Hormone Therapy

Liquid L-T4 therapy in hypothyroid patients with gastric diseases, an observational study.

TL;DR

Liquid L-T4 formulation therapy results in more stable control of TSH levels than tablet L-T4 in hypothyroid patients with gastric disorders in the long-term follow-up.

Key Findings

At baseline, the prevalence of patients with TSH above the normal range differed between the two treatment groups.

  • TSH normal range was defined as 0.3–3.5 μIU/mL
  • Prevalence of TSH >3.5 μIU/mL was 36% in the tablet L-T4 (T-LT4) group and 46% in the liquid L-T4 (L-LT4) group at basal evaluation (p<0.05)
  • Mean L-T4 dosage at basal evaluation was 1.22±0.27 μg/kg/day in T-LT4 group and 1.36±0.22 μg/kg/day in L-LT4 group (p>0.05)
  • The study included 120 patients in the T-LT4 group and 84 patients in the L-LT4 group

At the first re-evaluation after dosage adjustment, both groups had an equal prevalence of elevated TSH.

  • At the first re-evaluation, prevalence of TSH >3.5 μIU/mL was 13% in both the T-LT4 and L-LT4 groups
  • Re-evaluations occurred at intervals of 5–9 months over an overall period ranging from 23 to 31 months
  • Patients were re-evaluated 4 times after the initial dosage adjustment

At the second re-evaluation, the prevalence of elevated TSH was numerically higher in the tablet group but did not reach statistical significance.

  • Prevalence of TSH >3.5 μIU/mL was 26% in the T-LT4 group versus 13% in the L-LT4 group at the second re-evaluation (p>0.05)

At the third re-evaluation, the prevalence of elevated TSH was significantly higher in the tablet L-T4 group compared to the liquid L-T4 group.

  • Prevalence of TSH >3.5 μIU/mL was 19% in the T-LT4 group versus 9% in the L-LT4 group at the third re-evaluation (p=0.05)
  • The abstract notes the condition as 'TSH <3.5 μIU/mL' but contextually refers to the elevated TSH (>3.5) prevalence comparison

At the fourth and final re-evaluation, the liquid L-T4 group had a significantly lower prevalence of elevated TSH compared to the tablet group.

  • Prevalence of TSH >3.5 μIU/mL was 18% in the T-LT4 group versus 5% in the L-LT4 group at the fourth re-evaluation (p<0.05)
  • This finding supports greater long-term TSH stability with liquid L-T4 formulation

Mean circulating FT4 and FT3 levels were not significantly different between the two groups at any visit.

  • FT4 and FT3 levels were similar in both the T-LT4 and L-LT4 groups across all evaluation time points
  • Despite TSH differences, free thyroid hormone levels did not differ significantly between groups

The two patient groups had similar demographic and clinical characteristics at baseline.

  • Gender distribution, mean age, and body weight were similar in the two groups (p>0.05)
  • Types of gastric disease were comparable: T-LT4 group had 74 chronic gastritis, 4 gastrectomy for gastric cancer, 42 gastroplasties; L-LT4 group had 60 chronic gastritis, 3 gastrectomy, 21 gastroplasties (p>0.05)
  • Frequency of Helicobacter pylori infection was 17% in both groups
  • 66% of patients in the T-LT4 group were chronically treated with proton pump inhibitors (PPI) versus 51% in the L-LT4 group (p>0.05)

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Citation

Fallahi P, Ragusa F, Patrizio A, Mazzi V, Botrini C, Elia G, et al.. (2024). Liquid L-T4 therapy in hypothyroid patients with gastric diseases, an observational study.. Frontiers in endocrinology. https://doi.org/10.3389/fendo.2024.1386629