Serhat Bor1, Mesut Demir2, Oktay Ozdemir3, Kivanc Yuksel4. 1. Ege University School of Medicine, Division of Gastroenterology, Ege Reflux Study Group, Bornova, Izmir, Turkey. 2. Cukurova University School of Medicine, Division of Cardiology, Adana, Turkey. 3. Yorum Consulting Ltd., Department of Statistics, Istanbul, Turkey. 4. Ege University Centre for Drug Research & Development Pharmacokinetic Research and Applications (ARGEFAR), Bornova, Izmir, Turkey.
Abstract
BACKGROUND: This meta-analysis aimed to assess the cardiac safety profile of domperidone treatment for the risk of cardiovascular (CV) event and QT prolongation. METHODS: Data from nine studies involving 101,155 patients were used for the analysis of CV event risk, while data from eight studies involving 390 patients were used for the analysis of QT prolongation risk. RESULTS: Meta-analysis findings suggested a significant increase in CV risk under domperidone as compared to no treatment for domperidone doses of >30 mg/day (OR: 3.14, 95% CI, 1.191 to 8.304, p = 0.021), no significant increase in QT prolongation event rates with domperidone (3.54%, 95% CI, 1.73% to 7.10%) and a significantly lower CV risk for domperidone than for metoclopramide (OR: 0.63, 95% CI, 0.58 to 0.70, p < 0.001). CONCLUSIONS: The present meta-analysis indicates that domperidone treatment may not be associated with an overall CV event risk increase at doses ≤30 mg/day and does not result in QT prolongation.
BACKGROUND: This meta-analysis aimed to assess the cardiac safety profile of domperidone treatment for the risk of cardiovascular (CV) event and QT prolongation. METHODS: Data from nine studies involving 101,155 patients were used for the analysis of CV event risk, while data from eight studies involving 390 patients were used for the analysis of QT prolongation risk. RESULTS: Meta-analysis findings suggested a significant increase in CV risk under domperidone as compared to no treatment for domperidone doses of >30 mg/day (OR: 3.14, 95% CI, 1.191 to 8.304, p = 0.021), no significant increase in QT prolongation event rates with domperidone (3.54%, 95% CI, 1.73% to 7.10%) and a significantly lower CV risk for domperidone than for metoclopramide (OR: 0.63, 95% CI, 0.58 to 0.70, p < 0.001). CONCLUSIONS: The present meta-analysis indicates that domperidone treatment may not be associated with an overall CV event risk increase at doses ≤30 mg/day and does not result in QT prolongation.
Authors: Cristina Varas-Lorenzo; Alejandro Arana; Catherine B Johannes; Lisa J McQuay; Kenneth J Rothman; Daniel Fife Journal: Drugs Real World Outcomes Date: 2016-09
Authors: Maria Luísa Cordeiro Santos; Ronaldo Teixeira da Silva Júnior; Breno Bittencourt de Brito; Filipe Antônio França da Silva; Hanna Santos Marques; Vinícius Lima de Souza Gonçalves; Talita Costa Dos Santos; Carolina Ladeia Cirne; Natália Oliveira E Silva; Márcio Vasconcelos Oliveira; Fabrício Freire de Melo Journal: World J Clin Pediatr Date: 2022-03-09