Comparison among two liquid formulations of L-thyroxine in the treatment of congenital hypothyroidism in the first month of life: a pilot study
Open accessAbstract
The liquid formulation of L-thyroxine is the most used in the substitutive treatment of congenital hypothyroidism (CH). This formulation has higher TSH suppression rates with respect of L-thyroxine tablets and thus lower doses are indicated. Two types of liquid L-thyroxine (Tirosint© and Tifactor©) are currently approved in Italy for use in pediatric age and to date there are no data available in the Literature comparing the two liquid formulations. The aim of this study is to compare the efficacy of both formulations in normalizing TSH and fT4 levels in the first month of life and to compare the L-thyroxine requirement for both formulations over the same period. All newborns diagnosed with primary CH at the neonatal screening program in the Piedmont region of Italy in the period May 2020 – May 2021 were enrolled and divided into two groups according to the liquid formulation used: TS Group with Tirosint© and TF Group with Tifactor©. No difference was observed between the two groups considering the TSH at dried blood spot (DBS) at neonatal screening, the serum levels of TSH, fT4 and fT3 and initial dose of L-thyroxine. At 15 days the serum TSH in the TF Group was 0.08 ± 0.02 mcUI/ml, while in the TS Group it was 36.7 ± 14.7 mcUI/ml p=0.04). No differences were observed between the two groups considering fT4 levels and L-thyroxine requirement. Among the subjects in the TF Group, 5/9 showed suppressed TSH at 15 days after starting treatment, while none of the subjects in the TS Group showed TSH levels below the normal lower limit (p=0.011). Among the subjects in the TF Group, 5/9 patients showed suppressed TSH at 30 days after starting treatment, while 1/12 subjects in the TS Group showed TSH levels below the normal lower limit (p=0.017). In conclusion, this study confirms the efficacy in normalizing the thyroid hormonal profile in newborns with CH among the liquid solutions although the response seem to be different in timing therefore an individual approach is necessary considering the type of formulation used, the diagnostic category of CH and clinical features.
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A retrospective study on congenital hypothyroidism raised concerns about the bioequivalence of 2 liquid products (Tirosint and Tifactor).
“A retrospective study on congenital hypothyroidism raised concerns about the bioequivalence of 2 liquid products (Tirosint and Tifactor) (216).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [216]
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van Trotsenburg, P., Stoupa, A., Léger, J., Rohrer, T., Peters, C., Fugazzola, L., Cassio, A., Heinrichs, C., Beauloye, V., Pohlenz, J., et al. (2021) · Thyroid® · doi:10.1089/thy.2020.0333 · Cited by 469 · see citing works
Bongers-Schokking, J. J., Resing, W. C. M., de Rijke, Y. B., de Ridder, M. A. J., & de Muinck Keizer-Schrama, S. M. P. F. (2013) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2013-2175 · Cited by 94 · see citing works
Cassio, A., Monti, S., Rizzello, A., Bettocchi, I., Baronio, F., D'Addabbo, G., Bal, M. O., & Balsamo, A. (2013) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2012.11.070 · Cited by 68 · see citing works
Peroni, E., Vigone, M. C., Mora, S., Bassi, L. A., Pozzi, C., Passoni, A., & Weber, G. (2014) · Hormone Research in Paediatrics · doi:10.1159/000356047 · Cited by 63 · see citing works
Virili, C., Giovanella, L., Fallahi, P., Antonelli, A., Santaguida, M. G., Centanni, M., & Trimboli, P. (2018) · Frontiers in Endocrinology · doi:10.3389/fendo.2018.00010 · Cited by 61 · see citing works
Tuli, G., Munarin, J., Tessaris, D., Matarazzo, P., Einaudi, S., & SANCTIS, L. D. (2020) · Endocrine · doi:10.1007/s12020-020-02370-w · Cited by 43 · see citing works
Self-citationBongers-Schokking, J. J., Resing, W. C. M., Oostdijk, W., de Rijke, Y. B., & de Muinck Keizer-Schrama, S. M. P. F. (2018) · Hormone Research in Paediatrics · doi:10.1159/000494056 · Cited by 39 · see citing works
Antonelli, A., Elia, G., Ragusa, F., Paparo, S. R., Cavallini, G., Benvenga, S., Ferrari, S. M., & Fallahi, P. (2021) · Frontiers in Endocrinology · doi:10.3389/fendo.2021.633587 · Cited by 32 · see citing works
Laurent, I., Tang, S., Astère, M., Wang, K. R., Deng, S., Xiao, L., & Li, Q. F. (2018) · Endocrine · doi:10.1007/s12020-018-1574-8 · Cited by 30 · see citing works
Different formulations of levothyroxine for treating hypothyroidism: a real-life study
Trimboli, P., Scappaticcio, L., De Bellis, A., Maiorino, M. I., Knappe, L., Esposito, K., Bellastella, G., & Giovanella, L. (2020) · International Journal of Endocrinology · doi:10.1155/2020/4524759 · Cited by 27 · see citing works
Vigone, M. C., Ortolano, R., Vincenzi, G., et al. (2021) · European Journal of Endocrinology · doi:10.1530/eje-20-1444 · Cited by 10 · see citing works
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Levothyroxine: conventional and novel drug delivery formulations.
Liu, H., Li, W., Zhang, W., Sun, S., & Chen, C. (2023) · Endocrine Reviews · doi:10.1210/endrev/bnac030 · Cited by 63 · see citing works
- Authors
- Tuli, G., Munarin, J., & de Sanctis, L.
- Affiliations
- Ospedale Regina Margherita (IT)
- Corresponding author
- Tuli, Gerdi
- Venue
- Frontiers in Endocrinology
- Publisher
- Frontiers Media SA
- Published
- 2022-04-05
- Volume
- 13
- Pages
- 860775-860775
- ISSN
- 1664-2392 (ISSN-L)
- PMC
- PMC9037062
- OpenAlex
- W4223613016
- Cited by
- 9
- References
- 11
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2022: 3
- FWCI
- 1.30
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Endocrinology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Metabolism and Genetic Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- congenital hypothyroidism, levothyroxine, liquid formulation, TSH suppression, free thyroxine, free triiodothyronine, newborn screening, neonates, thyroid hormone replacement, formulation comparison
- MeSH terms
- Child, Congenital Hypothyroidism, Humans, Infant, Newborn, Pilot Projects, Thyrotropin, Thyroxine, Neonatal Screening
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