Evidence map›Paper›PMID 32997127›Full record

ArticleJAMA network open2020

Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels.

Juan P Brito, Joseph S Ross, Lindsey Sangaralingham, Sarah K Dutcher, David J Graham, Zhong Wang, Yute Wu, Xiaoxi Yao, Robert C Smallridge, Victor Bernet and 2 more

Open access · goldAbstract readComparative Study
In one paragraph

Article in JAMA network open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Impact and implications of national centralized drug procurement in China.International journal of clinical pharmacy · 2024
    Article
  6. Observational
  7. Towards De-Implementation of low-value thyroid care in older adults.Current opinion in endocrinology, diabetes, and obesity · 2022
    Review
  8. Surgeon specialty effect on early outcomes of elective posterior spinal fusion for adolescent idiopathic scoliosis: a propensity-matched analysis of 965 patients.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022
    Article
  9. Optimal Thyroid Hormone Replacement.Endocrine reviews · 2022
    Article
  10. Review
  11. Effect of once weekly oral levothyroxine therapy.Endocrinology, diabetes & metabolism case reports · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Juan P BritoKnowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
Joseph S RossSection of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine, New Haven, Connecticut.
Lindsey SangaralinghamRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.
Sarah K DutcherOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
David J GrahamOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Zhong WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Yute WuOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Xiaoxi YaoRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.
Robert C SmallridgeDivision of Endocrinology, Mayo Clinic, Jacksonville, Florida.
Victor BernetDivision of Endocrinology, Mayo Clinic, Jacksonville, Florida.
Nilay D ShahRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.
Kasia J LipskaCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Center for Drug Evaluation and Research · USMayo Clinic in Arizona · USMayo Clinic in Florida · USMayo Clinic · USWinnMed · USYale New Haven Health System · USYale New Haven Hospital · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
FDA HHS U01 FD005938NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

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.

Indexed as

AgedComparative Effectiveness ResearchDatabases, FactualDrug PrescriptionsDrugs, GenericFemaleHumansLongitudinal StudiesMaleMedicareMiddle AgedPropensity ScoreRetrospective StudiesThyroid DiseasesThyrotropinThyroxineDrugs, GenericThyrotropinThyroxine

Identifiers

PMID32997127
PMCPMC7527873
OpenAlexW3089363251

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.