{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T10:04:30Z","timestamp":1753869870198,"version":"3.41.2"},"reference-count":45,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T00:00:00Z","timestamp":1700006400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016348","name":"Kyowa Kirin Pharmaceutical Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016348","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Naloxegol has been shown to be an efficient alternative to treat opioid\u2010induced constipation (OIC). This study aimed at describing the characteristics of naloxegol users and assessing patterns of naloxegol use and associated factors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 17\u2009254 naloxegol users were identified across the countries. Their median age was 56\u201371\u2009years, and each country had a majority of women (ranging 57.5%\u201362.9%). 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%\u201390.9% of users, typically during the first 30\u2009days. Approximately 10%\u201330% 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The present study reflects real\u2010world 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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5710","type":"journal-article","created":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T06:29:30Z","timestamp":1700116170000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["An observational post\u2010authorization safety study (<scp>PASS<\/scp>) of naloxegol drug utilization in four European countries"],"prefix":"10.1002","volume":"33","author":[{"given":"Gunnvald","family":"Kvarstein","sequence":"first","affiliation":[{"name":"Institute for Clinical Medicine UiT The Arctic University of Norway  Troms\u00f8 Norway"},{"name":"Department of Pain Management and Research, Division of Emergencies and Critical Care Oslo University Hospital  Oslo Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna MS","family":"Kindlundh\u2010H\u00f6gberg","sequence":"additional","affiliation":[{"name":"Kyowa Kirin International plc  Galabank Business Park Galashiels UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8298-110X","authenticated-orcid":false,"given":"Mounir","family":"Ould Setti","sequence":"additional","affiliation":[{"name":"Global Database Studies, Real World Solutions, IQVIA  Espoo Finland"},{"name":"Institute of Public Health and Clinical Nutrition University of Eastern Finland  Kuopio Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafik","family":"Namane","sequence":"additional","affiliation":[{"name":"Kyowa Kirin International plc  Galabank Business Park Galashiels UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruvimbo","family":"Muzwidzwa","sequence":"additional","affiliation":[{"name":"RWE DBS Epidemiology, IQVIA  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hartmut","family":"Richter","sequence":"additional","affiliation":[{"name":"Epidemiology, Real World Solutions, IQVIA  Frankfurt\/Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katja M.","family":"Hakkarainen","sequence":"additional","affiliation":[{"name":"Global Database Studies, Real World Solutions, IQVIA  M\u00f6lndal Sweden"},{"name":"Epidemiology &amp; Real\u2010World Science, RWE Scientific Affairs, Parexel International  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,11,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpain.2005.06.009"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/2049463713493264"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bja.2019.03.023"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007991003689175"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.2147\/jpr.S244173"},{"volume-title":"Cancer Pain Relief: with a Guide to Opioid Availability","year":"1996","author":"World Health Organization","key":"e_1_2_11_7_1"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2004.09.019"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajem.2019.06.001"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1191\/026921698674125048"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102982.2009.01458.x"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/2050640618818305"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.07.016"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/pm\/pnw240"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0002\u20109610(01)00782\u20106"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/141737"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/dddt.S221278"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1089\/jpm.2021.0021"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/0897190017732263"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1517\/14728210902907847"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.4103\/0976\u2010500x.162015"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2015.51.8.2364896"},{"key":"e_1_2_11_23_1","unstructured":"European Medicines Agency (EMA).Summary of Product Characteristics: Moventig. 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