Prucalopride Improves Bowel Function and Colonic Transit Time in Patients With Chronic Constipation: An Integrated Analysis
Identifieur interne : 000001 ( Pmc/Curation ); précédent : 000000; suivant : 000002Prucalopride Improves Bowel Function and Colonic Transit Time in Patients With Chronic Constipation: An Integrated Analysis
Auteurs : Anton Emmanuel [Royaume-Uni] ; Marina Cools [Belgique] ; Lieve Vandeplassche [Belgique] ; René Kerstens [Belgique]Source :
- The American Journal of Gastroenterology [ 0002-9270 ] ; 2014.
Abstract
Constipation is often characterized by slow colonic transit, but the relationship between colonic transit time (CTT) and symptoms is unclear. The aims of this study were to investigate the effect of prucalopride, a 5-hydroxytryptamine receptor-4 agonist, on CTT and assess the relationship between CTT and symptoms.
This was an integrated analysis of three randomized, placebo-controlled, phase 2 dose-finding trials of prucalopride in patients with chronic constipation (ClinicalTrials.gov identifiers: NCT00617513; NCT00631813; and NCT00596596). Measurements of CTT were analyzed using radio-opaque markers at the start and end (4 or 12 weeks) of treatment. At these visits, patients assessed the presence and severity of their symptoms.
In total, 280 patients had CTT measurements before and at the end of treatment and were included in the analysis. Their mean age was 43 years, 93% were women, and mean duration of constipation was 19 years. After a once daily treatment with prucalopride 2 mg (
There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation. Treatment with prucalopride accelerated CTT in these individuals.
Url:
DOI: 10.1038/ajg.2014.74
PubMed: 24732867
PubMed Central: 4050523
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prucalopride Improves Bowel Function and Colonic Transit Time in Patients With Chronic Constipation: An Integrated Analysis</title><author><name sortKey="Emmanuel, Anton" sort="Emmanuel, Anton" uniqKey="Emmanuel A" first="Anton" last="Emmanuel">Anton Emmanuel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>GI Physiology Unit, University College London</institution>, London,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Cools, Marina" sort="Cools, Marina" uniqKey="Cools M" first="Marina" last="Cools">Marina Cools</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vandeplassche, Lieve" sort="Vandeplassche, Lieve" uniqKey="Vandeplassche L" first="Lieve" last="Vandeplassche">Lieve Vandeplassche</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kerstens, Rene" sort="Kerstens, Rene" uniqKey="Kerstens R" first="René" last="Kerstens">René Kerstens</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24732867</idno><idno type="pmc">4050523</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4050523</idno><idno type="RBID">PMC:4050523</idno><idno type="doi">10.1038/ajg.2014.74</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000001</idno><idno type="wicri:Area/Pmc/Curation">000001</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prucalopride Improves Bowel Function and Colonic Transit Time in Patients With Chronic Constipation: An Integrated Analysis</title><author><name sortKey="Emmanuel, Anton" sort="Emmanuel, Anton" uniqKey="Emmanuel A" first="Anton" last="Emmanuel">Anton Emmanuel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>GI Physiology Unit, University College London</institution>, London,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Cools, Marina" sort="Cools, Marina" uniqKey="Cools M" first="Marina" last="Cools">Marina Cools</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vandeplassche, Lieve" sort="Vandeplassche, Lieve" uniqKey="Vandeplassche L" first="Lieve" last="Vandeplassche">Lieve Vandeplassche</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kerstens, Rene" sort="Kerstens, Rene" uniqKey="Kerstens R" first="René" last="Kerstens">René Kerstens</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">The American Journal of Gastroenterology</title><idno type="ISSN">0002-9270</idno><idno type="eISSN">1572-0241</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives:</title><p>Constipation is often characterized by slow colonic transit, but the relationship between colonic transit time (CTT) and symptoms is unclear. The aims of this study were to investigate the effect of prucalopride, a 5-hydroxytryptamine receptor-4 agonist, on CTT and assess the relationship between CTT and symptoms.