Division of Endocrinology, Diabetes, Metabolism, Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.
Section of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA.
Endocrine. 2021 Dec;74(3):592-602. doi: 10.1007/s12020-021-02779-x. Epub 2021 Jun 5.
To compare cardiovascular outcomes and rates of fractures and falls among patients with persistent brand-name versus generic L-thyroxine use.
Retrospective, 1:1 propensity-matched longitudinal study using a national administrative claims database to examine adults (≥18 years) who initiated either brand or generic L-thyroxine between 2008 and 2018, censored at switch or discontinuation of L-thyroxine formulation or disenrollment from the health plan. Main outcome measures included rates of hospitalization for atrial fibrillation, myocardial infarction, congestive heart failure, stroke, spine and hip fractures, and rate of falls in the outpatient or inpatient setting. Hospitalizations for pneumonia were used as a negative control.
195,046 adults initiated treatment with L-thyroxine between 2008 and 2017: 87% generic and 13% brand formulations. They were mostly women (76%), young (94.6% under age 65), white (66%), and 47% had baseline thyroid stimulating hormone levels between 4.5 and 9.9 mIU/L. Among 35,667 propensity-matched patients, there were no significant differences between patients treated with brand versus generic L-thyroxine in atrial fibrillation (HR 0.96, 0.58-1.60), myocardial infarction (HR 0.66, 0.39-1.14), congestive heart failure (HR 1.30, 0.78-2.16), stroke (0.72, 0.49-1.06), spine (HR 0.87, 0.38-1.99) and hip fractures (HR 0.86, 0.26-2.82), or fall outcomes (HR 1.02, 0.14-7.32). Hospitalization rates for pneumonia (used as negative control) did not differ between groups (HR 0.85, 0.61-1.19). There were no interactions between brand versus generic L-thyroxine, these outcomes, and thyroid cancer, age, or L-thyroxine dose subgroups.
We found no significant differences in cardiovascular outcomes and rates of falls and fractures for patients who filled brand versus generic L-thyroxine.
比较持续使用品牌名与通用型左甲状腺素的患者心血管结局以及骨折和跌倒的发生率。
这是一项回顾性、1:1 倾向评分匹配的纵向研究，使用国家行政索赔数据库，纳入 2008 年至 2018 年间开始使用品牌或通用型左甲状腺素的成年人（≥18 岁），以左甲状腺素制剂转换或停用或退出健康计划为截止点。主要结局指标包括心房颤动、心肌梗死、充血性心力衰竭、中风、脊柱和髋部骨折的住院率，以及门诊或住院环境下跌倒的发生率。肺炎住院作为阴性对照。
2008 年至 2017 年期间，共有 195046 名成年人开始接受左甲状腺素治疗：87%为通用型，13%为品牌型。他们主要为女性（76%）、年轻（94.6%年龄＜65 岁）、白人（66%），47%的患者基线促甲状腺激素水平在 4.5 至 9.9mIU/L 之间。在 35667 名匹配的患者中，与使用品牌型左甲状腺素相比，使用通用型左甲状腺素的患者在心房颤动（HR 0.96，0.58-1.60）、心肌梗死（HR 0.66，0.39-1.14）、充血性心力衰竭（HR 1.30，0.78-2.16）、中风（0.72，0.49-1.06）、脊柱（HR 0.87，0.38-1.99）和髋部骨折（HR 0.86，0.26-2.82）或跌倒结局（HR 1.02，0.14-7.32）方面无显著差异。肺炎（作为阴性对照）的住院率在两组之间无差异（HR 0.85，0.61-1.19）。品牌与通用型左甲状腺素、这些结局与甲状腺癌、年龄或左甲状腺素剂量亚组之间无交互作用。
我们发现使用品牌名与通用型左甲状腺素的患者在心血管结局以及跌倒和骨折的发生率方面无显著差异。
