Evidence map›Paper›PMID 32473640›Full record

Trial reportLipids in health and disease2020

Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study.

Richard L Dunbar, Daniel Gaudet, Michael Davidson, Martin Rensfeldt, Hong Yang, Catarina Nilsson, Mats Kvarnström, Jan Oscarsson

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02189252 (A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT02189252 phase1completednot on this map

A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

TypeinterventionalSponsorAstraZenecaRan2014 to 2015Enrolled30ConditionsSevere HypertriglyceridemiaArmsEpanova, Lovaza
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 4 institutions in 4 countries.

Richard L DunbarCardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. r.l.dunbar@gmail.com.ORCID http://orcid.org/0000-0002-7059-4794
Daniel GaudetLipidology Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Saguenay, QC, Canada.
Michael DavidsonUniversity of Chicago Pritzker School of Medicine, Chicago, IL, USA.
Martin RensfeldtAstraZeneca, Gothenburg, Sweden.
Hong YangAstraZeneca, Gothenburg, Sweden.
Catarina NilssonAstraZeneca, Gothenburg, Sweden.
Mats KvarnströmAstraZeneca, Gothenburg, Sweden.
Jan OscarssonAstraZeneca, Gothenburg, Sweden.
AstraZeneca (Sweden) · SETranslational Therapeutics (United States) · USUniversité de Montréal · CAUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOmega-3 fatty acids (OM3-FAs) are recommended with a low-fat diet for severe hypertriglyceridemia (SHTG), to reduce triglycerides and acute pancreatitis (AP) risk. A low-fat diet may reduce pancreatic lipase secretion, which is required to absorb OM3-ethyl esters (OM3-EEs), but not OM3-carboxylic acids (OM3-CAs).

methodsIn this exploratory, randomized, open-label, crossover study, 15 patients with SHTG and previous AP were instructed to take OM3-CA (2 g or 4 g) and OM3-EE 4 g once daily for 4 weeks, while adhering to a low-fat diet. On day 28 of each treatment phase, a single dose was administered in the clinic with a liquid low-fat meal, to assess 24-h plasma exposure. Geometric least-squares mean ratios were used for between-treatment comparisons of baseline (day 0)-adjusted area under the plasma concentration versus time curves (AUC

resultsBefore initiating OM3-FA treatment, mean baseline fasting plasma EPA + DHA concentrations (nmol/mL) were 723 for OM3-CA 2 g, 465 for OM3-CA 4 g and 522 for OM3-EE 4 g. At week 4, mean pre-dose fasting plasma EPA + DHA concentrations increased by similar amounts (+ 735 - + 768 nmol/mL) for each treatment. During the 24-h exposure assessment (day 28), mean plasma EPA + DHA increased from pre-dose to the maximum achieved concentration by + 32.7%, + 45.8% and + 3.1% with single doses of OM3-CA 2 g, OM3-CA 4 g and OM3-EE 4 g, respectively. Baseline-adjusted AUC

conclusionsGreater 24-h exposure of OM3-CA versus OM3-EE was observed for some parameters when administered with a low-fat meal at the clinic on day 28. However, increases in pre-dose fasting plasma EPA + DHA over the preceding 4-week dosing period were similar between treatments, leading overall to non-significant differences in baseline (day 0)-adjusted AUC

trial registrationClinicalTrials.gov, NCT02189252, Registered 23 June 2014.

Indexed as

Diet, Fat-RestrictedAgedArea Under CurveCross-Over StudiesDietary SupplementsDocosahexaenoic AcidsEicosapentaenoic AcidFastingFatty Acids, Omega-3FemaleHumansHypertriglyceridemiaMaleMiddle AgedPancreatitisTriglyceridesDocosahexaenoic AcidsEicosapentaenoic AcidFatty Acids, Omega-3TriglyceridesClinical trialsDocosahexaenoic acidEicosapentaenoic acidFish oilOmega-3 carboxylic acidsOmega-3 ethyl estersOmega-3 fatty acidsPharmacokineticsTriglyceridesViscosity

Identifiers

PMID32473640
PMCPMC7260759
OpenAlexW3030932153

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.