An observational evaluation of the off-label prescribing and safety of glycopyrronium bromide for symptomatic treatment of severe sialorrhoea (drooling) and/or hyperhidrosis (excessive sweating) (Glycopyrronium Bromide)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients prescribed glycopyrronium bromide (GLY) for sialorrhoea and/or excessive sweating were compared to those not prescribed treatment.
• 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:
  3500

Study design details

• Main study objective:
  To quantify off-label prescribing of GLY for the symptomatic treatment of sialorrhoea(drooling) and/or excessive sweating.To evaluate adverse events (AE) in patients prescribed GLY for the symptomatictreatment of sialorrhoea (drooling) and/or excessive sweating compared to those notprescribed treatment.
• Data analysis plan:
  The Chi-squared test or the Fisher’s exact test will be used to compare adverse events between the two groups. The total number of AEs will be computed along with the treatment duration, and the incidence rates will be calculated for the two groups and compared.The Poisson regression model would be used to compare the rate of all AE events for theGLY group as compared to the controls.