Evidence map›Paper›PMID 29020251›Full record

Trial reportEuropean heart journal2017

Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) Trial.

Frank Ruschitzka, Jeffrey S Borer, Henry Krum, Andreas J Flammer, Neville D Yeomans, Peter Libby, Thomas F Lüscher, Daniel H Solomon, M Elaine Husni, David Y Graham and 8 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00346216 (A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen), which is not on this map. Cited by 44 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 5 pooled it
9.7field-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.

NCT00346216 phase4completednot on this map

A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2006 to 2016Enrolled24,081ConditionsArthritis, RheumatoidArmscelecoxib, Ibuprofen, Naproxen
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 119 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 3 countries.

Frank RuschitzkaCardiology, University Heart Center, University Hospital Zurich, Switzerland.
Jeffrey S BorerCardiovascular Medicine, Schiavone Cardiovascular Translational Research Institute, State University of New York, Downstate College of Medicine, New York, NY, USA.
Henry Krum
Andreas J FlammerCardiology, University Heart Center, University Hospital Zurich, Switzerland.
Neville D YeomansCardiovascular Medicine, Western Sydney University, Campbelltown, NSW, Australia.
Peter LibbyCardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Thomas F LüscherCardiology, University Heart Center, University Hospital Zurich, Switzerland.
Daniel H SolomonCardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
M Elaine HusniDepartment of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, USA.
David Y GrahamCardiovascular Medicine, Baylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA.
Deborah A DaveyDepartment for Cleveland Clinic, Cleveland Clinic, Cleveland, OH, USA.
Lisa M WisniewskiDepartment for Cleveland Clinic, Cleveland Clinic, Cleveland, OH, USA.
Venu MenonDepartment for Cleveland Clinic, Cleveland Clinic, Cleveland, OH, USA.
Rana FayyadCardiovascular Medicine, Pfizer, New York, NY, USA.
Bruce BeckermanCardiovascular Medicine, Pfizer, New York, NY, USA.
Dinu IorgaCardiovascular Medicine, Pfizer, New York, NY, USA.
A Michael LincoffCardiovascular Medicine, Baylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA.
Steven E NissenCardiovascular Medicine, Baylor College of Medicine, Veterans Affairs Medical Center, Houston, TX, USA.
Cleveland Clinic · USBaylor College of Medicine · USPfizer (United States) · USUniversity Hospital of Zurich · CHBrigham and Women's Hospital · USCamden and Campbelltown Hospitals · AUSUNY Downstate Health Sciences University · USUniversity of Zurich · CH

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Geoffrey A Preidis · 2001 to 2026
$28.3M
NIDDK NIH HHS P30 DK056338
6 · The paper itself

Abstract

aimsNon-steroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but associate with increased blood pressure (BP) and adverse cardiovascular (CV) events. PRECISION-ABPM, a substudy of PRECISION was conducted at 60 sites, to determine BP effects of the selective COX-2 inhibitor celecoxib vs. the non-selective NSAIDs naproxen and ibuprofen. METHODS AND

resultsIn this double-blind, randomized, multicentre non-inferiority CV-safety trial, 444 patients (mean age 62 ± 10 years, 54% female) with osteoarthritis (92%) or rheumatoid arthritis (8%) and evidence of or at increased risk for coronary artery disease received celecoxib (100-200 mg bid), ibuprofen (600-800 mg tid), or naproxen (375-500 mg bid) with matching placebos in a 1: 1: 1 allocation, to assess the effect on 24-h ambulatory BP after 4 months. The change in mean 24-h systolic BP (SBP) in celecoxib, ibuprofen and naproxen-treated patients was -0.3 mmHg [95% confidence interval (CI), -2.25, 1.74], 3.7 (95% CI, 1.72, 5.58) and 1.6 mmHg (95% CI, -0.40, 3.57), respectively. These changes resulted in a difference of - 3.9 mmHg (P = 0.0009) between celecoxib and ibuprofen, of - 1.8 mmHg (P = 0.12) between celecoxib and naproxen, and of - 2.1 mmHg (P = 0.08) between naproxen and ibuprofen. The percentage of patients with normal baseline BP who developed hypertension (mean 24-h SBP ≥ 130 and/or diastolic BP ≥ 80 mmHg) was 23.2% for ibuprofen, 19.0% for naproxen, and 10.3% for celecoxib (odds ratio 0.39, P = 0.004 and odds ratio 0.49, P = 0.03 vs. ibuprofen and naproxen, respectively).

conclusionsIn PRECISION-ABPM, allocation to the non-selective NSAID ibuprofen, compared with the COX-2 selective inhibitor celecoxib was associated with a significant increase of SBP, and a higher incidence of new-onset hypertension. CLINICALTRIALS: gov number NCT00346216.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidBlood PressureCelecoxibCoronary Artery DiseaseCyclooxygenase 2 InhibitorsDouble-Blind MethodFemaleHumansHypertensionIbuprofenMaleNaproxenOsteoarthritisProspective StudiesAnti-Inflammatory Agents, Non-SteroidalCelecoxibCyclooxygenase 2 InhibitorsIbuprofenNaproxenCardiovascular riskHypertensionNon-steroidal anti-inflammatory drugsOsteoarthritisPainSelective cyclooxygenase-2 (COX-2) inhibitors

Identifiers

PMID29020251
PMCPMC8139400
OpenAlexW2787676533

What OpenQuestion holds

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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.