Cardiac safety and clinical efficacy of high-dose domperidone for long-term treatment of gastroparesis symptoms. (June 2022)

• Record Type: Journal Article
• Authors: Woods, Kevin; Gajendran, Mahesh; Gonzalez, Zorisadday; Bustamante-Bernal, Marco; Sarosiek, Irene; Espino, Karina; Waterhouse, Nathan; Siddiqui, Tariq; McCallum, Richard
• Is Part Of: Journal of investigative medicine. Volume 70:Number 5(2022)
• Page Start: 1225
• Page End: 1232
• Publication Date: 2022-06
• Subjects: drug-related side effects and adverse reactions; Clinical medicine -- Periodicals; Medicine -- Research -- Periodicals; Medicine; Research -- United States; Clinical medicine; Medicine -- Research; Periodicals; 616.075
• DOI: 10.1136/jim-2021-001968
• Languages: English
• ISSNs: 1081-5589

Abstract

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.