{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:05:13Z","timestamp":1758931513101,"version":"3.44.0"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,6,16]],"date-time":"2025-06-16T00:00:00Z","timestamp":1750032000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>In 2013, risk minimization measures (RMMs) were introduced in Europe to address the increased cardiovascular risk linked to diclofenac. This study aimed to assess the impact of those RMMs on analgesic use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Primary care data from CPRD GOLD (UK) were used. Patients newly diagnosed with musculoskeletal disorders during 2010\u20132019 were categorized into 4 cohorts, according to their diagnosis: acute (inflammatory) musculoskeletal conditions, chronic arthritic conditions, secondary arthritic conditions, or other painful conditions. The impact of the RMMs was studied using interrupted time series and survival analyses. Analyses were stratified by cardiovascular risk: (i) no risk factors or contraindications mentioned by RMMs; (ii) at least 1 risk factor; and (iii) at least 1 contraindication (prior cardiovascular events).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 1\u2009798\u2009885 patients were included, with &gt;28% having at least 1 cardiovascular risk factor and &gt;7% having at least 1 contraindication for diclofenac. Initiation of diclofenac was already decreasing before the RMMs, but the RMMs were associated with a further immediate decrease in 2 cohorts (from \u22120.9 to \u22121.6%). No substantial difference in impact was observed depending on cardiovascular risk. The time from diagnosis to analgesic treatment increased after RMMs implementation, especially in patients with chronic arthritic conditions: median time increased from 4.2 to 7.6\u00a0months [95% confidence interval 4.0\u20134.5 and 7.4\u20137.8, respectively].<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The observed decrease of diclofenac initiation was unrelated to patients' cardiovascular risk. Continued prescribing of systemic diclofenac to patients with contraindications suggests limited impact of RMMs. Increased time from diagnosis to analgesic treatment suggests broader changes in analgesic prescribing practices.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bcp.70142","type":"journal-article","created":{"date-parts":[[2025,6,16]],"date-time":"2025-06-16T20:09:17Z","timestamp":1750104557000},"page":"2998-3008","source":"Crossref","is-referenced-by-count":1,"title":["Impact of diclofenac risk minimization measures addressing cardiovascular risk on analgesic use in musculoskeletal disorders"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8892-9820","authenticated-orcid":false,"given":"Tomas","family":"Lasys","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3086-446X","authenticated-orcid":false,"given":"Yared","family":"Santa\u2010Ana\u2010Tellez","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3095-9530","authenticated-orcid":false,"given":"Satu J.","family":"Siiskonen","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7044-2443","authenticated-orcid":false,"given":"Daniala L.","family":"Weir","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9238-6999","authenticated-orcid":false,"given":"Rolf H. H.","family":"Groenwold","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology Leiden University Medical Centre  Leiden The Netherlands"},{"name":"Department of Biomedical Data Science Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5623-9684","authenticated-orcid":false,"given":"Helga","family":"Gardarsdottir","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University  Utrecht The Netherlands"},{"name":"Department of Pharmaceutical Sciences School of Health Sciences, University of Iceland  Reykjavik Iceland"},{"name":"Department of Clinical Pharmacy University Medical Centre Utrecht  The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.prostaglandins.2006.05.019"},{"volume-title":"Procedure under article 31 of directive 2001\/83\/EC resulting from pharmacovigilance data","author":"European Medicines Agency","key":"e_1_2_11_3_1"},{"key":"e_1_2_11_4_1","unstructured":"European Medicines Agency.New safety advice for diclofenac new measures aim to minimise cardiovascular risks. Published online 25 September2013. Accessed July 18 2023.https:\/\/www.ema.europa.eu\/en\/documents\/referral\/diclofenac-article-31-referral-new-safety-advice-diclofenac_en.pdf"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4968"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2019.00294"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2010.06.003"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13469"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15874"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14478"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4955"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/joim.12990"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyv098"},{"key":"e_1_2_11_14_1","unstructured":"Medicines & Healthcare products Regulatory Agency.Clinical Practice Research Datalink (CPRD). Accessed March 24 2024www.cprd.com.http:\/\/www.cprd.com\/"},{"volume-title":"Guidelines for ATC classification and DDD assignment 2024","year":"2023","author":"WHO collaborating Centre for Drug Statistics Methodology","key":"e_1_2_11_15_1"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.12.018"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/medicina54020030"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2007.07010007"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(17)30980\u20107"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270009336234"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290\u2010022\u201000426\u2010y"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2019.1612875"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010024\u201001487\u20105"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606\u2010011\u20101714\u20109"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27692"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102013\u2010204858"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2009.03.010"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744\u2010016\u20100032\u20104"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010013\u20100126\u20107"},{"key":"e_1_2_11_30_1","doi-asserted-by":"crossref","unstructured":"LasysT Santa\u2010Ana\u2010TellezY SiiskonenSJ WeirDL GroenwoldRHH GardarsdottirH.Project repository \u2010 impact of diclofenac risk minimization measures addressing cardiovascular risk on analgesic use in musculoskeletal disorders. Published Online 28 February2025. Accessed February 28 2025.https:\/\/osf.io\/rebhj\/","DOI":"10.1002\/bcp.70142"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70142","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T07:31:09Z","timestamp":1758871869000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70142"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,16]]},"references-count":29,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/bcp.70142"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70142","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"type":"print","value":"0306-5251"},{"type":"electronic","value":"1365-2125"}],"subject":[],"published":{"date-parts":[[2025,6,16]]}}}