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Castellsague_et_al-2018-Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany.pdf 319,36KB
WeightNameValue
1000 Titel
  • Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany
1000 Autor/in
  1. Castellsague, Jordi |
  2. Poblador-Plou, Beatriz |
  3. Giner-Soriano, Maria |
  4. Linder, Marie |
  5. Scholle, Oliver |
  6. Calingaert, Brian |
  7. Bui, Christine |
  8. Arana, Alejandro |
  9. Laguna, Clara |
  10. Gonzalez Rubio, Francisca |
  11. Roso-Llorach, Albert |
  12. Prados-Torres, Alexandra |
  13. Perez-Gutthann, Susana |
1000 Erscheinungsjahr 2018
1000 LeibnizOpen
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2018-07-25
1000 Erschienen in
1000 Quellenangabe
  • 27(9):953-961
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2018
1000 Lizenz
1000 Verlagsversion
  • http://dx.doi.org/10.1002/pds.4584 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175151/ |
1000 Ergänzendes Material
  • https://onlinelibrary.wiley.com/doi/abs/10.1002/pds.4584#support-information-section |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • PURPOSE: The purpose of the study is to evaluate the effectiveness of risk minimization measures—labeling changes and communication to health care professionals—recommended by the European Medicines Agency for use of cilostazol for the treatment of intermittent claudication in Europe. METHODS: Observational study of cilostazol in The Health Improvement Network (United Kingdom), EpiChron Cohort (Spain), SIDIAP (Spain), Swedish National Databases, and GePaRD (Germany). Among new users of cilostazol, we compared the prevalence of conditions targeted by the risk minimization measures in the periods before (2002‐2012) and after (2014) implementation. Conditions evaluated were prevalence of smoking, cardiovascular conditions, concurrent use of ≥2 antiplatelet agents, concurrent use of potent CYP3A4/CYP2C19 inhibitors and high‐dose cilostazol, early monitoring of all users, and continuous monitoring of users at high cardiovascular risk. RESULTS: We included 22 593 and 1821 new users of cilostazol before and after implementation of risk minimization measures, respectively. After implementation, the frequency of several conditions related to the labeling changes improved in all the study populations: prevalence of use decreased between 13% (EpiChron) and 57% (SIDIAP), frequency of cardiovascular contraindications decreased between 8% (GePaRD) and 84% (EpiChron), and concurrent use of high‐dose cilostazol and potent CYP3A4/CYP2C19 inhibitors decreased between 6% (Sweden) and 100% (EpiChron). The frequency of other conditions improved in most study populations, except smoking, which decreased only in EpiChron (48% reduction). CONCLUSIONS: This study indicates that the risk minimization measures implemented by the EMA for the use of cilostazol have been effective in all European countries studied, except for smoking cessation before initiating cilostazol, which remains an area of improvement.
1000 Sacherschließung
lokal Risk minimization
lokal Cilostazol
lokal Pharmacoepidemiology
lokal Intermittent claudication
lokal Peripheral artery disease
lokal Database study
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/creator/Q2FzdGVsbHNhZ3VlLCBKb3JkaQ==|https://frl.publisso.de/adhoc/creator/UG9ibGFkb3ItUGxvdSwgQmVhdHJpeg==|http://orcid.org/0000-0003-3750-9233|https://frl.publisso.de/adhoc/creator/TGluZGVyLCBNYXJpZQ==|https://frl.publisso.de/adhoc/creator/U2Nob2xsZSwgT2xpdmVy|https://frl.publisso.de/adhoc/creator/Q2FsaW5nYWVydCwgQnJpYW4=|https://frl.publisso.de/adhoc/creator/QnVpLCBDaHJpc3RpbmU=|https://frl.publisso.de/adhoc/creator/QXJhbmEsIEFsZWphbmRybw==|https://frl.publisso.de/adhoc/creator/TGFndW5hLCBDbGFyYQ==|http://orcid.org/0000-0001-5939-4436|https://frl.publisso.de/adhoc/creator/Um9zby1MbG9yYWNoLCBBbGJlcnQ=|https://frl.publisso.de/adhoc/creator/UHJhZG9zLVRvcnJlcywgQWxleGFuZHJh|http://orcid.org/0000-0001-5798-3691
1000 Label
1000 Förderer
  1. Otsuka Pharmaceutical Europe Ltd. |
1000 Fördernummer
  1. -
1000 Förderprogramm
  1. -
1000 Dateien
  1. Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Otsuka Pharmaceutical Europe Ltd. |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6410321.rdf
1000 Erstellt am 2018-10-01T13:13:39.563+0200
1000 Erstellt von 266
1000 beschreibt frl:6410321
1000 Bearbeitet von 218
1000 Zuletzt bearbeitet Tue May 31 17:18:11 CEST 2022
1000 Objekt bearb. Tue May 31 17:18:10 CEST 2022
1000 Vgl. frl:6410321
1000 Oai Id
  1. oai:frl.publisso.de:frl:6410321 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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