Comparative effectiveness of generic vs brand-name levothyroxine in achieving normal thyrotropin levels.
Open accessAbstract
Importance: Whether the use of generic vs brand levothyroxine affects thyrotropin levels remains unclear. Objective: To compare the effectiveness of generic vs brand levothyroxine in achieving and maintaining normal thyrotropin levels among new users. Design, Setting, and Participants: This retrospective, 1:1 propensity score-matched longitudinal cohort study used the OptumLabs Data Warehouse administrative claims database linked to laboratory results from commercially insured and Medicare Advantage enrollees throughout the United States. Eligible patients were adults (aged ≥18 years) with thyrotropin levels ranging from 4.5 to 19.9 mIU/L who initiated use of generic or brand-name levothyroxine from January 1, 2008, to October 1, 2017. Data were analyzed from August 13, 2018, to October 25, 2019. Exposure: Patients received generic or brand-name levothyroxine. Main Outcomes and Measures: Proportion of patients with normal vs markedly abnormal thyrotropin levels (<0.1 or >10 mIU/L) within 3 months and with stable thyrotropin levels within 3 months after the thyrotropin value fell into the normal range. Results: A total of 17 598 patients were included (69.0% female; 74.0% White; mean [SD] age, 55.1 [16.0] years), of whom 15 299 filled generic and 2299 filled brand-name levothyroxine prescriptions during the study period. Among 4570 propensity score-matched patients (mean [SD] age, 50.3 [13.8] years; 3457 [75.6%] female; 3510 [76.8%] White), the proportion with normal thyrotropin levels within 3 months of filling levothyroxine prescriptions was similar for patients who received generic vs brand-name levothyroxine (1722 [75.4%; 95% CI, 71.9%-79.0%] vs 1757 [76.9%; 95% CI, 73.4%-80.6%]; P = .23), as was the proportion with markedly abnormal levels (94 [4.1%; 95% CI, 3.4%-5.0%] vs 88 [3.9%; 95% CI, 3.1%-4.7%]; P = .65). Among 1034 propensity score-matched patients who achieved a normal thyrotropin value within 3 months of initiation of levothyroxine, the proportion maintaining subsequent normal thyrotropin levels during the next 3 months was similar for patients receiving generic vs brand-name levothyroxine (427 [82.6%] vs 433 [83.8%]; P = .62). Conclusions and Relevance: Initiation of generic vs brand-name levothyroxine formulations was associated with similar rates of normal and stable thyrotropin levels. These results suggest that generic levothyroxine as initial therapy for mild thyroid dysfunction is as effective as brand-name levothyroxine.
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- Authors
- Brito, J. P., Ross, J. S., Sangaralingham, L., Dutcher, S. K., Graham, D. J., Wang, Z., Wu, Y., Yao, X., Smallridge, R. C., Bernet, V., Shah, N. D., & Lipska, K. J.
- Affiliations
- Mayo Clinic (US)
- Yale New Haven Hospital (US)
- United States Food and Drug Administration (US)
- Mayo Clinic in Florida (US)
- Corresponding author
- Brito, Juan P.
- ORCID
- Venue
- JAMA Network Open
- Publisher
- American Medical Association (AMA)
- Published
- 2020-09-30
- Volume
- 3
- Issue
- 9
- Pages
- e2017645
- ISSN
- 2574-3805 (ISSN-L)
- PMC
- PMC7527873
- OpenAlex
- W3089363251
- Cited by
- 28
- References
- 17
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 2 · 2023: 2 · 2022: 6 · 2021: 11 · 2020: 2
- FWCI
- 3.96
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JAMA Network Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Yale University
- National Institutes of Health (UL1TR001863)
- U.S. Food and Drug Administration (U01FD005938)
- Center of Excellence in Regulatory Science and Innovation (U01FD005938)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Keywords
- levothyroxine, generic drugs, brand-name drugs, thyroid-stimulating hormone, TSH levels, hypothyroidism, hyperthyroidism, thyroid hormone replacement, drug effectiveness, Medicare Advantage, commercially insured patients, new users, adverse drug reactions, drug shortages
- MeSH terms
- Aged, Female, Medicare, Humans, Longitudinal Studies, Male, Middle Aged, Drug Prescriptions, Retrospective Studies, Thyroid Diseases, Thyrotropin, Thyroxine, United States, Databases, Factual, Drugs, Generic, Treatment Outcome, Comparative Effectiveness Research, Propensity Score
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