Evidence map›Paper›PMID 32458077›Full record

SynthesisCurrent atherosclerosis reports2020

Efficacy and Safety of Volanesorsen (ISIS 304801): the Evidence from Phase 2 and 3 Clinical Trials.

Federica Fogacci, Giuseppe Danilo Norata, Peter P Toth, Marcello Arca, Arrigo F G Cicero

Open access · greenAbstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Current atherosclerosis reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 3% 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

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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  20. Severe insulin resistance syndromes.The Journal of clinical investigation · 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

5 authors at 5 institutions in 2 countries.

Federica FogacciMedical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Giuseppe Danilo NorataDepartment of Pharmacological and Biomolecular Sciences, Università degli Studi di Milano, Milan, Italy.
Peter P TothThe Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Marcello ArcaDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.
Arrigo F G CiceroMedical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, Bologna, Italy. arrigo.cicero@unibo.it.ORCID 0000-0002-4367-3884
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITJohns Hopkins University · USSapienza University of Rome · ITUniversity of Bologna · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purpose of reviewTo revise the clinical evidence supporting the use of volanesorsen as new lipid-lowering drug and to assess the efficacy and safety of volanesorsen (ISIS 304801) through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies. RECENT

findingsThe meta-analysis of three clinical studies comprising 11 arms (N = l 156 subjects, with 95 in the active-treated arm and 61 in the control one) shows that volanesorsen significantly affects plasma levels of triglycerides (TG) [MD = - 67.90%, 95%CI = - 85.32, - 50.48, P < 0.001], high-density lipoprotein cholesterol (HDL-C) [MD = 40.06%, 95%CI: 32.79, 47.34, P < 0.001], very-low-density lipoprotein cholesterol (VLDL-C) [MD = - 72.90%, 95%CI = - 82.73, - 63.07, P < 0.001], apolipoprotein B (Apo B) [MD = 8%, 95%CI = 2.17, 13.84, P = 0.007], Apo B-48 [MD = - 64.63, 95%CI = - 105.37, - 23.88, P = 0.002], ApoCIII [MD = - 74.83%, 95%CI = - 85.93, - 63.73, P < 0.001], and VLDL ApoCIII [MD = - 83.69%, 95%CI = - 94.08, - 73.29, P < 0.001], without significant impact on LDL-C [MD = 47.01%, 95%CI = - 1.31, 95.33, P = 0.057] levels. Treatment with volanesorsen was associated with an higher risk of injection site reaction (OR = 32.89, 95%CI = 7.97,135,74, P < 0.001) and with an increased risk of upper respiratory tract infections (OR = 10.58, 95%CI = 1.23, 90.93, P < 0.05) when compared to placebo. Volanesorsen has a relevant impact on plasma TG and related parameters without affecting LDL cholesterolemia and is associated with an acceptable safety profile.

Indexed as

AdultAgedAnimalsApolipoprotein C-IIICholesterol, HDLFemaleHumansHypertriglyceridemiaHypolipidemic AgentsMaleMiddle AgedOligonucleotidesTriglyceridesYoung AdultAPOC3 protein, humanApolipoprotein C-IIICholesterol, HDLHypolipidemic AgentsISIS 304801OligonucleotidesTriglyceridesAntisense oligonucleotidesApolipoprotein C-IIIEfficacyLipid-lowering drugMeta-analysisSafetyVolanesorsen

Identifiers

PMID32458077
OpenAlexW3030043260

What OpenQuestion holds

Textmetadata
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.