Thyroxine treatment with softgel capsule formulation: usefulness in hypothyroid patients without malabsorption
Open accessAbstract
Background. Levothyroxine sodium (LT4) is the therapy of choice for hypothyroidism. In the last decade new LT4 formulations, such as liquid and soft gel capsules, became available. Even if some evidence has been reached in the efficacy of liquid LT4 in patients with suboptimal TSH on tablet LT4, the usefulness of soft gel LT4 has been rarely studied. This study aimed at evaluating the effect of switching from tablet to soft gel LT4 patients without increased need for LT4. TSH was used as proxy of LT4 bioavailability and effectiveness. Methods. During the period from April to August 2017, 19 patients on tablet LT4 treatment for hypothyroidism, mostly due to autoimmune thyroiditis, were enrolled. Subjects with causes of malabsorption or increased requirement of LT4 were previously excluded. Patients finally included were asked to switch from tablet to soft gel LT4 formulation at unchanged dose and ingestion fashion (30 minutes before breakfast). TSH was measured with chemiluminescence immunoassays. Results. According to exclusion and inclusion criteria, 19 patients were finally selected. One of these had headache four days later and come back to tablet LT4, and 18 of them (16W/2M; mean age=55 years; BMI 22.7 kg/m2) completed the study. They were treated with a median LT4 dose of 88 µg/day and showed a median TSH value of 3.33 mIU/L. The rate of cases with TSH ≤4mU/l was 61.1% (11/18 cases). When patients were re-evaluated after three months of soft gel LT4, we observed that TSH reached levels under 4.0 mIU/L in 16/18 (88.9%) patients, TSH was lower in 11 cases, and in 6 out of 7 patients with pre-switch TSH values over the normal range. Overall, TSH values on soft gel LT4 (median 1.90 mIU/L) was significantly lower from that observed during tablet LT4 (p = 0.0039). Conclusions. These data show that hypothyroid patients with no proven malabsorption may have an improved TSH following three months from the switch from tablet to soft gel LT4 preparation at unchanged dose.
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Orally administered liquid and soft-gel LT4 formulations are associated with higher serum FT4 levels and lower TSH levels than tablet formulations, even when the overall LT4 dose level is the same.
“Other reports from both retrospective and prospective observational studies indicate that orally administered liquid and soft-gel formulations of LT4 are associated with higher serum FT4 levels and lower TSH levels than tablet formulations, even when the overall LT4 dose level is the same – perhaps due to the absence of gastric disintegration [ 38 – 44 ].”
From Factors influencing the levothyroxine dose in the hormone replacement therapy of primary hypothyroidism in adults (2022) · cites this paper as [42]
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References 38 · Cited by 21
- Authors
- Trimboli, P., Virili, C., Centanni, M., & Giovanella, L.
- Affiliations
- Istituto Oncologico della Svizzera Italiana (CH)
- Sapienza University of Rome (IT)
- Corresponding author
- Trimboli, Pierpaolo
- Venue
- Frontiers in Endocrinology
- Publisher
- Frontiers Media SA
- Published
- 2018-03-21
- Volume
- 9
- Pages
- 118-118
- ISSN
- 1664-2392 (ISSN-L)
- PMC
- PMC5871661
- OpenAlex
- W2793415285
- Cited by
- 21
- References
- 38
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2022: 2 · 2021: 8 · 2020: 3 · 2019: 3 · 2018: 2
- FWCI
- 3.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Frontiers in Endocrinology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, cc-by)
- IRIS Research product catalog (Sapienza University of Rome) (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, thyroid-stimulating hormone, drug formulation switching, autoimmune thyroiditis, malabsorption
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