Evidence map›Paper›PMID 31628482›Full record

Trial reportRheumatology (Oxford, England)2020

A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.

Cynthia Aranow, John Cush, Marcy B Bolster, Christopher C Striebich, Maria Dall'era, Meggan Mackay, Ewa Olech, Tracy Frech, Jane Box, Richard Keating and 14 more

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

Trial report in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00302952 (A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 35% 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.

NCT00302952 phase2terminatednot on this map

A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2012Enrolled64ConditionsRheumatoid ArthritisArmsLovastatin, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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

24 authors at 13 institutions in 1 country.

Cynthia AranowThe Feinstein Institute for Medical Research, Manhasset, USA.
John CushDivision of Rheumatology, Baylor University Medical Center, Dallas, USA.
Marcy B BolsterDivision of Rheumatology, Massachusetts General Hospital, Boston, USA.
Christopher C StriebichDivision of Rheumatology, University of Colorado, Denver, USA.
Maria Dall'eraDivision of Rheumatology, University of California, San Francisco, USA.
Meggan MackayThe Feinstein Institute for Medical Research, Manhasset, USA.
Ewa OlechDepartment of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.
Tracy FrechDepartment of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.
Jane BoxBox Arthritis & Rheumatology of the Carolinas, Charlotte, USA.
Richard KeatingDivision of Rheumatology, Scripps Green Hospital, La Jolla, USA.
Mary Chester WaskoDivision of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.
William St ClairDivision of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.
Alan KivitzAltoona Center for Clinical Research, Duncansville, USA.
Weiquang HuangThe Feinstein Institute for Medical Research, Manhasset, USA.
PetaGay RickettsThe Feinstein Institute for Medical Research, Manhasset, USA.
Beverly WelchNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.
Sherrie CallahanNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.
Meagan SpychalaRho Federal Systems Division, Chapel Hill, USA.
Karen BoyleRho Federal Systems Division, Chapel Hill, USA.
Kate YorkRho Federal Systems Division, Chapel Hill, USA.
Lynette Keyes-ElsteinRho Federal Systems Division, Chapel Hill, USA.
Ellen GoldmuntzNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.
Betty DiamondThe Feinstein Institute for Medical Research, Manhasset, USA.
Anne DavidsonThe Feinstein Institute for Medical Research, Manhasset, USA.
Feinstein Institute for Medical Research · USRho (United States) · USNational Institute of Allergy and Infectious Diseases · USAltoona Center for Clinical Research · USBaylor University Medical Center · USDuke University · USMassachusetts General Hospital · USScripps Green Hospital · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Nevada, Las Vegas · USUniversity of Utah · USWestern Pennsylvania Hospital · US

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
Supplement - Inflammatory Triggers in B Cell AutoimmunityU19AI056363 · NIAID · DUKE UNIVERSITY · PI ST. CLAIR, EUGENE WILLIAM · 2003 to 2017
$35.3M
Proposal for The Feinstein Center for Clinical Research in Autoimmune DiseaseUM1AI110494 · NIAID · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI ARANOW, CYNTHIA · 2014 to 2023
$1.0M
NIAID NIH HHS HHSN272200900057CNIAID NIH HHS U19 AI056363NIAID NIH HHS UM1 AI110494NIAID NIH HHS UM2 AI117870
6 · The paper itself

Abstract

objectives3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity.

methodsWe conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest.

resultsBaseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns.

conclusionThis study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.

Indexed as

AdultAnti-Citrullinated Protein AntibodiesArthritis, RheumatoidC-Reactive ProteinDouble-Blind MethodFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLovastatinMaleMiddle AgedRheumatoid FactorSeverity of Illness IndexTreatment OutcomeAnti-Citrullinated Protein AntibodiesC-Reactive ProteinHydroxymethylglutaryl-CoA Reductase InhibitorsLovastatinRheumatoid FactorC-reactive proteindisease activityinflammationrheumatoid arthritis

Identifiers

PMID31628482
PMCPMC7310095
OpenAlexW2980940582

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.