Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
Evaluation

Oral Presentation

Session: Time-travelling Trends

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

Wednesday, August 28, 2024
8:30 AM – 8:45 AM CEST
Location: Room IV
Background: Gastroparesis, characterized by delayed gastric emptying, poses challenges across age groups. Prokinetic medications, often used off-label, aim to manage symptoms.

Objectives: To explore real-world use of prokinetic medicines including erythromycin, metoclopramide, cisapride, domperidone, clebopride, itopride and cinitapride in children and adults diagnosed with gastroparesis.

Methods: We conducted a retrospective cohort study using primary and secondary health care records from 6 European countries including France (CHUBX), the United Kingdom (CPRD GOLD), Germany (IQVIA DA Germany), Belgium (IQVIA LPD Belgium), Spain (IMASIS and SIDIAP) and the Netherlands (IPCI) between 2012 and 2022. These were part of the selected data partners for the DARWIN EU initiative. All data was standardized to the OMOP Common Data Model. To explore real-world use of prokinetic medicines in gastroparesis, we: (1) described the characteristics of children and adults who were prescribed prokinetic medication, (2) determined the dose, formulation, cumulative duration and setting at time of prokinetic treatment initiation and (3) estimated incidence and prevalence of prokinetic medication use.

Results: The total number of new paediatric prokinetic users ranged from 69,849 (metoclopramide) to 231,536 (erythromycin), while adult users ranged from 460,256 (erythromycin) to 1,419,572 (metoclopramide) over the study period across respective databases. Prokinetic medication use indicated for gastroparesis was observed to be low ( < 0.1% paediatric group, < 0.2% adults). Median age of new users of prokinetic medication indicated for gastroparesis varied from 6 to 16 years in the paediatric population and 46 to 74 years in adults. Common comorbidities and medications differed by age category. Median duration of prokinetic medication use ranged from 60 to 81 days (paediatric) and 6 to 48 days (adult). Examination of incidence revealed that metoclopramide was the most frequently prescribed drug, with incidence rates ranging from 165/1,000 (SIDIAP) to 2,644/1,000 person-years (IMASIS). Trends in prevalent use aligned with incident use.

Conclusions: This study provides a detailed exploration of prokinetic medication use in paediatric and adult populations with gastroparesis. The findings revealed diverse demographic profiles and underscore the existence of distinct healthcare challenges and therapeutic approaches across age groups. These comprehensive insights into the real-world patterns of prokinetic medication use provide valuable information for clinicians and researchers in understanding the dynamics of managing gastroparesis with prokinetic therapies.