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Sanofi Drug Utilisation Study of alirocumab in Europe.

  • Research type

    Research Study

  • Full title

    A drug utilization study (DUS) of alirocumab in Europe to assess the effectiveness of the dosing recommendation to avoid very low LDL-C levels.

  • IRAS ID

    245146

  • Contact name

    Graeme Esslemont

  • Contact email

    graeme.esslemont@sanofi.com

  • Sponsor organisation

    Aventis Pharma Ltd, trading as Sanofi

  • Duration of Study in the UK

    2 years, 11 months, days

  • Research summary

    Sanofi 0B514697 is a multicentre drug utilization study (DUS) of alirocumab (Praluent) in 6 European countries. This observational study will assess how effective the current 3 dosing recommendations of Praluent are in avoiding very low LDL-C levels while lowering LDL-C levels. In addition, this study will investigate how the 3 recommended doses of Praluent are prescribed in real life and in certain clinical situations. Being retrospective (i.e. data is collected after the fact), this study involves no intervention and will not impact the usual medical care or affect the treatment of patients. The study aims to include approximately 1200 medical records of patients who were initiated on Praluent during defined eligibility periods.

  • REC name

    London - Queen Square Research Ethics Committee

  • REC reference

    18/LO/0801

  • Date of REC Opinion

    14 May 2018

  • REC opinion

    Further Information Favourable Opinion