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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43665
• EU PAS number:
  EUPAS21314
• Study ID:
  43665
• Official title and acronym:
  A drug utilization study (DUS) of alirocumab in Europe to assess the effectiveness of the dosing recommendation to avoid very low LDL-C levels
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  This is a drug utilization study to evaluate the effectiveness of the alirocumab dosing recommendations for the 3 approved dosage regimens to date, ie, 75 mg every two weeks, 150 mg every two weeks, and 300 mg once every 4 weeks (monthly) to avoid very low LDL C levels. The secondary objective is to describe the pattern of alirocumab utilization in real-world clinical practice with respect to the dosing recommendations in the labelling of the 3 approved dosage regimens to date, ie, 75 mg every two weeks, 150 mg every two weeks, and 300 mg once every 4 weeks (monthly) to avoid very low LDL-C levels.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 06/11/2017

Actual: 06/11/2017

Study start date

Planned: 30/03/2018

Actual: 20/08/2019

Date of final study report

Planned: 30/09/2021

Actual: 10/08/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi/Regeneron

Study protocol

Initial protocol

rdct-obs14697-16-1-1-pass-amended-protocol02-PDFA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

OBS14697