Observational Serial Chart Review of Repatha® Use in European Subjects with Hyperlipidaemia (20130296)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To describe clinical characteristics of subjects using Repatha
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multicountry, observational, serial chart review

Study drug and medical condition

• Medical condition to be studied:
  Hyperlipidaemia

Population studied

• Short description of the study population:
  Patients receiving Repatha® as part of routine clinical management of their hyperlipidaemia.; ; All inclusion criteria need to be met, as follows:; • Adults (≥ 18 years); • Provided informed consent if applicable according to local requirements; • Initiated on Repatha® at physician’s discretion, after 1st August 2015; • Received at least one dose of Repatha®; ; Exclusion Criteria; If at least one exclusion criterion is met, subject is not eligible for participation in the study, as follows:; • Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®; • Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®
• 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:
  2000

Study design details

• Main study objective:
  To ascertain the clinical characteristics of patients who are prescribed Repatha® in the post-launch period, and how their treatment is managed
• Outcomes:
  To describe the clinical characteristic of subjects at initiation of Repatha®, To describe LDL-C and other cholesterol concentrations over time To described treatment patterns of use of Repatha® over time To describe treatment patterns of use of other lipid modifying therapies over time To describe Health Resource Utilisation components, including hospitalisations and physician visits
• Data analysis plan:
  All summaries of the data will be descriptive in nature. For categorical variables the frequency and percentage, with 95% confidence interval, will be given. Summary statistics for continuous variables will include the number of subjects, mean, median, standard deviation or standard error, 25th percentile (Q1), 75th percentile (Q3), minimum, and maximum. Regarding the primary endpoints, summaries displaying frequency and percentage, with 95% confidence intervals will be presented for FH status, CV history and diabetic status at the time of initiation of Repatha®, while summary statistics displaying the number of subjects, mean, median, standard deviation, 25th percentile (Q1), 75th percentile (Q3), minimum, and maximum will be presented for LDL-C at the time of initiation of Repatha®. The primary intention is to analyse data for each country separately, but the final analysis will also be conducted for all countries pooled.

Documents

Study results

Observational Research Study Report 20130296_Redacted