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Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation
Background Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C). Aim To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity. Methods Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 ...
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| Published in: | Digestive diseases and sciences 2024-05, Vol.69 (5), p.1731-1738 |
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| container_title | Digestive diseases and sciences |
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| creator | Brenner, Darren M. Sharma, Amol Rao, Satish S. C. Laitman, Adam P. Heimanson, Zeev Allen, Christopher Sayuk, Gregory S. |
| description | Background
Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C).
Aim
To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity.
Methods
Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed. Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]). Assessments included change from baseline in bloating, abdominal pain, and complete spontaneous bowel movement (CSBM) frequency. Abdominal pain and bloating composite responders were defined as patients with ≥ 30% improvement from baseline in both bloating and abdominal pain at Week 12.
Results
At baseline, 1104/1436 patients with IBS-C (76.9%) reported moderate-to-severe bloating. In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: − 1.7 vs − 1.3;
P
= 0.002), reduced abdominal pain (− 1.7 vs − 1.3;
P
= 0.006), and increased CSBM frequency (1.4 vs 0.8;
P
|
| doi_str_mv | 10.1007/s10620-024-08330-y |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11098865</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3055651991</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-e1095c6a9e033b4ab871ae52b8d0c682ee90075594b9ee8834a1bcc430fbe15d3</originalsourceid><addsrcrecordid>eNp9kUtv1DAUhS1ERYfCH2CBLLFhE7i2Y8dZoXbEY6RKIAFry3buzKRK7GBnWs2_x-2UaWHBypbOd899HEJeMXjHAJr3mYHiUAGvK9BCQLV_QhZMNqLiUumnZAFMlT9j6pQ8z_kKANqGqWfkVGjZ1jVvF2T7bUBvg537DulqnFK8xkzPXRfHPtiBXgyxaGFDbejoRbzBgX7fj9Mcx0zjmq5S6mfrBjxqoUtxRHrTz1u6jCHP_VQMYnhBTtZ2yPjy_j0jPz99_LH8Ul1-_bxanl9Wvm7kXCGDVnplWwQhXG2dbphFyZ3uwCvNEduyuizjuxZRa1Fb5ryvBawdMtmJM_Lh4Dvt3IidxzAnO5gp9aNNexNtb_5WQr81m3htWOmstZLF4e29Q4q_dphnM_bZ4zDYgHGXjQAhZQ2c84K--Qe9irtU7nZLSakka1tWKH6gfIo5J1wfp2FgbpM0hyRNSdLcJWn2pej14z2OJX-iK4A4ALlIYYPpofd_bH8DAOernQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3055651991</pqid></control><display><type>article</type><title>Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation</title><source>Springer Nature</source><creator>Brenner, Darren M. ; Sharma, Amol ; Rao, Satish S. C. ; Laitman, Adam P. ; Heimanson, Zeev ; Allen, Christopher ; Sayuk, Gregory S.</creator><creatorcontrib>Brenner, Darren M. ; Sharma, Amol ; Rao, Satish S. C. ; Laitman, Adam P. ; Heimanson, Zeev ; Allen, Christopher ; Sayuk, Gregory S.</creatorcontrib><description>Background
Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C).
Aim
To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity.
Methods
Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed. Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]). Assessments included change from baseline in bloating, abdominal pain, and complete spontaneous bowel movement (CSBM) frequency. Abdominal pain and bloating composite responders were defined as patients with ≥ 30% improvement from baseline in both bloating and abdominal pain at Week 12.
Results
At baseline, 1104/1436 patients with IBS-C (76.9%) reported moderate-to-severe bloating. In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: − 1.7 vs − 1.3;
P
= 0.002), reduced abdominal pain (− 1.7 vs − 1.3;
P
= 0.006), and increased CSBM frequency (1.4 vs 0.8;
P
< 0.0001). In the mild bloating subgroup, significant improvements were observed with plecanatide versus placebo for abdominal pain (LSMC: − 1.3 vs − 1.0;
P
= 0.046) and CSBM frequency (2.0 vs 1.2;
P
= 0.003) but not bloating (− 0.9 vs − 0.8;
P
= 0.28). A significantly greater percentage of patients were abdominal pain and bloating composite responders with plecanatide versus placebo (moderate-to-severe bloating: 33.6% vs 26.8% [
P
= 0.02]; mild bloating: 38.4% vs 27.2% [
P
= 0.03]).
Conclusion
Plecanatide treatment improved IBS-C abdominal and bowel symptoms, including in those who present with moderate-to-severe bloating.
