DARWIN EU® - Incidence of myoclonus in heart failure: a descriptive analysis in patients treated with sacubitril/valsartan and other treatments

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ENTRESTO
• Study drug International non-proprietary name (INN) or common name:
  SACUBITRIL

  VALSARTAN
• Anatomical Therapeutic Chemical (ATC) code:
  (C09DX04) valsartan and sacubitril

  valsartan and sacubitril
• Medical condition to be studied:
  Myoclonus

Population studied

• Short description of the study population:
  The source population will include all patients present in the database from January 1st, 2015 (first EU approval of sacubitril/valsartan) to 31st December 2023 (or the last available date). All patients will be required to have at least 365 days of observation time before the index date and be 18 years of age or above at index date.

Study design details

• Study design:
  The incidence of the event of interest will be assessed using a population-level descriptive epidemiology design.
• Main study objective:
  1. To calculate the incidence rate of myoclonus in a newly diagnosed heart failure population and the general population, stratified by age groups and sex. ; 2. To calculate the incidence rate of myoclonus in a heart failure population following first initiation of treatment cohorts: sacubitril/valsartan, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARBs) (index date being the start of the treatment).

Documents

Study report

DARWIN EU_Report_P3-C1-015_Sacubitril valsartan and risk of myoclonus V3.pdf