Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use

被引:1
|
作者
Brito, Juan P. [1 ]
Ross, Joseph S. [2 ,3 ,4 ,5 ]
Deng, Yihong [6 ]
Sangaralingham, Lindsey [6 ]
Graham, David J. [7 ]
Qiang, Yandong [7 ]
Wang, Zhong [8 ]
Yao, Xiaoxi [6 ,9 ]
Zhao, Liang [8 ]
Smallridge, Robert C. [10 ]
Bernet, Victor [10 ]
Shah, Nilay D. [6 ,9 ,11 ]
Lipska, Kasia J. [5 ,12 ]
机构
[1] Mayo Clin, Div Endocrinol Diabet Metab Nutr, Dept Internal Med, Rochester, MN 02115 USA
[2] Yale Sch Med, Sect Gen Internal Med, New Haven, CT USA
[3] Yale Sch Med, Natl Clinician Scholars Program, New Haven, CT USA
[4] Yale Sch Publ Hlth, Dept Hlth Policy & Management, New Haven, CT USA
[5] Yale New Haven Med Ctr, Ctr Outcomes Res & Evaluat, New Haven, CT USA
[6] Mayo Clin, Robert D & Patricia E Kern Ctr Sci Hlth Care Deli, Rochester, MN USA
[7] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[8] US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[9] Mayo Clin, Div Hlth Care Policy & Res, Rochester, MN USA
[10] Mayo Clin, Div Endocrinol, Jacksonville, FL 32224 USA
[11] Optum Labs, Cambridge, MA USA
[12] Yale Sch Med, Sect Endocrinol, Dept Internal Med, New Haven, CT USA
关键词
Generic; Brand; Levothyroxine; Hypothyroidism;
D O I
10.1007/s12020-021-02779-x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Purpose To compare cardiovascular outcomes and rates of fractures and falls among patients with persistent brand-name versus generic L-thyroxine use. Methods 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. Results 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. Conclusions We found no significant differences in cardiovascular outcomes and rates of falls and fractures for patients who filled brand versus generic L-thyroxine.
引用
收藏
页码:592 / 602
页数:11
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