{"id":"https://openalex.org/W1993444635","doi":"https://doi.org/10.1136/gutjnl-2013-304907.685","title":"PTH-198 Pooled Analysis of the most Frequent Adverse Events Associated with the use of Lubiprostone","display_name":"PTH-198 Pooled Analysis of the most Frequent Adverse Events Associated with the use of Lubiprostone","publication_year":2013,"publication_date":"2013-06-01","ids":{"openalex":"https://openalex.org/W1993444635","doi":"https://doi.org/10.1136/gutjnl-2013-304907.685","mag":"1993444635"},"language":"en","primary_location":{"id":"doi:10.1136/gutjnl-2013-304907.685","doi":"https://doi.org/10.1136/gutjnl-2013-304907.685","is_oa":true,"landing_page_url":"https://doi.org/10.1136/gutjnl-2013-304907.685","pdf_url":"https://gut.bmj.com/content/gutjnl/62/Suppl_1/A292.2.full.pdf","source":{"id":"https://openalex.org/S3251770","display_name":"Gut","issn_l":"0017-5749","issn":["0017-5749","1468-3288"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Gut","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","is_traditional":false,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://gut.bmj.com/content/gutjnl/62/Suppl_1/A292.2.full.pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5032770263","display_name":"Taryn R. Joswick","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4387154415","display_name":"Sucampo (United States)","ror":"https://ror.org/04t7jhw56","country_code":"US","type":"company","lineage":["https://openalex.org/I4210102181","https://openalex.org/I4387154415"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"T Joswick","raw_affiliation_strings":["R&D, Sucampo Pharmaceuticals, Bethesda, United States","1R&D, Sucampo Pharmaceuticals, Bethesda, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"R&D, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":["https://openalex.org/I4387154415"]},{"raw_affiliation_string":"1R&D, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":["https://openalex.org/I4387154415"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002872621","display_name":"Gayle Dolecek","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4387154415","display_name":"Sucampo (United States)","ror":"https://ror.org/04t7jhw56","country_code":"US","type":"company","lineage":["https://openalex.org/I4210102181","https://openalex.org/I4387154415"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"G Dolecek","raw_affiliation_strings":["R&D, Sucampo Pharmaceuticals, Bethesda, United States","1R&D, Sucampo Pharmaceuticals, Bethesda, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"R&D, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":["https://openalex.org/I4387154415"]},{"raw_affiliation_string":"1R&D, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":["https://openalex.org/I4387154415"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5028533210","display_name":"Peter Lichtlen","orcid":"https://orcid.org/0009-0002-3441-0553","observed_orcids":["https://orcid.org/0009-0002-3441-0553"]},"institutions":[{"id":"https://openalex.org/I1307320085","display_name":"Sucampo (Switzerland)","ror":"https://ror.org/05gmffx67","country_code":"CH","type":"company","lineage":["https://openalex.org/I1307320085"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"P Lichtlen","raw_affiliation_strings":["R&D, Sucampo Pharmaceuticals, Zug, Switzerland","2R&D, Sucampo Pharmaceuticals, Zug, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"R&D, Sucampo Pharmaceuticals, Zug, Switzerland","institution_ids":["https://openalex.org/I1307320085"]},{"raw_affiliation_string":"2R&D, Sucampo Pharmaceuticals, Zug, Switzerland","institution_ids":["https://openalex.org/I1307320085"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111044632","display_name":"D Panigrahi","orcid":"https://orcid.org/0009-0008-3972-1864","observed_orcids":["https://orcid.org/0009-0008-3972-1864"]},"institutions":[{"id":"https://openalex.org/I4387154415","display_name":"Sucampo (United States)","ror":"https://ror.org/04t7jhw56","country_code":"US","type":"company","lineage":["https://openalex.org/I4210102181","https://openalex.org/I4387154415"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"D Panigrahi","raw_affiliation_strings":["Medical Affairs, Sucampo Pharmaceuticals, Bethesda, United States","3Medical Affairs, Sucampo Pharmaceuticals, Bethesda, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medical Affairs, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":["https://openalex.org/I4387154415"]},{"raw_affiliation_string":"3Medical Affairs, Sucampo Pharmaceuticals, Bethesda, United States","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5113738093","display_name":"Ryuji Ueno","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1307320085","display_name":"Sucampo (Switzerland)","ror":"https://ror.org/05gmffx67","country_code":"CH","type":"company","lineage":["https://openalex.org/I1307320085"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"R