Evidence map›Paper›PMID 40719983›Full record

ArticleClinical pharmacokinetics2025

The Influence of Patient Factors on the Population Pharmacokinetics of Colchicine: Implications for Safe and Effective Dosing.

Daniel F B Wright, Hailemichael Z Hishe, Nicola Dalbeth, Anne Horne, Jill Drake, Janine Haslett, Lisa K Stamp

Abstract read
In one paragraph

Article in Clinical pharmacokinetics, 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. Caspase-1 in cancer and inflammatory diseases: a potential therapeutic target.Apoptosis : an international journal on programmed cell death · 2026
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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

7 authors.

Daniel F B WrightFaculty of Medicine and Health, Sydney Pharmacy School, University of Sydney, Sydney, 2006, Australia. dan.wright@sydney.edu.au.ORCID 0000-0001-9313-9252
Hailemichael Z HishePumas-AI Inc., Dover, DE, USA.ORCID 0000-0002-8557-2766
Nicola DalbethDepartment of Medicine, University of Auckland, Auckland, New Zealand.ORCID 0000-0003-4632-4476
Anne HorneDepartment of Medicine, University of Auckland, Auckland, New Zealand.
Jill DrakeDepartment of Rheumatology, Immunology and Allergy, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand.
Janine HaslettDepartment of Medicine, University of Otago-Christchurch, Christchurch, New Zealand.
Lisa K StampDepartment of Rheumatology, Immunology and Allergy, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand.ORCID 0000-0003-0138-2912

Funding

Australian and New Zealand Society for Geriatric Medicine R295Health Research Council of New Zealand 18/151
6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe factors that predict colchicine plasma concentrations and the impact on safety and efficacy are under-researched. We aimed to determine the probability of achieving steady-state plasma concentrations within the nominal therapeutic range of 0.5-3 ng/mL.

methodsColchicine plasma concentrations from 78 people with gout were analysed using non-linear mixed effects. Body size, kidney function, concomitant drugs, ethnicity, sex, age and adherence were tested as covariates in the model. Simulations were conducted to determine the probability of achieving steady-state minimum, maximum and average concentrations within the therapeutic range of 0.5-3 ng/mL under different doses and for different patient characteristics. We considered colchicine doses that produced > 80% of steady-state average concentrations < 3 ng/mL and > 0.5 ng/mL to have a reasonable probability of safety and efficacy.

resultsA two-compartment pharmacokinetic model with zero-order absorption was the best fit. Body weight, sex and statin use were significant predictors of colchicine pharmacokinetics, reducing the between-subject variance on clearance by about 40%. The model predicted that colchicine dosages of ≤ 1.5 mg daily carry a low risk of toxicity based on the criteria defined here. Efficacious concentrations were achieved for all dosages tested except 0.5 mg daily, where concentrations below the proposed therapeutic range may occur in those with a body weight > 80 kg. Higher colchicine dosages of > 1.5 mg daily may exceed the proposed upper limit of safety in many individuals, particularly those with low body weight who are taking statins.

conclusionA model for the pharmacokinetics of colchicine was developed and evaluated. Low-dose regimes (≤ 1.5 mg daily) are not predicted to achieve concentrations above the proposed safety threshold of 3 ng/mL in most people, although concentrations below the lower limit of the therapeutic range may occur in those taking 0.5-mg doses who are > 80 kg in body weight. Higher colchicine dosages of > 1.5 mg daily may exceed the proposed upper limit of safety in individuals with low body weight who are taking statins.

Indexed as

ColchicineGoutGout SuppressantsModels, BiologicalAdultAgedAged, 80 and overBody WeightDose-Response Relationship, DrugFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedColchicineGout SuppressantsHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID40719983
PMCPMC12479679

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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.