Thyroxine softgel capsule in patients with gastric-related T4 malabsorption
Abstract
The key role of an intact gastric acid secretion for subsequent intestinal T4 absorption is supported by an increased requirement of thyroxine in patients with gastric disorders. A better pH-related dissolution profile has been described in vitro for softgel T4 preparation than for T4 tablets. Our study was aimed at comparing softgel and tablet T4 requirements in patients with gastric disorders. A total of 37 patients with gastric-related T4 malabsorption were enrolled, but only 31 (28F/3M; median age = 50 years; median T4 dose = 2.04 μg/kg/day) completed the study. All patients were in long-lasting treatment (>2 years) with the same dose of T4 tablets when treatment was switched to a lower dose of softgel T4 capsules (-17 %; p = 0.0002). Assessment of serum FT4 and TSH was carried out at baseline and after 3, 6, 12, and 18 months after the treatment switch. In more than 2/3 of patients (good-responders n = 21), despite the reduced dose of T4, median TSH values were similar at each time point (p = 0.3934) with no change in FT4 levels. In the remaining patients (poor-responders n = 10), TSH levels were significantly higher at each time point than at baseline (p < 0.0001). To note, in five of them intestinal comorbidity was subsequently detected. Comorbidity associated with poor-responders status was the only significant predictor in multivariate analysis (OR = 11.333). Doses of softgel T4 capsules lower than T4 tablet preparation are required to maintain the therapeutic goal in 2/3 of patients with impaired gastric acid secretion.
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Most patients with definite gastric disorders benefited by changing from traditional tablet formulations to the softgel levothyroxine preparation at a reduced dose.
“In particular, Santaguida et al. [121] have shown that most patients with definite gastric disorders benefited by changing from the traditional tablet formulations to the softgel levothyroxine preparation at a reduced dose.”
From Diagnosis and management of treatment-refractory hypothyroidism: an expert consensus report (2017) · cites this paper as [121]
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- Authors
- Santaguida, M. G., Virili, C., Duca, S. C. D., Cellini, M., Gatto, I., Brusca, N., De Vito, C., Gargano, L., & Centanni, M.
- Affiliations
- Sapienza University of Rome (IT)
- Corresponding author
- Centanni, Marco
- Venue
- Endocrine
- Published
- 2015-01-17
- Volume
- 49
- Issue
- 1
- Pages
- 51-57
- ISSN
- 0969-711X (ISSN-L)
- 1355-008X
- 1559-0100
- OpenAlex
- W2465907210
- Cited by
- 68
- References
- 41
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 5 · 2023: 3 · 2022: 5 · 2021: 6 · 2020: 4 · 2019: 7 · 2018: 6 · 2017: 9 · 2016: 11 · 2015: 6
- FWCI
- 9.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Endocrine (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Keywords
- thyroxine, gastric diseases, gastric acid secretion, TSH response, free thyroxine, dose reduction, drug formulation comparison
- MeSH terms
- Adult, Capsules, Female, Gastritis, Gels, Humans, Male, Middle Aged, Thyroid Diseases, Thyrotropin, Thyroxine, Helicobacter Infections, Gastric Absorption
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