ArticleThe Journal of clinical endocrinology and metabolism2013
Generic levothyroxine compared with synthroid in young children with congenital hypothyroidism.
Article in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Real world evidence in effectiveness, safety, and cost savings of generic levothyroxine: a systematic review.Endocrine · 2021Pooled it
- Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products.The AAPS journal · 2021Pooled it
- Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement.Thyroid : official journal of the American Thyroid Association · 2014Guideline
- Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution.Advances in therapy · 2019Review
- Evaluation and management of the child with hypothyroidism.World journal of pediatrics : WJP · 2019Review
- Provider and Patient Determinants of Generic Levothyroxine Prescribing: An Electronic Health Records-Based Study.The Annals of pharmacotherapy · 2017Article
- Hypothyroidism in the newborn period.Current opinion in endocrinology, diabetes, and obesity · 2013Review
- Treating congenital hypothyroidism--which levothyroxine?Nature reviews. Endocrinology · 2013Article
Corrections and comments
- Commented on by
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextClinicians who prescribe levothyroxine (LT4) for hypothyroidism often feel strongly about using a brand-name drug instead of a generic.
objectiveThe objective of the study was to determine whether Synthroid resulted in better control of congenital hypothyroidism than generic LT4.
designThis was a 5-year retrospective study.
settingThe study was conducted at 1 tertiary care center. PATIENTS: Children who were 0-36 months old with congenital hypothyroidism followed up at our center from 2006 to 2011 were treated with either Synthroid exclusively (35 subjects) or generic LT4 exclusively (27 subjects).
interventionsWe recorded the subjects' TSH and free T(4) measurements, how often their LT4 dose was adjusted, and the duration of follow-up.
main outcome measureTSH variance between the groups was measured. Secondary end points were the frequency of LT4 dose changes and the variance in free T(4).
resultsUsing the Wilcoxon rank sum test, there was no difference in TSH SD in the Synthroid group compared with the generic group (median 3.0 vs 2.2, P = .27). Using a linear mixed model, children treated with the generic LT4 had lower TSH estimated SD [1.35 with 95% confidence interval (CI) (1.194, 1.526)] than the Synthroid group [1.66 with 95% CI (1.536, 1.803)]. Similarly, no difference was observed in free T(4) SD between the groups using the Wilcoxon rank sum test (median 0.29 generic vs 0.36 Synthroid, P = .11), but the generic group had lower free T(4) estimated SD than the Synthroid group using the linear mixed model [0.216 with 95% CI (0.187, 0.249) vs 0.298 with 95% CI (0.273,0.326)]. Frequency of LT4 dosing adjustments was similar between the groups, both in total (median 2.0 for generic vs 3.0 for Synthroid, P = .097) and when adjusted for number of TSH checks (ratio 0.25 generic vs 0.31 Synthroid, P = .45).
conclusionsIn our study of congenital hypothyroidism, generic LT4 treatment resulted in similar or better control of hypothyroidism compared with Synthroid, as assessed by the clinical outcomes of TSH variance and the frequency of LT4 dosing adjustments.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.