Evidence map›Paper›PMID 40223442›Full record

Trial reportArthritis care & research2025

Colchicine Concentrations and Relationship With Colchicine Efficacy and Adverse Events: Post Hoc Analysis of a Randomized Clinical Trial of Colchicine for Gout Flare Prophylaxis.

Lisa K Stamp, Anne Horne, Borislav Mihov, Jill Drake, Janine Haslett, Peter Chapman, Daniel F B Wright, Christopher Frampton, Nicola Dalbeth

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  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

9 authors.

Lisa K StampUniversity of Otago, Christchurch, Christchurch, and Health New Zealand Te Whatu Ora, New Zealand.ORCID 0000-0003-0138-2912
Anne HorneUniversity of Auckland, Auckland, New Zealand.
Borislav MihovUniversity of Auckland, Auckland, New Zealand.
Jill DrakeUniversity of Otago, Christchurch, Christchurch, New Zealand.
Janine HaslettUniversity of Otago, Christchurch, Christchurch, New Zealand.
Peter ChapmanHealth New Zealand, Te Whatu Ora, New Zealand.
Daniel F B WrightUniversity of Sydney, St Vincent's Hospital, and St Vincent's Clinical Campus, University of New South Wales Medicine, Sydney, New South Wales, Australia.
Christopher FramptonUniversity of Otago, Christchurch, Christchurch, New Zealand.
Nicola DalbethHealth New Zealand, Te Whatu Ora, and University of Auckland, Auckland, New Zealand.ORCID 0000-0003-4632-4476

Funding

Health Research Council of New Zealand 18/151
6 · The paper itself

Abstract

objectiveOur objective was to examine the relationship between colchicine plasma concentrations and clinical and demographic factors and to determine the relationship between colchicine concentrations and colchicine efficacy and colchicine-specific adverse events.

methodsPost hoc analyses were undertaken using data from a 12-month randomized controlled trial involving 200 people with gout that compared low-dose colchicine to placebo for the first six months while starting allopurinol, with a further six-month follow-up. Steady-state colchicine plasma concentrations were measured 30 to 80 minutes post dose (assumed peak) and just before the dose (trough) at month three, and creatine kinase (CK) levels were measured at months zero, three, and six. Self-reported gout flares, adverse events, and serious adverse events were collected monthly.

resultsPeak and trough colchicine concentrations were available for 79 participants in the colchicine arm. Multivariable analysis showed that those taking a statin and non-Māori and non-Pacific ethnicity were independently associated with higher trough concentrations, and age older than 60 years was independently associated with higher peak concentrations. Trough and peak colchicine concentrations were significantly higher in those who had any adverse event between months four and six. However, there was no association between colchicine concentrations and colchicine-specific adverse events (gastrointestinal and muscle) or with CK changes in the colchicine-treated patients.

conclusionTrough or peak colchicine concentrations are not associated with gout flare prophylaxis efficacy. There is no consistent relationship between colchicine concentrations and colchicine-specific adverse events. Although colchicine concentrations increase with concomitant statin use, this does not result in muscle-related adverse events. These findings indicate that colchicine therapeutic drug monitoring is of limited value in clinical practice.

Indexed as

ColchicineGoutGout SuppressantsAdultAgedAllopurinolDouble-Blind MethodFemaleHumansMaleMiddle AgedSymptom Flare UpTreatment OutcomeAllopurinolColchicineGout Suppressants

Identifiers

PMID40223442
PMCPMC12371308

What OpenQuestion holds

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Registered trials

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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.