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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PRALUENT

Population studied

• Short description of the study population:
  Patients who were initiated with Praluent (brand name of alirocumab), 75 mg once every two weeks, 150 mg once every two weeks, or 300 mg once every 4 weeks (monthly). ; Inclusion criteria; Physicians who meet the following inclusion criterion will be eligible to participate in this study:; I 01. At least one initial prescription of Praluent during the eligibility period.; Eligible patients for retrospective data collection will be those meeting the following criteria:; I 02. Initiated with Praluent following a first prescription during the eligibility period.; I 03. Signed written informed consent, if it is required by the country.; Exclusion criteria; Physicians who meet one or more of the following exclusion criteria will be excluded from this study:; E 01. Have participated in any randomized clinical trials with Praluent (alirocumab).; E 02. Have participated in a previous wave of this study.; Patients who meet one or more of the following exclusion criteria will be excluded from this study:; E 03. Have participated in any randomized clinical trials with Praluent (alirocumab).; E 04. Medical chart not retrievable, empty or missing
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  890

Study design details

• Main study objective:
  The primary objective of this study is to assess the effectiveness of the dosing recommendations for the 3 approved dosage regimens to date. The secondary objective is to describe the pattern of alirocumab utilization in real-world clinical practice
• Outcomes:
  - Occurrence of very low LDL-C levels (both definitions of very low LDL-C <25 mg/dL 0.65 mmol/L and <15 mg/dL 0.39 mmol/L will be presented), - Evolution of LDL-C level after the occurrence of very low LDL-C level, - Change in treatment after the occurrence of very low LDL-C level. - The starting dose of Praluent, - The dosage regimen modification of Praluent, - Timing of LDL-C tests, - Discontinuation of Praluent: reasons will be described, if available, - Reason for Praluent prescription, - Adverse events.
• Data analysis plan:
  The following descriptive analyses will be presented on the eligible population: A. Occurrence of very low LDL-C level A LDL-C level <25 mg/dL (0.65 mmol/L) is defined as very low, and an alternative definition with a cut-off at 15 mg/dL (0.39 mmol/L) will also be used. B. Evolution of LDL-C level after the occurrence of very low LDL-C level C. Change in treatment after the occurrence of very low LDL-C level

Documents

Study results

rdct-obs14697-CSR synopsis-PDFA