Abstract

Introduction: Dabigatran etexilate is used for preventing blood clots and tends to replace older anticoagulants in many of their indications. However, the 'one dose fits all' policy is subject to criticism. Recent findings assert the anxiety of the scientific community concerning the pharmacokinetic properties of dabigatran etexilate, that is, an important interindividual variability including an important genetic variant with a significant dependence of the renal function as route of elimination.Areas covered: This meta-opinion provides an overview of the current knowledge and evidence on the dose tailoring of dabigatran etexilate. It also discusses the remaining challenges to benefit from this perspective strategy to enhance the benefit-risk balance of dabigatran etexilate. Data were searched in the published literature and on regulatory agencies' websites. Additionally, unpublished data were searched and discussed.Expert opinion: Causality between dabigatran exposure and bleeding risk is now established and recommendations on how to best estimate the drug exposure are published. Additionally, simulating studies revealed that a dose adaptation based on dabigatran plasma concentration estimations could improve the benefit-risk profile of the drug. This accumulating evidence suggests that some patients under dabigatran etexilate may benefit from a tailoring of the dose beyond the ones already proposed by the manufacturer.

Original languageEnglish
Pages (from-to)1283-1289
Number of pages7
JournalExpert Opinion On Drug Safety
Volume14
Issue number8
Early online date21 May 2015
DOIs
Publication statusPublished - 1 Aug 2015

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Expert Testimony
Dabigatran
Causality
Pharmaceutical Preparations
Anticoagulants
Thrombosis
Anxiety
Pharmacokinetics
Hemorrhage
Kidney

Keywords

  • Anticoagulant drugs
  • Benefit-risk assessment
  • Dabigatran etexilate
  • Drug monitoring

Cite this

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title = "Dose tailoring of dabigatran etexilate: Obvious or excessive?",
abstract = "Introduction: Dabigatran etexilate is used for preventing blood clots and tends to replace older anticoagulants in many of their indications. However, the 'one dose fits all' policy is subject to criticism. Recent findings assert the anxiety of the scientific community concerning the pharmacokinetic properties of dabigatran etexilate, that is, an important interindividual variability including an important genetic variant with a significant dependence of the renal function as route of elimination.Areas covered: This meta-opinion provides an overview of the current knowledge and evidence on the dose tailoring of dabigatran etexilate. It also discusses the remaining challenges to benefit from this perspective strategy to enhance the benefit-risk balance of dabigatran etexilate. Data were searched in the published literature and on regulatory agencies' websites. Additionally, unpublished data were searched and discussed.Expert opinion: Causality between dabigatran exposure and bleeding risk is now established and recommendations on how to best estimate the drug exposure are published. Additionally, simulating studies revealed that a dose adaptation based on dabigatran plasma concentration estimations could improve the benefit-risk profile of the drug. This accumulating evidence suggests that some patients under dabigatran etexilate may benefit from a tailoring of the dose beyond the ones already proposed by the manufacturer.",
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Dose tailoring of dabigatran etexilate : Obvious or excessive? / Douxfils, Jonathan; Mullier, François; Dogné, Jean Michel.

In: Expert Opinion On Drug Safety, Vol. 14, No. 8, 01.08.2015, p. 1283-1289.

Research output: Contribution to journalArticle

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