Expert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation : Tirosint SOL

2020
journal article
review article
11
cris.lastimport.wos2024-04-09T21:09:38Z
dc.abstract.enHypothyroidism is a common endocrine disorder affecting 3–15% of the adult population in subclinical form and 0.3–0.8% as overt disease. The mainstay of treatment is replacement monotherapy with levothyroxine (LT4). Currently several oral LT4 formulations including tablets, softgel capsules, and liquid formulations are available. Liquid LT4 is manufactured as LT4 solution in 85% glycerol and 96% ethanol and as LT4 solution in purified water and glycerol. The latest formulation, Tirosint SOL, gained FDA approval in 2017. To evaluate the clinical utility of liquid LT4 we reviewed the literature using three databases: PubMed/MEDLINE, Scopus, and Embase and found 405 articles among which 23 prospective and two retrospective studies were further evaluated. Finally, several case reports on rare clinical conditions were discussed. Our review demonstrated that liquid LT4 was more effective than tablet formulation in patients with malabsorption caused by interfering diseases, drugs, and bariatric surgery. The better pharmacokinetics of liquid LT4 was also confirmed in subjects without malabsorption: patients on replacement or suppressive therapy, who switched from tablet to liquid formulation in equivalent dose, gained better hormonal control, and required less frequent TSH measurements. The drug also appeared effective and easy to handle in patients fed by enteric tube. Liquid LT4 appeared equally effective whenever taken before or during breakfast. The analysis of the drug utility in particular populations including newborns, pregnant women, and the elderly confirmed the high value and safety of liquid LT4. However, in neonates the higher incidence of TSH suppression on liquid in comparison to tablet LT4 therapy was noted, and particular attention to avoid over-treatment must be paid. Concluding: the literature review revealed that liquid LT4 is especially advantageous in patients with malabsorption and the critically ill, but it seems also very promising in common therapy. The lack of alcohol content in the new formulation makes Tirosint SOL especially attractive.pl
dc.affiliationWydział Lekarski : Klinika Endokrynologiipl
dc.cm.date2021-02-15
dc.cm.id101925
dc.contributor.authorGietka-Czernel, Małgorzatapl
dc.contributor.authorHubalewska-Dydejczyk, Alicja - 129732 pl
dc.contributor.authorKos-Kudła, Beatapl
dc.contributor.authorLewiński, Andrzejpl
dc.contributor.authorRuchała, Marekpl
dc.contributor.authorSyrenicz, Anhellipl
dc.contributor.authorZgliczyński, Wojciechpl
dc.date.accessioned2021-02-15T01:24:37Z
dc.date.available2021-02-15T01:24:37Z
dc.date.issued2020pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.additionalPublikacja w języku polskim i angielskimpl
dc.description.number5pl
dc.description.physical441-465pl
dc.description.points40
dc.description.versionostateczna wersja wydawcy
dc.description.volume70pl
dc.identifier.doi10.5603/EP.a2020.0065pl
dc.identifier.eissn2299-8306pl
dc.identifier.issn0423-104Xpl
dc.identifier.projectROD UJ / OPpl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/264563
dc.languageengpl
dc.language.containerengpl
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Bez utworów zależnych 4.0 Międzynarodowa*
dc.rights.licenceCC-BY-NC-ND
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/legalcode.pl*
dc.share.typeotwarte czasopismo
dc.subject.enhypothyroidismpl
dc.subject.enliquid levothyroxinepl
dc.subject.enTirosint SOLpl
dc.subject.plniedoczynność tarczycypl
dc.subject.plpłynna lewotyroksynapl
dc.subject.plTirosint SOLpl
dc.subtypeReviewArticlepl
dc.titleExpert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation : Tirosint SOLpl
dc.title.alternativeOpinia ekspertów dotycząca stosowania płynnej postaci lewotyroksyny oraz nowego preparatu Tirosint SOL u chorych na niedoczynność tarczycypl
dc.title.journalEndokrynologia Polskapl
dc.typeJournalArticlepl
dspace.entity.typePublication