Ueno","raw_affiliation_strings":["Sucampo Pharmaceuticals, Zug, Switzerland","4Sucampo Pharmaceuticals, Zug, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sucampo Pharmaceuticals, Zug, Switzerland","institution_ids":["https://openalex.org/I1307320085"]},{"raw_affiliation_string":"4Sucampo Pharmaceuticals, Zug, Switzerland","institution_ids":["https://openalex.org/I1307320085"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"62","issue":"Suppl 1","first_page":"A292.2","last_page":"A292"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10365","display_name":"Gastrointestinal motility and disorders","score":0.9883000254631042,"subfield":{"id":"https://openalex.org/subfields/2715","display_name":"Gastroenterology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10365","display_name":"Gastrointestinal motility and disorders","score":0.9883000254631042,"subfield":{"id":"https://openalex.org/subfields/2715","display_name":"Gastroenterology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.00570000009611249,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11785","display_name":"Nausea and vomiting management","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/lubiprostone","display_name":"lubiprostone","score":0.9710000157356262},{"id":"https://openalex.org/keywords/chronic-constipation","display_name":"chronic constipation","score":0.796999990940094},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.9330000281333923},{"id":"https://openalex.org/keywords/nausea","display_name":"nausea","score":0.9549999833106995},{"id":"https://openalex.org/keywords/headache","display_name":"headache","score":0.9649999737739563},{"id":"https://openalex.org/keywords/diarrhea","display_name":"diarrhea","score":0.9940000176429749},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.6299999952316284},{"id":"https://openalex.org/keywords/elderly-patients","display_name":"elderly patients","score":0.8199999928474426},{"id":"https://openalex.org/keywords/sex-differences","display_name":"sex differences","score":0.7630000114440918},{"id":"https://openalex.org/keywords/dose-reduction","display_name":"dose reduction","score":0.6990000009536743},{"id":"https://openalex.org/keywords/placebo-controlled-comparison","display_name":"placebo comparison","score":0.46700000762939453},{"id":"https://openalex.org/keywords/pooled-analysis-of-clinical-trials","display_name":"pooled analysis of clinical trials","score":0.5839999914169312},{"id":"https://openalex.org/keywords/treatment-discontinuation","display_name":"treatment discontinuation","score":0.37700000405311584},{"id":"https://openalex.org/keywords/dose-limiting-adverse-events","display_name":"dose-limiting adverse events","score":0.44699999690055847},{"id":"https://openalex.org/keywords/gastrointestinal-tolerability","display_name":"gastrointestinal tolerance","score":0.3779999911785126},{"id":"https://openalex.org/keywords/quality-of-life","display_name":"quality of life","score":0.5799999833106995}],"concepts":[{"id":"https://openalex.org/C2780580376","wikidata":"https://www.wikidata.org/wiki/Q186889","display_name":"Nausea","level":2,"score":0.9632307887077332},{"id":"https://openalex.org/C2781093762","wikidata":"https://www.wikidata.org/wiki/Q6695342","display_name":"Lubiprostone","level":4,"score":0.9473924040794373},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7568156123161316},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.7107547521591187},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6416065692901611},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.6325723528862},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.5684314966201782},{"id":"https://openalex.org/C2781112942","wikidata":"https://www.wikidata.org/wiki/Q178436","display_name":"Constipation","level":2,"score":0.44782957434654236},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.43968790769577026},{"id":"https://openalex.org/C2780852908","wikidata":"https://www.wikidata.org/wiki/Q127076","display_name":"Vomiting","level":2,"score":0.43432140350341797},{"id":"https://openalex.org/C3017955636","wikidata":"https://www.wikidata.org/wiki/Q178436","display_name":"Chronic constipation","level":3,"score":0.09199011325836182},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1136/gutjnl-2013-304907.685","doi":"https://doi.org/10.1136/gutjnl-2013-304907.685","is_oa":true,"landing_page_url":"https://doi.org/10.1136/gutjnl-2013-304907.685","pdf_url":"https://gut.bmj.com/content/gutjnl/62/Suppl_1/A292.2.full.pdf","source":{"id":"https://openalex.org/S3251770","display_name":"Gut","issn_l":"0017-5749","issn":["0017-5749","1468-3288"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Gut","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1136/gutjnl-2013-304907.685","doi":"https://doi.org/10.1136/gutjnl-2013-304907.685","is_oa":true,"landing_page_url":"https://doi.org/10.1136/gutjnl-2013-304907.685","pdf_url":"https://gut.bmj.com/content/gutjnl/62/Suppl_1/A292.2.full.pdf","source":{"id":"https://openalex.org/S3251770","display_name":"Gut","issn_l":"0017-5749","issn":["0017-5749","1468-3288"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Gut","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":1.0}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W1993444635.pdf","grobid_xml":"https://content.openalex.org/works/W1993444635.