Evidence map›Paper›PMID 21477202›Full record

Trial reportBritish journal of haematology2011

A pilot study of the short-term use of simvastatin in sickle cell disease: effects on markers of vascular dysfunction.

Carolyn Hoppe, Frans Kuypers, Sandra Larkin, Ward Hagar, Elliott Vichinsky, Lori Styles

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in British journal of haematology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
4.0field-weighted citation impact, top 7% 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.

NCT00508027 phase1 / phase2completednot on this map

Phase I/II Study of Simvastatin (Zocor) Therapy in Sickle Cell Disease

TypeinterventionalSponsorUCSF Benioff Children's Hospital OaklandRan2007 to 2011Enrolled42ConditionsSickle Cell DiseaseArmsSimvastatin
NCT01702246 phase1 / phase2completednot on this mapstarted 2012, after this paper: background citation

Phase 2 Study of Simvastatin Treatment Effects on Vaso-occlusive Pain in Sickle Cell Disease

TypeinterventionalSponsorUCSF Benioff Children's Hospital OaklandRan2012 to 2015Enrolled24ConditionsSickle Cell DiseaseArmsSimvastatin
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 80 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. The Evolving Pharmacotherapeutic Landscape for the Treatment of Sickle Cell Disease.Mediterranean journal of hematology and infectious diseases · 2020
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. New insights into the pathophysiology and development of novel therapies for sickle cell disease.Hematology. American Society of Hematology. Education Program · 2018
    Review
  18. Article
  19. Inflammation in sickle cell disease.Clinical hemorheology and microcirculation · 2018
    Article
  20. Article
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

6 authors at 1 institution in 1 country.

Carolyn HoppeDepartment of Haematology/Oncology, Children's Hospital & Research Center Oakland, 747 52nd Street, Oakland, CA 94609, USA. choppe@mail.cho.org
Frans Kuypers
Sandra Larkin
Ward Hagar
Elliott Vichinsky
Lori Styles
Asian Health Services · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
PHASE I/II STUDY OF SIMVASTATIN (ZOCOR) THERAPY IN SICKLE CELL DISEASER01FD003080 · FDA · CHILDREN'S HOSPITAL & RES CTR AT OAKLAND · PI HOPPE, CAROLYN CHRISTINA · 2007 to 2008
$540k
FDA HHS 1R01FD-03080-01A1FDA HHS R01 FD003080NCRR NIH HHS UL1 RR024131
6 · The paper itself

Abstract

Sickle cell disease (SCD) is characterized by progressive vascular injury and its pathophysiology is strikingly similar to that of atherosclerosis. Statins decrease inflammation and improve endothelial function in cardiovascular disease, but their effect in SCD is not known. In this pilot study, we examined the safety and effect of short-term simvastatin on biomarkers of vascular dysfunction in SCD. We treated 26 SCD patients with simvastatin, 20 or 40 mg/d, for 21 d. Plasma nitric oxide metabolites (NOx), C-reactive protein (CRP), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), tissue factor (TF) and vascular endothelial growth factor (VEGF) were analyzed and responses to simvastatin were compared between the two treatment groups. Simvastatin increased NOx levels by 23% in the low-dose (P =0·01) and 106% in the moderate-dose (P =0·01) groups, and by 52% overall (P=0·0008). CRP decreased similarly in both dose groups and by 68% overall (P =0·02). Levels of IL-6 decreased by 50% (P=0·04) and 71% (P<0·05) in the low- and moderate-dose groups, respectively. Simvastatin had no effect on VEGF, VCAM1 or TF. Simvastatin was well-tolerated and safe. Our preliminary findings showing a dose-related effect of simvastatin on levels of NOx, CRP and IL-6 suggest a potential therapeutic role for simvastatin in SCD.

Indexed as

AdolescentAdultAnemia, Sickle CellBiomarkersBlood CoagulationC-Reactive ProteinDose-Response Relationship, DrugEndothelium, VascularHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInflammation MediatorsInterleukin-6LipidsNitric OxidePilot ProjectsSimvastatinBiomarkersC-Reactive ProteinHydroxymethylglutaryl-CoA Reductase InhibitorsInflammation MediatorsInterleukin-6LipidsNitric OxideSimvastatinVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID21477202
PMCPMC3601917
OpenAlexW1955305991

What OpenQuestion holds

Textmetadata
LicenceTDM
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.