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Vol 71, No 5 (2020)
Review paper
Submitted: 2020-09-05
Accepted: 2020-09-06
Published online: 2020-10-30
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Expert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation — Tirosint SOL [Opinia ekspertów dotycząca stosowania płynnej postaci lewotyroksyny oraz nowego preparatu Tirosint SOL u chorych na niedoczynność tarczycy]

Małgorzata Gietka-Czernel1, Alicja Hubalewska-Dydejczyk2, Beata Kos-Kudła3, Andrzej Lewiński45, Marek Ruchała6, Anhelli Syrenicz7, Wojciech Zgliczyński1
DOI: 10.5603/EP.a2020.0065
·
Pubmed: 33202031
·
Endokrynol Pol 2020;71(5):441-465.
Affiliations
  1. Department of Endocrinology, Medical Centre of Postgraduate Education, Warsaw, Poland
  2. Department of Endocrinology, Jagiellonian University Medical College, Krakow, Poland
  3. Department of Endocrinology and Neuroendocrine Tumours, Department of Pathophysiology and Endocrinology, Medical University of Silesia, Katowice, Poland
  4. Department of Endocrinology and Metabolic Disorders, Medical University of Lodz, Poland
  5. Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland
  6. Department of Endocrinology, Metabolism, and Internal Medicine, University of Medical Sciences, Poznan, Poznan, Poland
  7. Department of Endocrinology, Pomeranian Medical University, Szczecin, Poland

open access

Vol 71, No 5 (2020)
Reviews — Postgraduate Education
Submitted: 2020-09-05
Accepted: 2020-09-06
Published online: 2020-10-30

Abstract

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.

Abstract

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.

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Keywords

hypothyroidism; liquid levothyroxine; Tirosint SOL

About this article
Title

Expert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation — Tirosint SOL [Opinia ekspertów dotycząca stosowania płynnej postaci lewotyroksyny oraz nowego preparatu Tirosint SOL u chorych na niedoczynność tarczycy]

Journal

Endokrynologia Polska

Issue

Vol 71, No 5 (2020)

Article type

Review paper

Pages

441-465

Published online

2020-10-30

Page views

2569

Article views/downloads

2548

DOI

10.5603/EP.a2020.0065

Pubmed

33202031

Bibliographic record

Endokrynol Pol 2020;71(5):441-465.

Keywords

hypothyroidism
liquid levothyroxine
Tirosint SOL

Authors

Małgorzata Gietka-Czernel
Alicja Hubalewska-Dydejczyk
Beata Kos-Kudła
Andrzej Lewiński
Marek Ruchała
Anhelli Syrenicz
Wojciech Zgliczyński

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