</p></sec><sec><title>Methods:</title><p>This was an integrated analysis of three randomized, placebo-controlled, phase 2 dose-finding trials of prucalopride in patients with chronic constipation (ClinicalTrials.gov identifiers: NCT00617513; NCT00631813; and NCT00596596). Measurements of CTT were analyzed using radio-opaque markers at the start and end (4 or 12 weeks) of treatment. At these visits, patients assessed the presence and severity of their symptoms.</p></sec><sec><title>Results:</title><p>In total, 280 patients had CTT measurements before and at the end of treatment and were included in the analysis. Their mean age was 43 years, 93% were women, and mean duration of constipation was 19 years. After a once daily treatment with prucalopride 2 mg (<italic>n</italic>=98) and 4 mg (<italic>n</italic>=70), CTT was reduced by 12.0 h (95% confidence interval (CI): –18.9, –5.1) and 13.9 h (95% CI: –20.5, –7.4), respectively; CTT increased by 0.5 h (95% CI: –4.5, 5.5) with placebo (<italic>n</italic>=112). At the end of the trial, symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT (>48 h) than by those with normal CTT.</p></sec><sec><title>Conclusions:</title><p>There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Am J Gastroenterol</journal-id><journal-id journal-id-type="iso-abbrev">Am. J. Gastroenterol</journal-id><journal-title-group><journal-title>The American Journal of Gastroenterology</journal-title></journal-title-group><issn pub-type="ppub">0002-9270</issn><issn pub-type="epub">1572-0241</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24732867</article-id><article-id pub-id-type="pmc">4050523</article-id><article-id pub-id-type="pii">ajg201474</article-id><article-id pub-id-type="doi">10.1038/ajg.2014.74</article-id><article-categories><subj-group subj-group-type="heading"><subject>Functional GI Disorders</subject></subj-group></article-categories><title-group><article-title>Prucalopride Improves Bowel Function and Colonic Transit Time in Patients With Chronic Constipation: An Integrated Analysis</article-title><alt-title alt-title-type="running">Prucalopride Improves Bowel Function and CTT</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Emmanuel</surname><given-names>Anton</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="caf1">*</xref></contrib><contrib contrib-type="author"><name><surname>Cools</surname><given-names>Marina</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Vandeplassche</surname><given-names>Lieve</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Kerstens</surname><given-names>René</given-names></name><degrees>MSc</degrees><xref ref-type="aff" rid="aff2">2</xref></contrib><aff id="aff1"><label>1</label><institution>GI Physiology Unit, University College London</institution>, London,<country>UK</country></aff><aff id="aff2"><label>2</label><institution>Shire-Movetis NV</institution>, Turnhout,<country>Belgium</country></aff></contrib-group><author-notes><corresp id="caf1"><label>*</label><institution>GI Physiology Unit, University College London</institution>, London, <country>UK</country>. E-mail: <email>a.emmanuel@ucl.ac.uk</email></corresp></author-notes><pub-date pub-type="ppub"><month>06</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>15</day><month>04</month><year>2014</year></pub-date><volume>109</volume><issue>6</issue><fpage>887</fpage><lpage>894</lpage><history><date date-type="received"><day>20</day><month>12</month><year>2013</year></date><date date-type="accepted"><day>03</day><month>03</month><year>2014</year></date></history><permissions><copyright-statement>Copyright © 2014 American College of Gastroenterology</copyright-statement><copyright-year>2014</copyright-year><copyright-holder>American College of Gastroenterology</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/3.0/"><pmc-comment>author-paid</pmc-comment>
<license-p>This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License. To view a copy of this license, visit <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/3.0/">http://creativecommons.org/licenses/by-nc-nd/3.0/</ext-link></license-p></license></permissions><abstract><sec><title>Objectives:</title><p>Constipation is often characterized by slow colonic transit, but the relationship between colonic transit time (CTT) and symptoms is unclear. The aims of this study were to investigate the effect of prucalopride, a 5-hydroxytryptamine receptor-4 agonist, on CTT and assess the relationship between CTT and symptoms.</p></sec><sec><title>Methods:</title><p>This was an integrated analysis of three randomized, placebo-controlled, phase 2 dose-finding trials of prucalopride in patients with chronic constipation (ClinicalTrials.gov identifiers: NCT00617513; NCT00631813; and NCT00596596). Measurements of CTT were analyzed using radio-opaque markers at the start and end (4 or 12 weeks) of treatment. At these visits, patients assessed the presence and severity of their symptoms.