Clinical trial: the efficacy of open‐label prucalopride treatment in patients with chronic constipation – follow‐up of patients from the pivotal studies

Camilleri, Michael; Outryve, Marc J. Van; Beyens, Georges; Kerstens, René; Robinson, P.; Vandeplassche, Lieve

doi:10.1111/j.1365-2036.2010.04455.x

Cited by 86 publications

(67 citation statements)

References 30 publications

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“…159 Satisfaction with bowel function was maintained for up to 18 months of treatment with prucalopride. 160 Recently, prucalopride was more efficacious than placebo in improving stool frequency and life quality in men with chronic constipation, and was found to be safe and well-tolerated. 161 Prucalopride is recommended at 2 mg once daily, however the dose for the elderly (> 65 years) and patients with severe renal impairment (glomerular filtration rate < 30 mL/min/m 2 ) and severe hepatic impairment (Child-Pugh class C) should start at 1 mg once daily.…”

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Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Shin

Jung

Lee

et al. 2016

J Neurogastroenterol Motil

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The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This article includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation (AGREE) II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.

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Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Shin

Jung

Lee

et al. 2016

J Neurogastroenterol Motil

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“…Le differenze tra dosi di prucalopride e il placebo è risultata altamente significativa (p < 0,001). L'efficacia a lungo termine di prucalopride nei pazienti con stipsi cronica è stata valutata in un consistente sottogruppo di pazienti arruolati nei tre studi di fase III, trattati in aperto nel follow-up per un massimo di 24 mesi (mediana circa 12 mesi) [62]. L'efficacia è stata valutata ogni 3 mesi mediante la scala di soddisfazione del PAC-QOL.…”

Section: Efficacia Clinicaunclassified

“…Solo il 10% circa dei pazienti che aveva ottenuto la normalizzazione delle funzioni intestinali al termine degli studi pivotali ha sospeso il trattamento per insufficiente risposta durante la fase di follow-up in aperto. Gli eventi avversi più frequenti che hanno comportato la sospensione di prucalopride sono stati quelli gastrointestinali (3,3%) e la cefalea (1%) [62]. Complessivamente, gli studi clinici di fase III, incluso i periodi di follow-up, hanno dimostrato che mediamente non c'è alcun beneficio incrementale della dose di prucalopride di 4 mg su quella di 2 mg in nessuno degli end point di efficacia analizzati, nonostante accurati studi di farmacodinamica indicassero una correlazione dose-effetto positiva [49].…”

Section: Efficacia Clinicaunclassified

Clinical and economic profile of prucalopride in the treatment of chronic constipation in women

Stanghellini

Eandi

2012

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stinali, di recente autorizzato nei Paesi della Comunità Europea e disponibile anche in Italia per il trattamento della stipsi cronica idiopatica delle donne che non hanno avuto benefici dall'uso di lassativi [2]. LA STIPSI CRONICA IDIOPATICA DefinizioneLa stipsi è una sindrome (disordine plurisintomatico) costituita da molti sintomi suggestivi di disordini intestinali e/o anorettali: non solo ridotto numero di evacuazioni (< 3/ settimana) [3], ma anche difficoltà nell'espellere le feci (straining), flatulenza, feci troppo aride, fastidio addominale, dolore e gonfiore addominale, dolore rettale, sensazione di evacuazione incompleta, sensazione di falsa urgenza all'evacuazione [4]. Le più recenti definizioni di stipsi considerano sia le difficoltà dell'atto di evacuazione riferite dai soggetti affetti, sia alcuni parametri quantizzabili oggettivamente quali la frequenza dell'alvo e il tipo di feci [5,6]. Sulla base dei distur- INTRODUZIONELa stipsi cronica è un disturbo comune difficile da trattare e le opzioni disponibili per i diversi sottogruppi di stipsi sono limitate e nella maggior parte dei casi insoddisfacenti. Le forme più gravi di stipsi cronica spesso richiedono l'uso di lassativi ad alte dosi o il ricorso a terapie invasive, come evacuazioni manuali e clisteri, e talvolta a interventi di resezione del colon, nei casi limite nei quali tutti i rimedi sono inefficaci o causano effetti avversi e la malattia è fortemente inabilitante [1]. L'introduzione di un nuovo farmaco, come prucalopride, attivo nel promuovere il transito intestinale, può contribuire a migliorare la terapia dei pazienti affetti da stipsi cronica idiopatica che non hanno trovato sollievo dalle precedenti terapie con lassativi. In questa rassegna, dopo una breve analisi della fisiopatologia e della terapia farmacologica della stipsi cronica, valuteremo il profilo farmacologico, terapeutico ed economico di prucalopride, nuovo enterocinetico ad azione agonista selettiva sui recettori 5-HT4 inte- Corresponding authorProf. Mario Eandi mario.eandi@unito.it DisclosureIl presente lavoro è stato realizzato grazie a un supporto incondizionato di Shire Italia S.p.A. ABSTRACTChronic constipation is a common disorder, especially in women. Options available for different subgroups of constipation are limited and in most cases unsatisfactory. The most severe forms of chronic constipation often require the use of laxatives in high doses or the use of invasive therapies. The introduction of a new drug, such as prucalopride, active in promoting intestinal transit, can help to improve the therapy of patients with chronic idiopathic constipation who have not found relief from previous treatment with laxatives. In this review, after a brief discussion of pathophysiology and pharmacotherapy of chronic constipation, we evaluate the pharmacological profile, therapeutic and cost of prucalopride, recently authorized in the EU countries and also available in Italy for the treatment of chronic constipation in women who did not benefit from the use of laxatives.

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“…Improvements in disease-specific quality of life were maintained during open-label treatment for up to 18 months. 70 Most frequent adverse events resulting in discontinuation were GI events (nausea, abdominal pain and diarrhea [3.3%]) and headache (1.0%). The serious cardiac adverse events (palpitations, myocardial infarction, ventricular fibrillation, torsades de pointes and sudden death) and medication interactions that led to the withdrawal of the less selective serotonergic agonists cisapride and tegaserod have not been observed with prucalopride.…”

Section: Serotonin Receptor Modulatorsmentioning

confidence: 99%

Emerging Pharmacologic Therapies for Constipation-predominant Irritable Bowel Syndrome and Chronic Constipation

Eswaran¹,

Guentner²,

Chey³

2014

J Neurogastroenterol Motil

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Irritable bowel syndrome with constipation and chronic functional constipation are common digestive disorders that negatively impact quality of life and account for billions of dollars in health care costs. Related to the heterogeneity of pathogenesis that underlie these disorders and the failure of symptoms to reliably predict underlying pathophysiology, traditional therapies provide relief to only a subset of affected individuals. The evidence surrounding new and emerging pharmacologic treatments, which include both luminally and systemically acting drugs, is discussed here. These include agents such as lubiprostone, bile acid modulations, guanylate cyclase-C receptor agonists, serotonin receptor modulators and herbal therapies.

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Clinical trial: the efficacy of open‐label prucalopride treatment in patients with chronic constipation – follow‐up of patients from the pivotal studies

Abstract: SUMMARY BackgroundPrucalopride is approved in Europe for symptomatic treatment of chronic constipation in women with inadequate relief from laxatives.

Cited by 86 publications

References 30 publications

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Clinical and economic profile of prucalopride in the treatment of chronic constipation in women

Emerging Pharmacologic Therapies for Constipation-predominant Irritable Bowel Syndrome and Chronic Constipation

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