The Risk of Dystonia among Children and Adolescents Treated with Atomoxetine within the Truven MarketScan Database (B4Z-MC-B031)

Study type

• Study topic:
  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:
  (N06BA09) atomoxetine

  atomoxetine

Population studied

• Short description of the study population:
  Children and adolescents (6-17 years of age) treated with atomoxetine with at least 6 months (180 days) of continuous enrolment in the Truven Health Analytics MarketScan database prior to index date.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  337182

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the incidence and risk of dystonia among atomoxetine treated patients between 6 to 17 years of age relative to a propensity score matched cohort of stimulant treated patients.
• Outcomes:
  Dystonia (as indicated by presence of ICD-9-CM codes 333.7, 333.72, 333.79, 333.81, 333.83, 333.84, or 333.89).
• Data analysis plan:
  The primary analysis will be a comparison of the risk of dystonia in patients initiating atomoxetine relative to a propensity score matched cohort of individuals initiating a stimulant. This comparison will be carried out using Cox proportional hazards regression. An overview of the analysis strategy is outlined below:-Estimate propensity score for atomoxetine initiation for each patient in the atomoxetine and stimulant cohorts-Use Greedy 1:1 matching algorithm to form propensity score matched sample-Assess balance between cohorts across all baseline covariates using standardised differences-Revise and finalize propensity score as needed-Estimate the hazard ratio (HR) (with 95% confidence interval) of dystonia associated with atomoxetine using a Cox proportional hazards regression model-Perform sensitivity analyses-Assess generalisability by summarising population characteristics and outcomes for patients included and excluded by matching process

Documents

Study results

LY139603-B4Z-MC-B031 PASS Final Study Report Version 2

Study publications

Meyers KJ, Upadhyaya HP, et al. Evaluation of dystonia in children and adolesce…