Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study复制标题

普鲁卡必利治疗慢性便秘患者的心血管安全性: 一项基于多国人群的队列研究

Chronic constipation is a common and often debilitating medical problem, with an impact on quality of life. The 5-hydroxytryptamine (serotonin) receptor type 4 (5-HT4) receptor agonists have the potential to treat disorders of gastrointestinal motility, including delayed gastric emptying and colonic dysmotility. The frst-generation 5-HT4 receptor agonists cisapride and tegaserod were with drawn from the US market because of serious concerns about associated cardiovascular risk, arrythmias thought to be associated with QTc prolongation with cisapride, and ischemic events of uncertain origin with tegaserod. Prucalopride, a selective 5-HT4 agonist with high affinity and selectivity for the 5-HT4 receptors, has been licensed in the European Union since 2009 for adult women and since 2015 for adult men for the treatment of chronic constipation and is currently approved in 82 countries. No signal for an increased risk of adverse cardiovascular events or QTc prolongation has been observed for prucalopride during non-clinical and clinical cardiovascular investigations or as a result of safety monitoring.

译文