Domperidone is an effective antiemetic used worldwide, but there have been reports of possible cardiotoxicity. Our goal was to explore the cardiac safety and clinical efficacy of long-term domperidone, titrated as high as 120 mg/day, in patients not responding or unable to tolerate other therapies for gastroparesis (GP).This retrospective cohort study was conducted at a single tertiary care academic center. We objectively assessed the safety and efficacy of domperidone through questionnaires, clinical follow-up and frequent ECGs as mandated by the Food and Drug Administration. We excluded patients with a history of dangerous arrhythmias, prolonged QTc, clinically significant electrolyte disturbances, gastrointestinal hemorrhage or obstruction, presence of a prolactinoma, pregnant or breastfeeding females, or allergy to domperidone. A total of 21 patients met the inclusion criteria for eligibility in this study (52.4% white, 42.9% Hispanic; mean age 50.1 years; 90.5% female). The mean duration of domperidone therapy was 52.3 (range 16–97) months with a mean highest dose of 80 mg/day (range 40–120 mg). Two patients (9.5%) taking 120 mg/day experienced asymptomatic meaningful QTc prolongation (>450 ms in males, >470 ms in females). One-third of patients had asymptomatic non-meaningful QTc prolongation. Palpitations or chest pain was reported in 19% of patients without ECG abnormalities or adverse cardiac events. The mean severity of vomiting and nausea was improved by 82% and 55%, respectively.Long-term treatment with high doses of domperidone (40–120 mg/day) improved GP symptoms in patients previously refractory to other medical therapies and with a satisfactory cardiovascular risk profile.
- drug-related side effects and adverse reactions
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.
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Contributors KW drafted the article, compiled the data and interpreted the data under the guidance of RM. MG did formal data analysis, substantial revision of the manuscript, and literature search. ZG drafted and edited the article. MB-B drafted the article. IS reinforced the IRB protocol compliance and contributed to the manuscript input. KE participated in acquisition of data. NW assisted in data compilation and analysis. TS individually reviewed and interpreted all patient EKGs. RM conceptualized and designed the study, drafted the article, and revised it critically for intellectual content and final approval of the version to be submitted. All authors discussed the results and contributed to the final manuscript. RM is responsible for the overall content as the guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Richard McCallum is the editor-in-chief of the Journal of Investigative Medicine. All other authors declare no competing interests.
Provenance and peer review Not commissioned; externally peer reviewed.
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