</p></sec><sec><title>Results:</title><p>In total, 280 patients had CTT measurements before and at the end of treatment and were included in the analysis. Their mean age was 43 years, 93% were women, and mean duration of constipation was 19 years. After a once daily treatment with prucalopride 2 mg (<italic>n</italic>=98) and 4 mg (<italic>n</italic>=70), CTT was reduced by 12.0 h (95% confidence interval (CI): –18.9, –5.1) and 13.9 h (95% CI: –20.5, –7.4), respectively; CTT increased by 0.5 h (95% CI: –4.5, 5.5) with placebo (<italic>n</italic>=112). At the end of the trial, symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT (>48 h) than by those with normal CTT.</p></sec><sec><title>Conclusions:</title><p>There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation. Treatment with prucalopride accelerated CTT in these individuals.</p></sec></abstract></article-meta></front><floats-group><fig id="fig1"><label>Figure 1</label><caption><p>Change in CTT from before treatment to the end of treatment with placebo, prucalopride 2 mg, or prucalopride 4 mg in (<bold>a</bold>) all patients and (<bold>b</bold>) patients with slow or very slow CTTs (>48 h) at baseline. **<italic>P</italic><0.001 vs. baseline; two-sample <italic>t</italic>-test. Data are shown as mean±95% confidence intervals. CTT, colonic transit time.</p></caption><graphic xlink:href="ajg201474f1"></graphic></fig><fig id="fig2"><label>Figure 2</label><caption><p>(<bold>a</bold>) Proportion of responders and (<bold>b</bold>) mean colonic transit times in responders and nonresponders after treatment with placebo, prucalopride 2 mg, or prucalopride 4 mg. <sup>††</sup><italic>P</italic><0.001 vs. placebo; <sup>‡</sup><italic>P</italic><0.05 vs. nonresponders calculated using the paired <italic>t</italic>-tests. Numbers in each bar indicate the number of patients in each group.</p></caption><graphic xlink:href="ajg201474f2"></graphic></fig><fig id="fig3"><label>Figure 3</label><caption><p>Relationship between CTTs at the end of treatment and the proportion of patients with severe or very severe constipation-related symptoms. Normal CTT <italic>n</italic>=84; slow CTT <italic>n</italic>=150; very slow CTT <italic>n</italic>=46. CTT, colonic transit time.</p></caption><graphic xlink:href="ajg201474f3"></graphic></fig><fig id="fig4"><label>Figure 4</label><caption><p>Proportion of bowel movements with (<bold>a</bold>) hard/very hard consistency or (<bold>b</bold>) normal consistency in patients with normal and slow CTTs at the end of treatment. Data are shown as mean±95% confidence intervals. CTT, colonic transit time.</p></caption><graphic xlink:href="ajg201474f4"></graphic></fig><table-wrap id="tbl1"><label>Table 1</label><caption><title>Outline of symptoms assessed and how these were combined across the three trials</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="left"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Symptoms as defined in this study</bold></th><th align="left" valign="top" charoff="50"><bold>Symptoms as described in the original trial</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50"> Straining</td><td align="left" valign="top" charoff="50">Difficulty of stool passage/straining</td></tr><tr><td align="left" valign="top" charoff="50"> Abdominal bloating/flatulence/distension</td><td align="left" valign="top" charoff="50">Abdominal bloating
Abdominal distension
Flatulence</td></tr><tr><td align="left" valign="top" charoff="50"> Abdominal pain/cramps</td><td align="left" valign="top" charoff="50">Abdominal pain
Abdominal cramps</td></tr><tr><td align="left" valign="top" charoff="50"> Incomplete evacuation</td><td align="left" valign="top" charoff="50">Incomplete evacuation</td></tr><tr><td align="left" valign="top" charoff="50"> Urgency</td><td align="left" valign="top" charoff="50">Urgency</td></tr><tr><td align="left" valign="top" charoff="50"> Unproductive calls to stool</td><td align="left" valign="top" charoff="50">Unproductive calls</td></tr><tr><td align="left" valign="top" charoff="50"> Tenesmus</td><td align="left" valign="top" charoff="50">Tenesmus</td></tr><tr><td align="left" valign="top" charoff="50"> Nausea (with or without vomiting)</td><td align="left" valign="top" charoff="50">Nausea</td></tr><tr><td align="left" valign="top" charoff="50"> Anorexia</td><td align="left" valign="top" charoff="50">Anorexia (loss of