Prucalopride
Sources réglementaires consultées
Indications approuvées
- Traitement symptomatique de la constipation chronique chez l'adulte lorsque les laxatifs ne procurent pas un soulagement suffisant.
Contre-indications
Absolues
- Hypersensibilité au prucalopride ou à l'un des excipients.
- Insuffisance rénale nécessitant une dialyse.
- Perforation ou obstruction intestinale due à un trouble structurel ou fonctionnel de la paroi intestinale, iléus obstructif ou maladie inflammatoire intestinale sévère, notamment maladie de Crohn, rectocolite hémorragique et mégacôlon ou mégarectum toxique.
Mises en garde cliniques
- Mise en garde majeure · Des idées et comportements suicidaires, des automutilations ainsi qu'une dépression nouvelle ou aggravée ont été signalés. Surveiller tout changement de l'humeur ou du comportement ; arrêter le prucalopride et contacter immédiatement le professionnel de santé s'ils surviennent. — DailyMed prucalopride setid 89a7bdb1-e1cd-4986-bab9-a939dc764faa
Effets indésirables
Communs (≥1%)
Céphalées · Douleur abdominale · Nausées · Diarrhée · Distension abdominale · Étourdissements · Vomissements · Flatulences · Fatigue
Rares mais graves
Idées ou comportements suicidaires
Grossesse et allaitement
Non recommandé pendant la grossesse ni chez les femmes susceptibles de devenir enceintes qui n'utilisent pas de contraception efficace. Le prucalopride est excrété dans le lait humain ; décider d'interrompre soit l'allaitement, soit le traitement en tenant compte des deux bénéfices.
Bibliographie récente (PubMed)
Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed by the American Gastroenterological Association and the American College of Gastroenterology, aims to inform clinicians and patients by providing evidence-based practice recommendations for the pharmacological treatment of CIC in adults. The American Gastroenterological Association and the American College of Gastroenterology formed a multidisciplinary guideline panel that conducted systematic reviews of the following agents: fiber, osmotic laxatives (polyethylene glycol, magnesium oxide, lactulose), stimulant laxatives (bisacodyl, sodium picosulfate, senna), secretagogues (lubiprostone, linaclotide, plecanatide), and serotonin type 4 agonist (prucalopride). The panel prioritized clinical questions and outcomes and used the Grading of Recommendations Assessment, Development, and Evaluation framework to assess the certainty of evidence for each intervention. The Evidence to Decision framework was used to develop clinical recommendations based on the balance between the desirable and undesirable effects, patient values, costs, and health equity considerations. The panel agreed on 10 recommendations for the pharmacological management of CIC in adults. Based on available evidence, the panel made strong recommendations for the use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride for CIC in adults. Conditional recommendations were made for the use of fiber, lactulose, senna, magnesium oxide, and lubiprostone. This document provides a comprehensive outline of the various over-the-counter and prescription pharmacological agents available for the treatment of CIC. The guidelines are meant to provide a framework for approaching the management of CIC; clinical providers should engage in shared decision making based on patient preferences as well as medication cost and avai
Gastroparesis is a complex gastric motility disorder characterized by nausea, vomiting, and other symptoms associated with a delay in gastric emptying in the absence of mechanical obstruction. Variations in diagnostic testing and limited effective treatments make caring for this patient population challenging. The American Gastroenterological Association developed this guideline to provide recommendations for ensuring an accurate diagnosis and identifying evidence-based, effective treatments among the available pharmacologic and procedural interventions for patients with idiopathic gastroparesis or gastroparesis related to diabetes. The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and develop this guideline. The Guideline Panel prioritized clinical questions and outcomes, conducted an evidence review, and used the Evidence to Decision Framework to develop recommendations. The Guideline Panel agreed on 12 recommendations. A conditional recommendation was issued against using 2-hour gastric emptying testing and in favor of 4-hour testing in patients with suspected gastroparesis. There are conditional recommendations for the use of metoclopramide and erythromycin in patients with gastroparesis. Conditional recommendations were issued against the use of domperidone, prucalopride, aprepitant, nortriptyline, buspirone, and cannabidiol as first-line therapies. In addition, conditional recommendations were issued against the routine initial use of gastric per-oral endoscopic pyloromyotomy or gastric electrical stimulation in patients with gastroparesis, reserving these treatments for select patients with symptoms refractory to medical therapies. No recommendation was given regarding the use of surgical pyloromyotomy and surgical pyloroplasty, which were identified as procedures with knowledge gaps in their use for treatment for gastroparesis. The diagnosis of gastroparesis requires the use of 4-hour gastric emptying
