Juan P Brito1, Joseph S Ross2,3,4, Yihong Deng5, Lindsey Sangaralingham5, David J Graham6, Yandong Qiang6, Zhong Wang7, Xiaoxi Yao5,8, Liang Zhao7, Robert C Smallridge9, Victor Bernet9, Nilay D Shah5,8,10, Kasia J Lipska4,11. 1. Division of Endocrinology, Diabetes, Metabolism, Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA. brito.juan@mayo.edu. 2. Section of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA. 3. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. 4. Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. 5. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA. 6. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. 7. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. 8. Division of Health Care Policy & Research, Mayo Clinic, Rochester, MN, USA. 9. Division of Endocrinology, Mayo Clinic, Jacksonville, FL, USA. 10. Optum Labs, Cambridge, MA, USA. 11. Section of Endocrinology, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Abstract
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.
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.
Authors: Jacqueline Jonklaas; Antonio C Bianco; Andrew J Bauer; Kenneth D Burman; Anne R Cappola; Francesco S Celi; David S Cooper; Brian W Kim; Robin P Peeters; M Sara Rosenthal; Anna M Sawka Journal: Thyroid Date: 2014-12 Impact factor: 6.568
Authors: Robert C Smallridge; Lindsey R Sangaralingham; Raphael Mwangi; Fred Kusumoto; Holly Van Houten; Victor Bernet Journal: Mayo Clin Proc Date: 2019-04-26 Impact factor: 7.616
Authors: Joseph S Ross; Stefanie Rohde; Lindsey Sangaralingham; Juan P Brito; Lauren Choi; Sarah K Dutcher; David J Graham; Marjorie R Jenkins; Kasia J Lipska; Martin Mendoza; Yandong Qiang; Zhong Wang; Yute Wu; Xiaoxi Yao; Nilay D Shah Journal: J Clin Endocrinol Metab Date: 2019-06-01 Impact factor: 5.958
Authors: Daniel F McCaffrey; Beth Ann Griffin; Daniel Almirall; Mary Ellen Slaughter; Rajeev Ramchand; Lane F Burgette Journal: Stat Med Date: 2013-03-18 Impact factor: 2.373
Authors: Jeremi M Carswell; Joshua H Gordon; Erica Popovsky; Andrea Hale; Rosalind S Brown Journal: J Clin Endocrinol Metab Date: 2012-12-21 Impact factor: 5.958
Authors: Jigar R Desai; Craig L Hyde; Shaum Kabadi; Matthew St Louis; Vinicius Bonato; A Katrina Loomis; Aaron Galaznik; Marc L Berger Journal: Med Care Date: 2017-03 Impact factor: 2.983