Evidence map›Paper›PMID 38719803›Full record

ArticleNature communications2024

Population pharmacokinetic modelling of primaquine exposures in lactating women and breastfed infants.

Thanaporn Wattanakul, Mary Ellen Gilder, Rose McGready, Warunee Hanpithakpong, Nicholas P J Day, Nicholas J White, François Nosten, Joel Tarning, Richard M Hoglund

Registry-linked trialAbstract read
In one paragraph

Article in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01780753 (A Study of the Pharmacokinetics of Primaquine in Lactating Women and Breastfed Infants for the Radical Treatment of Uncomplicated Maternal P. Vivax), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT01780753 phase1completednot on this map

A Study of the Pharmacokinetics of Primaquine in Lactating Women and Breastfed Infants for the Radical Treatment of Uncomplicated Maternal P. Vivax

TypeinterventionalSponsorUniversity of OxfordRan2012 to 2014Enrolled20ConditionsVivax MalariaArmsPrimaquine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

9 authors.

Thanaporn WattanakulMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID http://orcid.org/0000-0002-7570-4665
Mary Ellen GilderShoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Mae Sot, Thailand.
Rose McGreadyShoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Mae Sot, Thailand.ORCID http://orcid.org/0000-0003-1621-3257
Warunee HanpithakpongMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Nicholas P J DayMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Nicholas J WhiteMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID http://orcid.org/0000-0002-1897-1978
François NostenShoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Mae Sot, Thailand.ORCID http://orcid.org/0000-0002-7951-0745
Joel TarningMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID http://orcid.org/0000-0003-4566-4030
Richard M HoglundMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. richard.hoglund@ndm.ox.ac.uk.ORCID http://orcid.org/0000-0002-5322-912X

Funding

Wellcome TrustWellcome Trust 220211
6 · The paper itself

Abstract

Current guidelines advise against primaquine treatment for breastfeeding mothers to avoid the potential for haemolysis in infants with G6PD deficiency. To predict the haemolytic risk, the amount of drug received from the breast milk and the resulting infant drug exposure need to be characterised. Here, we develop a pharmacokinetic model to describe the drug concentrations in breastfeeding women using venous, capillary, and breast milk data. A mother-to-infant model is developed to mimic the infant feeding pattern and used to predict their drug exposures. Primaquine and carboxyprimaquine exposures in infants are <1% of the exposure in mothers. Therefore, even in infants with the most severe G6PD deficiency variants, it is highly unlikely that standard doses of primaquine (0.25-1 mg base/kg once daily given to the mother for 1-14 days) would cause significant haemolysis. After the neonatal period, primaquine should not be restricted for breastfeeding women (Clinical Trials Registration: NCT01780753).

Indexed as

AntimalarialsBreast FeedingLactationMilk, HumanPrimaquineAdultFemaleHemolysisHumansInfantInfant, NewbornModels, BiologicalAntimalarialsPrimaquine

Identifiers

PMID38719803
PMCPMC11078975

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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.