{"id":11575,"date":"2021-02-26T09:19:21","date_gmt":"2021-02-26T09:19:21","guid":{"rendered":"https:\/\/jurmed.ro\/medici\/?p=11575"},"modified":"2021-02-26T09:19:21","modified_gmt":"2021-02-26T09:19:21","slug":"indicatie-noua-pentru-plavix-clopidogrel-aprobata-acum-in-uniunea-europeana","status":"publish","type":"post","link":"https:\/\/jurmed.ro\/medici\/indicatie-noua-pentru-plavix-clopidogrel-aprobata-acum-in-uniunea-europeana\/","title":{"rendered":"Indicatie noua pentru Plavix (clopidogrel), aprobata acum in Uniunea Europeana"},"content":{"rendered":"

Plavix (clopidogrel) un medicament pentru reducerea accidentului vascular cerebral, infarctului miocardic si a decesului de cauze vasculare la pacientii cu istoric de accident vascular cerebral ischemic, infarct miocardic si boala vasculara periferica a fost aprobat de catre Comisia Europeana intr-o noua formula.<\/strong><\/p>\n

 <\/p>\n

Comisia Europeana a aprobat o indicatie suplimentara pentru Plavix (clopidogrel), pentru a include utilizarea sa in asociere cu aspirina la pacienti adulti cu accident vascular cerebral ischemic tranzitoriu (AIT) cu risc moderat pana la crescut (scor ABCD2 \u22654) sau cu accident vascular cerebral ischemic (AVC ischemic) minor (NIHSS1<\/sup> \u22643), in decurs de 24 de ore fie de la evenimentul de AIT, fie de la evenimentul de AVC ischemic2.<\/sup> Utilizarea conform acestei noi indicatii poate continua timp de 21 de zile, urmata de monoterapie antiagreganta plachetara pe termen lung.<\/p>\n

Indicatia suplimentara se bazeaza pe rezultatele a doua studii clinice dublu-orb, randomizate, controlate cu placebo, initiate de investigator, de faza 3, care au inclus peste 10.000 de pacienti. Studiile au aratat faptul ca asocierea de clopidogrel si aspirina initiata in decurs de 24 de ore este superioara tratamentului cu aspirina in monoterapie pentru reducerea riscului de accident vascular cerebral ulterior, cu un profil de siguranta general acceptabil3,4<\/sup>.<\/p>\n

\u201eO noua indicatie terapeutica aprobata de autoritati pentru clopidogrel, o medicatie consacrata deja in arsenalul terapeutic antitrombotic, reprezinta o speranta in plus pentru viata. Studiile clinice recente, care au stat la baza obtinerii acestei noi indicatii, au demonstrat reducerea riscului de recurenta a unui Accident Vascular Cerebral dupa un AVC ischemic minor sau un AIT cu risc moderat pana la crescut si extind astfel gama de cazuri clinice in care clopidogrel poate fi utilizat\u201d,<\/em> a declarat Dr. Eduard Prisacariu, Medical Head South Europe in cadrul Sanofi. \u201eAcest succes se adreseaza intregii comunitati medicale, ca o dovada a angajamentului nostru ferm pentru cresterea nivelului de ingrijire a pacientilor cu patologie cardiovasculara.\u201d<\/em><\/p>\n

De la lansarea sa acum 20 de ani, Plavix (clopidogrel) a fost utilizat de peste 200 de milioane de pacienti, cu sau fara aspirina, pentru diferite boli vasculare. A fost studiat la peste 250.000 de pacienti in cadrul studiilor clinice cu rezultate cardiovasculare (CVOT).<\/p>\n

In cadrul unei populatii internationale, studiul POINT3<\/sup> a testat asocierea de clopidogrel si aspirina pe 4.881 de pacienti, constatandu-se faptul ca un procent cu 25% mai mic de persoane au suferit evenimente ischemice majore dupa tratamentul cu clopidogrel si aspirina, comparativ cu tratamentul cu aspirina in monoterapie (5,0% fata de 6,5%; HR: 0,75; II 95%: 0,59 pana la 0,95; p=0,02).<\/p>\n

In cadrul studiului CHANCE4<\/sup>, care a randomizat 5.170 de pacienti din China dupa un eveniment initial de AVC ischemic minor sau AIT cu risc crescut, cu 32% mai putine persoane tratate cu clopidogrel si aspirina au suferit accidente vasculare cerebrale ulterioare comparativ cu cele tratate cu aspirina in monoterapie (8,2% fata de 11,7%; rata hazardului (HR): 0,68%; interval de incredere (II) 95%: 0,57 pana la 0,81; p<0,001) la 90 de zile.<\/p>\n

