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Secular trends in the use of valproate-containing medicines in young women in Europe: a multinational DARWIN EU® network study
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  • Lucía Bellas,
  • Martí Català,
  • Edward Burn,
  • Yuchen Guo,
  • Mike Du,
  • Katia Verhamme,
  • Egil Fridgeirsson,
  • Talita Duarte,
  • Tommi Kauko,
  • Eeva Kronqvist,
  • James T. Brash,
  • Sarah Seager,
  • Daniel Prieto-Alhambra,
  • Annika M. Jödicke,
  • Albert Prats-Uribe
Lucía Bellas
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Martí Català
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Edward Burn
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Yuchen Guo
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Mike Du
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Katia Verhamme
Erasmus MC
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Egil Fridgeirsson
Erasmus MC
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Talita Duarte
Erasmus MC
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Tommi Kauko
Turun yliopisto Kliininen laitos
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Eeva Kronqvist
Turun yliopisto Kliininen laitos
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James T. Brash
IQVIA Real World Evidence
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Sarah Seager
IQVIA Real World Evidence
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Daniel Prieto-Alhambra
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Annika M. Jödicke
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
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Albert Prats-Uribe
University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences

Corresponding Author:a.prats-uribe@darwin-eu.org

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Abstract

Valproate-containing medicines (VPA) are first-line treatment for epilepsy; however, they pose teratogenic risks, restricting their use in women of childbearing age. We aimed to estimate the secular trends in use of VPA and alternative treatments in young women, and to characterise dose/strength, treatment duration and indication in new VPA users We conducted a population-based cohort study using primary care records from the Netherlands, Spain and the UK, primary and outpatient specialist care records from Germany and Belgium (and hospital records from Finland, all mapped to the OMOP Common data model. All women present in the databases aged ≥12 years and ≤55 years on 1st of January of each year in the period 2010-2022 (or latest available), with at least 365 days of prior observation were included. Incidence and prevalence of VPA use in young women decreased between 2010 and 2021, while prevalence of the alternative treatments pregabalin and gabapentin increased, especially in CPRD (it rises from 0.5% to 1.5%). Median age of new VPA users ranged between 40-43 years. Anxiety and depressive disorder were frequent comorbidities, and use of hormonal contraceptives low. Average treatment duration varied substantially across databases . Incidence and prevalence of use of VPA among young women declined since 2015. Conversely, alternative antiepileptics have increased in uptake, particularly gabapentinoids. The use of standardized federated analytics allowed for a rapid assessment of VPA utilisation, supporting the regulatory agencies in their decision making and improving patient safety across Europe.
04 Sep 2024Submitted to Pharmacoepidemiology and Drug Safety
04 Sep 2024Submission Checks Completed
04 Sep 2024Assigned to Editor
04 Sep 2024Review(s) Completed, Editorial Evaluation Pending
16 Sep 2024Reviewer(s) Assigned
26 Nov 2024Editorial Decision: Revise Major
14 Dec 20241st Revision Received