Evidence map›Paper›PMID 39657237›Full record

Trial reportRheumatology (Oxford, England)2025

Blood pressure changes during methotrexate treatment: results from a randomized placebo-controlled trial among patients with cardiovascular risk.

Jing Cui, Paul M Ridker, Daniel H Solomon

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01594333 (A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT01594333 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Cardiovascular Events Among Stable Coronary Artery Disease Patients With Type 2 Diabetes or Metabolic Syndrome

TypeinterventionalSponsorBrigham and Women's HospitalRan2013 to 2019Enrolled4,786ConditionsCardiovascular DiseaseArmsMethotrexate, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

3 authors.

Jing CuiDivision of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0001-8657-1741
Paul M RidkerDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Daniel H SolomonDivision of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Funding

Cardiovascular Inflammation Reduction Trial (CIRT)U01HL101422 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI RIDKER, PAUL M. · 2011 to 2018
$55.4M
Joint Biology Consortium Resource-based CenterP30AR070253 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Peter A Nigrovic, Jeffrey Andrew Sparks · 2016 to 2026
$9.4M
Cardiovascular Inflammation Reduction Trial (CIRT): DCCU01HL101389 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI GLYNN, ROBERT J · 2011 to 2016
$6.6M
Towards Evidence-Based Monitoring of Low Dose Methotrexate: CIRT Ancillary StudyR01HL119718 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SOLOMON, DANIEL HAL · 2014 to 2018
$3.9M
NHLBI NIH HHS R01 HL119718NHLBI NIH HHS U01 HL101389NHLBI NIH HHS U01 HL101422NIAMS NIH HHS P30 AR070253NIH HHS NIH R01 HL119718NIH HHS P30 AR070253NIH HHS U01 HL101389NIH HHS U01 HL101422
6 · The paper itself

Abstract

objectiveLow-dose MTX (LD-MTX) has been associated with a reduced risk of cardiovascular disease (CVD) among patients with systemic rheumatic diseases but not among the general population. Prior reports suggest that LD-MTX may reduce blood pressure (BP). We studied the effect of LD-MTX on BP.

methodWe examined data that compared LD-MTX to placebo in a randomized double-blind controlled clinical trial conducted among patients who had known CVD but without rheumatic disease. Systolic and diastolic BP (SBP, DBP) were collected as vital sign measurements at each scheduled study visit during 5 years of follow-up. Longitudinal SBP and DBP were compared between patients of LD-MTX and placebo arms using a linear mixed model.

resultData were used from 2391 patients randomized to LD-MTX and 2395 to placebo, with a mean follow-up of 26 months. At baseline, SBP and DBP were normally distributed with similar medians [SBP: 128 mmHg (IQR 118-139), DBP: 74 mmHg (IQR 67-80)] between patients from both treatment groups; 93% patients reported at baseline using at least one type of medication for hypertension. After treatment, compared with placebo, the estimated differences in changes of SBP and DBP in the LD-MTX group were <1 mm (SBP: β = -0.75 mmHg, 95% CI -0.02 to -1.49; DBP: β = -0.56 mmHg, 95% CI -0.12 to -1.01).

conclusionPatients randomized to LD-MTX without systemic rheumatic disease had no clinically meaningful difference in BP compared with placebo.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT01594333.

Indexed as

Antirheumatic AgentsBlood PressureCardiovascular DiseasesMethotrexateRheumatic DiseasesAdultAgedDouble-Blind MethodFemaleFollow-Up StudiesHeart Disease Risk FactorsHumansHypertensionMaleMiddle AgedTreatment OutcomeAntirheumatic AgentsMethotrexateblood pressureCIRTlow dose methotrexate

Identifiers

PMID39657237
PMCPMC12107077

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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.