{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T15:48:12Z","timestamp":1747151292511,"version":"3.40.5"},"reference-count":18,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2019,9,4]],"date-time":"2019-09-04T00:00:00Z","timestamp":1567555200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011725","name":"Servier","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100011725","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":[[2019,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>This drug utilization study of ivabradine evaluated prescriber compliance with the new risk minimization measures (RMMs), communicated starting 2014 following preliminary results from the SIGNIFY study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a multinational (five European countries) chart review study with two study periods: pre\u2010RMM and post\u2010RMM. Patients initiating ivabradine for chronic stable angina pectoris in routine clinical practice were identified across general practitioners and specialists. The primary outcome analysis evaluated the compliance with the new RMMs, ie, use in patients with a heart rate greater than or equal to 70 bpm at initiation, no doses higher than those recommended in the summary of product characteristics (SmPC) at initiation and during 6 months of follow\u2010up, and no concomitant use of verapamil or diltiazem.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 711 and 506 eligible patients were included in the pre\u2010RMM and post\u2010RMM periods, respectively. The percentage of patients prescribed ivabradine according to the new RMMs increased significantly in the post\u2010RMM period (70.6% and 78.4% in the pre\u2010 and post\u2010RMM periods respectively; <jats:italic>P<\/jats:italic> value = .0035). The compliance to RMMs increased for all the criteria assessed independently: the proportions of patients with (a) heart rate \u2265 70 bpm at initiation (79.4% and 85.2%, respectively; <jats:italic>P<\/jats:italic> value = .0141), (b) no dose higher than the SmPC doses at initiation and during follow\u2010up (92.8% and 94.1%, respectively; <jats:italic>P<\/jats:italic> value = .3957), and (c) no concomitance with verapamil or diltiazem (96.1% and 99.2%, respectively; <jats:italic>P<\/jats:italic> value = .0007).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The RMMs for ivabradine were well implemented across the five participating European countries confirming a favorable benefit\u2010risk balance of ivabradine in chronic stable angina pectoris.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4880","type":"journal-article","created":{"date-parts":[[2019,9,5]],"date-time":"2019-09-05T03:35:13Z","timestamp":1567654513000},"page":"1470-1479","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Ivabradine drug utilization study in five European countries: A multinational, retrospective, observational study to assess effectiveness of risk\u2010minimization measures"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0246-615X","authenticated-orcid":false,"given":"Linda","family":"Salem","sequence":"first","affiliation":[{"name":"Department of Pharmacoepidemiology and Real World Evidence Les Laboratoires Servier  CEDEX France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandre","family":"Malouvier","sequence":"additional","affiliation":[{"name":"PRA Health Sciences  Levallois\u2010Perret France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon","family":"Blatchford","sequence":"additional","affiliation":[{"name":"PRA Health Sciences  Reading United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Rivero\u2010Ferrer","sequence":"additional","affiliation":[{"name":"RTI Health Solutions  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Deltour","sequence":"additional","affiliation":[{"name":"Department of Pharmacoepidemiology and Real World Evidence Les Laboratoires Servier  CEDEX France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuelle","family":"Jacquot","sequence":"additional","affiliation":[{"name":"Department of Pharmacoepidemiology and Real World Evidence Les Laboratoires Servier  CEDEX France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,9,4]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Procoralan summary of product characteristics (SmPC). Updated April2018. Available at:http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/000597\/human_med_000995.jsp&mid=WC0b01ac058001d124. Accessed 07 December 2018."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1406430"},{"key":"e_1_2_11_4_1","unstructured":"European Commission.Commission implementing regulation (EU) No 520\/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726\/2004 of the European Parliament and of the Council and Directive 2001\/83\/EC of the European Parliament and of the Council. 20 June2012. Available at:http:\/\/eurlex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF. Accessed 02 November 2018."},{"key":"e_1_2_11_5_1","unstructured":"European Medicines Agency.PRAC recommends measures to reduce risk of heart problems with Corlentor\/Procoralan (ivabradine) [press release]. 11 November2014. 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