Graphical Abstract</description><identifier>ISSN: 0163-2116</identifier><identifier>ISSN: 1573-2568</identifier><identifier>EISSN: 1573-2568</identifier><identifier>DOI: 10.1007/s10620-024-08330-y</identifier><identifier>PMID: 38594429</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Abdomen ; Abdominal Pain - drug therapy ; Abdominal Pain - etiology ; Adult ; Biochemistry ; Constipation ; Constipation - drug therapy ; Defecation - drug effects ; Double-Blind Method ; Female ; Gastroenterology ; Gastrointestinal Agents - therapeutic use ; Hepatology ; Humans ; Irritable bowel syndrome ; Irritable Bowel Syndrome - complications ; Irritable Bowel Syndrome - drug therapy ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Natriuretic Peptides - therapeutic use ; Oncology ; Original ; Original Article ; Pain ; Severity of Illness Index ; Transplant Surgery ; Treatment Outcome</subject><ispartof>Digestive diseases and sciences, 2024-05, Vol.69 (5), p.1731-1738</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-e1095c6a9e033b4ab871ae52b8d0c682ee90075594b9ee8834a1bcc430fbe15d3</citedby><cites>FETCH-LOGICAL-c475t-e1095c6a9e033b4ab871ae52b8d0c682ee90075594b9ee8834a1bcc430fbe15d3</cites><orcidid>0000-0002-8732-3632</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38594429$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brenner, Darren M.</creatorcontrib><creatorcontrib>Sharma, Amol</creatorcontrib><creatorcontrib>Rao, Satish S. C.</creatorcontrib><creatorcontrib>Laitman, Adam P.</creatorcontrib><creatorcontrib>Heimanson, Zeev</creatorcontrib><creatorcontrib>Allen, Christopher</creatorcontrib><creatorcontrib>Sayuk, Gregory S.</creatorcontrib><title>Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation</title><title>Digestive diseases and sciences</title><addtitle>Dig Dis Sci</addtitle><addtitle>Dig Dis Sci</addtitle><description>Background
Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C).
Aim
To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity.
Methods
Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed. Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]). Assessments included change from baseline in bloating, abdominal pain, and complete spontaneous bowel movement (CSBM) frequency. Abdominal pain and bloating composite responders were defined as patients with ≥ 30% improvement from baseline in both bloating and abdominal pain at Week 12.
Results
At baseline, 1104/1436 patients with IBS-C (76.9%) reported moderate-to-severe bloating. In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: − 1.7 vs − 1.3;
P
= 0.002), reduced abdominal pain (− 1.7 vs − 1.3;
P
= 0.006), and increased CSBM frequency (1.4 vs 0.8;
P
< 0.0001). In the mild bloating subgroup, significant improvements were observed with plecanatide versus placebo for abdominal pain (LSMC: − 1.3 vs − 1.0;
P
= 0.046) and CSBM frequency (2.0 vs 1.2;
P
= 0.003) but not bloating (− 0.9 vs − 0.8;
P
= 0.28). A significantly greater percentage of patients were abdominal pain and bloating composite responders with plecanatide versus placebo (moderate-to-severe bloating: 33.6% vs 26.8% [
P
= 0.02]; mild bloating: 38.4% vs 27.2% [
P
= 0.03]).
Conclusion
Plecanatide treatment improved IBS-C abdominal and bowel symptoms, including in those who present with moderate-to-severe bloating.
Graphical Abstract</description><subject>Abdomen</subject><subject>Abdominal Pain - drug therapy</subject><subject>Abdominal Pain - etiology</subject><subject>Adult</subject><subject>Biochemistry</subject><subject>Constipation</subject><subject>Constipation - drug therapy</subject><subject>Defecation - drug effects</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Irritable bowel syndrome</subject><subject>Irritable Bowel Syndrome - complications</subject><subject>Irritable Bowel Syndrome - drug therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Natriuretic Peptides - therapeutic use</subject><subject>Oncology</subject><subject>Original</subject><subject>Original Article</subject><subject>Pain</subject><subject>Severity of Illness Index</subject><subject>Transplant Surgery</subject><subject>Treatment Outcome</subject><issn>0163-2116</issn><issn>1573-2568</issn><issn>1573-2568</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kUtv1DAUhS1ERYfCH2CBLLFhE7i2Y8dZoXbEY6RKIAFry3buzKRK7GBnWs2_x-2UaWHBypbOd899HEJeMXjHAJr3mYHiUAGvK9BCQLV_QhZMNqLiUumnZAFMlT9j6pQ8z_kKANqGqWfkVGjZ1jVvF2T7bUBvg537DulqnFK8xkzPXRfHPtiBXgyxaGFDbejoRbzBgX7fj9Mcx0zjmq5S6mfrBjxqoUtxRHrTz1u6jCHP_VQMYnhBTtZ2yPjy_j0jPz99_LH8Ul1-_bxanl9Wvm7kXCGDVnplWwQhXG2dbphFyZ3uwCvNEduyuizjuxZRa1Fb5ryvBawdMtmJM_Lh4Dvt3IidxzAnO5gp9aNNexNtb_5WQr81m3htWOmstZLF4e29Q4q_dphnM_bZ4zDYgHGXjQAhZQ2c84K--Qe9irtU7nZLSakka1tWKH6gfIo5J1wfp2FgbpM0hyRNSdLcJWn2pej14z2OJX-iK4A4ALlIYYPpofd_bH8DAOernQ</recordid><startdate>20240501</startdate><enddate>20240501</enddate><creator>Brenner, Darren M.</creator><creator>Sharma, Amol</creator><creator>Rao, Satish S. C.</creator><creator>Laitman, Adam P.