{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:30:35Z","timestamp":1753878635745,"version":"3.41.2"},"reference-count":27,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Whether or not vascular endothelial growth factor pathway inhibitors (VPIs) increase the risk of artery dissection is still unknown. This study aimed to quantitatively evaluate the possibility of artery dissection as a class effect of VPIs using nationwide real\u2010world data. This cohort study was conducted based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which spans nearly the entire Japanese population of over 100 million individuals. We included the patients prescribed with 12 types of VPIs between 2012 and 2020. The incidence rate (IR) ratio of artery dissection for each VPI were estimated in comparison with bevacizumab, the only VPI in Japan with artery dissection listed in the package insert. Artery dissection as an outcome was targeted for acute artery dissection requiring hospitalization (including dissecting aneurysm). As a reference, a natural IR standardized by sex and age of bevacizumab\u2010prescribed patients was also estimated using the direct method for the general population of NDB. Of 503,342 patients, the IR of artery dissection for bevacizumab was 44.4 (\/100,000 person\u2010years), and the adjusted IR ratios for each VPI compared with bevacizumab were consistently similar to or &gt;1.0. The IRs for each VPI were also higher than the crude natural IR (1.66\/100,000 person\u2010years; 95% CI: 1.59\u20131.73) and the standardized natural IR (2.18\/100,000 person\u2010years; 95% CI: 1.86\u20132.50). Real\u2010world evidence suggests the risk of artery dissection as a class effect of VPIs. More attention on this risk will be necessary when using VPIs in clinical practice.<\/jats:p>","DOI":"10.1111\/cts.70096","type":"journal-article","created":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T05:59:17Z","timestamp":1733119157000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Risk of artery dissection during systemic exposure to vascular endothelial growth factor pathway inhibitors"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5226-1347","authenticated-orcid":false,"given":"Jun","family":"Okui","sequence":"first","affiliation":[{"name":"Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0656-5198","authenticated-orcid":false,"given":"Takashi","family":"Waki","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0570-2792","authenticated-orcid":false,"given":"Kazuhiro","family":"Kajiyama","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Office of Regulatory Science Research, Center for Regulatory Science Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sono","family":"Sawada","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinya","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukari","family":"Namba","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ayano","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuichi","family":"Kawarasaki","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kohei","family":"Amakasu","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toyotaka","family":"Iguchi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoya","family":"Horiuchi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0430-9887","authenticated-orcid":false,"given":"Yoshiaki","family":"Uyama","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology Pharmaceuticals and Medical Devices Agency  Tokyo Japan"},{"name":"Center for Regulatory Science Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,12]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_11_2_1","DOI":"10.1038\/nm0603-669"},{"doi-asserted-by":"publisher","key":"e_1_2_11_3_1","DOI":"10.1056\/NEJM197111182852108"},{"unstructured":"U.S. Food and Drug Administration Drug Approval Package: Avastin (Bevacizumab). 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