Prevalence and bleeding risk associated with the concomitant use of direct oral anticoagulants and antiarrhythmic drugs in patients with atrial fibrillation, based on the French healthcare insurance database.

Purpose: Pharmacokinetic interactions exist between apixaban or rivaroxaban, and CYP3A4 and P-glycoprotein inhibitors such as amiodarone, verapamil and diltiazem. We aimed to estimate the prevalence of exposure to this drug-drug association (DDA) and to assess the bleeding risk associated in patient...

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Publicado en:European Journal of Clinical Pharmacology Vol. 79; no. 7; pp. 937 - 946
Autores principales: Gosselin, Laëtitia, Vilcu, Ana-Maria, Souty, Cécile, Steichen, Olivier, Launay, Titouan, Conte, Cécile, Saint-Salvi, Béatrice, Turbelin, Clément, Sarazin, Marianne, Blanchon, Thierry, Hanslik, Thomas, Lapeyre-Mestre, Maryse, Rossignol, Louise
Formato: research tables/charts Journal Article
Publicado: Springer Nature Jul2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jul2023
      vid: 79
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00228-023-03501-8
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        atl: Prevalence and bleeding risk associated with the concomitant use of direct oral anticoagulants and antiarrhythmic drugs in patients with atrial fibrillation, based on the French healthcare insurance database.
      aug:
        au:
          Gosselin, Laëtitia
          Vilcu, Ana-Maria
          Souty, Cécile
          Steichen, Olivier
          Launay, Titouan
          Conte, Cécile
          Saint-Salvi, Béatrice
          Turbelin, Clément
          Sarazin, Marianne
          Blanchon, Thierry
          Hanslik, Thomas
          Lapeyre-Mestre, Maryse
          Rossignol, Louise
        affil: Sorbonne Université, INSERM, Institut Pierre Louis d'épidémiologie et de Santé publique (IPLESP), Paris, France
      sug:
        subj:
          Anticoagulants Therapeutic Use
          Hemorrhage Risk Factors
          Risk Assessment
          Antiarrhythmia Agents Therapeutic Use
          Atrial Fibrillation Drug Therapy
          Drug Interactions
          Adverse Drug Event
          Human
          Prospective Studies
          Rivaroxaban
          Hospitalization
          Cox Proportional Hazards Model
          Confidence Intervals
          Age Factors
          Sex Factors
          Pharmacovigilance
          Funding Source
          Prevalence
          France
      ab: Purpose: Pharmacokinetic interactions exist between apixaban or rivaroxaban, and CYP3A4 and P-glycoprotein inhibitors such as amiodarone, verapamil and diltiazem. We aimed to estimate the prevalence of exposure to this drug-drug association (DDA) and to assess the bleeding risk associated in patients with atrial fibrillation (AF). Methods: We conducted a cohort study using a representative 1/97th sample of the French healthcare insurance database between 2014 and 2019. Patients with AF receiving apixaban or rivaroxaban were included and followed-up until hospitalization for bleeding, death, discontinuation of apixaban or rivaroxaban, exposure to strong CYP3A4 inhibitor, or until December 31st 2019, whichever came first. Primary outcome was hospitalization for bleeding registered as primary diagnosis. The association between the exposure to the DDA and hospitalization for bleeding was evaluated as a time-dependent variable in Cox model. Results: Between 2014 and 2019, the AF population under apixaban or rivaroxaban represented 10,392 patients. During the study period, the annual average prevalence of DDA exposure in this population was 38.9%. Among the 10,392 patients, 223 (2.1%) were hospitalized for bleeding, of which 75 (33.6%) received the association and 148 (66.4%) received apixaban or rivaroxaban alone. There was no association between DDA exposure and risk of hospitalization for bleeding (aHR = 1.19, [95% CI: 0.90, 1.58]). Age (HR 1.03 [1.02, 1.05]) and male gender (HR 1.72 [1.28, 2.30]) were associated with an increased risk of hospitalization for bleeding. Conclusion: Exposure to antiarrhythmic drugs was not associated with an increased risk of hospitalization for bleeding in patients with AF under rivaroxaban or apixaban.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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