Evidence map›Paper›PMID 35369705›Full record

Trial reportCirculation2022

Effect of Vupanorsen on Non-High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70.

Brian A Bergmark, Nicholas A Marston, Candace R Bramson, Madelyn Curto, Vesper Ramos, Alexandra Jevne, Julia F Kuder, Jeong-Gun Park, Sabina A Murphy, Subodh Verma and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04516291 (A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Vupanorsen), which is not on this map. Cited by 111 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 1 pooled it
27.9field-weighted citation impact, top 1% 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.

NCT04516291 phase2completednot on this map

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Vupanorsen (PF-07285557) in Statin-Treated Participants With Dyslipidemia

TypeinterventionalSponsorPfizerRan2020 to 2021Enrolled286ConditionsDyslipidemias, Hyperlipidemias, HyperlipoproteinemiasArmsVupanorsen, Placebo
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 1 synthesis or guideline pooled it, 187 citations in OpenAlex.

  1. The promising novel therapies for familial hypercholesterolemia.Journal of clinical laboratory analysis · 2022
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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 3 countries.

Brian A Bergmark *TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).ORCID 0000-0003-4360-7606
Nicholas A Marston *TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).ORCID 0000-0001-6164-4617
Candace R BramsonPfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).
Madelyn CurtoPfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).
Vesper RamosPfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).
Alexandra JevneTIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).
Julia F KuderTIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).
Jeong-Gun ParkTIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).
Sabina A MurphyTIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).
Subodh VermaDepartment of Surgery, University of Toronto, Canada (S.V.).ORCID 0000-0002-4018-8533
Wojtek WojakowskiMedical University of Silesia, Katowice, Poland (W.W.).ORCID 0000-0002-3681-5207
Steven G TerraPfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).
Marc S Sabatine *TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).ORCID 0000-0002-0691-3359
Stephen D Wiviott *TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).ORCID 0000-0002-4922-9880
TRANSLATE-TIMI 70 Investigators
Thrombolysis in Myocardial Infarction Study Group · USPfizer (United States) · USMedical University of Silesia · PLUniversity of Toronto · CA

Funding

Discovery and Application of Germline and Somatic Mutations for Risk Prediction and Personalized Therapy to Prevent Recurrent Myocardial InfarctionK08HL153950 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MARSTON, NICHOLAS · 2020 to 2024
$647k
NHLBI NIH HHS K08 HL153950
6 · The paper itself

Abstract

backgroundGenetic loss-of-function variants in

methodsAdults with non-high-density lipoprotein cholesterol (non-HDL-C) ≥100 mg/dL and triglycerides 150 to 500 mg/dL on statin therapy were randomized in a double-blind fashion to placebo or 1 of 7 vupanorsen dose regimens (80, 120, or 160 mg SC every 4 weeks, or 60, 80, 120, or 160 mg SC every 2 weeks). The primary end point was placebo-adjusted percentage change from baseline in non-HDL-C at 24 weeks. Secondary end points included placebo-adjusted percentage changes from baseline in triglycerides, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and ANGPTL3.

resultsTwo hundred eighty-six subjects were randomized: 44 to placebo and 242 to vupanorsen. The median age was 64 (interquartile range, 58-69) years, 44% were female, the median non-HDL-C was 132.4 (interquartile range, 118.0-154.1) mg/dL, and the median triglycerides were 216.2 (interquartile range, 181.4-270.4) mg/dL. Vupanorsen resulted in significant decreases from baseline over placebo in non-HDL-C ranging from 22.0% in the 60 mg every 2 weeks arm to 27.7% in the 80 mg every 2 weeks arm (all

conclusionsVupanorsen administered at monthly equivalent doses from 80 to 320 mg significantly reduced non-HDL-C and additional lipid parameters. Injection site reactions and liver enzyme elevations were more frequent at higher doses, and there was a dose-dependent increase in hepatic fat fraction. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04516291.

Indexed as

Hydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaAdultAngiopoietin-Like Protein 3Angiopoietin-like ProteinsApolipoproteins BCholesterolCholesterol, HDLCholesterol, LDLDouble-Blind MethodFemaleHumansInjection Site ReactionLipoproteinsMaleMiddle AgedAngiopoietin-Like Protein 3Angiopoietin-like ProteinsANGPTL3 protein, humanApolipoproteins BCholesterolCholesterol, HDLCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteinsTriglyceridesAngiopoietin-like proteinsantisense oligonucleotidelipidstriglycerides

Identifiers

PMID35369705
PMCPMC9047643
OpenAlexW4225261270

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.