cris.lastimport.wos
2024-04-09T21:09:38Z
dc.abstract.enpl
Hypothyroidism is a common endocrine disorder affecting 3–15% of the adult population in subclinical form and 0.3–0.8% as overt disease. The mainstay of treatment is replacement monotherapy with levothyroxine (LT4). Currently several oral LT4 formulations including tablets, softgel capsules, and liquid formulations are available. Liquid LT4 is manufactured as LT4 solution in 85% glycerol and 96% ethanol and as LT4 solution in purified water and glycerol. The latest formulation, Tirosint SOL, gained FDA approval in 2017. To evaluate the clinical utility of liquid LT4 we reviewed the literature using three databases: PubMed/MEDLINE, Scopus, and Embase and found 405 articles among which 23 prospective and two retrospective studies were further evaluated. Finally, several case reports on rare clinical conditions were discussed. Our review demonstrated that liquid LT4 was more effective than tablet formulation in patients with malabsorption caused by interfering diseases, drugs, and bariatric surgery. The better pharmacokinetics of liquid LT4 was also confirmed in subjects without malabsorption: patients on replacement or suppressive therapy, who switched from tablet to liquid formulation in equivalent dose, gained better hormonal control, and required less frequent TSH measurements. The drug also appeared effective and easy to handle in patients fed by enteric tube. Liquid LT4 appeared equally effective whenever taken before or during breakfast. The analysis of the drug utility in particular populations including newborns, pregnant women, and the elderly confirmed the high value and safety of liquid LT4. However, in neonates the higher incidence of TSH suppression on liquid in comparison to tablet LT4 therapy was noted, and particular attention to avoid over-treatment must be paid. Concluding: the literature review revealed that liquid LT4 is especially advantageous in patients with malabsorption and the critically ill, but it seems also very promising in common therapy. The lack of alcohol content in the new formulation makes Tirosint SOL especially attractive.
dc.affiliationpl
Wydział Lekarski : Klinika Endokrynologii
dc.cm.date
2021-02-15
dc.cm.id
101925
dc.contributor.authorpl
Gietka-Czernel, Małgorzata
dc.contributor.authorpl
Hubalewska-Dydejczyk, Alicja - 129732
dc.contributor.authorpl
Kos-Kudła, Beata
dc.contributor.authorpl
Lewiński, Andrzej
dc.contributor.authorpl
Ruchała, Marek
dc.contributor.authorpl
Syrenicz, Anhelli
dc.contributor.authorpl
Zgliczyński, Wojciech
dc.date.accessioned
2021-02-15T01:24:37Z
dc.date.available
2021-02-15T01:24:37Z
dc.date.issuedpl
2020
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.additionalpl
Publikacja w języku polskim i angielskim
dc.description.numberpl
5
dc.description.physicalpl
441-465
dc.description.points
40
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
70
dc.identifier.doipl
10.5603/EP.a2020.0065
dc.identifier.eissnpl
2299-8306
dc.identifier.issnpl
0423-104X
dc.identifier.projectpl
ROD UJ / OP
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/264563
dc.languagepl
eng
dc.language.containerpl
eng
dc.rights*
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Bez utworów zależnych 4.0 Międzynarodowa
dc.rights.licence
CC-BY-NC-ND
dc.rights.uri*
http://creativecommons.org/licenses/by-nc-nd/4.0/legalcode.pl
dc.share.type
otwarte czasopismo
dc.subject.enpl
hypothyroidism
dc.subject.enpl
liquid levothyroxine
dc.subject.enpl
Tirosint SOL
dc.subject.plpl
niedoczynność tarczycy
dc.subject.plpl
płynna lewotyroksyna
dc.subject.plpl
Tirosint SOL
dc.subtypepl
ReviewArticle
dc.titlepl
Expert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation : Tirosint SOL
dc.title.alternativepl
Opinia ekspertów dotycząca stosowania płynnej postaci lewotyroksyny oraz nowego preparatu Tirosint SOL u chorych na niedoczynność tarczycy
dc.title.journalpl
Endokrynologia Polska
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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