Drug utilisation and incident rates of adverse events in children with sialorrhoea who are treated with glycopyrronium (Glyco Sialorrhoea)

Study type

• Study topic:
  Human medicinal product

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GLYCOPYRRONIUM BROMIDE
• Medical condition to be studied:
  Salivary hypersecretion

Population studied

• Short description of the study population:
  The study participants were sialorrhoea children treated with glycopyrronium bromide identified from the Optimum Patient Care Research Database (OPCRD).
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with sialorrhoea
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  Retrospective Cohort study comprising of two components: Descriptive drug utilisation study of children with sialorrhoea who have been prescribed glycopyrronium. Hypothesis generating study regarding frequency or incidence of treatment-emergent adverse events in patients who have been prescribed glycopyrronium, as compared to those who are non users.
• Outcomes:
  Adverse Events in the cardiovascular, respiratory and renal systems in patients with sialorrhoea.
• Data analysis plan:
  1. As part of the drug utilisation study, we will record baseline demographics and duration of treatment, We will count the number of patient with diagnostic codes for sialorrhea, use of glycopyrronium, and the number of children with diagnoses of chronic neurological conditions (such as cerebral palsy). 2. We will use Poisson regression to analyse incidence rate of specific adverse events for all glycopyrronium users with sialorrhoea as compared to patients who have not been treated with glycopyrronium. For each particular adverse effect (classified according to major organ systems), we will only consider treatment-emergent adverse events in children who are ‘current users’ at that point in time. Follow-up time will be based on date of first prescription until 30 days after the last recorded prescription before age of 18 years is attained. We will estimate incidence in the control group based on follow-up time from diagnosis of sialorrhoea till age of 18 years.