{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T03:15:28Z","timestamp":1764731728605,"version":"3.41.2"},"reference-count":26,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T00:00:00Z","timestamp":1728259200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["PJT\u2010165882"],"award-info":[{"award-number":["PJT\u2010165882"]}],"id":[{"id":"10.13039\/501100000024","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":[[2024,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The optimal design for pharmacoepidemiologic drug\u2013drug interactions (DDIs) studies is unclear. Using the association between concomitant use of sulfonylureas and warfarin and the risk of severe hypoglycemia as a case study, a DDI with little or no clinical impact, we tested whether the prevalent new\u2010user design can be applied in the area.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Among all patients initiating sulfonylureas in the UK's Clinical Practice Research Datalink (1998\u20132020), we identified those adding\u2010on warfarin while on a sulfonylurea. For each co\u2010exposed patient, we defined a prescription\u2010based exposure set including other sulfonylurea users not adding\u2010on warfarin (comparators). Within each exposure set, we matched each co\u2010exposed patient to five comparators on time\u2010conditional propensity scores (TCPS) and followed them using an as\u2010treated approach. Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) of severe hypoglycemia associated with concomitant use of sulfonylureas and warfarin compared to use of sulfonylureas alone. Sensitivity analyses addressed the impact of different potential sources of bias.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study cohort included 17\u2009890 patients co\u2010exposed to sulfonylureas and warfarin and 88\u2009749 matched comparators. After TCPS matching, patient characteristics were well\u2010balanced between groups. Compared to use of sulfonylureas alone, concomitant use of sulfonylureas and warfarin was not associated with the risk of severe hypoglycemia (HR, 1.04; 95% CI, 0.92\u20131.17). Sensitivity analyses were consistent with the primary analysis (HRs ranging from 1.01 to 1.15, all not statistically significant).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our study suggests that the prevalent new\u2010user design could be used for the assessment of clinical effects of DDIs.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70014","type":"journal-article","created":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T05:29:38Z","timestamp":1728365378000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The Prevalent New\u2010User Design to Study Drug\u2013Drug Interactions: The Example of Sulfonylureas and Warfarin Interaction on the Risk of Severe Hypoglycemia"],"prefix":"10.1002","volume":"33","author":[{"given":"Wanqi","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Epidemiology, Biostatistics and Occupational Health McGill University  Montreal Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Cui","sequence":"additional","affiliation":[{"name":"Centre for Clinical Epidemiology Lady Davis Institute  Montreal Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oriana\u00a0Hoi\u00a0Yun","family":"Yu","sequence":"additional","affiliation":[{"name":"Centre for Clinical Epidemiology Lady Davis Institute  Montreal Quebec Canada"},{"name":"Division of Endocrinology and Metabolism Jewish General Hospital\/McGill University  Montreal Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1281-5296","authenticated-orcid":false,"given":"Samy","family":"Suissa","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Biostatistics and Occupational Health McGill University  Montreal Quebec Canada"},{"name":"Centre for Clinical Epidemiology Lady Davis Institute  Montreal Quebec 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