RETrospective Observational Study of Evolocumab Use in Spanish Endocrinology Units (RETOSS-Endo) (20160140)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  The clinical characteristics of patients initiating evolocumab in Spanish Hospital Endocrinology Units, and how is their clinical management
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Observational Study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EVOLOCUMAB
• Medical condition to be studied:
  Hyperlipidaemia

Population studied

• Short description of the study population:
  Patients with hypercholesterolemia, who initiated evolocumab as part of routine clinical management of their hyperlipidaemia, from February 1st, 2016 to April 30th 2017, by an specialist in an Hospital Endocrinology Unit in Spain.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with hyperlipidaemia
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  To describe the main clinical characteristics of patients with hyperlipidemia initiating evolocumab in Hospital Endocrinology Units
• Outcomes:
  LDL-C pre-initiation of evolocumab, Diabetes status at evolocumab initiation, year of diagnosis, insulin and/or oral hypoglycemic treatment, retinopathy, diabetic nephropathy or diabetic foot), FH status at evolocumab initiation, Demographic and clinical variables at evolocumab initiation, Family medical history at evolocumab initiation, Medical history and CV risk at evolocumab initiation, Laboratory parameters over time, Clinical Factor/s that determined evolocumab prescription at initiation, use of evolocumab and other lipid-lowering therapies over time
• Data analysis plan:
  Analyses will be performed on all included subjects who fulfill all the selection criteria. 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.For the outcome measure of LDL-C and other laboratory values over time, the data will be assigned to predefined time-points according to specific windows detailed in the protocol.Statistical analyses will be descriptive only. No statistical inference or imputations of missing data are planned.

Documents

Study results

RETOSS-Endo (AMG1092)_CSR_Final_Abstract