Nota editorului:<\/strong><\/p>\n

Plavix (clopidogrel) este un inhibitor P2Y12, care face trombocitele mai putin \u201elipicioase\u201d, cu scopul de a preveni formarea cheagurilor de sange in arterele pacientului. Este aprobat in peste 100 de tari la nivel mondial, in cadrul Uniunii Europene (UE), America de Nord si de Sud, Asia, Africa si Australia. Clopidogrel a fost aprobat prima data in U.E. in 1998 pentru reducerea accidentului vascular cerebral, infarctului miocardic si a decesului de cauze vasculare la pacientii cu istoric de accident vascular cerebral ischemic, infarct miocardic si boala vasculara periferica. Medicamentul antiplachetar a fost primul antagonist al receptorului ADP care a fost aprobat in U.E.<\/p>\n

In cei peste 20 de ani de la lansarea sa, acesta a fost utilizat de peste 200 de milioane de pacienti, cu sau fara aspirina, pentru diverse boli vasculare si a fost studiat la peste 250.000 de pacienti in cadrul studiilor clinice.<\/p>\n

Referinte<\/strong><\/p>\n

    \n
  1. National Institutes of Health, \u201cNIH Stroke Scale\u201d, disponibila la <\/em>https:\/\/www.ninds.nih.gov\/sites\/default\/files\/NIH_Stroke_Scale_Booklet.pdf<\/em><\/a> [accesat in februarie 2021]<\/em><\/li>\n
  2. Sanofi (2021): \u201ePlavix: Annex I – Summary of Product Characteristics\u201d, disponibil la: <\/em>https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/plavix-epar-product-information_ro.pdf<\/em><\/a><\/li>\n
  3. Johnston SC et al., 2018, N Engl J Med 2018; 379:215-225, DOI: 10.1056\/NEJMoa1800410.<\/em><\/li>\n
  4. Wang Y et al., 2013, N Engl J Med 2013; 369:11-19, DOI: 10.1056\/NEJMoa1215340.<\/em><\/li>\n<\/ol>\n

     <\/p>\n

    Despre Sanofi<\/a><\/p>\n

    Suntem o companie biofarmaceutica globala dedicata sanatatii umane. Cu ajutorul a peste 100.000 de angajati in 100 de tari, Sanofi transforma inovatia stiintifica in solutii pentru sanatate pretutindeni in lume.<\/p>\n

    Le suntem aproape si celor care sufera de boli rare, dar si milioanelor de persoane care au fost diagnosticate cu o boala acuta sau cronica.<\/p>\n

    Sanofi, Empowering Life<\/p>\n

    Despre Sanofi Romania<\/a><\/p>\n

    Sanofi Romania este unul dintre liderii industriei farmaceutice locale, avand un portofoliu complex, gestionat prin intermediul a 4 divizii: ingrijire medicala primara (General Medicine – diabet, boli cardiovasculare, medicamente mature), ingrijire specializata (Specialty Care \u2013 boli rare, scleroza multipla, oncologie), vaccinuri (Sanofi Pasteur), si medicamente fara prescriptie si suplimente alimentare (Consumer HealthCare). Aducem stiinta si inovatia mai aproape de pacientii din Romania.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Plavix (clopidogrel) un medicament pentru reducerea accidentului vascular cerebral, infarctului miocardic si a decesului de cauze vasculare la pacientii cu istoric de accident vascular cerebral ischemic, infarct miocardic si boala […]<\/p>\n","protected":false},"author":6,"featured_media":10281,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[717,716,86],"class_list":["post-11575","post","type-post","status-publish","format-standard","has-post-thumbnail","category-stiri-noutati","tag-clopidogrel","tag-plavix","tag-sanofi"],"yoast_head":"\nPlavix (clopidogrel) indicatie noua aprobata de Uniunea Europeana<\/title>\n<meta name=\"description\" content=\"Plavix (clopidogrel); Sanofi; Comisia Europeana; aspirina; AVC ischemic; accident vascular cerebral ischemic cu risc crescut;\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jurmed.ro\/medici\/indicatie-noua-pentru-plavix-clopidogrel-aprobata-acum-in-uniunea-europeana\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Plavix (clopidogrel) indicatie noua aprobata de Uniunea Europeana\" \/>\n<meta property=\"og:description\" content=\"Plavix (clopidogrel); 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