Gastroparesis treatment options metoclopramide and prucalopride: analysis of the FDA Adverse Event Reporting System (FAERS) database.

IF 3.8 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Expert Review of Gastroenterology & Hepatology Pub Date : 2024-07-01 Epub Date: 2024-07-15 DOI:10.1080/17474124.2024.2380315

Michael B Andrews, Douglas G Adler

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引用次数: 0

Abstract

Background: We aimed to examine the common adverse drug reactions (ADRs) of metoclopramide, FDA-approved for treating many gastrointestinal conditions including gastroparesis, and prucalopride, FDA-approved for treating chronic idiopathic constipation but used off-label for other gastrointestinal conditions including gastroparesis.

Research design and methods: The FDA Adverse Event Reporting System (FAERS) was analyzed from January 2013 to December 2023. ADR reports regarding use of only metoclopramide or prucalopride were analyzed following exclusion of reports indicating use for treatment of non-gastrointestinal conditions.

Results: Analysis of 1,085 reports on metoclopramide revealed tardive dyskinesia (n = 393, 36.2%) and dystonia (n = 170, 15.7%) among the most reported ADRs in addition to QTc prolongation (n = 16, 1.5%) with progression to Torsade de pointes (n = 5, 0.5%) and triggering of pheochromocytoma crisis (n = 24, 2.2%). Analysis of 865 reports on prucalopride revealed headache (n = 120, 13.9%), diarrhea (n = 116, 13.4%), and abdominal pain (n = 100, 11.6%) as the most common ADRs with 22 reports (2.5%) of dystonia with the use of prucalopride.

Conclusions: This FAERS database analysis shows post-marketing reports of ADRs from metoclopramide most frequently include tardive dyskinesia, dystonia, and tremor in addition to potentially fatal arrhythmias such as Torsade de pointes. Consumers of prucalopride may also be at risk of dystonia and other ADRs.

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胃痉挛治疗方案甲氧氯普胺和普鲁卡必利：FDA 不良事件报告系统 (FAERS) 数据库分析。

背景：我们旨在研究甲氧氯普胺和普鲁卡必利的常见药物不良反应（ADRs）。甲氧氯普胺被美国食品药品管理局批准用于治疗包括胃瘫在内的多种胃肠道疾病，而普鲁卡必利被美国食品药品管理局批准用于治疗慢性特发性便秘，但在标签外被用于治疗包括胃瘫在内的其他胃肠道疾病：对 2013 年 1 月至 2023 年 12 月期间的 FDA 不良事件报告系统 (FAERS) 进行了分析。在排除了用于治疗非胃肠道疾病的报告后，只分析了有关使用甲氧氯普胺或普鲁卡必利的 ADR 报告：对1,085份关于甲氧氯普胺的报告进行分析后发现，除QTc延长（16份，1.5%）并发展为Torsade de pointes（5份，0.5%）和引发嗜铬细胞瘤危象（24份，2.2%）外，迟发性运动障碍（393份，36.2%）和肌张力障碍（170份，15.7%）也是报告最多的不良反应。对865份关于普鲁卡必利的报告进行分析后发现，头痛（120份，13.9%）、腹泻（116份，13.4%）和腹痛（100份，11.6%）是最常见的不良反应，22份报告（2.5%）显示使用普鲁卡必利后出现肌张力障碍：FAERS数据库分析显示，甲氧氯普胺上市后的不良反应报告中最常见的是迟发性运动障碍、肌张力障碍和震颤，此外还有可能致命的心律失常，如Torsade de pointes。普鲁卡必利的消费者也可能面临肌张力障碍和其他不良反应的风险。

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来源期刊

Expert Review of Gastroenterology & Hepatology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.80

自引率

2.60%

发文量

审稿时长

6-12 weeks

期刊介绍： The enormous health and economic burden of gastrointestinal disease worldwide warrants a sharp focus on the etiology, epidemiology, prevention, diagnosis, treatment and development of new therapies. By the end of the last century we had seen enormous advances, both in technologies to visualize disease and in curative therapies in areas such as gastric ulcer, with the advent first of the H2-antagonists and then the proton pump inhibitors - clear examples of how advances in medicine can massively benefit the patient. Nevertheless, specialists face ongoing challenges from a wide array of diseases of diverse etiology.