Different formulations of levothyroxine for treating hypothyroidism: a real-life study
Open accessAbstract
Objective. Hypothyroid patients are treated by sodium levothyroxine (LT4). Tablet is the mostly used LT4 formulation, and the fasting regimen is required for the absorption of active principle. Also, gastrointestinal diseases and drugs may impair the LT4 bioavailability when tablet is used. Nonsolid LT4 formulations (i.e., liquid solution (LS) and soft gel (SG) capsule) were manufactured to overcome the limitations of LT4 tablet. This study was conceived to evaluate the performance of nonsolid LT4 formulations in a real-life scenario. Methods. Two institutions participated in the study that was conducted in two phases (i.e., enrollment and re-evaluation). Adults with autoimmune or postsurgical hypothyroidism and on LT4 from a few months were selected. A nonparametric statistical analysis for paired or unpaired data was performed. Results. 121 consecutive cases were included. At the enrollment phase, a 52% of patients took the therapy at least 30 min before breakfast with no difference between tablet and SG/LS users. TSH was 1.65 mIU/L (0.86–2.70) in patients on LT4 tablet and 1.70 mIU/L (1.10–2.17) in those on SG/LS ( p=0.66 ). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group ( p=0.22 ) and significantly reduced in SG/LS group ( p=0.004 ); among the patients using incorrect LT4 assumption, TSH was significantly increased in those on tablet ( p=0.0029 ) and stable in those on SG/LS ( p=0.36 ). Conclusion. The performance of nonsolid LT4 formulations is not influenced by correct or incorrect use of therapy. On the contrary, LT4 tablet does not guarantee euthyroidism when it is ingested without waiting for at least 30 minutes before breakfast. These new data, obtained in a real-life scenario, suggest that LT4 SG/LS should be regarded as first-line therapy for treating adults with newly diagnosed hypothyroidism.
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For patients with incorrect administration, TSH levels were more stable in those who took liquid solutions or soft gels, as suggested by a real-life study.
“For patients with incorrect administration, TSH levels were more stable in those who took liquid solutions or soft gels, as suggested by a real-life study (213).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [213]
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Levothyroxine: conventional and novel drug delivery formulations.
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Analysis of dose-TSH response effect of levothyroxine soft-gel formulation
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- Authors
- Trimboli, P., Scappaticcio, L., De Bellis, A., Maiorino, M. I., Knappe, L., Esposito, K., Bellastella, G., & Giovanella, L.
- Affiliations
- Ente Ospedaliero Cantonale (CH)
- University of Campania "Luigi Vanvitelli" (IT)
- Unit of Endocrinology and Metabolic Diseases, University of Campania “L. Vanvitelli”, Naples, Italy
- University of Zurich (CH)
- Corresponding author
- Trimboli, Pierpaolo
- ORCID
- Venue
- International Journal of Endocrinology
- Publisher
- Wiley
- Published
- 2020-01-20
- Volume
- 2020
- Pages
- 1-5
- ISSN
- 1687-8337 (ISSN-L)
- 1687-8345
- PMC
- PMC7059087
- OpenAlex
- W3002961634
- Cited by
- 27
- References
- 22
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 3 · 2022: 10 · 2021: 5 · 2020: 1
- FWCI
- 3.58
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- International Journal of Endocrinology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Cancer Diagnosis and Treatment
- Keywords
- levothyroxine, hypothyroidism, soft gel capsules, liquid solutions, tablet formulation, thyroid-stimulating hormone, drug absorption, autoimmune hypothyroidism, bioavailability, euthyroidism
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