Although there have been multiple drugs tested in gastroparesis, their relative efficacy and safety are unknown. We evaluated this in a network meta-analysis of randomized controlled trials (RCTs). We searched the literature to September 7, 2022. We judged the efficacy of drugs based on global symptoms of gastroparesis; individual symptoms, including nausea, vomiting, abdominal pain, bloating, or fullness; and safety according to total adverse events and adverse events leading to withdrawal. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of not improving with 95% confidence intervals (CIs), ranking drugs according to P-score. We identified 29 RCTs (3772 patients). Based on global symptoms, clebopride ranked first for efficacy (RR, 0.30; 95% CI, 0.16-0.57; P-score = .99) followed by domperidone (RR, 0.68; 95% CI, 0.48-0.98; P-score = .76). No other drug was superior to placebo. Only 2 drug classes were efficacious: in rank order, oral dopamine antagonists (RR, 0.58; 95% CI, 0.44-0.77; P-score = .96) and tachykinin-1 antagonists (RR, 0.69; 95% CI, 0.52-0.93; P-score = .83). For individual symptoms, oral metoclopramide ranked first for nausea (RR 0.46; 95% CI, 0.21-1.00; P-score = .95), fullness (RR 0.67; 95% CI, 0.35-1.28; P-score = .86), and bloating (RR 0.53; 95% CI, 0.30-0.93; P-score = .97), based on only 1 small trial. Only prucalopride was more likely to be associated with adverse events than placebo. In a network meta-analysis, oral dopamine antagonists and tachykinin-1 antagonists were more efficacious than placebo for gastroparesis, but confidence in the evidence was low to moderate for most comparisons. There is an unmet need for efficacious therapies for gastroparesis.
Constipation is a common gastrointestinal problem in the elderly. Because of the limitations of life style modifications and the comorbidity, laxative use is also very common. Therefore, this study reviews the latest literature on the effect and safety of laxative in the elderly. A systematic review of randomized controlled trials investigating the effectiveness and safety of laxatives for constipation in elderly patients over 65 years old were performed using the following databases: PubMed, EMBASE, and the Cochrane Library. Twenty-three randomized controlled trials were included in this review. Among the selected studies, 9 studies compared laxative with placebo and 5 studies compared laxatives of the same type. Four studies compared different types of laxatives or compared combination agents. Five studies compared novel medications such as prucalopride, lubiprostone, and elobixibat with placebo. Psyllium, calcium polycarbophil, lactulose syrup, lactitol, polyethylene glycol, magnesium hydroxide, stimulant laxative with or without fiber, and other medications were more effective than placebo in elderly constipation patients in short-term. Generally, the frequency and severity of adverse effects of laxative were similar between the arms of studies. Bulk laxative, osmotic laxative, stimulant laxative with or without fiber, and other medications can be used in elderly patients in short-term within 3 months with reasonable safety. However, the quality of included studies was not high and most of studies was conducted in a small number of patients. Among these laxatives, polyethylene glycol seems to be safe and effective in long-term use of about 6 months in elderly patients.
Acute Colonic Pseudo-obstruction (ACPO) is a cause of large intestinal dilation and obstruction without any physical transition point. It remains difficult to diagnose and treat. We review the recent updates on diagnosis and management of ACPO. Recent guidelines have posited that conservative management can be tried in most cases of ACPO, but that early decompression and surgery should be considered. Use of neostigmine is still a viable option but there is also promising data on pyridostigmine as well as prucalopride. Resolution of ACPO should be followed by daily use of polyethylene glycol (PEG) to help prevent recurrence. ACPO warrants early and accurate diagnosis with exclusion of alternate causes of large bowel dilation. Conservative management can be attempted for 48-72 h in those with cecal diameters < 12 cm and without signs of peritonitis and perforation. Early escalation of management should be attempted with neostigmine followed by endoscopy and/or surgery as needed, given that longer periods of dilation are associated with worse outcomes. There is promising new evidence for use of pyridostigmine and prucalopride, but further trials are needed prior to incorporating them into regular use. Finally, studies are lacking regarding prevention of ACPO after initial resolution.