An Observational Post-Authorisation Safety Study of Lesinurad Patients (SATURATES)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional population based prospective cohort study

Study drug and medical condition

• Name of medicine:
  ZURAMPIC
• Anatomical Therapeutic Chemical (ATC) code:
  (M04AB05) lesinurad

  lesinurad
• Medical condition to be studied:
  Hyperuricaemia

  Gout

Population studied

• 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:
  131200

Study design details

• Main study objective:
  To assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (MACE+) events in patients with gout after lesinurad is added to their existing XOI therapy regimen and in patients continuing on XOI monotherapy.
• Outcomes:
  Major Adverse Cardiac Events (MACE+), a composite endpoint comprised of: hospitalisation for non-fatal AMI, stroke, or unstable angina and cardiovascular (CV) death. CV death includes the following causes, occurring in or out of the hospital: AMI, sudden cardiac, heart failure, CV procedures, CV haemorrhage, stroke, underlying cerebrovascular cause, other CV causes. Hospitalisation for AKI including renal failure (with AKI as the primary diagnosis) and each individual component of MACE+.
• Data analysis plan:
  Characteristics for both cohorts will be summarised at the index date. The primary effect estimate is the relative incidence and 95% CI of MACE+ during person-time exposed to lesinurad+XOI compared to that exposed to XOI mono. Time to event for the primary analysis is the day after the start of the index treatment until the first occurrence of a MACE+ or censoring event. Descriptive analyses of MACE+ events and person-time of follow-up will be stratified by patient age group and history of CV disorders. Analysis for secondary endpoints will be conducted analogously.Sensitivity analyses will evaluate the robustness of the estimate for the relative incidence of MACE+ between the two cohorts by differing assumptions for inclusion criteria, exposure definition, outcome definition, and potential unmeasured confounding.If feasible, separate pooled analyses of European data sources and US data sources may be performed.