{"id":"https://openalex.org/W4403727996","doi":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d","title":"S417 A Post Hoc Safety Analysis of Flavored Polyethylene Glycol and Sulfate Solution Bowel Preparation in Elderly Patients and Patients With Renal Insufficiency","display_name":"S417 A Post Hoc Safety Analysis of Flavored Polyethylene Glycol and Sulfate Solution Bowel Preparation in Elderly Patients and Patients With Renal Insufficiency","publication_year":2024,"publication_date":"2024-10-01","ids":{"openalex":"https://openalex.org/W4403727996","doi":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d"},"language":"en","primary_location":{"id":"doi:10.14309/01.ajg.0001031036.21101.0d","doi":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d","is_oa":false,"landing_page_url":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d","pdf_url":null,"source":{"id":"https://openalex.org/S66441642","display_name":"The American Journal of Gastroenterology","issn_l":"0002-9270","issn":["0002-9270","1572-0241"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Gastroenterology","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","is_traditional":false,"indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5111390995","display_name":"Jack A. DiPalma","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I83809506","display_name":"University of South Alabama","ror":"https://ror.org/01s7b5y08","country_code":"US","type":"education","lineage":["https://openalex.org/I83809506"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jack DiPalma","raw_affiliation_strings":["University of South Alabama, Mobile, AL;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of South Alabama, Mobile, AL;","institution_ids":["https://openalex.org/I83809506"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103997887","display_name":"Raj Bhandari","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Raj Bhandari","raw_affiliation_strings":["Delta Research Partners, Monroe, LA;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Delta Research Partners, Monroe, LA;","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083845259","display_name":"Douglas Kevin Rex","orcid":"https://orcid.org/0000-0002-9836-4309","observed_orcids":["https://orcid.org/0000-0002-9836-4309"]},"institutions":[{"id":"https://openalex.org/I4394709130","display_name":"Indiana University School of Medicine","ror":"https://ror.org/02ets8c94","country_code":"US","type":"education","lineage":["https://openalex.org/I4394709130","https://openalex.org/I592451"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Douglas Rex","raw_affiliation_strings":["Indiana University School of Medicine, Indianapolis, IN;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Indiana University School of Medicine, Indianapolis, IN;","institution_ids":["https://openalex.org/I4394709130"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5107846713","display_name":"Andrew Swanson","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405270752","display_name":"Braintree Laboratories (United States)","ror":"https://ror.org/018wj4g64","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270752"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Andrew Swanson","raw_affiliation_strings":["Braintree Laboratories, Inc., Braintree, MA;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Braintree Laboratories, Inc., Braintree, MA;","institution_ids":["https://openalex.org/I4405270752"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5114393347","display_name":"Michael E. Beckelic","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405270752","display_name":"Braintree Laboratories (United States)","ror":"https://ror.org/018wj4g64","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270752"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Michael E. Beckelic","raw_affiliation_strings":["Braintree Laboratories, Inc., Roswell, GA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Braintree