Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA12) lisdexamfetamine

  lisdexamfetamine
• Additional medical condition(s):
  Major Cardiovascular Events (MACE)

Population studied

• Short description of the study population:
  The source population will be all individuals aged 18 years or older registered in the study databases from the date LDX will become available for the treatment of ADHD in adults in each country until the end of study period. To be eligible for inclusion into the study population, individuals should have at least 12 months of data available prior to cohort entry. The study will include two cohorts identified from all eligible individuals in the study data sources: the LDX cohort and the remote use of other ADHD treatments cohort.
• 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:
  170940

Study design details

• Main study objective:
  The primary objective of this study is to estimate, in real-world settings, the incidence rate (IR) and the adjusted incidence rate ratios (IRRs) of the composite major adverse cardiovascular events (MACE) endpoint in a cohort of adult patients who are current new users of LDX compared with a cohort of remote users of other ADHD treatments in three European data sources.
• Outcomes:
  Major cardiovascular events (MACE). MACE, will comprise hospitalisation for acute myocardial infarction (AMI), fatal or non-fatal, hospitalisation for stroke, fatal or non-fatal, out-of-hospital coronary heart disease death, and out-of-hospital cerebrovascular death. Extended MACE (EMACE). EMACE comprises all MACE components plus hospitalisation for either unstable angina or transient ischaemic attack (TIA), the composite coronary and stroke components of EMACE, and a composite of sudden cardiac death and serious ventricular arrhythmias.
• Data analysis plan:
  Each research partner will conduct country-specific analyses within each data source to (1) select the study population, (2) describe the study cohorts, including patterns of demographics, medical history, exposures, and endpoints, (3) within its data, estimate exposure propensity scores that will be used to control for confounding, (4) create a summary of aggregated data set based on counts of patients, person-years, and outcome events according to the strata of age, sex and propensity scores, (5) analyse IR and standardised IRs, and (6) analyse crude and adjusted IRRs. IRs will be standardised to the distribution of person-time of LDX users by age, sex, quintiles of the propensity score, and data source. The coordinating centre activities include conducting a (1) pooled description analysis of study cohorts, (2) pooled analysis of IR and standardised IRs, and (3) pooled analysis of crude and adjusted IRRs. Mantel-Haenszel methods will be used to summarise IRRs across strata.

Documents

Study results

4765_Elvanse PASS_exec summary_FINAL_18Dec2020_Redacted