Evidence map›Paper›PMID 34089480›Full record

ArticleEndocrine2021

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

Juan P Brito, Joseph S Ross, Yihong Deng, Lindsey Sangaralingham, David J Graham, Yandong Qiang, Zhong Wang, Xiaoxi Yao, Liang Zhao, Robert C Smallridge and 3 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Endocrine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Optimal Thyroid Hormone Replacement.Endocrine reviews · 2022
    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

13 authors at 6 institutions in 1 country.

Juan P BritoDivision of Endocrinology, Diabetes, Metabolism, Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA. brito.juan@mayo.edu.ORCID http://orcid.org/0000-0003-1840-1745
Joseph S RossSection of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA.ORCID http://orcid.org/0000-0002-9218-3320
Yihong DengRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
Lindsey SangaralinghamRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
David J GrahamOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Yandong QiangOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Zhong WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Xiaoxi YaoRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-9906-7106
Liang ZhaoOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Robert C SmallridgeDivision of Endocrinology, Mayo Clinic, Jacksonville, FL, USA.
Victor BernetDivision of Endocrinology, Mayo Clinic, Jacksonville, FL, USA.
Nilay D ShahRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0002-8597-3447
Kasia J LipskaCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
United States Food and Drug Administration · USMayo Clinic in Arizona · USMayo Clinic in Florida · USYale New Haven Hospital · USMayo Clinic · USOptum (United States) · US

Funding

Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)R01HL131535 · NHLBI · MAYO CLINIC ROCHESTER · PI MONTORI, VICTOR MANUEL · 2016 to 2020
$3.2M
Predicting Severe Hypoglycemia among Older Adults with DiabetesK23AG048359 · NIA · YALE UNIVERSITY · PI LIPSKA, KASIA JOANNA · 2014 to 2018
$778k
Diffusion of Clinical Evidence into Practice: Physician Networks, Delivery Organizations, and MarketsR56HL130496 · NHLBI · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2016 to 2016
$634k
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164AHRQ HHS R01 HS025402AHRQ HHS R03 HS025517AHRQ HHS U19 HS024075FDA HHS U01 FD005938NHLBI NIH HHS R01 HL131535NHLBI NIH HHS R56 HL130496NIA NIH HHS K23 AG048359
6 · The paper itself

Abstract

purposeTo compare cardiovascular outcomes and rates of fractures and falls among patients with persistent brand-name versus generic L-thyroxine use.

methodsRetrospective, 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.

results195,046 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.

conclusionsWe found no significant differences in cardiovascular outcomes and rates of falls and fractures for patients who filled brand versus generic L-thyroxine.

Indexed as

Drugs, GenericThyroxineAgedFemaleHumansLongitudinal StudiesRetrospective StudiesThyroid HormonesDrugs, GenericThyroid HormonesThyroxineBrandGenericHypothyroidismLevothyroxine

Identifiers

PMID34089480
PMCPMC9210353
OpenAlexW3164537852

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.