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dc.contributor.authorKvarstein, Gunnvald
dc.contributor.authorKindlundh-Högberg, Anna MS
dc.contributor.authorOuld Setti, Mounir
dc.contributor.authorNamane, Rafik
dc.contributor.authorMuzwidzwa, Ruvimbo
dc.contributor.authorRichter, Hartmut
dc.contributor.authorHakkarainen, Katja M.
dc.date.accessioned2024-01-09T09:57:20Z
dc.date.available2024-01-09T09:57:20Z
dc.date.issued2023-11-15
dc.description.abstractPurpose - Naloxegol has been shown to be an efficient alternative to treat opioid-induced constipation (OIC). This study aimed at describing the characteristics of naloxegol users and assessing patterns of naloxegol use and associated factors.<p> <p>Methods - This drug utilization cohort study used observational registry data on patients newly prescribed naloxegol in four European countries. Patient characteristics and patterns of naloxegol use and associated factors were described.<p> <p>Results - A total of 17 254 naloxegol users were identified across the countries. Their median age was 56–71 years, and each country had a majority of women (ranging 57.5%–62.9%). Multiple comorbidities, including cancer, were common. Natural opium alkaloids and osmotically acting laxatives (excluding saline) were the most frequently used opioids and laxatives. Overall prior use of opioids ranged from 91.9% to 99.6% and overall prior use of laxatives ranged from 69.9% to 92.4%. Up to 77.7% had prior use of medications with interaction potential, and up to 44.5% used them concurrently with naloxegol. Naloxegol was discontinued by 55.1%–90.9% of users, typically during the first 30 days. Approximately 10%–30% switched to or augmented the treatment with another constipation medication or restarted naloxegol after discontinuation. Augmentation with another constipation medication was relatively common, suggesting that naloxegol was used for multifactorial constipation.<p> <p>Conclusion - The present study reflects real-world clinical use of naloxegol, including in vulnerable patient groups. Some naloxegol users lacked laxative or regular opioid use within six months before index date or used naloxegol concomitantly with medications presenting an interaction potential.en_US
dc.identifier.citationKvarstein, Kindlundh-Högberg, Ould Setti, Namane, Muzwidzwa, Richter, Hakkarainen. An observational post-authorization safety study (PASS) of naloxegol drug utilization in four European countries. Pharmacoepidemiology and Drug Safety. 2023
dc.identifier.cristinIDFRIDAID 2207529
dc.identifier.doi10.1002/pds.5710
dc.identifier.issn1053-8569
dc.identifier.issn1099-1557
dc.identifier.urihttps://hdl.handle.net/10037/32377
dc.language.isoengen_US
dc.publisherWileyen_US
dc.relation.journalPharmacoepidemiology and Drug Safety
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0en_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)en_US
dc.titleAn observational post-authorization safety study (PASS) of naloxegol drug utilization in four European countriesen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
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