{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T07:14:27Z","timestamp":1768806867259,"version":"3.49.0"},"posted":{"date-parts":[[2023,4,4]]},"group-title":"Gastroenterology","reference-count":19,"publisher":"openRxiv","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2023,4,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>We describe a novel colopathy associated with pentosan polysulfate (PPS) use and measure the strength of the drug-disease association.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Two-part investigation. In the cohort study of individuals with a history of prior long-term PPS use, case histories were obtained and gastrointestinal disease course was followed with review of endoscopy records and histopathology specimens. Findings were summarized with descriptive statistics. In the cross-sectional study of individuals with interstitial cystitis, drug exposure and medical histories were obtained for patients seen at a single clinical center. Strength of association between PPS use and diagnoses of inflammatory bowel disease (IBD) and\/or irritable bowel syndrome (IBS) was measured with multivariate logistic regression.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the cohort study of 13 participants, median PPS exposure was 2.04 kg (0.99\u20132.54). Eleven (84.6%) developed symptoms suggestive of IBD and\/or IBS after initiation of PPS therapy. Of the 10 participants whose endoscopic and histopathologic findings we reviewed, six had abnormal-appearing colonic mucosa on endoscopy and all 10 had abnormal mucosal changes on histology. Clinical and histologic improvement was observed after PPS cessation. In the cross-sectional study of 219 subjects with interstitial cystitis, PPS use was a statistically significant predictor of both the IBD [adjusted odds ratio=3.3 (95% confidence interval, 1.2\u20138.8, p=0.02)] and the composite IBD+IBS [adjusted odds ratio=3.3 (95% confidence interval, 1.5\u20137.3, p=0.002)] outcomes.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>We describe a strong association between PPS use and a clinical diagnosis of IBD and\/or IBS. Histopathologic findings suggest a novel drug-associated colopathy, with some subjects requiring colectomy for dysplasia.<\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2023.04.03.23288071","type":"posted-content","created":{"date-parts":[[2023,4,4]],"date-time":"2023-04-04T18:40:14Z","timestamp":1680633614000},"source":"Crossref","is-referenced-by-count":1,"title":["Colopathy Associated with Pentosan Polysulfate Use"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8496-7806","authenticated-orcid":false,"given":"Emily H.","family":"Jung","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan J.","family":"Weiss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Namita E.","family":"Mathew","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin I.","family":"Meyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Azhar","family":"Nizam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heba","family":"Iskandar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2218-6611","authenticated-orcid":false,"given":"Nieraj","family":"Jain","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"key":"2023040605551692000_2023.04.03.23288071v1.1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000002756"},{"key":"2023040605551692000_2023.04.03.23288071v1.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ogc.2014.05.004"},{"key":"2023040605551692000_2023.04.03.23288071v1.3","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2018.1491968"},{"key":"2023040605551692000_2023.04.03.23288071v1.4","unstructured":"Janssen Pharmaceuticals. Elmiron (pentosan polysulfate sodium) [package insert]. U.S. Food and Drug Administration. March 2021. Available at https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020193s014lbl.pdf. Accessed 5 January 2022."},{"key":"2023040605551692000_2023.04.03.23288071v1.5","unstructured":"U.S. Food and Drug Administration. A Statistical and Medical Review of an Amendment to the New Drug Application for Elmiron (Pentosan Polysulfate). 31 January 1996. Available at https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/pre96\/020193Orig1s000rev.pdf. Accessed 31 August 2022."},{"issue":"1","key":"2023040605551692000_2023.04.03.23288071v1.6","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/S0094-0143(21)00587-5","article-title":"Epidemiology of interstitial cystitis","volume":"21","year":"1994","journal-title":"Urol Clin North Am. 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