Dataset Information

Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption.

ABSTRACT: Levothyroxine sodium (LT4) is the therapy of choice for hypothyroidism. In the last decade, new LT4 formulations, such as liquid and softgel 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 softgel LT4 has been rarely studied. This study aimed at evaluating the effect of switching from tablet to softgel LT4 patients without increased need for LT4. TSH was used as proxy of LT4 bioavailability and effectiveness.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 softgel LT4 formulation at unchanged dose and ingestion fashion (30?min before breakfast). TSH was measured with chemiluminescence immunoassays.According to exclusion and inclusion criteria, 19 patients were finally selected. One of these had headache 4?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??g/day and showed a median TSH value of 3.33?mIU/L. The rate of cases with TSH???4.0?mIU/L was 61.1% (11/18 cases). When patients were re-evaluated after 3?months of softgel 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 softgel LT4 (median 1.90?mIU/L) was significantly lower from that observed during tablet LT4 (p?=?0.0039).These data show that hypothyroid patients with no proven malabsorption may have an improved TSH following 3?months from the switch from tablet to softgel LT4 preparation at unchanged dose.

SUBMITTER: Trimboli P

PROVIDER: S-EPMC5871661 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption.

Trimboli Pierpaolo P Virili Camilla C Centanni Marco M Giovanella Luca L

Frontiers in endocrinology 20180321

<h4>Background</h4>Levothyroxine sodium (LT4) is the therapy of choice for hypothyroidism. In the last decade, new LT4 formulations, such as liquid and softgel 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 softgel LT4 has been rarely studied. This study aimed at evaluating the effect of switching from tablet to softgel LT4 patients without increased need for LT4. TSH was used as pr ...[more]

PMID: 29619010

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Project description:The thyroid gland and thyroid hormones control a multitude of homeostatic functions including maintenance of fluid and electrolyte balance and normal functioning of the kidneys. Thyroid dysfunction alters the sytemic hemodynamic and metabolic balance, thereby affecting the kidney. In this study, we aimed to identify and characterize the urinary proteome of the patients with hypothyroidism. An untargeted proteomic approach with network analysis was used to identify changes in total urinary proteome in patients with newly diagnosed overt hypothyroidism. Urine samples were collected from nine age-matched patients' before and after l-thyroxine treatment. Differences in the abundance of urinary proteins between hypothyroid and euthyroid states were determined using a two-dimensional difference in gel electrophoresis (2D-DIGE) coupled to matrix-assisted laser desorption and ionization time-of-flight (MALDI TOF) mass spectrometry. Alterations in the abundance of urinary proteins, analyzed by Progenesis software, revealed statistically significant differential abundance in a total of 49 spots corresponding to 42 proteins, 28 up and 14 down (≥1.5-fold change, analysis of variance (ANOVA), p ≤ 0.05). The proteins identified in the study are known to regulate processes related to transport, acute phase response, oxidative stress, generation of reactive oxygen species, cellular proliferation, and endocytosis. Bioinformatic analysis using Ingenuity Pathway Analysis (IPA) identified dysregulation of pathways related to amino acid metabolism, molecular transport, and small-molecule biochemistry and involved the MAPK kinase, vascular endothelial growth factor (VEGF), PI3 kinase/Akt, protein kinase C (PKC), signaling pathways. The identified proteins were involved in the regulation of thyroglobulin (Tg) and thyrotropin (TSH) metabolism. Alterations in their levels indicate the presence of a compensatory mechanism aimed at increasing the regulation of Tg in the hypothyroid state.

Project description:ObjectiveEvidence indicates that L-T4 in liquid and softgel capsule are absorbed better than tablets in hypothyroid patients, even when patients are under medications that impair the intestinal absorption of L-T4. However, no study has evaluated all three L-T4 formulations in the same hypothyroid patients. This study aims to fill this gap. The outcome was the degree of TSH change in the liquid and softgel formulations, using tablet L-T4 as the reference, regardless of sequence of formulation and regardless of whether patients were co-ingesting with interfering medications.MethodsWe recorded serum TSH levels in two groups of L-T4 replaced patients with primary hypothyroidism (23 subjects who did not co-ingest interfering medications, and 20 subjects who did). Either group of patients took one formulation of L-T4 at a time with variable sequences. In the first group, the median durations of exposure to tablet, liquid or softgel L-T4 were 14, 9 and 10?months, respectively. In the second group the corresponding durations were 13, 11 and 10?months, during which patients co-ingested interfering medications.ResultsIn the 23 patients, there were 78, 74 or 101 TSH determinations during liquid, softgel capsule or tablet L-T4 regimens. Serum TSH levels associated with liquid, capsule or tablet L-T4 were 1.62?±?0.51, 1.77?±?0.44?mU/L (P?=?0.049 vs liquid) or 2.38?±?0.69?mU/L (P?<?0.0001 vs liquid or capsule). Rates of TSH???2.50?mU/L were 97.4% (liquid), 95.9% (softgel) or 64.4% (tablet, P?<?0.0001 vs liquid or capsule). Rates of TSH???4.12?mU/L were 100%, 100% or 98.0%.In the 20 patients, the corresponding TSH determinations were 56, 57 and 41, and corresponding TSH levels were 2.74?±?0.98, 2.70?±?0.79 or 7.53?±?2.82?mU/L. Rates of TSH???2.50?mU/L were 51.8% (liquid), 47.4% (capsule, P?=?0.64) or 2.4% (tablet, P?<?0.0001 vs liquid or capsule). Rates of TSH???4.12?mU/L were 92.8% (liquid), 94.7% (capsule, P?=?0.68) or 12.2% (tablet, P?<?0.0001 vs liquid or capsule).ConclusionsL-T4 ingested as liquid solution or softgel capsule is more bioavailable compared to L-T4 ingested as tablet, and it is slightly superior to capsule L-T4 only in the absence of co-ingestion of interfering medications.

Dataset Information

Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption.

Publications

Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption.

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