{"id":"https://openalex.org/W2559946799","doi":"https://doi.org/10.1007/s40268-016-0150-z","title":"Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study","display_name":"Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study","publication_year":2016,"publication_date":"2016-12-09","ids":{"openalex":"https://openalex.org/W2559946799","doi":"https://doi.org/10.1007/s40268-016-0150-z","mag":"2559946799","pmid":"https://pubmed.ncbi.nlm.nih.gov/27943146","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/5318319"},"language":"en","primary_location":{"id":"doi:10.1007/s40268-016-0150-z","doi":"https://doi.org/10.1007/s40268-016-0150-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s40268-016-0150-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s40268-016-0150-z.pdf","source":{"id":"https://openalex.org/S35266406","display_name":"Drugs in R&D","issn_l":"1174-5886","issn":["1174-5886","1179-6901"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","medline","norway-1","oarl","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Drugs in R&amp;D","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://link.springer.com/content/pdf/10.1007/s40268-016-0150-z.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5079749032","display_name":"Frank R. Ernst","orcid":"https://orcid.org/0000-0001-6927-9765","observed_orcids":["https://orcid.org/0000-0001-6927-9765"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Frank R. Ernst","raw_affiliation_strings":["Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA. frankrernstrx@gmail.com","Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA. frankrernstrx@gmail.com","institution_ids":[]},{"raw_affiliation_string":"Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5023972459","display_name":"Walter Sandulli","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Walter Sandulli","raw_affiliation_strings":["Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008751324","display_name":"Riad Elmor","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Riad Elmor","raw_affiliation_strings":["Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084568072","display_name":"Jennifer Welstead","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Jennifer Welstead","raw_affiliation_strings":["Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5080847145","display_name":"Arnold B. Sterman","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Arnold B. Sterman","raw_affiliation_strings":["Arnold Sterman, LLC, Morristown, NJ, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Arnold Sterman, LLC, Morristown, NJ, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5047983177","display_name":"MaryKate Lavan","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"MaryKate Lavan","raw_affiliation_strings":["Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5079749032"],"corresponding_institution_ids":[],"apc_list":{"value":3490,"currency":"USD","value_usd":3490},"apc_paid":{"value":3490,"currency":"USD","value_usd":3490},"fwci":1.2808,"has_fulltext":true,"cited_by_count":23,"citation_normalized_percentile":{"value":0.81057307,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"17","issue":"1","first_page":"103","last_page":"115"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10293","display_name":"Thyroid Disorders and Treatments","score":0.9970999956130981,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"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/T10293","display_name":"Thyroid Disorders and Treatments","score":0.9970999956130981,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"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/T11728","display_name":"Thyroid and Parathyroid Surgery","score":0.0012000000569969416,"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"}},{"id":"https://openalex.org/T10329","display_name":"Thyroid Cancer Diagnosis and Treatment","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"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/levothyroxine","display_name":"levothyroxine","score":0.9990000128746033},{"id":"https://openalex.org/keywords/formulation-switching","display_name":"formulation switching","score":0.6480000019073486},{"id":"https://openalex.org/keywords/hypothyroidism","display_name":"hypothyroidism","score":0.9649999737739563},{"id":"https://openalex.org/keywords/thyroid-stimulating-hormone","display_name":"thyroid-stimulating hormone","score":0.9279999732971191},{"id":"https://openalex.org/keywords/dose-titration","display_name":"dose titration","score":0.8889999985694885},{"id":"https://openalex.org/keywords/drug-tolerability","display_name":"drug tolerability","score":0.7419999837875366}],"concepts":[{"id":"https://openalex.org/C2775883008","wikidata":"https://www.wikidata.org/wiki/Q773449","display_name":"Levothyroxine","level":3,"score":0.9869233965873718},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.9071043729782104},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8468418717384338},{"id":"https://openalex.org/C167135981","wikidata":"https://www.wikidata.org/wiki/Q2146302","display_name":"Retrospective cohort study","level":2,"score":0.4195452928543091},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.41717225313186646},{"id":"https://openalex.org/C71315377","wikidata":"https://www.wikidata.org/wiki/Q11364","display_name":"Hormone","level":2,"score":0.33695805072784424},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.2870170474052429}],"mesh":[{"descriptor_ui":"D000284","descriptor_name":"Administration, Oral","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000368","descriptor_name":"Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004305","descriptor_name":"Dose-Response Relationship, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004339","descriptor_name":"Drug Compounding","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005782","descriptor_name":"Gels","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007037","descriptor_name":"Hypothyroidism","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012189","descriptor_name":"Retrospective Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013607","descriptor_name":"Tablets","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013974","descriptor_name":"Thyroxine","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D013974","descriptor_name":"Thyroxine","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D013974","descriptor_name":"Thyroxine","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1007/s40268-016-0150-z","doi":"https://doi.org/10.1007/s40268-016-0150-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s40268-016-0150-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s40268-016-0150-z.pdf","source":{"id":"https://openalex.org/S35266406","display_name":"Drugs