Effect of Domperidone Therapy on Gastroparesis Symptoms: Results of a Dynamic Cohort Study by NIDDK Gastroparesis Consortium

Authors

Irene Sarosiek
Mark Van Natta
Henry P Parkman
Thomas Abell
Kenneth L Koch
Braden Kuo
Robert J Shulman
Gianrico Farrugia
Madhusudan Grover
Frank A Hamilton
Pankaj J Pasricha
Katherine P Yates
Laura Miriel
Laura Wilson
Goro Yamada
James Tonascia
Richard W McCallum

Publication Date

3-1-2022

Journal

Clinical Gastroenterology and Hepatology

DOI

10.1016/j.cgh.2021.05.063

PMID

34089855

PMCID

PMC8636553

PubMedCentral® Posted Date

3-1-2023

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

Cohort Studies, Domperidone, Gastric Emptying, Gastroparesis, Humans, National Institute of Diabetes and Digestive and Kidney Diseases (U.S.), Quality of Life, Treatment Outcome, United States, Diabetes Mellitus, Gastroparesis, Nausea, Prokinetics, Vomiting

Abstract

BACKGROUND & AIMS: The use of domperidone (DOM) for gastroparesis (GP) remains controversial and limited. We aimed to present outcomes of DOM therapy for treatment of patients participating in the multicenter National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium (GpCRC) Registries (GpR).

METHODS: The GpCRC cohort consisted of patients with GP (75%) and with GP-like symptoms but with normal gastric emptying (25%). The DOM group initiated therapy during the 96 weeks of enrollment in GpR1 and GpR2. Patients who had previously taken or who were on DOM therapy at enrollment were excluded from this analysis. The control group did not use domperidone (non-DOM group) before or after enrollment. The following outcome measures were identified: change from baseline in Gastroparesis Cardinal Symptom Index total score, with 3 subscales, plus Gastroesophageal Reflux Disease and Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scores.

RESULTS: Overall, of 748 patients, 181 (24%) were in the DOM group, whereas 567 were in the non-DOM group. Sixty-three percent of participants had idiopathic GP. At baseline, DOM patients compared with non-DOM patients were significantly younger, had lower body mass index, non-Hispanic ethnicity, a higher annual household income, lower narcotic utilization, lower supplemental and complimentary medication use, and were more likely to have delayed gastric emptying time, as well as worse nausea and fullness scores. Compared with non-DOM patients, DOM patients experienced moderate but significantly more improvement in GP outcome measures: Gastroparesis Cardinal Symptom Index total score (P = .003), nausea (P = .003), and fullness subscales (P =.005), upper abdominal pain score (P = .04), Gastroesophageal Reflux Disease score (P = .05), and Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score (P = .05).

CONCLUSIONS: Utilizing the method of pragmatic modeling to evaluate long-term treatment of GP in a large GpCRC database, DOM treatment resulted in moderately but significantly improved GP.

NOTE: This project was based on data generated by 2 GpCRC Registry studies recognized under the Clinicaltrial.gov numbers: NCT00398801 and NCT01696747 symptoms compared with a group receiving standard-of-care but not DOM.