Therapeutic efficacy and patient compliance of levothyroxine liquid and softgel formulations taken with meals: a systematic review.

IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Endocrine Pub Date : 2025-01-01 Epub Date: 2024-08-31 DOI:10.1007/s12020-024-04016-7
Vittorio Oteri, Salvatore Volpe, Mariarita Lopes, Giulia Sceusa, Andrea Tumminia, Antonino Belfiore, Francesco Frasca, Damiano Gullo
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引用次数: 0

Abstract

Purpose: Levothyroxine (L-T4) is the drug of choice for treating primary hypothyroidism. L-T4 tablets should be taken at least 30 min before breakfast. Several studies have suggested that serum thyroid profile is not affected by concomitant intake of liquid/softgel L-T4 with meals. Our aim is to review the evidence on therapeutic efficacy and patient compliance with the liquid and softgel formulation of L-T4 taken with meals, also compared with the standard tablet therapy regimen, in hypothyroid patients.

Methods: We performed a systematic review of literature by searching PubMed, Embase, and Cochrane Library databases. PRISMA guidelines were applied, and the risk of bias of the included studies was assessed using the RoB 2 and ROBINS tools. The methodological quality was assessed following the GRADE criteria.

Results: We included 13 studies, accounting for a total of 1697 patients. The timing of liquid L-T4 intake from breakfast did not affect the therapeutic efficacy of the treatment. No significant differences in the absorption of liquid L-T4 were found when administered together with different foods, beverages, drugs, or other supplements. TSH levels are not influenced by taking softgel L-T4 at breakfast; the efficacy of softgel and liquid formulation is similar when they are taken with a meal, but superior to that of tablet formulation. Shifting from L-T4 tablets taken 30 min before breakfast to liquid/softgel formulation taken with the meal improved medication adherence and perceived quality of life of patients.

Conclusion: Liquid and softgel formulation of L-T4 can be taken at breakfast or close to meals, without losing therapeutic efficacy. These formulations could also improve patient compliance and quality of life compared to L-T4 tablet therapy taken 30 min before breakfast.

Abstract Image

随餐服用左旋甲状腺素液体和软胶囊制剂的疗效和患者依从性:系统性综述。
目的:左甲状腺素(L-T4)是治疗原发性甲状腺功能减退症的首选药物。左旋甲状腺素片应在早餐前至少 30 分钟服用。多项研究表明,进餐时同时服用液体/软胶囊左旋甲状腺素不会影响血清甲状腺功能。我们的目的是回顾有关甲状腺功能减退症患者进餐时服用液态和软胶囊制剂 L-T4 的疗效和患者依从性的证据,并与标准片剂治疗方案进行比较:我们检索了 PubMed、Embase 和 Cochrane 图书馆数据库,对文献进行了系统性回顾。采用了 PRISMA 指南,并使用 RoB 2 和 ROBINS 工具评估了纳入研究的偏倚风险。研究方法的质量按照 GRADE 标准进行评估:我们纳入了 13 项研究,共计 1697 名患者。从早餐开始摄入液态 L-T4 的时间不会影响治疗效果。在与不同食物、饮料、药物或其他补充剂同时服用时,液态 L-T4 的吸收率没有发现明显差异。早餐时服用软胶囊 L-T4 不会影响促甲状腺激素水平;软胶囊和液体制剂在餐后服用的疗效相似,但优于片剂。将早餐前 30 分钟服用的 L-T4 片剂改为餐后服用液体/软胶囊制剂可提高患者的服药依从性和生活质量:L-T4的液体和软胶囊制剂可在早餐或临近进餐时服用,且不会失去疗效。与早餐前 30 分钟服用 L-T4 片剂相比,这些制剂还能提高患者的依从性和生活质量。
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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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