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Gastrointestinal bleeding occurs more frequently early after initiation of low\u2010dose aspirin therapy than in later years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the associations of low\u2010dose aspirin with gastric and duodenal ulcer incidence in prevalent\u2010 and new\u2010user design.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Multivariate Cox regression models in the German ESTHER study (<jats:italic>N<\/jats:italic>\u00a0=\u00a07737) and the UK Biobank (<jats:italic>N<\/jats:italic>\u00a0=\u00a0213,598) with more than 10\u2009years of follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the prevalent\u2010user design, there was no significant association between low\u2010dose aspirin and gastric ulcer observed in both cohorts. Furthermore, low\u2010dose aspirin was weakly, statistically significantly associated with prevalent duodenal ulcer in the UK Biobank (hazard ratio [95% confidence interval]: 1.27 [1.07\u20131.51]) but not in the ESTHER study (1.33 [0.54\u20133.29]). When restricting the exposure to only new users, the hazard ratios for incident gastric and duodenal ulcer disease were 1.82 [1.58\u20132.11] and 1.66 [1.36\u20132.04] in the UK Biobank, respectively, and 2.83 [1.40\u20135.71] and 3.89 [1.46\u201310.42] in the ESTHER study, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study shows that low\u2010dose aspirin is an independent risk factor for both gastric and duodenal ulcers. The associations were not significant or weak in the prevalent\u2010user design and strong and statistically significant in the new\u2010user design in both cohorts. Thus, it is important to weigh risks against benefits when low\u2010dose aspirin treatment shall be initiated and to monitor adverse gastrointestinal symptoms after the start of low\u2010dose aspirin therapy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.17050","type":"journal-article","created":{"date-parts":[[2022,5,27]],"date-time":"2022-05-27T09:34:18Z","timestamp":1653644058000},"page":"251-262","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Strongly increased risk of gastric and duodenal ulcers among new users of low\u2010dose aspirin: results from two large cohorts with new\u2010user design"],"prefix":"10.1111","volume":"56","author":[{"given":"Thi Ngoc Mai","family":"Nguyen","sequence":"first","affiliation":[{"name":"Division of Clinical Epidemiology and Aging Research German Cancer Research Center (DKFZ)  Heidelberg Germany"},{"name":"Network Aging Research University of Heidelberg  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sha","family":"Sha","sequence":"additional","affiliation":[{"name":"Division of Clinical Epidemiology and Aging Research German Cancer Research Center (DKFZ)  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li\u2010Ju","family":"Chen","sequence":"additional","affiliation":[{"name":"Division of Clinical Epidemiology and Aging Research German Cancer Research Center (DKFZ)  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Holleczek","sequence":"additional","affiliation":[{"name":"Saarland Cancer Registry  Saarbr\u00fccken Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hermann","family":"Brenner","sequence":"additional","affiliation":[{"name":"Division of Clinical Epidemiology and Aging Research German Cancer Research Center (DKFZ)  Heidelberg Germany"},{"name":"Network Aging Research University of Heidelberg  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1217-4521","authenticated-orcid":false,"given":"Ben","family":"Sch\u00f6ttker","sequence":"additional","affiliation":[{"name":"Division of Clinical Epidemiology and Aging Research German Cancer Research Center (DKFZ)  Heidelberg Germany"},{"name":"Network Aging Research University of Heidelberg  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,27]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.10.824"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199405053301808"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.7326\/M16-0577"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15-2129"},{"key":"e_1_2_9_6_1","article-title":"Long\u2010term low\u2010dose acetylsalicylic use shows protective potential for the development of both vascular dementia and Alzheimer's disease in patients with coronary heart disease but not in other individuals from the general population: results from two large cohort studies","author":"Nguyen MTN","year":"2022","journal-title":"Alzheimer's Res Ther"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2005.10.039"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.191087"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.310.6983.827"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2005.02649.x"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32404-7"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2006.00518.x"},{"issue":"1","key":"e_1_2_9_13_1","first-page":"126","article-title":"Risk of upper gastrointestinal bleeding in a cohort of new users of low\u2010dose ASA for secondary prevention of cardiovascular outcomes","volume":"14","author":"Soriano CL","year":"2010","journal-title":"Front Pharmacol"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/gerona\/gly253"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2011.12.036"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hlpt.2012.07.003"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001779"},{"key":"e_1_2_9_18_1","unstructured":"UK Biobank.Algorithmically\u2010defined health outcomes2017. https:\/\/biobank.ctsu.ox.ac.uk\/crystal\/ukb\/docs\/alg_outcome_main.pdf."},{"key":"e_1_2_9_19_1","unstructured":"UK Biobank.Code lists for algorithmically\u2010defined outcomes2019. https:\/\/biobank.ctsu.ox.ac.uk\/crystal\/refer.cgi?id=594"},{"key":"e_1_2_9_20_1","unstructured":"UK Biobank.Touch Screen Questionnaire.2011.https:\/\/biobank.ndph.ox.ac.uk\/ukb\/ukb\/docs\/Touchscreen.pdf. 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