Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Other

If ‘other’, further details on the scope of the study

Impact of safety recommendations
Non-interventional study

Non-interventional study design

Cross-sectional
Other

Non-interventional study design, other

3 studies: repeated cross-sectional studies, prospective cohort, practice survey
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

DOMPERIDONE

Medical condition to be studied

Parkinson's disease
Population studied

Age groups

Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

150000
Study design details

Main study objective

The overall objective of this project will be to evaluate the conditions of domperidone use and misuse in PD patients in France.

Outcomes

Misuse of domperidone defined as - Maximum daily dose > 30 mg - Maximum duration of prescription > 7 days - Age of patient > 60 years old- Contraindicated drug-drug interactions

Data analysis plan

A description of the main characteristics of the PD population will be done: age, gender, comorbidities (using categories of the Charlson’s score), duration of follow-up, deaths during the follow-up. Characteristics of PD treatment (type of drugs, mono or poly therapy) and other drugs (main ATC Classes) will be investigated. Co-medications, specifically those potentially interacting with domperidone (pharmacodynamics or pharmacokinetic interaction) will be displayed, as well as drugs with similar indications than domperidone (other dopamine antagonists, setrons, apepritant…). Prevalence of misuse will be assessed as a whole in the PD population stratified on age, and for each category of misuse