Comparison of tablet versus liquid ethanol-free Levothyroxine in thyroidectomised patients.

IF 2.9 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Laura Croce, Spyridon Chytiris, Marsida Teliti, Jacopo Bertini, Lidia Pizzuto, Marzia Dal Molin, Matteo Limiroli, Benedetto Calì, Flavia Magri, Mario Rotondi
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引用次数: 0

Abstract

Purpose: Since the introduction of an ethanol-free liquid levothyroxine formulation, only few studies assessed its therapeutic efficacy. The present study aimed to compare the efficacy of tablet (T-LT4) versus L-EF-LT4 in achieving the patient-specific TSH target in thyroidectomized patients. The primary objective was to assess whether the required LT4 dose differed between formulations in a real-life setting.

Methods: The study was conducted on 275 patients who underwent total thyroidectomy and were treated with either T-LT4 (n = 152) or L-EF-LT4 (n = 123) between 2020 and 2023. Clinical and biochemical data, including LT4 dose, BMI, TSH levels, and potential causes of malabsorption, were collected. The primary endpoint was the pro-kg LT4 dose required to achieve individualized TSH targets. Multivariate regression analysis was used to evaluate predictors of LT4 requirement.

Results: At final follow-up, 227 patients (82.5%) achieved their TSH target and were under stable doses of LT4 with no significant difference in mean LT4 dose between groups (T-LT4: 1.54 ± 0.35 µg/kg/day; L-EF-LT4: 1.60 ± 0.32 µg/kg/day, p = 0.160). TSH levels were comparable (p = 0.311). Regression analysis showed that age and BMI were inversely correlated with LT4 dose, while a diagnosis of differentiated thyroid cancer was positively correlated with LT4 dose. Formulation type was not a significant predictor.

Conclusion: In patients with post-surgical hypothyroidism, L-EF-LT4 demonstrated equivalent therapeutic efficacy to T-LT4 in terms of dose requirement and TSH control. These findings support the use of L-EF-LT4 as a viable alternative to tablet LT4, particularly in clinical scenarios where flexible timing of ingestion may improve patient compliance.

甲状腺切除术患者口服片剂与液体无乙醇左甲状腺素的比较。
目的:自引入无乙醇液体左甲状腺素制剂以来,只有少数研究评估其治疗效果。本研究旨在比较T-LT4片与L-EF-LT4片在甲状腺切除术患者实现患者特异性TSH目标方面的疗效。主要目的是评估在现实环境中不同制剂所需的LT4剂量是否存在差异。方法:该研究纳入了2020年至2023年期间接受甲状腺全切除术并接受T-LT4 (n = 152)或L-EF-LT4 (n = 123)治疗的275例患者。收集临床和生化数据,包括LT4剂量、BMI、TSH水平和吸收不良的潜在原因。主要终点是达到个体化TSH目标所需的前千克LT4剂量。采用多元回归分析评估LT4需求的预测因素。结果:最终随访时,227例(82.5%)患者达到TSH目标,LT4剂量稳定,组间平均LT4剂量无显著差异(T-LT4: 1.54±0.35µg/kg/day;L-EF-LT4: 1.60±0.32µg/kg/day, p = 0.160)。TSH水平比较(p = 0.311)。回归分析显示,年龄、BMI与LT4剂量呈负相关,分化型甲状腺癌的诊断与LT4剂量呈正相关。配方类型不是显著的预测因子。结论:在术后甲状腺功能减退患者中,L-EF-LT4在剂量要求和TSH控制方面与T-LT4的治疗效果相当。这些发现支持使用L-EF-LT4作为片剂LT4的可行替代方案,特别是在临床情况下,灵活的摄入时间可能会提高患者的依从性。
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来源期刊
Endocrine
Endocrine ENDOCRINOLOGY & METABOLISM-
CiteScore
6.50
自引率
5.40%
发文量
295
审稿时长
1.5 months
期刊介绍: Well-established as a major journal in today’s rapidly advancing experimental and clinical research areas, Endocrine publishes original articles devoted to basic (including molecular, cellular and physiological studies), translational and clinical research in all the different fields of endocrinology and metabolism. Articles will be accepted based on peer-reviews, priority, and editorial decision. Invited reviews, mini-reviews and viewpoints on relevant pathophysiological and clinical topics, as well as Editorials on articles appearing in the Journal, are published. Unsolicited Editorials will be evaluated by the editorial team. Outcomes of scientific meetings, as well as guidelines and position statements, may be submitted. The Journal also considers special feature articles in the field of endocrine genetics and epigenetics, as well as articles devoted to novel methods and techniques in endocrinology. Endocrine covers controversial, clinical endocrine issues. Meta-analyses on endocrine and metabolic topics are also accepted. Descriptions of single clinical cases and/or small patients studies are not published unless of exceptional interest. However, reports of novel imaging studies and endocrine side effects in single patients may be considered. Research letters and letters to the editor related or unrelated to recently published articles can be submitted. Endocrine covers leading topics in endocrinology such as neuroendocrinology, pituitary and hypothalamic peptides, thyroid physiological and clinical aspects, bone and mineral metabolism and osteoporosis, obesity, lipid and energy metabolism and food intake control, insulin, Type 1 and Type 2 diabetes, hormones of male and female reproduction, adrenal diseases pediatric and geriatric endocrinology, endocrine hypertension and endocrine oncology.
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