DARWIN EU® Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis

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

• Medicinal product name, other:
  - Cisapride; - Clebopride; - Itopride; - Cinitapride
• Study drug International non-proprietary name (INN) or common name:
  DOMPERIDONE

  ERYTHROMYCIN

  METOCLOPRAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A03FA01) metoclopramide

  metoclopramide

  (A03FA02) cisapride

  cisapride

  (A03FA03) domperidone

  domperidone

  (A03FA06) clebopride

  clebopride

  (A03FA07) itopride

  itopride

  (A03FA08) cinitapride

  cinitapride

  (J01FA01) erythromycin

  erythromycin
• Medical condition to be studied:
  Diabetic gastroparesis

  Dyspepsia

  Irritable bowel syndrome

  Vomiting

  Diabetes mellitus

  Hypothyroidism

  Scleroderma

  Parkinson's disease

  Multiple sclerosis

  Gastroptosis
• Additional medical condition(s):
  Gastroparesis syndrome, Gastroesophageal reflux disease, Chronic constipation, Systemic Lupus Erythematous, Ehlers Danlos Syndrome, Acute migraine, Cerebrovascular disease

Population studied

• Age groups:
  • 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:
  2000000

Study design details

• Study design:
  - New drug user cohort study; - Population-level cohort study
• Main study objective:
  The main objective of the study is to determine the dose, formulation, cumulative duration and setting at time of treatment initiation of any of the prokinetic drugs of interest for patients diagnosed with gastroparesis and to determine the incidence and prevalence of use of medications with prokinetics properties in patients diagnosed with gastroparesis, in children and adults separately.
• Setting:
  Inpatient vs outpatient. Whether or not patient was an in- or outpatient was assessed at index date (date of first prescription of the prokinetic drug of interest). For inpatient visits, we further stratified in patients admitted to (Pediatric)ICU at time of prescription and patients not admitted to (P)ICU.
• Data analysis plan:
  Patient-level drug utilization: Large-scale patient-level characterization will be conducted at index date including patient demographics, comorbidity and medication. Cumulative duration of use of medication with prokinetic properties, dose, formulation and different types of setting will be reported. Population-level utilization of medication with prokinetic properties: Annual period prevalence of the use of medications with prokinetics properties and annual incidence rates per 100000 person years will be estimated. For all analyses a minimum cell count of 5 will be used when reporting results, with any smaller counts obscured.
• Summary results:
  CONCLUSION ; This study delved into the utilization of prokinetic medication in both paediatric and adult populations with gastroparesis. The findings revealed varying numbers of new users across different prokinetic drugs, with low ; percentages indicated for gastroparesis, in both paediatric and adult populations. The median age of new users exhibited a wide range, emphasizing the diverse demographic profile of individuals prescribed prokinetic medication. Common comorbidities and symptoms differed between age groups, reflecting distinct healthcare challenges. Medications such as PPIs, opioids, and anticholinergics were frequently recorded, highlighting concurrent therapies. The duration of prokinetic medication use varied, with notable differences in formulation preferences and ICU usage, particularly for erythromycin and metoclopramide in adults. At the population level, the examination of incidence and prevalence in paediatric cases faced limitations because of low numbers, while in adults, metoclopramide predominated in prescriptions, exhibiting fluctuations over time. The study revealed comparable patterns in the incidence rates between broad and narrow definitions, though prokinetic utilisation rates were generally lower in the former. Notably, trends in prevalent use aligned with incident use. Our findings offer comprehensive insights into the complexities of prokinetic medication utilization in the context of gastroparesis.