Evidence map›Paper›PMID 27943146›Full record

ArticleDrugs in R&D2017

Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study.

Frank R Ernst, Walter Sandulli, Riad Elmor, Jennifer Welstead, Arnold B Sterman, MaryKate Lavan

Open access · goldAbstract read
In one paragraph

Article in Drugs in R&D, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.2field-weighted citation impact, top 18% 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

14 citing papers in PubMed, 23 citations in OpenAlex.

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  6. L-T4 Therapy in Enteric Malabsorptive Disorders.Frontiers in endocrinology · 2021
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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

6 authors at 1 institution in 1 country.

Frank R ErnstHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA. frankrernstrx@gmail.com.
Walter SandulliAkrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
Riad ElmorHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
Jennifer WelsteadHealth Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
Arnold B StermanArnold Sterman, LLC, Morristown, NJ, USA.
MaryKate LavanAkrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
Health Economics and Outcomes Research (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMedication changes involving levothyroxine-either dose titrations or switching formulations-occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a gel cap formulation of levothyroxine might reduce dose adjustments and improve tolerability and efficacy outcomes.

objectivesPrimary study objectives included quantifying the percentage of patients achieving TSH levels within a pre-specified range, median dose changes experienced, and the percentage of patients with improved hypothyroid symptom control after switching from levothyroxine tablets to levothyroxine gel caps.

methodsA retrospective medical chart review was conducted among 99 randomly selected hypothyroid patients who were switched from a tablet to a gel cap formulation of levothyroxine. Patients were required to have been on levothyroxine monotherapy for ≥1 year prior to the medication switch. Data was collected for 6 months pre-switch and up to 6 months post-switch.

resultsOf the 99 patients studied, the majority (51.5%) experienced no documented change in TSH status after the switch (P < 0.0001). However, there was a decrease in the mean number of dose changes experienced (1.61 ± 0.96 vs. 0.73 ± 0.96; P < 0.0001). Improved hypothyroid symptom control was reported among 61.6% of patients (61 of 99; P < 0.0001).

conclusionThe results of CONTROL Switch support a strategy of switching patients who may experience tolerability or efficacy problems with standard levothyroxine tablets to the levothyroxine gel cap formulation.

Indexed as

Drug CompoundingAdministration, OralAdultAgedDose-Response Relationship, DrugFemaleGelsHumansHypothyroidismMaleMiddle AgedRetrospective StudiesTabletsThyroxineYoung AdultGelsTabletsThyroxine

Identifiers

PMID27943146
PMCPMC5318319
OpenAlexW2559946799

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.