比较左甲状腺素治疗甲状腺功能减退症的通用和品牌制剂的心血管不良事件发生率。
Comparison of Incident Cardiovascular Event Rates Between Generic and Brand l-Thyroxine for the Treatment of Hypothyroidism.
机构信息
Division of Endocrinology, Mayo Clinic, Jacksonville, FL.
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; OptumLabs, Cambridge, MA.
出版信息
Mayo Clin Proc. 2019 Jul;94(7):1190-1198. doi: 10.1016/j.mayocp.2018.11.030. Epub 2019 Apr 26.
OBJECTIVE
To determine whether levothyroxine (L-T4) preparation (generic vs brand) affected hospitalization for cardiovascular events.
PATIENTS AND METHODS
We performed a retrospective analysis using a large administrative claims database, OptumLabs Data Warehouse, creating two 1-to-1 propensity score-matched cohorts initiating generic or brand L-T4. Patients were followed for a mean of 1.0±1.2 years (range, 0-9.3 years). We included 87,902 propensity score-matched patients (43,951 patients per cohort) initiating generic or brand L-T4. Variables included in matching were age, sex, race/ethnicity, residence region, selected comorbidities, and Charlson-Deyo comorbidity score. Patients with previous use of any thyroid preparation, amiodarone, or lithium were excluded. Primary outcomes were the event rates for hospitalizations for incident atrial fibrillation, myocardial infarction, congestive heart failure, or stroke.
RESULTS
In the generic L-T4 cohort, 35,242 (80.2%) were women and 7327 (16.7%) were 65 years of age or older; in the brand L-T4 cohort, 34,633 (78.8%) were women and 8092 (18.4%) were 65 years of age or older. We found no differences in event rates (events per 1000 person-years) for 4 outcomes comparing generic and brand L-T4 therapy: (1) atrial fibrillation (1.82 vs 2.19; hazard ratio [HR], 1.22; 95% CI, 0.90-1.65; P=.19); (2) myocardial infarction (2.12 vs 1.83; HR, 0.86; 95% CI, 0.64-1.17; P=.35); (3) congestive heart failure (2.27 vs 2.00; HR, 0.88; 95% CI, 0.66-1.18; P=.41); and (4) stroke (3.10 vs 2.38; HR, 0.77; 95% CI, 0.59-1.00; P=.05). Stratification by age group revealed no differences.
CONCLUSION
In patients with newly treated hypothyroidism, cardiovascular event rates were similar for generic and brand L-T4.
目的
确定左甲状腺素（L-T4）制剂（仿制药与品牌药）是否会影响心血管事件的住院治疗。
方法
我们使用大型行政索赔数据库 OptumLabs Data Warehouse 进行了回顾性分析，创建了两个 1:1 倾向评分匹配队列，分别起始使用仿制药或品牌 L-T4。患者平均随访 1.0±1.2 年（范围：0-9.3 年）。我们纳入了 87902 名倾向评分匹配患者（每个队列 43951 名患者），起始使用仿制药或品牌 L-T4。匹配中包含的变量有年龄、性别、种族/民族、居住地区、选定的合并症和 Charlson-Deyo 合并症评分。排除了既往使用任何甲状腺制剂、胺碘酮或锂的患者。主要结局是新发心房颤动、心肌梗死、充血性心力衰竭或卒中住院的发生率。
结果
在仿制药 L-T4 队列中，35242 名（80.2%）患者为女性，7327 名（16.7%）患者年龄在 65 岁或以上；在品牌 L-T4 队列中，34633 名（78.8%）患者为女性，8092 名（18.4%）患者年龄在 65 岁或以上。我们发现，在比较仿制药和品牌 L-T4 治疗的 4 种结局的发生率（每 1000 人年的事件数）时，并无差异：（1）心房颤动（1.82 比 2.19；风险比 [HR]，1.22；95%置信区间 [CI]，0.90-1.65；P=.19）；（2）心肌梗死（2.12 比 1.83；HR，0.86；95% CI，0.64-1.17；P=.35）；（3）充血性心力衰竭（2.27 比 2.00；HR，0.88；95% CI，0.66-1.18；P=.41）；和（4）卒中（3.10 比 2.38；HR，0.77；95% CI，0.59-1.00；P=.05）。按年龄组分层也未发现差异。
结论
在新诊断为甲状腺功能减退症的患者中，仿制药和品牌 L-T4 的心血管事件发生率相似。
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