in R&D","issn_l":"1174-5886","issn":["1174-5886","1179-6901"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","medline","norway-1","oarl","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Drugs in R&amp;D","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:5318319","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/5318319","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Drugs R D","raw_type":"Text"},{"id":"pmid:27943146","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/27943146","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Drugs in R&D","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1007/s40268-016-0150-z","doi":"https://doi.org/10.1007/s40268-016-0150-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s40268-016-0150-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s40268-016-0150-z.pdf","source":{"id":"https://openalex.org/S35266406","display_name":"Drugs in R&D","issn_l":"1174-5886","issn":["1174-5886","1179-6901"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","medline","norway-1","oarl","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Drugs in R&amp;D","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9922999739646912,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/observational-study","display_name":"Observational Study"}],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2559946799.pdf","grobid_xml":"https://content.openalex.org/works/W2559946799.grobid-xml"},"referenced_works_count":38,"referenced_works":["https://openalex.org/W81942398","https://openalex.org/W126069483","https://openalex.org/W145192667","https://openalex.org/W1594076929","https://openalex.org/W1747119434","https://openalex.org/W1761292796","https://openalex.org/W1965376259","https://openalex.org/W1973003306","https://openalex.org/W1976679490","https://openalex.org/W1984273763","https://openalex.org/W1985550170","https://openalex.org/W2006295413","https://openalex.org/W2013324388","https://openalex.org/W2017578266","https://openalex.org/W2024127533","https://openalex.org/W2036524590","https://openalex.org/W2068657346","https://openalex.org/W2069654197","https://openalex.org/W2073346341","https://openalex.org/W2088262036","https://openalex.org/W2098635731","https://openalex.org/W2098649021","https://openalex.org/W2118978221","https://openalex.org/W2126532627","https://openalex.org/W2128595203","https://openalex.org/W2140936682","https://openalex.org/W2147794245","https://openalex.org/W2150696101","https://openalex.org/W2164053205","https://openalex.org/W2166619307","https://openalex.org/W2169531519","https://openalex.org/W2179799499","https://openalex.org/W2210773316","https://openalex.org/W2221982530","https://openalex.org/W2326662527","https://openalex.org/W2330783135","https://openalex.org/W2465907210","https://openalex.org/W4294988676"],"related_works":["https://openalex.org/W2793415285","https://openalex.org/W2782229485","https://openalex.org/W2039613202","https://openalex.org/W2556149235","https://openalex.org/W2584191594","https://openalex.org/W2788457030","https://openalex.org/W4318475504","https://openalex.org/W2765142022","https://openalex.org/W1966108960","https://openalex.org/W4381144811"],"abstract_inverted_index":{"INTRODUCTION:":[0],"Medication":[1],"changes":[2,67,178],"involving":[3],"levothyroxine-either":[4],"dose":[5,40,66,177],"titrations":[6],"or":[7,222],"switching":[8,26,80,216],"formulations-occur":[9],"frequently":[10],"in":[11,158,172],"patients":[12,27,57,73,101,149,199,217],"with":[13,74,225],"erratic":[14],"thyroid-stimulating":[15],"hormone":[16],"(TSH)":[17],"levels":[18,60],"and":[19,42,45,69,139],"persistent":[20],"hypothyroid":[21,76,100,191],"symptoms.":[22],"We":[23],"investigated":[24],"whether":[25],"from":[28,81,105],"levothyroxine":[29,37,82,85,122,227,231],"tablets":[30,83,228],"to":[31,84,108,118,128,141,229],"a":[32,62,106,109,170,213],"gel":[33,86,110,232],"cap":[34,111,233],"formulation":[35,112],"of":[36,56,72,113,176,198,201,209,215],"might":[38],"reduce":[39],"adjustments":[41],"improve":[43],"tolerability":[44,221],"efficacy":[46,223],"outcomes.":[47],"OBJECTIVES:":[48],"Primary":[49],"study":[50],"objectives":[51],"included":[52],"quantifying":[53],"the":[54,70,129,147,151,162,173,230],"percentage":[55,71],"achieving":[58],"TSH":[59,159],"within":[61],"pre-specified":[63],"range,":[64],"median":[65],"experienced,":[68],"improved":[75],"symptom":[77,192],"control":[78,193],"after":[79,161],"caps.":[87],"METHODS:":[88],"A":[89],"retrospective":[90],"medical":[91],"chart":[92],"review":[93],"was":[94,133,169,194],"conducted":[95],"among":[96,196],"99":[97,148],"randomly":[98],"selected":[99],"who":[102,218],"were":[103,116],"switched":[104],"tablet":[107],"levothyroxine.":[114],"Patients":[115],"required":[117],"have":[119],"been":[120],"on":[121],"monotherapy":[123],"for":[124,135],"\u22651":[125],"year":[126],"prior":[127],"medication":[130],"switch.":[131],"Data":[132],"collected":[134],"6":[136,142],"months":[137,143],"pre-switch":[138],"up":[140],"post-switch.":[144],"RESULTS:":[145],"Of":[146],"studied,":[150],"majority":[152],"(51.5%)":[153],"experienced":[154,179],"no":[155],"documented":[156],"change":[157],"status":[160],"switch":[163],"(P":[164],"<":[165,188,204],"0.0001).":[166,189,205],"However,":[167],"there":[168],"decrease":[171],"mean":[174],"number":[175],"(1.61":[180],"\u00b1":[181,185],"0.96":[182],"vs.":[183],"0.73":[184],"0.96;":[186],"P":[187,203],"Improved":[190],"reported":[195],"61.6%":[197],"(61":[200],"99;":[202],"CONCLUSION:":[206],"The":[207],"results":[208],"CONTROL":[210],"Switch":[211],"support":[212],"strategy":[214],"may":[219],"experience":[220],"problems":[224],"standard":[226],"formulation.":[234]},"counts_by_year":[{"year":2025,"cited_by_count":2},{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":4},{"year":2021,"cited_by_count":4},{"year":2020,"cited_by_count":4},{"year":2019,"cited_by_count":2},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-12-16T00:00:00"}
