Evidence map›Paper›PMID 28543601›Full record

ArticleJournal of clinical pharmacology2017

Influence of Meals and Glycemic Changes on QT Interval Dynamics.

Brenda Cirincione, Philip T Sager, Donald E Mager

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.3field-weighted citation impact, top 10% 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

16 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
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  7. Confirmation of the Cardiac Safety of PGFClinical pharmacology in drug development · 2018
    Trial
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  14. The Cardiovascular Effects of a Meal: J-TJournal of clinical pharmacology · 2019
    Article
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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

3 authors at 2 institutions in 4 countries.

Brenda CirincioneResearch and Development, Bristol-Myers Squibb, Princeton, NJ, USA.
Philip T SagerSager Consulting Experts, San Francisco, CA, USA.
Donald E MagerDepartment of Pharmaceutical Sciences, University at Buffalo, SUNY, Buffalo, NY, USA.
University at Buffalo, State University of New York · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Thorough QT/QTc studies have become an integral part of early drug development programs, with major clinical and regulatory implications. This analysis expands on existing pharmacodynamic models of QT interval analysis by incorporating the influence of glycemic changes on the QT interval in a semimechanistic manner. A total of 21 healthy subjects enrolled in an open-label phase 1 pilot study and provided continuous electrocardiogram monitoring and plasma glucose and insulin concentrations associated with a 24-hour baseline assessment. The data revealed a transient decrease in QTc, with peak suppression occurring approximately 3 hours after the meal. A semimechanistic modeling approach was applied to evaluate temporal delays between meals and subsequent changes that might influence QT measurements. The food effect was incorporated into a model of heart rate dynamics, and additional delayed effects of the meal on QT were incorporated using a glucose-dependent hypothetical transit compartment. The final model helps to provide a foundation for the future design and analysis of QT studies that may be confounded by meals. This study has significant implications for QT study assessment following a meal or when a cohort is receiving a medication that influences postprandial glucose concentrations.

Indexed as

Blood GlucoseHeart RateMealsModels, BiologicalAdultElectrocardiographyFemaleHealthy VolunteersHumansInsulinMaleMiddle AgedPilot ProjectsPostprandial PeriodBlood GlucoseInsulinglucoseheart ratemathematical modelingQT interval

Identifiers

PMID28543601
PMCPMC5518218
OpenAlexW2618051972

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.