Prucalopride Is No More Effective Than Placebo for Children With Functional Constipation

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

“…Finally, a similarly designed clinical trial in children suffering from chronic constipation also demonstrated that the active control (PEG) was more effective than prucalopride. 56 Our results do not only raise questions about proposed mechanisms of symptom relief in IBS-C, they also have potential implications for trial design. As there is no firmly established standard of care in constipation or IBS-C, placebo-controlled trials are justifiable.…”

Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials

“…Sixteen randomized, controlled trials [43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] on 3943 patients were retrieved from the search of standard medical electronic databases. The characteristics, salient features and treatment protocols adopted in the included randomized, controlled trials are given in the Table. All trials were adequately randomized using either computer generated sequential pattern or other reliable random pattern methods.…”

“…The characteristics, salient features and treatment protocols adopted in the included randomized, controlled trials are given in the Table. All trials were adequately randomized using either computer generated sequential pattern or other reliable random pattern methods. These trials varied from phase II 46 to phase III, 51 and were placebo-controlled [43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] …”

“…45,46,54,57,63,65 Like other 5-HT 4 agonists such as cisapride, there were concerns about the risk of cardiac side effects after the use of prucalopride because prucalopride has not been found to interact with either the human ether-à-go-go-related gene (hERG) potassium channel (responsible for cisapride-induced arrhythmias) or 5-HT 1B receptors (mechanism behind tegaserod induced side effects), both assumed to be responsible for the bradycardia and cardiovascular adverse events. 45,46,51,56,57,59,63,69 In a similar study evaluating the cardiovascular safety profile of prucalopride in a relatively high-risk population of old-age care home patients with 80% having a prior history of cardiovascular disease, no significant hemodynamic or electrocardiographic changes were reported. Explicitly, there was no increased incidence of prolongation of the QT interval or bradycardia in the prucalopride group compared to placebo.…”

Drugs Acting on the Gut: Prokinetics, Antispasmodics, Laxatives

“…There are two published studies of its use in children with functional constipation and they came to opposing conclusions. Dosing ranged from a mean of 0.024 [ 99 ] to 0.04 mg/kg/day [ 100 ] not exceeding the adult dosage of 2 mg daily. Both studies were conducted over an 8-week period and no major adverse events were reported.…”