CoC remain rare. Substantial reductions over time were observed in the incidence of CoC and in symptoms suggestive of IC or CoC, while IC incidence has been stable at approximately 1.0 case/1000 patient-years. Decreases in AEs and serious outcomes associated with IC and CoC since the reintroduction of alosetron are likely attributable to the RMP.

Authors+Show Affiliations

Medical Affairs 360, San Diego, CA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24003335

Citation

Tong, Kenneth, et al. "A 9-year Evaluation of Temporal Trends in Alosetron Postmarketing Safety Under the Risk Management Program." Therapeutic Advances in Gastroenterology, vol. 6, no. 5, 2013, pp. 344-57.
Tong K, Nicandro JP, Shringarpure R, et al. A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program. Therap Adv Gastroenterol. 2013;6(5):344-57.
Tong, K., Nicandro, J. P., Shringarpure, R., Chuang, E., & Chang, L. (2013). A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program. Therapeutic Advances in Gastroenterology, 6(5), 344-57. https://doi.org/10.1177/1756283X13491798
Tong K, et al. A 9-year Evaluation of Temporal Trends in Alosetron Postmarketing Safety Under the Risk Management Program. Therap Adv Gastroenterol. 2013;6(5):344-57. PubMed PMID: 24003335.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program. AU - Tong,Kenneth, AU - Nicandro,Jean Paul, AU - Shringarpure,Reshma, AU - Chuang,Emil, AU - Chang,Lin, PY - 2013/9/5/entrez PY - 2013/9/5/pubmed PY - 2013/9/5/medline KW - alosetron KW - complications of constipation KW - ischemic colitis KW - postmarketing KW - risk evaluation and mitigation strategy KW - risk management program KW - safety KW - severe diarrhea-predominant irritable bowel syndrome SP - 344 EP - 57 JF - Therapeutic advances in gastroenterology JO - Therap Adv Gastroenterol VL - 6 IS - 5 N2 - OBJECTIVES: Adverse events (AEs) of ischemic colitis (IC) and complications of constipation (CoC) associated with alosetron are rare and have been adjudicated during the first 5.5 years of the risk management program (RMP); however, changes in incidence rates relative to reductions in AE reports and increases in alosetron prescriptions over the 9-year RMP have not been evaluated. The authors aim to evaluate temporal trends in alosetron postmarketing safety over the 9-year RMP. METHODS: The alosetron safety database was searched to identify cases of IC, CoC, and related AEs from 20 November 2002 to 31 December 2011. Adjudication of IC and CoC cases were based on US Food and Drug Administration-defined criteria. Incidence rates were calculated using the number of AEs and alosetron prescriptions (expressed as cases/1000 patient-years exposure). RESULTS: A total of 29 cases were adjudicated as probable/possible IC and 7 cases were adjudicated as CoC. Cumulative adjudicated incidence rate of IC (1.03 cases/1000 patient-years) is low and stable, while that of CoC (0.25 cases/1000 patient-years) is low, declining progressively over time. Decreases in the incidence rates of potential symptoms of IC (abdominal pain with bloody diarrhea/hematochezia) and CoC (constipation) were also observed. CONCLUSIONS: Over the 9-year RMP period, incidence rates of IC and CoC remain rare. Substantial reductions over time were observed in the incidence of CoC and in symptoms suggestive of IC or CoC, while IC incidence has been stable at approximately 1.0 case/1000 patient-years. Decreases in AEs and serious outcomes associated with IC and CoC since the reintroduction of alosetron are likely attributable to the RMP. SN - 1756-283X UR - https://www.unboundmedicine.com/medline/citation/24003335/A_9_year_evaluation_of_temporal_trends_in_alosetron_postmarketing_safety_under_the_risk_management_program_ L2 - http://journals.sagepub.com/doi/full/10.1177/1756283X13491798?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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