Information über potentielle Wechselwirkungen von Protonen-Pumpen-Inhibitoren (PPI’s) mit Clopidogrel-haltigen Arzneimitteln

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7. Dezember 2009 – Sanofi Pharma Bristol-Myers Squibb informiert in Übereinstimmung mit dem Deutschen Bundesinstitut für Arzneimittel und Medizinalprodukte (BfArM) darüber, dass die Europäische Fachinformation (Summary of Product Characteristics, SPC) für Clopidogrel-Hydrogensulfat, in Verkehr gebracht als Plavix®, überarbeitet worden ist.

Danach wird in die SPC ein Warnhinweis aufgenommen, dass die gleichzeitige Einnahme von Clopidogrel-haltigen Arzneimitteln und Protonen-Pumpen-Inhibitoren (PPI’s) vermieden werden sollte, es sei denn, sie ist absolut notwendig. Clopidogrel [Plavix] kann bei Patienten, die solche Arzneimittelkombinationen erhalten, weniger wirksam sein. Diese Aktualisierung beruht auf mehreren neueren publizierten klinischen Studien über eine potentielle Wechselwirkung mit PPIs, die die Wirksamkeit Clopidogrel-haltiger Arzneimittel vermindem könnte.

Clopidogrel [Plavix] ist eine Prodrug, welche teilweise über das Cytocbrom P450 2C19 (CYP2C19) in der Leber metabolisiert wird, bevor es seine biologische Wirksamkeit zur Prävention atherotbrombotischer Ereignisse entfalten kann. PPI’s, also Arzneimittel, die eingesetzt werden, um peptischen Ulcera und gastroosophagealem Reflux vorzubeugen oder diese zu behandeln, können die Aktivität von CYP2C19 inhibieren. Obwohl die Evidenz der CYP2C19-Hemmung in der Gruppe der PPI’s variiert, betrifft diese Wechselwirkung möglicherweise alle Substanzen dieser Gruppe.

Zu den Arzneimitteln, die CYP2C19 hemmen, gehören neben PPI’s (Omeprazol- und Esomeprazol-haltige Arzneimittlel) auch andere Arzneimittel welche die Wirkstoffe Fluvoxamin, Fluoxetin, Moclobemid, Voriconazol, Fluconazol, Ticlopidin, Ciprofloxacin, Cimetidin, Carbamazepin, Oxcarbazepin oder Chloramphenicol enthalten.

Der Zulassungsinhaber Sanofi-Pharma Bristol-Myers Squibb führt gegenwärtig Studien durch, urn die potentiellen Effekte von PPIs und der genetischer Varianten von CYP2C19 auf die Aktivitat von Clopidrogel [Plavix] zucharakterisieren. Diese Untersuchungen sind wichtig da homozygote Träger der “Loss of Function” (Verlust der Funktion) -Varianten des CYP2C19 Genes, vor allem CYP2C19*2 und CYP2C19*3, tragen, sogar ohne Interaktion mit PPI’s und den anderen oben aufgeführten Arzneimitteln eine verminderte Umsetzung der Prodrug Clopidorgel [Plavix] und damit eine verminderte Wirksamkeit aufweisen könnten.

Die hier aufgeführten Betrachtungen gelten sinngemäss auch für das Arzneimittel Clopidogrel [Iscover].

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About the Author
Joseph Gut - thasso Professor in Pharmakologie und Toxikologie. Experte in theragenomischer und personalisierter Medizin und individualisierter Arzneimittelsicherheit. Experte in Pharmako- und Toxiko-Genetik. Experte in der klinischen Sicherheit von Arzneimitteln, Chemikalien, Umweltschadstoffen und Nahrungsinhaltsstoffen.

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