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2977981041","https://openalex.org/W2748730319","https://openalex.org/W6977156842","https://openalex.org/W3031576275","https://openalex.org/W1486462492","https://openalex.org/W2079471195","https://openalex.org/W2003147380","https://openalex.org/W4410602504","https://openalex.org/W4292647012","https://openalex.org/W2041581988"],"abstract_inverted_index":{"Introduction":[0],"Lubiprostone,":[1],"a":[2],"novel":[3],"ClC-2":[4],"activator,":[5],"has":[6],"been":[7],"shown":[8],"to":[9,58,193,248,343,366],"be":[10,194],"efficacious":[11],"and":[12,21,53,70,83,101,117,127,135,157,179,211,220,225,238,242,261,279,284,302,309,314,324,327,336,346,351,357,371],"well-tolerated":[13],"by":[14,206],"patients":[15,48,67,186,208,299,319],"with":[16,35,152,155,159,174,177,181,289,360],"chronic":[17],"constipation":[18],"in":[19,50,88,109,144,166,198,258,266,273,276,317,368,373],"short-":[20],"long-term":[22],"clinical":[23],"trials.":[24],"To":[25],"better":[26],"characterise":[27],"the":[28,36,212,295,328],"most":[29],"frequent":[30],"adverse":[31],"events":[32,204,217,254,264,316,333],"(AEs)":[33],"associated":[34,359],"use":[37,362],"of":[38,47,56,90,111,115,146,168,202,215,232,252,263,281,291,297,331,376],"lubiprostone":[39,77,126,147,185,207,224,241,282,298,318,361],"24":[40,78],"mcg":[41,79],"BID,":[42],"we":[43],"examined":[44],"pooled":[45,69,122],"results":[46],"enrolled":[49],"Phase":[51],"2":[52],"3":[54,57],"trials":[55],"48":[59],"weeks\u2019":[60],"duration.":[61,374],"Methods":[62],"Data":[63],"for":[64,223,240],"all":[65],"safety-evaluable":[66],"were":[68,86,107,133,137,209,218,236,320,334,348],"compared":[71,288],"between":[72],"treatment":[73,259],"groups":[74],"(placebo":[75],"vs":[76],"BID).":[80],"Nausea,":[81,355],"headache,":[82,156,178,345,356],"diarrhoea":[84,303,315,347,358],"AEs":[85],"analysed":[87],"terms":[89],"severity,":[91,369],"duration,":[92],"frequency,":[93],"action":[94,249],"taken":[95],"(eg,":[96],"drug":[97],"withdrawn,":[98],"dose":[99,267],"reduced),":[100],"outcome.":[102],"In":[103],"addition,":[104],"nausea-related":[105],"variables":[106],"explored":[108],"subpopulations":[110],"elderly":[112,134,283],"(\u226565":[113],"years":[114],"age)":[116],"male":[118,285],"patients.":[119,130,293],"Results":[120],"The":[121],"population":[123],"included":[124,150,172],"1113":[125],"316":[128],"placebo":[129,169,226,243],"Approximately":[131],"16%":[132],"13%":[136],"male.":[138],"At":[139,161],"least":[140,162],"1":[141,163],"AE":[142,164],"occurred":[143,165],"79.1%":[145],"patients,":[148,170,227,244,286],"which":[149,171],"31.1%":[151],"nausea,":[153,175,189,344],"13.2%":[154,158],"diarrhoea.":[160,182],"39.6%":[167],"5.1%":[173],"6.6%":[176],"0.9%":[180],"Of":[183],"those":[184],"who":[187],"experienced":[188],"88.7%":[190],"reported":[191,205],"nausea":[192,203,216,233,253],"mild":[195,365],"or":[196],"moderate":[197,367],"severity.":[199],"Overall,":[200],"74.5%":[201],"intermittent,":[210,370],"median":[213,329],"durations":[214],"12":[219],"7.5":[221],"days":[222],"respectively.":[228,245,339,353],"Notably,":[229],"mean":[230],"incidences":[231],"per":[234],"patient":[235],"1.3":[237],"1.0":[239],"With":[246],"regard":[247],"taken,":[250],"64.1%":[251],"required":[255],"no":[256],"change":[257],"regimen,":[260],"9.6%":[262],"resulted":[265],"reduction.":[268],"Nausea":[269],"was":[270],"less":[271],"prevalent":[272],"subpopulations,":[274],"occurring":[275],"only":[277],"18.8%":[278],"8.2%":[280],"respectively,":[287],"34.5%":[290],"female":[292],"Similarly,":[294],"majority":[296],"experiencing":[300],"headache":[301,313],"had":[304],"mild-to-moderate":[305],"symptom":[306],"severity":[307],"(89.8%":[308],"82.3%,":[310],"respectively).":[311],"Furthermore,":[312],"mostly":[321],"intermittent":[322],"(64.2%":[323],"74.0%,":[325],"respectively),":[326],"duration":[330],"these":[332],"9":[335],"4":[337],"days,":[338],"Discontinuation":[340],"rates":[341],"due":[342],"8.7%,":[349],"3.7%,":[350],"2.2%,":[352],"Conclusion":[354],"are":[363],"generally":[364],"limited":[372],"Disclosure":[375],"Interest":[377],"None":[378],"Declared.":[379]},"counts_by_year":[],"updated_date":"2026-09-07T09:17:50.787605","created_date":"2016-06-24T00:00:00"}