Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
BMJ Open. 2023 Apr 25;13(4):e070741. doi: 10.1136/bmjopen-2022-070741.
Many older persons use the thyroid hormone levothyroxine which is often continued for life. Scientifically, there is much uncertainty whether simple continuation is the optimal approach. First, the physical need for levothyroxine can decrease with age thereby posing a higher risk of overtreatment and adverse effects. Second, large trials in subclinical hypothyroidism have shown no benefit for the use of levothyroxine. Interestingly, guidelines do not address re-evaluation of the indication. This self-controlled trial aims to determine the effects of discontinuation of levothyroxine treatment in older adults.
Participants are community-dwelling subjects aged ≥60 years using levothyroxine continuously at a stable dosage of ≤150 µg and a level of thyroid-stimulating hormone (TSH) <10 mU/L. After a control period of 12 weeks, levothyroxine treatment is discontinued gradually using a stepwise approach with regular monitoring of thyroid function guided by their GP. The primary outcome is the proportion of participants withdrawn from levothyroxine while maintaining a free T4 level within the reference range and a TSH level <10 mU/L, 52 weeks after the start of discontinuation. Secondary outcomes are compared with the control period (self-controlled) and include among others, the effects on thyroid-specific and general health-related quality of life. Furthermore, patients' attitudes towards deprescribing and regret regarding discontinuing levothyroxine treatment will be recorded. A total of 513 participants will be recruited to estimate the expected proportion of 50% with a 95% CI ranging from 45% to 55%.
Approval was obtained from the institutional Medical Ethics Committee. The Older People Advisory Board Health and Well-being has reviewed the research proposal and their comments were used for improvement. In line with the funding policies of the grant organisation funding this study, the study results will be proactively disseminated to the general public and key public health stakeholders.
NL7978; NCT05821881.
许多老年人使用甲状腺激素左旋甲状腺素，这种药物通常需要终身服用。从科学角度来看，简单地继续用药是否是最佳方法还存在很多不确定性。首先，随着年龄的增长，身体对左旋甲状腺素的需求可能会减少，从而增加过度治疗和产生不良反应的风险。其次，亚临床甲状腺功能减退症的大型试验表明，使用左旋甲状腺素并没有获益。有趣的是，指南并没有解决重新评估用药指征的问题。本项自身对照试验旨在确定停止老年患者使用左旋甲状腺素治疗的效果。
参与者为连续服用左旋甲状腺素且剂量稳定在 150μg 以下、促甲状腺激素（TSH）水平<10mU/L 的社区居住的年龄≥60 岁的患者。在 12 周的对照期后，采用逐步停药的方法逐渐停用左旋甲状腺素，由他们的全科医生定期监测甲状腺功能。主要结局是在停止用药 52 周后，保持游离 T4 水平在参考范围内且 TSH 水平<10mU/L 的情况下，参与者中停止使用左旋甲状腺素的比例。次要结局与对照期（自身对照）进行比较，包括甲状腺特异性和一般健康相关生活质量的影响等。此外，还将记录患者对去药物治疗的态度以及对停止使用左旋甲状腺素治疗的后悔程度。计划招募 513 名参与者来估计预计有 50%的参与者（95%CI 为 45%至 55%）。
该研究已获得机构医学伦理委员会的批准。老年人咨询委员会健康与福祉审查了研究方案，他们的意见被用于改进方案。根据资助该研究的拨款组织的资助政策，将积极向公众和主要公共卫生利益相关者传播研究结果。
NL7978；NCT05821881。