Laboratories, Inc., Roswell, GA","institution_ids":["https://openalex.org/I4405270752"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5114393347"],"corresponding_institution_ids":["https://openalex.org/I4405270752"],"apc_list":{"value":4390,"currency":"USD","value_usd":4390},"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"119","issue":"10S","first_page":"S296","last_page":"S296"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10552","display_name":"Colorectal Cancer Screening and Detection","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T10552","display_name":"Colorectal Cancer Screening and Detection","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T10365","display_name":"Gastrointestinal motility and disorders","score":0.004900000058114529,"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/T11378","display_name":"Gastrointestinal Bleeding Diagnosis and Treatment","score":0.0019000000320374966,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/bowel-preparation","display_name":"bowel preparation","score":0.972000002861023},{"id":"https://openalex.org/keywords/elderly-patients","display_name":"elderly patients","score":0.8109999895095825},{"id":"https://openalex.org/keywords/kidney-failure","display_name":"renal failure","score":0.9929999709129333},{"id":"https://openalex.org/keywords/colonoscopy","display_name":"colonoscopy","score":0.6840000152587891},{"id":"https://openalex.org/keywords/safety","display_name":"safety","score":0.4020000100135803},{"id":"https://openalex.org/keywords/renal-function","display_name":"renal function","score":0.6809999942779541},{"id":"https://openalex.org/keywords/electrolyte-shifts","display_name":"electrolyte shifts","score":0.7400000095367432},{"id":"https://openalex.org/keywords/magnesium","display_name":"magnesium","score":0.7369999885559082},{"id":"https://openalex.org/keywords/qt-interval","display_name":"QT interval","score":0.7360000014305115},{"id":"https://openalex.org/keywords/creatinine","display_name":"creatinine","score":0.6190000176429749},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.7559999823570251},{"id":"https://openalex.org/keywords/osmotic-laxatives","display_name":"osmotic laxatives","score":0.6639999747276306},{"id":"https://openalex.org/keywords/post-hoc-analysis","display_name":"post hoc analysis","score":0.6060000061988831},{"id":"https://openalex.org/keywords/split-dose-regimen","display_name":"split-dose regimen","score":0.7059999704360962},{"id":"https://openalex.org/keywords/non-inferiority","display_name":"non-inferiority","score":0.5709999799728394},{"id":"https://openalex.org/keywords/glossoptosis","display_name":"glossoptosis","score":0.453000009059906},{"id":"https://openalex.org/keywords/dysphagia","display_name":"dysphagia","score":0.5230000019073486},{"id":"https://openalex.org/keywords/dyspepsia","display_name":"dyspepsia","score":0.4009999930858612}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9626303911209106},{"id":"https://openalex.org/C3019222653","wikidata":"https://www.wikidata.org/wiki/Q194517","display_name":"Bowel preparation","level":5,"score":0.7307267189025879},{"id":"https://openalex.org/C2776964284","wikidata":"https://www.wikidata.org/wiki/Q410083","display_name":"Polyethylene glycol","level":2,"score":0.6582046747207642},{"id":"https://openalex.org/C67761136","wikidata":"https://www.wikidata.org/wiki/Q2105849","display_name":"Post-hoc analysis","level":2,"score":0.5892482995986938},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.4042334258556366},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.3996681571006775},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3456350564956665},{"id":"https://openalex.org/C2778435480","wikidata":"https://www.wikidata.org/wiki/Q840387","display_name":"Colonoscopy","level":4,"score":0.16095322370529175},{"id":"https://openalex.org/C55493867","wikidata":"https://www.wikidata.org/wiki/Q7094","display_name":"Biochemistry","level":1,"score":0.08017575740814209},{"id":"https://openalex.org/C526805850","wikidata":"https://www.wikidata.org/wiki/Q188874","display_name":"Colorectal