Post-authorisation Safety Study to Evaluate the Long-term Safety of Dexamfetamine (Amfexa) (PASS for dexamfetamine)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-authorisation Safety Study (PASS)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA02) dexamfetamine

  dexamfetamine
• Medical condition to be studied:
  Cardiovascular disorder

  Psychiatric symptom

  Delayed puberty

  Growth retardation

Population studied

• Short description of the study population:
  ADHD children newly exposed to dexamfetamine or another stimulant; Inclusion criteria; - Boys and girls 6 to 17 years of age at the time of first stimulant prescription; - At least 1 diagnosis of ADHD based on; o Read code (THIN) (e.g., E2E0.00 child attention deficit disorder, E2E0100 attention deficit with hyperactivity, etc.); o Three character ICD10 code, i.e., F90 (German DA); o ICD 9 codes, i.e., 314.01 (PharMetrics Plus); - At least 1 prescription of a stimulant (dexamfetamine, methylphenidate or lisdexamfetamine) used for the treatment of ADHD (refer to Annex 3 for list of drug codes); - At least 6 months of enrolment in the database prior to first prescription of stimulant; Exclusion criteria; The following exclusion criteria apply to all three databases:; - Previous diagnosis of cardiovascular disease, psychiatric illness, or impairment in growth or sexual maturation, to be applied for each subcohort separately (see table in Section 9.3.1). For example, for cohort 1 that has incident cardiovascular events as outcome of interest, only patients with a history of cardiovascular disease will be excluded.; - History of narcolepsy (all four cohorts); - Congenital heart disorders (all four cohorts)
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Cardiovascular disorder, Psychiatric symptom, Delayed puberty, Growth retardation
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  Assess the incidence proportion and incidence rate for cardiovascular, psychiatric and growth related adverse events Compare the relative risk of long-term cardiovascular, psychiatric and growth related adverse events
• Data analysis plan:
  Descriptive analyses will be performed to compare populations who have taken dexamfetamine with those who have taken other stimulants on the market. Incidence proportions and incident rates of each AE grouping will be provided. Multivariate analysis will be performed for each adverse event of interest using regression methods as appropriate to control for any potential confounders. Stratification based on sex and dosage will also be conducted.

Documents

Study results

Dexamfetamine PASS Abstract of Final Report V3 18-05-2021 privacy