appetite)</td></tr><tr><td align="left" valign="top" charoff="50"> Malaise</td><td align="left" valign="top" charoff="50">Malaise</td></tr><tr><td align="left" valign="top" charoff="50"> Fatigue</td><td align="left" valign="top" charoff="50">Fatigue</td></tr><tr><td align="left" valign="top" charoff="50"> Dysmenorrhea and/or irregular period</td><td align="left" valign="top" charoff="50">Irregular menstrual cycle</td></tr><tr><td align="left" valign="top" charoff="50"> Difficulty in starting micturition</td><td align="left" valign="top" charoff="50">Difficulty in starting urination</td></tr></tbody></table></table-wrap><table-wrap id="tbl2"><label>Table 2</label><caption><title>Patient characteristics at baseline</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="left"></col><col align="center"></col><col align="char" char="("></col><col align="char" char="("></col><col align="char" char="("></col><col align="center"></col><col align="center"></col><col align="center"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" charoff="50"><bold>Total <italic>n</italic></bold></th><th align="char" valign="top" char="(" charoff="50"><bold>Women, <italic>n</italic> (%)</bold></th><th align="char" valign="top" char="(" charoff="50"><bold>Age, years, mean (range)</bold></th><th align="char" valign="top" char="(" charoff="50"><bold>Duration of constipation, years, mean (range)</bold></th><th align="center" valign="top" charoff="50"><bold>CTT, hours, mean (range)</bold></th><th align="center" valign="top" charoff="50"><bold>Patients with slow or very slow CTT (>48 h), <italic>n</italic> (%)</bold></th><th align="center" valign="top" charoff="50"><bold>Patients with very slow CTT (>96 h), <italic>n</italic> (%)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">All patients enrolled in the phase 2 trials</td><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50">651</td><td align="char" valign="top" char="(" charoff="50">596 (92%)</td><td align="char" valign="top" char="(" charoff="50">42 (18–73)</td><td align="char" valign="top" char="(" charoff="50">18.3 (0.5–64)</td><td align="center" valign="top" charoff="50">—</td><td align="center" valign="top" charoff="50">—</td><td align="center" valign="top" charoff="50">—</td></tr><tr><td align="left" valign="top" charoff="50">Study population: patients CTT measurements both before and at the end of treatment</td><td align="left" valign="top" charoff="50">All patients</td><td align="center" valign="top" charoff="50">280</td><td align="char" valign="top" char="(" charoff="50">260 (93%)</td><td align="char" valign="top" char="(" charoff="50">43 (18–70)</td><td align="char" valign="top" char="(" charoff="50">19 (0.5–64)</td><td align="center" valign="top" charoff="50">66 (2–144)</td><td align="center" valign="top" charoff="50">196 (70%)</td><td align="center" valign="top" charoff="50">46 (16%)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50">Placebo</td><td align="center" valign="top" charoff="50">112</td><td align="char" valign="top" char="(" charoff="50">102 (91%)</td><td align="char" valign="top" char="(" charoff="50">43 (18–70)</td><td align="char" valign="top" char="(" charoff="50">19 (1.0–54)</td><td align="center" valign="top" charoff="50">66 (2–144)</td><td align="center" valign="top" charoff="50">79 (71%)</td><td align="center" valign="top" charoff="50">18 (16%)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50">Prucalopride, 2 mg</td><td align="center" valign="top" charoff="50">98</td><td align="char" valign="top" char="(" charoff="50">93 (95%)</td><td align="char" valign="top" char="(" charoff="50">43 (19–70)</td><td align="char" valign="top" char="(" charoff="50">18 (0.7–50)</td><td align="center" valign="top" charoff="50">65 (3–144)</td><td align="center" valign="top" charoff="50">67 (68%)</td><td align="center" valign="top" charoff="50">18 (18%)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50">Prucalopride, 4 mg</td><td align="center" valign="top" charoff="50">70</td><td align="char" valign="top" char="(" charoff="50">64 (91%)</td><td align="char" valign="top" char="(" charoff="50">41 (18–70)</td><td align="char" valign="top" char="(" charoff="50">21 (0.6–64)</td><td align="center" valign="top" charoff="50">67 (4–144)</td><td align="center" valign="top" charoff="50">50 (71%)</td><td align="center" valign="top" charoff="50">10 (14%)</td></tr></tbody></table><table-wrap-foot><fn id="t2-fn1"><p>CTT, colonic transit time.</p></fn></table-wrap-foot></table-wrap></floats-group></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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