Evidence map›Paper›PMID 25733584›Full record

Trial reportBlood2015

Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use.

Marilyn J Telen, Ted Wun, Timothy L McCavit, Laura M De Castro, Lakshmanan Krishnamurti, Sophie Lanzkron, Lewis L Hsu, Wally R Smith, Seungshin Rhee, John L Magnani and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01119833 (A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of GMI-1070, A Pan-Selectin Inhibitor, In Subjects Hospitalized For Sickle Cell Vaso-Occlusive Crisis), which is not on this map. Cited by 112 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 1 pooled it
18.5field-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.

NCT01119833 phase2completednot on this map

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of GMI-1070, A Pan-Selectin Inhibitor, In Subjects Hospitalized For Sickle Cell Vaso-Occlusive Crisis

TypeinterventionalSponsorGlycoMimetics IncorporatedRan2010 to 2013Enrolled81ConditionsSickle Cell Disease, Vaso-occlusive Crisis, Pain CrisisArmsGMI-1070, Placebo
3 · Its place in the literature

Who cites it

112 citing papers in PubMed, 1 synthesis or guideline pooled it, 204 citations in OpenAlex.

  1. Pooled it
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  13. Sickle Cell Disease.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2024
    Review
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  18. Using disease-modifying therapies in sickle cell disease.Hematology. American Society of Hematology. Education Program · 2023
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52 more citing papers are in PubMed but not listed here.

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

11 authors at 10 institutions in 1 country.

Marilyn J TelenDepartment of Medicine, Division of Hematology, Duke University, Durham, NC;
Ted WunDepartment of Internal Medicine, Division of Hematology/Oncology, University of California Davis Medical Center and VA Northern California Health Care System, Sacramento, CA;
Timothy L McCavitDepartment of Pediatric Hematology/Oncology, University of Texas Southwestern Medical Center, Dallas, TX;
Laura M De CastroDepartment of Medicine, Division of Hematology and Oncology, University of Pittsburgh, Pittsburgh, PA;
Lakshmanan KrishnamurtiAflac Cancer and Blood Disorders Center, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA;
Sophie LanzkronDepartment of Medicine, Division of Hematology, Johns Hopkins School of Medicine, Baltimore, MD;
Lewis L HsuDepartment of Pediatrics, University of Illinois, Chicago, IL;
Wally R SmithDivision of General Internal Medicine, Virginia Commonwealth University, Richmond, VA;
Seungshin RheeRho, Inc., Chapel Hill, NC; and.
John L MagnaniGlycoMimetics, Inc., Gaithersburg, MD.
Helen ThackrayGlycoMimetics, Inc., Gaithersburg, MD.
GlycoMimetics (United States) · USDuke University · USEmory University · USJohns Hopkins University · USRho (United States) · USThe University of Texas Southwestern Medical Center · USUniversity of California Davis Medical Center · USUniversity of Illinois Chicago · USUniversity of Pittsburgh · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment of vaso-occlusive crises (VOC) or events in sickle cell disease (SCD) remains limited to symptom relief with opioids. Animal models support the effectiveness of the pan-selectin inhibitor GMI-1070 in reducing selectin-mediated cell adhesion and abrogating VOC. We studied GMI-1070 in a prospective multicenter, randomized, placebo-controlled, double-blind, phase 2 study of 76 SCD patients with VOC. Study drug (GMI-1070 or placebo) was given every 12 hours for up to 15 doses. Other treatment was per institutional standard of care. All subjects reached the composite primary end point of resolution of VOC. Although time to reach the composite primary end point was not statistically different between the groups, clinically meaningful reductions in mean and median times to VOC resolution of 41 and 63 hours (28% and 48%, P = .19 for both) were observed in the active treatment group vs the placebo group. As a secondary end point, GMI-1070 appeared safe in acute vaso-occlusion, and adverse events were not different in the two arms. Also in secondary analyses, mean cumulative IV opioid analgesic use was reduced by 83% with GMI-1070 vs placebo (P = .010). These results support a phase 3 study of GMI-1070 (now rivipansel) for SCD VOC. This trial was registered at www.clinicaltrials.gov as #NCT01119833.

Indexed as

AdolescentAdultAnalgesicsAnalgesics, OpioidAnemia, Sickle CellChildDouble-Blind MethodFemaleGlycolipidsHumansMaleMiddle AgedProspective StudiesVascular DiseasesYoung AdultAnalgesicsAnalgesics, OpioidGlycolipidsrivipansel

Identifiers

PMID25733584
PMCPMC4408290
OpenAlexW2077716817

What OpenQuestion 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 OpenQuestion graph.