cancer","level":3,"score":0.04993435740470886},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.0},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.14309/01.ajg.0001031036.21101.0d","doi":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d","is_oa":false,"landing_page_url":"https://doi.org/10.14309/01.ajg.0001031036.21101.0d","pdf_url":null,"source":{"id":"https://openalex.org/S66441642","display_name":"The American Journal of Gastroenterology","issn_l":"0002-9270","issn":["0002-9270","1572-0241"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Gastroenterology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W3209028255","https://openalex.org/W4403719166","https://openalex.org/W3024683141","https://openalex.org/W3033824235","https://openalex.org/W4385235742","https://openalex.org/W3031320171","https://openalex.org/W4385172610","https://openalex.org/W2978025507","https://openalex.org/W2496921443","https://openalex.org/W4387749450"],"abstract_inverted_index":{"Introduction:":[0],"A":[1,66,257],"flavored":[2],"polyethylene":[3,27],"glycol":[4],"and":[5,14,30,37,56,89,93,147,159,161,194,228,277,281,324,367,396,620],"sulfate":[6],"solution":[7],"(FPSS)":[8],"bowel":[9],"prep":[10,125],"was":[11,217],"US":[12],"Food":[13],"Drug":[15],"Administration":[16],"approved":[17,131],"in":[18,42,58,106,175,202,268,318,332,364],"June":[19],"2023.":[20],"FPSS":[21,54,60,72,81,135,239,255,303,359],"is":[22,360],"an":[23,140],"osmotic":[24],"agent":[25],"containing":[26],"glycol,":[28],"sodium":[29,38],"magnesium":[31,233],"sulfate,":[32],"as":[33,35],"well":[34],"potassium":[36],"chloride.":[39],"Pivotal":[40],"studies":[41],"adults,":[43],"including":[44,243],"elderly":[45,77,206,366],"and/or":[46,78,207,393],"renally":[47,79],"impaired":[48,80,193,196,254],"subjects,":[49],"were":[50,104,117,149,169,182,205,226],"conducted":[51,170],"to":[52,75,171,251,371,384,467,498,558],"evaluate":[53,172],"efficacy":[55],"safety":[57],"which":[59],"established":[61],"non-inferiority":[62],"against":[63],"comparative":[64],"preps.":[65],"post-hoc":[67,355],"analysis":[68,356],"compared":[69,250],"the":[70,76,107,120,124,203,238,252,262,295,365],"pooled":[71],"control":[73],"group":[74],"group.":[82,256],"Methods:":[83],"Elderly":[84],"subjects":[85,189,201,272],"(65-80":[86],"years":[87],"old)":[88],"those":[90,278],"with":[91,110,133,139,190,220,237,273,279,287,310,369],"mild":[92,280,370],"moderate":[94,209,282,372],"renal":[95,112,176,197,210,263,275,283,288,308,351,373],"insufficiency":[96,113,211,374],"[glomerular":[97],"filtration":[98],"rate":[99],"(GFR)":[100],"30-89":[101],"ml/min/1.73":[102],"m2]":[103],"included":[105,188],"analysis;":[108],"patients":[109,315,329,368],"severe":[111],"(GFR":[114,212],"<":[115,213,397],"30)":[116],"excluded":[118],"from":[119,555],"studies.":[121],"Subjects":[122],"consumed":[123],"via":[126],"split-dose":[127],"regimen":[128],"per":[129],"FDA":[130],"labeling,":[132],"each":[134],"dose":[136],"being":[137,222],"followed":[138],"additional":[141],"16":[142,517],"oz.":[143],"water.":[144],"Electrocardiograms":[145],"(ECGs)":[146],"chemistries":[148],"collected":[150,183],"at":[151],"baseline,":[152],"day":[153],"of":[154,259,314,328],"colonoscopy,":[155],"24-48":[156],"hours":[157],"post-exam,":[158],"7":[160,505,515,532,546],"30":[162],"days":[163],"post-exam":[164],"(if":[165],"required).":[166],"Further":[167],"analyses":[168],"persistent":[173],"shifts":[174,225],"function.":[177,198,352],"Treatment-Emergent":[178],"Adverse":[179],"Events":[180],"(TEAEs)":[181],"within":[184],"a":[185,291],"cohort":[186,264],"that":[187,302,358],"normal,":[191],"mildly":[192],"moderately":[195],"Results:":[199],"132":[200],"study":[204,297],"had":[208,304],"60).":[214],"Average":[215],"age":[216],"68.5":[218],"years,":[219],"54.5%":[221],"male.":[223],"Electrolyte":[224],"rare":[227],"similar":[229],"between":[230],"groups.