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Cardiac safety and clinical efficacy of high-dose domperidone for long-term treatment of gastroparesis symptoms
  1. Kevin Woods1,
  2. Mahesh Gajendran1,2,
  3. Zorisadday Gonzalez3,
  4. Marco Bustamante-Bernal1,
  5. Irene Sarosiek1,
  6. Karina Espino1,
  7. Nathan Waterhouse1,
  8. Tariq Siddiqui4,
  9. Richard McCallum1
  1. 1 Department of Internal Medicine, Texas Tech University Health Sciences Center El Paso Paul L Foster School of Medicine, El Paso, Texas, USA
  2. 2 Department of Gastroenterology, UT Health San Antonio Long School of Medicine, San Antonio, Texas, USA
  3. 3 Department of Gastroenterology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA
  4. 4 Department of Gastroenterology, Texas Tech University Health Sciences Center El Paso Paul L Foster School of Medicine, El Paso, Texas, USA
  1. Correspondence to Dr Mahesh Gajendran, Department of Internal Medicine, Texas Tech University Health Sciences Center El Paso Paul L Foster School of Medicine, El Paso, TX, USA; gajendran{at}uthscsa.edu

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.

  • 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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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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Footnotes

  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.