Evidence map›Paper›PMID 40523664›Full record

ArticleBritish journal of clinical pharmacology2025

Impact of diclofenac risk minimization measures addressing cardiovascular risk on analgesic use in musculoskeletal disorders.

Tomas Lasys, Yared Santa-Ana-Tellez, Satu J Siiskonen, Daniala L Weir, Rolf H H Groenwold, Helga Gardarsdottir

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

6 authors.

Tomas LasysDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0002-8892-9820
Yared Santa-Ana-TellezDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0003-3086-446X
Satu J SiiskonenDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0003-3095-9530
Daniala L WeirDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0001-7044-2443
Rolf H H GroenwoldDepartment of Clinical Epidemiology, Leiden University Medical Centre, Leiden, The Netherlands.ORCID https://orcid.org/0000-0001-9238-6999
Helga GardarsdottirDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0001-5623-9684

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIn 2013, risk minimization measures (RMMs) were introduced in Europe to address the increased cardiovascular risk linked to diclofenac. This study aimed to assess the impact of those RMMs on analgesic use.

methodsPrimary care data from CPRD GOLD (UK) were used. Patients newly diagnosed with musculoskeletal disorders during 2010-2019 were categorized into 4 cohorts, according to their diagnosis: acute (inflammatory) musculoskeletal conditions, chronic arthritic conditions, secondary arthritic conditions, or other painful conditions. The impact of the RMMs was studied using interrupted time series and survival analyses. Analyses were stratified by cardiovascular risk: (i) no risk factors or contraindications mentioned by RMMs; (ii) at least 1 risk factor; and (iii) at least 1 contraindication (prior cardiovascular events).

resultsIn total, 1 798 885 patients were included, with >28% having at least 1 cardiovascular risk factor and >7% having at least 1 contraindication for diclofenac. Initiation of diclofenac was already decreasing before the RMMs, but the RMMs were associated with a further immediate decrease in 2 cohorts (from -0.9 to -1.6%). No substantial difference in impact was observed depending on cardiovascular risk. The time from diagnosis to analgesic treatment increased after RMMs implementation, especially in patients with chronic arthritic conditions: median time increased from 4.2 to 7.6 months [95% confidence interval 4.0-4.5 and 7.4-7.8, respectively].

conclusionThe observed decrease of diclofenac initiation was unrelated to patients' cardiovascular risk. Continued prescribing of systemic diclofenac to patients with contraindications suggests limited impact of RMMs. Increased time from diagnosis to analgesic treatment suggests broader changes in analgesic prescribing practices.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalCardiovascular DiseasesDiclofenacMusculoskeletal DiseasesAdultAgedContraindications, DrugFemaleHeart Disease Risk FactorsHumansMaleMiddle AgedPrimary Health CareAnti-Inflammatory Agents, Non-SteroidalDiclofenacdiclofenacimpact studypharmacovigilancerisk minimization measures

Identifiers

PMID40523664
PMCPMC12464631

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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.