Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

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

DOMPERIDONE
Population studied

Short description of the study population

All patients receiving domperidone in the outpatient setting during the pre-defined periods (pre- and post- implementation periods of the risk minimisation activity) in the selected European Union countries (France, Germany, United Kingdom, Belgium, and Spain).
Patients were included in the study cohort if they have at least 1 prescription for domperidone in the selected databases during the pre-defined periods, and have membership or have been registered with the practice and have available medical history for at least 180 days before the domperidone prescription.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

110000
Study design details

Main study objective

To describe the prescription patterns before and after the changes to the domperidone label and distribution of a DHPC and estimate and compare the overall proportion of domperidone prescriptions before and after implementation of the risk minimisation measures.

Outcomes

Composite endpoint consisting of the following components:- maximum daily dose,- duration of use (> 7 days),- concomitant medications that prolong the QT-interval or are potent or strong CYP3A4 inhibitors,- prescribing to patients with contraindicated conditions- prescribing for off-label indications, To estimate the overall proportion of domperidone prescriptions before and after the implementation of the risk minimisation measures for domperidone for each of the components of the composite endpoint individually, the time trend of apparent indication, and days supplied (< 7 days vs > 7 days), and the age and sex of the people receiving prescriptions

Data analysis plan

Data analysis in the study will be descriptive. Continuous variables will be presented using appropriate descriptive statistics, such as mean, median, standard deviation and range. Categorical variables will be presented using percent and frequency tables. The rates and 95% CI of all study endpoints (i.e. risk minimisation indicators) will be calculated for the 2011-2015 period, using quarterly time blocks for the pre- and post- risk minimisation implementation periods. The rates will be calculated per 1000 domperidone-treated patients or as percentage of domperidone prescriptions, as appropriate.Paediatric data will be described separately from adult patients and rate of paediatric use will be calculated as fraction of overall domperidone utilisation. All data analysis will be done in SAS using the version that is current when the analyses are done.
Documents
Study results

DOMP-DUS-PASS database CSR_15DEC2017 FINAL_Synopsis

English (838.54 KB - PDF)View document