Trial reportCardiology2016

Icosabutate, a Structurally Engineered Fatty Acid, Improves the Cardiovascular Risk Profile in Statin-Treated Patients with Residual Hypertriglyceridemia.

John J P Kastelein, Jonas Hallén, Runar Vige, David A Fraser, Rong Zhou, Svein Olaf Hustvedt, David G Orloff, Harold E Bays

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cardiology, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map: it favours the comparator in 1. Cited by 7 papers.

1number the graph read from it
1cell of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

← favours the comparatorfavours the treatment →
-7.400 · no effect
Lipidsfavours the comparator · against placebo · arrhythmia, ascvdfeeds one cell of the map
Δ -7.40p = 0.02
RESULTS: With icosabutate, non-HDL-C levels were reduced (-9.2%) when compared with the control (-0.4%) for a between-group difference of -7.4% (p = 0.02).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×lipids

ContradictsOpen on the map →What to test next →

38 readable studies in this cell: 27 favour the treatment, 5 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 21 families support, 7 contradict · against placebo
Without it
0.78This paper moves it by −0.28. It would be replicated.
← favours the comparatorfavours the treatment →
0 · no effect
This paper · 2016
Δ -7.40
NCT002899002,340 enrolled · 2006
Δ -13.2-16.8 to -9.60
reduced -66.0-73.0 to -58.0
NCT02546323543 enrolled · 2015
Δ -35.5-40.2 to -30.7
NCT01678820299 enrolled · 2012
Δ 0.50-4.80 to 5.80
NCT01218204287 enrolled · 2010
Δ 5.47-15.7 to 26.7
NCT0093525931 enrolled · 2009
Δ -51.7
reductions -33.6-38.8 to -28.4
4 · 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.

5 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Dual targeting of hepatic fibrosis and atherogenesis by icosabutate, an engineered eicosapentaenoic acid derivative.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

John J P KasteleinDepartment of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Jonas Hallén
Runar Vige
David A Fraser
Rong Zhou
Svein Olaf Hustvedt
David G Orloff
Harold E Bays
Medpace (United States) · USAcademic Medical Center · NLLouisville Metabolic and Atherosclerosis Research Center · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectivesTo evaluate the efficacy and safety of icosabutate, an oral, once-daily, first-in-class medication, in reducing non-high-density lipoprotein cholesterol (non-HDL-C) in patients with persistent hypertriglyceridemia despite statin therapy.

methodsThe study was designed to randomly assign 140 patients with fasting triglyceride levels ≥200 but <500 mg/dl on a stable dose of statin therapy to receive either masked icosabutate 600 mg once daily or a control for 12 weeks. The primary end point was a percentage change in non-HDL-C from baseline to 12 weeks.

resultsWith icosabutate, non-HDL-C levels were reduced (-9.2%) when compared with the control (-0.4%) for a between-group difference of -7.4% (p = 0.02). Compared with the control, icosabutate reduced triglycerides (-27.0%, p < 0.001), very- low-density lipoprotein (VLDL) cholesterol (-31.5%, p < 0.001) and apolipoprotein C-III (-22.5%, p < 0.001). LDL-C levels did not change (0.5%, p = 0.87). HDL-C (10.2%, p < 0.001) was increased. After 113 subjects had been randomized, the study was terminated due to a partial clinical hold imposed by US regulators after observing QT prolongation at supratherapeutic doses of icosabutate in a dog study. In this study, adverse events were balanced between treatment arms, and there were no discontinuations due to adverse events.

conclusionsIcosabutate was efficacious in lowering non-HDL-C and other biomarkers of cardiovascular risk and was generally well tolerated.

Indexed as

AdultAgedAnimalsArrhythmias, CardiacButyratesCardiovascular DiseasesDogsDrug Therapy, CombinationEarly Termination of Clinical TrialsFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypertriglyceridemiaHypolipidemic AgentsLipidsMaleButyratesHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsicosabutateLipids

Identifiers

PMID27160246
OpenAlexW2347160677

What Socratic holds

Texttitle and abstract
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 Socratic graph.