Evidence mapPaperPMID 24481874Full record

Trial reportClinical cardiology2014

Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy.

Jennifer G Robinson, William J Rogers, Bettina S Nedergaard, Jonathan Fialkow, Joel M Neutel, David Ramstad, Ransi Somaratne, Jason C Legg, Patric Nelson, Rob Scott and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cardiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01763866. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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.

NCT01763866 phase3completed

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

Ran2013Enrolled2,067Registered outcomes22Posted comparisons308ConditionsHyperlipidemiaArmsAtorvastatin, Evolocumab, Ezetimibe, Placebo to Evolocumab, Placebo to Ezetimibe
Open the trial in the graph
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Management of Statin Intolerance in 2018: Still More Questions Than Answers.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2018
    Review
  3. Review
  4. PCSK9 in chronic kidney disease.International urology and nephrology · 2017
    Review
  5. Review
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

12 authors at 8 institutions in 2 countries.

Jennifer G RobinsonDepartments of Epidemiology and Medicine, College of Public Health, University of Iowa, Iowa, Iowa.
William J Rogers
Bettina S Nedergaard
Jonathan Fialkow
Joel M Neutel
David Ramstad
Ransi Somaratne
Jason C Legg
Patric Nelson
Rob Scott
Scott M Wasserman
Robert Weiss
Amgen (United States) · USCenter for Clinical & Basic Research · DKFlorida International University · USMaine Research Associates · USOrange County Research Center · USSuffolk University · USUniversity of Alabama · USUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Low-density lipoprotein cholesterol (LDL-C) levels are significantly associated with atherosclerotic cardiovascular disease (ASCVD) risk, and studies using interventions that lower LDL-C levels have been shown to reduce the risk of ASCVD events and mortality. Statin treatment is the current first-line therapy for lowering LDL-C and reducing ASCVD risk. However, many patients are still unable to reach recommended LDL-C goals on maximally tolerated statin therapy. Monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9, including evolocumab (previously AMG 145), dramatically lowered LDL-C in phase 2 clinical trials when administered alone or in combination with a statin. The aim of this phase 3 study is to evaluate the efficacy of 12 weeks of subcutaneous evolocumab (vs placebo) administered every 2 weeks or every month in combination with a statin in patients with hypercholesterolemia and mixed dyslipidemia. This study will also provide comparative efficacy, safety, and tolerability data between evolocumab and ezetimibe when added to background atorvastatin therapy.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsAzetidinesDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationDyslipidemiasEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsAzetidinesevolocumabEzetimibeHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID24481874
PMCPMC6649582
OpenAlexW1989343587

What Socratic holds

Texttitle and abstract
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.