</creator><creator>Heimanson, Zeev</creator><creator>Allen, Christopher</creator><creator>Sayuk, Gregory S.</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8732-3632</orcidid></search><sort><creationdate>20240501</creationdate><title>Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation</title><author>Brenner, Darren M. ; Sharma, Amol ; Rao, Satish S. C. ; Laitman, Adam P. ; Heimanson, Zeev ; Allen, Christopher ; Sayuk, Gregory S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-e1095c6a9e033b4ab871ae52b8d0c682ee90075594b9ee8834a1bcc430fbe15d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Abdomen</topic><topic>Abdominal Pain - drug therapy</topic><topic>Abdominal Pain - etiology</topic><topic>Adult</topic><topic>Biochemistry</topic><topic>Constipation</topic><topic>Constipation - drug therapy</topic><topic>Defecation - drug effects</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Irritable bowel syndrome</topic><topic>Irritable Bowel Syndrome - complications</topic><topic>Irritable Bowel Syndrome - drug therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Natriuretic Peptides - therapeutic use</topic><topic>Oncology</topic><topic>Original</topic><topic>Original Article</topic><topic>Pain</topic><topic>Severity of Illness Index</topic><topic>Transplant Surgery</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brenner, Darren M.</creatorcontrib><creatorcontrib>Sharma, Amol</creatorcontrib><creatorcontrib>Rao, Satish S. C.</creatorcontrib><creatorcontrib>Laitman, Adam P.</creatorcontrib><creatorcontrib>Heimanson, Zeev</creatorcontrib><creatorcontrib>Allen, Christopher</creatorcontrib><creatorcontrib>Sayuk, Gregory S.</creatorcontrib><collection>Springer_OA刊</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Digestive diseases and sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brenner, Darren M.</au><au>Sharma, Amol</au><au>Rao, Satish S. C.</au><au>Laitman, Adam P.</au><au>Heimanson, Zeev</au><au>Allen, Christopher</au><au>Sayuk, Gregory S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation</atitle><jtitle>Digestive diseases and sciences</jtitle><stitle>Dig Dis Sci</stitle><addtitle>Dig Dis Sci</addtitle><date>2024-05-01</date><risdate>2024</risdate><volume>69</volume><issue>5</issue><spage>1731</spage><epage>1738</epage><pages>1731-1738</pages><issn>0163-2116</issn><issn>1573-2568</issn><eissn>1573-2568</eissn><abstract>Background
Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C).
Aim
To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity.
Methods
Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed. Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]). Assessments included change from baseline in bloating, abdominal pain, and complete spontaneous bowel movement (CSBM) frequency. Abdominal pain and bloating composite responders were defined as patients with ≥ 30% improvement from baseline in both bloating and abdominal pain at Week 12.
Results
At baseline, 1104/1436 patients with IBS-C (76.9%) reported moderate-to-severe bloating. In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: − 1.7 vs − 1.3;
P
= 0.002), reduced abdominal pain (− 1.7 vs − 1.3;
P
= 0.006), and increased CSBM frequency (1.4 vs 0.8;
P
< 0.0001). In the mild bloating subgroup, significant improvements were observed with plecanatide versus placebo for abdominal pain (LSMC: − 1.3 vs − 1.0;
P
= 0.046) and CSBM frequency (2.0 vs 1.2;
P
= 0.003) but not bloating (− 0.9 vs − 0.8;
P
= 0.28). A significantly greater percentage of patients were abdominal pain and bloating composite responders with plecanatide versus placebo (moderate-to-severe bloating: 33.6% vs 26.8% [
P
= 0.02]; mild bloating: 38.4% vs 27.2% [
P
= 0.03]).
Conclusion
Plecanatide treatment improved IBS-C abdominal and bowel symptoms, including in those who present with moderate-to-severe bloating.
Graphical Abstract</abstract><cop>New York</cop><pub>Springer US</pub><pmid>38594429</pmid><doi>10.1007/s10620-024-08330-y</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-8732-3632</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0163-2116 |
| ispartof | Digestive diseases and sciences, 2024-05, Vol.69 (5), p.1731-1738 |
| issn | 0163-2116 1573-2568 1573-2568 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11098865 |
| source | Springer Nature |
| subjects | Abdomen Abdominal Pain - drug therapy Abdominal Pain - etiology Adult Biochemistry Constipation Constipation - drug therapy Defecation - drug effects Double-Blind Method Female Gastroenterology Gastrointestinal Agents - therapeutic use Hepatology Humans Irritable bowel syndrome Irritable Bowel Syndrome - complications Irritable Bowel Syndrome - drug therapy Male Medicine Medicine & Public Health Middle Aged Natriuretic Peptides - therapeutic use Oncology Original Original Article Pain Severity of Illness Index Transplant Surgery Treatment Outcome |
| title | Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation |
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