Evidence map›Paper›PMID 33777820›Full record

ArticleEuropean thyroid journal2021

Therapeutic Equivalence of a New Preparation of Liquid Levothyroxine with Tablets in Patients with Overt Primary Hypothyroidism.

Georgios K Markantes, Konstantinos Dimitropoulos, Irene Mamali, Ioulia Tseti, George Sakellaropoulos, Kostas B Markou, Marina A Michalaki

Erratum issuedOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in European thyroid journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Georgios K MarkantesDivision of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
Konstantinos DimitropoulosDivision of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
Irene MamaliDivision of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
Ioulia TsetiUni-Pharma S.A., Athens, Greece.
George SakellaropoulosDepartment of Medical Physics, School of Medicine, University of Patras, Patras, Greece.
Kostas B MarkouDivision of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
Marina A MichalakiDivision of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
University of Patras · GRUni Pharma (Greece) · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA new liquid levothyroxine (LT4) dissolved in glycerol and water has recently been developed by a Greek pharmaceutical company (Uni-Pharma, Athens, Greece).

objectivesTo evaluate the therapeutic equivalence of this new liquid LT4 preparation versus the already existing tablet formulation of the same manufacturer, in order to obtain approval by the Greek National Organization for Medicines.

methodsThis was a prospective, randomized, cross-over phase III study. The study included 50 patients (9 men and 41 non-pregnant women, with a mean age of 42.5 ± 12.5 years), with documented overt primary hypothyroidism. All subjects were well controlled on substitution therapy with various LT4 formulations. None of the patients had known LT4 malabsorption. The patients were randomized into 2 groups (A and B). The individuals of group A initially received T4® tablets for 10 ± 2 weeks and subsequently switched to T4® drops (100 μg/mL solution) at the same dose for another 10 ± 2 weeks. In group B, the reverse procedure was followed. Total T3 (T3), free T4 (fT4), and TSH were measured in all participants at enrollment and at the end of each 10 ± 2-week trial period.

resultsOut of the 50 recruited patients, 6 were lost to follow-up and 5 were excluded due to non-compliance with the study protocol. In the 39 patients who completed the study, the serum TSH levels after 10 ± 2 weeks of treatment either with T4® tablets or with T4® drops did not differ (1.759 ± 1.104 vs. 2.076 ± 1.334 mIU/L, mean ± SD).

conclusionsIn hypothyroid patients, the new liquid LT4 preparation (T4® drops) is therapeutically equivalent to the tablet form (T4® tablets).

Indexed as

HypothyroidismLevothyroxineLiquid levothyroxineTherapeutic equivalenceTSH

Identifiers

PMID33777820
PMCPMC7983587
OpenAlexW3037368553

What OpenQuestion holds

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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.