Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives

Tack, Jan; Outryve, M. Van; Beyens, Georges; Kerstens, René; Vandeplassche, Lieve

doi:10.1136/gut.2008.162404

Cited by 300 publications

(371 citation statements)

References 46 publications

(37 reference statements)

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“…This analysis used integrated data from six phase 3 and 4, multicentre, double‐blind, randomised, placebo‐controlled, parallel‐group trials of the efficacy and safety of prucalopride in patients with chronic constipation, performed across three continents (Table 1; ClinicalTrials.gov identifiers: SPD555‐302 [NCT01147926], SPD555‐401 [NCT01424228], PRU‐CRC‐3001 [NCT01116206], PRU‐USA‐13 [NCT00485940], PRU‐USA‐11 [NCT00483886] and PRU‐INT‐6 [NCT00488137]) 11, 23, 24, 25, 26, 27. The designs of these trials were similar and have been described in detail previously 11, 23, 24, 25, 26, 27…”

Section: Methodsmentioning

confidence: 99%

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ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundThe Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC‐SYM score used to define a clinical response on this 0‐4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.AimTo determine the minimal important difference in PAC‐SYM score, and the optimum cut‐off value for defining responders.MethodsThe minimal important difference was estimated using data from six international phase 3/4, double‐blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor‐ and distribution‐based approaches. Five appropriate patient‐reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.ResultsData from 2884 patients were included. Minimal important difference estimates ranged from –0.52 to –0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution‐based estimates were considerably lower than anchor‐based estimates. ROC curve analyses showed optimum cut‐off scores for discriminating responders to be similar to anchor‐based minimal important difference estimates.ConclusionsAnchor‐based methods gave consistent results for the minimal important difference, at approximately –0.6, and this value was close to the ROC‐determined optimal cut‐off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg –0.75) could be used in clinical trials to reduce the placebo response rate.

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Section: Methodsmentioning

confidence: 99%

“…The designs of these trials were similar and have been described in detail previously 11, 23, 24, 25, 26, 27…”

Section: Methodsmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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“…Interestingly, the correlation between aggregate measures of published studies addressing bowel patterns and pain correspond with results of a pilot study, which demonstrated a significant relationship between changes in bowel frequency and pain ratings for individual patients receiving linaclotide for constipation. 62 The described correlation between improved pain ratings were not only reported in studies of the newly introduced agents for IBS-C, [63][64][65][66][67] but were also observed in many other trials, which did not meet inclusion criteria for this analysis and examined the effects of interventions ranging from fiber supplements, 68,69 to herbal preparations, 70 biofeedback, 71 bisacodyl, 72 or osmotic laxatives. [73][74][75] While not the focus of this analysis, we noted some statistically significant, but clinically minor, differences in the endpoints between patient cohorts with constipation and IBS-C.…”

Section: Discussionmentioning

confidence: 71%

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

Bielefeldt

Levinthal

Nusrat

2015

J Neurogastroenterol Motil

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Background/AimsThe marketing of newer agents for treatment of constipation and irritable bowel syndrome with constipation (IBS-C) emphasize improvements in abdominal pain. However, it is not clear whether this observation reflects a unique visceral analgesic effect of these agents or is a general feature of effective laxation. We sought to determine the relationship between improvements in bowel frequency and decreases in abdominal pain in clinical trials of patients with constipation or IBS-C. MethodsWe searched "PubMed" and "Embase" databanks for clinical trials in patients with constipation or IBS-C, targeting publications that provided detailed data on bowel movement frequency and pain intensity before and after an intervention. We abstracted the results and performed meta-analytic and meta-regression analyses. Results Twenty

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“…Three pivotal studies have shown significant effects vs placebo on the key symptom of constipation (i.e. more frequent bowel movements), and have also reported positive effects on quality of life and reassuring safety data [22][23][24]. Interestingly, other symptoms associated with constipation, such as bloating, discomfort, a sensation of incomplete bowel movement and excessive straining, have the potential to be improved by treatment [25].…”

Section: Constipationmentioning

confidence: 98%

Treatment of gastrointestinal autonomic neuropathy

Törnblom

2015

Diabetologia

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The symptoms caused by gastrointestinal autonomic neuropathy in diabetes mellitus is important to highlight since it affects a large proportion of people with diabetes, regardless of whether this is type 1 or type 2. Gastroparesis and general signs of bowel dysfunction, such as constipation, diarrhoea and abdominal pain are most often encountered and involve both pharmacological and non-pharmacological treatment options. This mini-review summarises a presentation given at the 'Diagnosis and treatment of autonomic diabetic neuropathy in the gut' symposium at the 2015 annual meeting of the EASD. It is accompanied by another mini-review on a topic from this symposium (by Azpiroz and Malagelada,

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Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives

Abstract: Prucalopride significantly and consistently improved bowel function, associated symptoms and satisfaction in chronically constipated patients.

Cited by 300 publications

References 46 publications

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

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

Treatment of gastrointestinal autonomic neuropathy

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