Evidence map›Paper›PMID 20008831›Full record

Trial reportJournal of lipid research2010

Effect of apolipoprotein-B synthesis inhibition on liver triglyceride content in patients with familial hypercholesterolemia.

Maartje E Visser, Fatima Akdim, Diane L Tribble, Aart J Nederveen, T Jesse Kwoh, John J P Kastelein, Mieke D Trip, Erik S G Stroes

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

Trial report in Journal of lipid research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00362180 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Apolipoprotein B), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT00362180 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Apolipoprotein B(ApoB) Reduction by ISIS 301012 on Liver Triglyceride Content in Subjects With Varying Degrees of Hyperlipidemia

TypeinterventionalSponsorKastle Therapeutics, LLCRan2006 to 2010Enrolled38ConditionsLipid Metabolism, Inborn Errors, Hyperlipidemias, Metabolic Diseases, HypolipoproteinemiaArmsmipomersen, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 110 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
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  10. Article
  11. Antisense Oligonucleotides Targeting Lipoprotein(a).Current atherosclerosis reports · 2019
    Review
  12. Article
  13. Review
  14. Article
  15. Injection site reactions after subcutaneous oligonucleotide therapy.British journal of clinical pharmacology · 2016
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Maartje E VisserDepartment of Vascular Medicine, Academic Medical Center Amsterdam, The Netherlands.
Fatima Akdim
Diane L Tribble
Aart J Nederveen
T Jesse Kwoh
John J P Kastelein
Mieke D Trip
Erik S G Stroes
Academic Medical Center · NLIonis Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate the impact of mipomersen, an apolipoprotein B-100 (apoB) synthesis inhibitor, on intra-hepatic triglyceride content (IHTG content), we conducted a randomized, double-blind, placebo-controlled study in 21 patients with familial hypercholesterolemia (FH). Subjects received a weekly subcutaneous dose of 200 mg mipomersen or placebo for 13 weeks while continuing conventional lipid lowering therapy. The primary endpoint was change in IHTG content from week 0 to week 15 as measured by localized proton magnetic resonance spectroscopy (1H-MRS). Thirteen weeks of mipomersen administration reduced LDL-cholesterol by 22.0 (17.8) % and apoB by 19.9 (17.4) % (both P < 0.01). One of 10 patients (10%) in the mipomersen-treated group developed mild hepatic steatosis at week 15, which was reversible following mipomersen discontinuation. For the group, there was a trend toward an increase in IHTG content [placebo; baseline: 1.2% and week 15: 1.1%; change -0.1 (0.9). Mipomersen; baseline: 1.2% and week 15: 2.1%; change 0.8 (1.7) (P = 0.0513)]. Mipomersen administration for 13 weeks to subjects with FH is associated with a trend toward an increase in IHTG content. Future studies evaluating the effects of long-term use of mipomersen reaching more profound reductions in apoB are required prior to broader use of this compound.

Indexed as

AdolescentAdultAgedApolipoproteins BDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHeterozygoteHumansHyperlipoproteinemia Type IILiverMagnetic Resonance SpectroscopyMaleMiddle AgedOligonucleotidesProtein BiosynthesisApolipoproteins BmipomersenOligonucleotidesTriglycerides

Identifiers

PMID20008831
PMCPMC2853432
OpenAlexW2023572044

What Socratic holds

Textmetadata
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 Socratic graph.