":[231],"Elevated":[232],"levels":[234,320],"are":[235],"consistent":[236],"formulation.":[240],"ECG":[241,462],"parameters,":[242],"corrected":[244],"QT-interval,":[245],"showed":[246,265],"no":[247,347],"difference":[248],"when":[249],"non-elderly/non-renal":[253],"review":[258],"TEAEs":[260,270],"for":[261,362,388],"negligible":[266,305],"differences":[267],"reported":[269],"among":[271],"normal":[274],"function":[276],"insufficiency.":[284],"No":[285],"subject":[286],"impairment":[289],"experienced":[290],"serious":[292],"AE.":[293],"In":[294],"overall":[296],"population,":[298],"chemistry":[299],"data":[300],"confirmed":[301],"impact":[306,349],"on":[307,350],"indicators,":[309],"fewer":[311],"than":[312,326],"3%":[313],"experiencing":[316,330],"elevation":[317],"creatinine":[319],"(":[321,334],">0.3":[322],"mg/dL)":[323],"less":[325],"2%":[327],"decrease":[331],"GFR":[333],">25%)":[335],"following":[336],"preparation.":[337],"These":[338],"results":[339],"confirm":[340],"previous":[341],"publications":[342],"indicating":[343],"low-volume":[344],"preps":[345],"have":[346],"adverse":[348],"Conclusion:":[353],"This":[354],"confirms":[357],"safe":[361],"use":[363],"(see":[375],"Table":[376,378],"1).":[377],"1.":[379],"-":[380,421],"Change":[381],"From":[382],"Baseline":[383,556],"Visit":[385,559],"2":[386,503,521,527,560],"(Colonoscopy)":[387],"Key":[389],"Safety":[390],"Parameters":[391],"FPSSRenal":[392],"\u226565":[394],"FPSSNon-Renal":[395],"65":[398],"Vital":[399],"Signs":[400],"\u2013":[401,405,413,429],"Mean":[402],"(SD)":[403,557],"Diastolic":[404,420],"Sitting":[406,414,437],"(mmHg)":[407,415,423,431],"0.2":[408,446,448,612],"(7.87)":[409],"-0.3":[410,569,571,600],"(7.64)":[411],"Systolic":[412,428],"0.7":[416],"(14.81)":[417],"-0.7":[418],"(11.48)":[419],"Standing":[422,430],"0.6":[424],"(8.36)":[425],"-0.8":[426],"(9.16)":[427],"-1.7":[432],"(13.43)":[433],"-1.9":[434],"(11.54)":[435],"PR,":[436],"(BPM)":[438],"3.1":[439],"(10.06)":[440],"1.7":[441],"(8.48)":[442],"Respiratory":[443],"Rate":[444],"(breaths/min)":[445],"(1.48)":[447],"(1.49)":[449],"Temperature":[450],"(F)":[451],"-0.1":[452,454,614],"(0.82)":[453],"(0.76)":[455],"Weight":[456],"(lb)":[457],"-3.2":[458],"(2.85)":[459],"-2.4":[460],"(3.20)":[461],"Shiftn":[463],"(%)":[464],"Shift":[465,494],"(Normal":[466],"Abnormal)":[468],"9":[469],"(6.9)":[470,516,533],"38":[471],"(11.7)":[472],"QTcF":[473,483],"Interval":[474,484],"Increase":[475,485],">":[476,486],"450":[477],"ms":[478,488],"12":[479],"(10.2)":[480],"5":[481,544],"(1.6)":[482],"500":[487],"0":[489,491,509,529,550],"(0)":[490,492],"Chemistry":[493,553],"n":[495],"(%)Normal":[496],"V1":[497],"Abnormal":[499],"V2":[500],"Bicarbonate":[501,561],"(mEq/L)":[502,508,562,568],"(1.8)":[504,528],"(2.5)":[506,547],"Chloride":[507,567],"1":[510,523],"(0.4)":[511,524],"Creatine":[512,573],"Kinase":[513,574],"(U/L)":[514,575],"(6.6)":[518],"Creatinine":[519,580],"(mg/dL)":[520,531,581,593],"(1.9)":[522],"eGFR":[525,586],"(mL/min/1.73m2)":[526,587],"Magnesium":[530,592],"41":[534],"(15.5)":[535],"Osmolality":[536,598],"(mOsm/kg)":[537,599],"17":[538],"(38.6)":[539],"44":[540],"(29.5)":[541],"Potassium":[542,604],"(mmol/L)":[543,549,605,611],"(4.6)":[545],"Sodium":[548,610],"8":[551],"(2.8)":[552],"\u2206":[554],"-1.4":[563],"(2.50)":[564,572],"-1.0":[565],"(2.89)":[566],"(2.66)":[570],"2.2":[576],"(56.30)":[577],"-40.5":[578],"(501.09)":[579],"0.027":[582],"(0.1148)":[583],"0.016":[584],"(0.0822)":[585],"-1.8":[588],"(7.32)":[589],"-1.2":[590],"(8.65)":[591],"0.04":[594],"(0.155)":[595],"0.08":[596],"(0.174)":[597],"(6.03)":[601],"-0.5":[602],"(6.69)":[603],"-0.03":[606],"(0.351)":[607],"-0.01":[608],"(0.338)":[609],"(2.49)":[613],"(2.12)":[615],"FPSS,":[616],"Flavored":[617],"Polyethylene":[618],"Glycol":[619],"Sulfate":[621],"Solution;":[622],"eGFR,":[623],"Estimated":[624],"Glomerular":[625],"Filtration":[626],"Rate.":[627]},"counts_by_year":[],"updated_date":"2026-10-27T15:51:10.671819","created_date":"2024-10-25T00:00:00"}
