EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care DA VINCI

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Characterise unmet medical need
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  REPATHA
• Medical condition to be studied:
  Ischaemic stroke

  Myocardial infarction

  Peripheral vascular disorder

  Hypercholesterolaemia

Population studied

• Short description of the study population:
  1. Low density lipoprotein-cholesterol (LDL-C) measurement within 14 months of enrolment, obtained independently of participation in a clinical trial; 2. Use of any LMT (may include statin/ezetimibe/fibrate/PCSK9 inhibitor/bile acid absorption inhibitor/nicotinic acid/other) at time of enrolment, or any LMT; prescribed within 12 months prior to date of enrolment, or any LMT prescribed at date of enrolment; 3. Age 18 years or older at enrolment; 4. Provided informed consent/notified according to local requirements; 5. Subject expected to survive for at least 1 year after enrolment
• 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:
  6000

Study design details

• Main study objective:
  To estimate the proportion of subjects in EU primary and secondary care, with or without established ASCVD and receiving LMT, with LDL-C above 2016 Joint ESC Guideline recommended levels
• Outcomes:
  LDL-C measurement most recent to enrolment, Lipid levels (total cholesterol, non-HDL-C, HDL, triglycerides, Lp(a), apo B100, apo A1) most recent to enrolment, use of Lipid-modifying therapy (type, dose, frequency), clinical characteristics at time of enrolment
• Data analysis plan:
  All summaries of data will be descriptive in nature: categorical variables in frequency and percentage with 95% confidence intervals and continuous variables in mean (standard deviation) and/or median with percentiles, minimum and maximum.

Documents

Study results

20150333_DA VINCI FINAL ORSR abstract 16AUG19 incl PI signature - 120919_redacted