{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T06:00:00Z","timestamp":1757311200126,"version":"3.40.5"},"reference-count":32,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,8,15]],"date-time":"2022-08-15T00:00:00Z","timestamp":1660521600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["HHSF223201400030I"],"award-info":[{"award-number":["HHSF223201400030I"]}],"id":[{"id":"10.13039\/100000038","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":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Cutaneous small vessel vasculitis (CSVV) was identified as a safety signal among patients treated with direct oral anticoagulants (DOAC). This study aimed to determine if CSVV risk differed among patients with atrial fibrillation (Afib) who newly initiated warfarin or a DOAC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We identified enrollees aged \u226521\u2009years diagnosed with Afib who newly initiated rivaroxaban, dabigatran, apixaban, and warfarin in the Sentinel Distributed Database from October 19, 2010 to February 29, 2020. We selected and followed patients who did not have evidence of the following in the 183\u2009days prior to initiating treatment: CSVV diagnosis, dispensing of other study drugs, select autoimmune diseases or autoimmune medications, cancer diagnoses or chemotherapeutic treatment, kidney dialysis or transplant, alternative anticoagulation indications, or an institutional (nursing home, hospice, hospital) stay on the treatment initiation date (index date) until CSVV outcome or pre\u2010specified censoring. We conducted 1:1 propensity score matching in six comparisons.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>CSVV incidence rates for DOACs and warfarin ranged from 3.3 to 5.6 per 10\u2009000\u2010person years in our matched Afib population. The adjusted CSVV hazard ratio (HR) and 95% confidence interval (CI) was 0.94 (0.64, 1.39) for rivaroxaban versus warfarin; 1.17 (0.67, 2.06) for dabigatran vs. warfarin; 0.85 (0.62, 1.16) for apixaban vs. warfarin; 0.86 (0.49, 1.50) for rivaroxaban vs. dabigatran; 0.99 (0.68, 1.45) for rivaroxaban versus apixaban; and 1.70 (0.90, 3.21) for dabigatran versus apixaban.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We did not find significant evidence of differential CSVV risk in pair\u2010wise comparisons of DOACs and warfarin.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5514","type":"journal-article","created":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T05:03:55Z","timestamp":1659330235000},"page":"1164-1173","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A cohort study to assess risk of cutaneous small vessel vasculitis among users of different oral anticoagulants"],"prefix":"10.1002","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4913-1234","authenticated-orcid":false,"given":"Adebola","family":"Ajao","sequence":"first","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Austin","family":"Cosgrove","sequence":"additional","affiliation":[{"name":"Harvard Medical School Department of Population Medicine Harvard Pilgrim Healthcare Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8971-9748","authenticated-orcid":false,"given":"Efe","family":"Eworuke","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohamed","family":"Mohamoud","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rongmei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Division of Biometrics VII, Office of Biostatistics, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oren","family":"Shapira","sequence":"additional","affiliation":[{"name":"Harvard Medical School Department of Population Medicine Harvard Pilgrim Healthcare Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joy","family":"Kolonoski","sequence":"additional","affiliation":[{"name":"Harvard Medical School Department of Population Medicine Harvard Pilgrim Healthcare Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John G.","family":"Connolly","sequence":"additional","affiliation":[{"name":"Harvard Medical School Department of Population Medicine Harvard Pilgrim Healthcare Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,15]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_11_2_1","DOI":"10.1002\/art.37715"},{"doi-asserted-by":"publisher","key":"e_1_2_11_3_1","DOI":"10.2165\/00128071-200809020-00001"},{"doi-asserted-by":"publisher","key":"e_1_2_11_4_1","DOI":"10.1007\/s40257-014-0076-6"},{"doi-asserted-by":"publisher","key":"e_1_2_11_5_1","DOI":"10.1007\/s11926-015-0545-9"},{"doi-asserted-by":"publisher","key":"e_1_2_11_6_1","DOI":"10.1002\/art.1780330802"},{"issue":"5","key":"e_1_2_11_7_1","first-page":"920","article-title":"Cutaneous vasculitis in a defined population\u2010\u2010clinical and epidemiological associations","volume":"25","author":"Watts RA","year":"1998","journal-title":"J 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