Edoxaban prescription patterns in Europe: a retrospective drug utilisation chart review study (ETNA-DUS)

Study identification

• EU PAS number:
  EUPAS17062
• Study ID:
  26641
• Official title and acronym:
  Edoxaban prescription patterns in Europe: a retrospective drug utilisation chart review study (ETNA-DUS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Portugal

  Spain

  Switzerland

  United Kingdom
• Study description:
  Edoxaban (E.) is an orally administered anticoagulant that inhibits coagulation factor Xa. It is currently approved for use in adult patients with Non-Valvular Atrial Fibrillation (NVAF) with one or more risk factors, such as Congestive Heart Failure (CHF), hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or Transient Ischemic Attack (TIA) for prevention of stroke and systemic embolism. In addition, E. is approved for the treatment of Venous Thromboembolism (VTE) including Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE), and prevention of recurrent VTE in adults.Clinical development programs have been undertaken to support marketing authorization submissions for E. in those indications. However, as it is the case with any medicinal product, real-life use of E. may differ from or extend beyond the patient population that has been studied in the phase 3 program or is included under the approved indication. One of the concerns in real-world use of medicinal practices is the off-label use. Daiichi Sankyo (DS) addressed this concern in the Risk Management Plan in order to anticipate necessary risk minimization activities. The potential off-label use of E. in unapproved indications was considered low, because of the availability of approved, indicated and well-established treatment alternatives. In order to further optimise the correct use of the medicinal product by the physician, DS is implementing additional risk minimisation activities such as a prescriber guide as part of the educational programs for prescribers (information about approved indications, E. eligible patients, dosing and safety concerns management) and patient alert card.The Drug Utilisation Study (DUS) aims to gain insight on how this new European medicinal product is going to be used in real practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Barnet General Hospital

PD Dr. Ameet Bakhai

Study timelines

Date when funding contract was signed

Actual:08/08/2016

Study start date

Actual:12/12/2016

Date of interim report, if expected

Planned:29/09/2017

Actual:27/09/2017

Date of final study report

Planned:30/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daiichi Sankyo Europe GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable