{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T00:13:46Z","timestamp":1791764026693,"version":"4.3.4"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,3,22]],"date-time":"2022-03-22T00:00:00Z","timestamp":1647907200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Recent epidemiologic studies have examined the risk of maculopathy with pentosan polysulfate sodium (PPS), a drug indicated for the treatment of interstitial cystitis. However, results have been contradictory. Thus, we quantified the risk of maculopathy with PPS with a focus on risk with duration of use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We used a new user, retrospective cohort study with an active comparator. We created a cohort of mutually exclusive 6221 PPS users and 89\u2009744 amitriptyline users, a tricyclic antidepressant also used for the treatment of pain secondary to interstitial cystitis. Subjects were selected from the PharMetrics Plus database (IQVIA, Durham, NC) from 2006 to 2020. Cohort members were followed to the first event of the study outcome (maculopathy) or end of enrolment. A Cox regression model was constructed to adjust for potential confounders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mean follow\u2010up was 3.0\u00a0years for PPS users and amitriptyline users. The adjusted hazard ratio (HR) for maculopathy in PPS users was 2.64 (95% confidence interval [CI]: 1.90\u20133.68). The HR for the sensitivity analysis that combined maculopathy and age\u2010related macular degeneration (AMD) was 1.38 (95% CI: 1.16\u20131.65). A cumulative duration\u2010response pattern was observed, with use greater than 3\u00a0years having a 9.5\u2010fold risk of maculopathy (HR\u2009=\u20099.56, 95% CI: 3.60\u201325.37) compared to a 2.3\u2010fold risk of maculopathy with use for 1\u2009year or less (HR\u2009=\u20092.27, 95% CI: 1.50\u20133.43). The number needed to harm for the first 4\u00a0years of use was 250.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results of this study suggest an increased risk of maculopathy with PPS use, particularly with longer duration of use.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15303","type":"journal-article","created":{"date-parts":[[2022,3,12]],"date-time":"2022-03-12T11:09:03Z","timestamp":1647083343000},"page":"3428-3433","source":"Crossref","is-referenced-by-count":11,"title":["Risk of maculopathy with pentosan polysulfate sodium use"],"prefix":"10.1111","volume":"88","author":[{"given":"Steven S.","family":"Bae","sequence":"first","affiliation":[{"name":"Collaboration for Epidemiology of Ocular Diseases (CEPOD), Department of Ophthalmology and Visual Sciences, Faculty of Medicine University of British Columbia  Vancouver Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit","family":"Sodhi","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics, Faculty of Medicine University of British Columbia  Vancouver Canada"},{"name":"Faculty of Medicine University of British Columbia  Vancouver Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Maberley","sequence":"additional","affiliation":[{"name":"Collaboration for Epidemiology of Ocular Diseases (CEPOD), Department of Ophthalmology and Visual Sciences, Faculty of Medicine University of British Columbia  Vancouver Canada"},{"name":"Department of Ophthalmology, Faculty of Medicine University of Ottawa  Ottawa Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abbas","family":"Kezouh","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology and Occupational Health McGill University  Montreal Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4628-6270","authenticated-orcid":false,"given":"Mahyar","family":"Etminan","sequence":"additional","affiliation":[{"name":"Collaboration for Epidemiology of Ocular Diseases (CEPOD), Department of Ophthalmology and Visual Sciences, Faculty of Medicine University of British Columbia  Vancouver Canada"},{"name":"Department of Pharmacology and Therapeutics, Faculty of Medicine University of British Columbia  Vancouver Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,3,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0090\u20104295(97)00714\u20100"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2018.04.026"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2019.3392"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2020.01.017"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol\u20102019\u2010314765"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2019.10.036"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2019.10.038"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2014.3459"},{"key":"e_1_2_10_10_1","unstructured":"IQVIA PharMectrics Plus Fact Sheet.https:\/\/www.greygreenmedia.com\/app\/uploads\/sites\/2\/2020\/09\/IQVIA\u2010PharMetrics\u2010Plus\u2010US\u2010Fact\u2010Sheet.pdf. 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