Evidence map›Paper›PMID 25963981›Full record

ArticleAntimicrobial agents and chemotherapy2015

Population pharmacokinetics, tolerability, and safety of dihydroartemisinin-piperaquine and sulfadoxine-pyrimethamine-piperaquine in pregnant and nonpregnant Papua New Guinean women.

John M Benjamin, Brioni R Moore, Sam Salman, Madhu Page-Sharp, Somoyang Tawat, Gumal Yadi, Lina Lorry, Peter M Siba, Kevin T Batty, Leanne J Robinson and 2 more

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
5.6field-weighted citation impact, top 4% 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.

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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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  5. Piperaquine-Induced QTc Prolongation Decreases With Repeated Monthly Dihydroartemisinin-Piperaquine Dosing in Pregnant Ugandan Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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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

12 authors at 5 institutions in 3 countries.

John M BenjaminPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Brioni R MoorePapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea School of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
Sam SalmanSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
Madhu Page-SharpSchool of Pharmacy, Curtin University of Technology, Bentley, Western Australia, Australia Curtin Health Innovation Research Institute, Curtin University, Bentley, Western Australia, Australia.
Somoyang TawatPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Gumal YadiPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Lina LorryPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Peter M SibaSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia Department of Microbiology, Division of Veterinary and Biomedical Sciences, James Cook University, Townsville, Australia.
Kevin T BattySchool of Pharmacy, Curtin University of Technology, Bentley, Western Australia, Australia Curtin Health Innovation Research Institute, Curtin University, Bentley, Western Australia, Australia.
Leanne J RobinsonPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea Infection and Immunity, Walter and Eliza Hall Institute, Melbourne, Victoria, Australia Department of Medical Biology, University of Melbourne, Victoria, Australia.
Ivo MuellerDepartment of Microbiology, Division of Veterinary and Biomedical Sciences, James Cook University, Townsville, Australia Department of Medical Biology, University of Melbourne, Victoria, Australia Center de Recerca en Salut Internacional de Barcelona, Barcelona, Spain.
Timothy M E DavisSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia tim.davis@uwa.edu.au.
Papua New Guinea Institute of Medical Research · PGUniversity of Western Australia · AUCurtin University · AUCentre de Recerca en Economia Internacional · ESJames Cook University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The tolerability, safety, and disposition of dihydroartemisinin (DHA) and piperaquine (PQ) were assessed in 32 pregnant (second/third trimester) and 33 nonpregnant Papua New Guinean women randomized to adult treatment courses of DHA-PQ (three daily doses) or sulfadoxine-pyrimethamine (SP)-PQ (three daily PQ doses, single dose of SP). All dose adminstrations were observed, and subjects fasted for 2 h postdose. Plasma PQ was assayed by using high-performance liquid chromatography, and DHA was assessed by using liquid chromatography-mass spectrometry. Compartmental pharmacokinetic models were developed using a population-based approach. Both regimens were well tolerated. There was an expected increase in the rate-corrected electrocardiographic QT interval which was independent of pregnancy and treatment. Two pregnant and two nonpregnant women had Plasmodium falciparum parasitemia which cleared within 48 h, and no other subject became slide positive for malaria during 42 days of follow-up. Of 30 pregnant women followed to delivery, 27 (90%) delivered healthy babies and 3 (10%) had stillbirths; these obstetric outcomes are consistent with those in the general population. The area under the plasma PQ concentration-time curve (AUC0-∞) was lower in the pregnant patients (median [interquartile range], 23,721 μg · h/liter [21,481 to 27,951 μg · h/liter] versus 35,644 μg · h/liter [29,546 to 39,541 μg · h/liter]; P < 0.001) in association with a greater clearance relative to bioavailability (73.5 liters/h [69.4 to 78.4] versus 53.8 liters/h [49.7 to 58.2]; P < 0.001), but pregnancy did not influence the pharmacokinetics of DHA. The apparent pharmacokinetic differences between the present study and results from other studies of women with uncomplicated malaria that showed no effect of pregnancy on the AUC0-∞ of PQ and greater bioavailability may reflect differences in postdose fat intake, proportions of women with malaria, and/or racial differences in drug disposition.

Indexed as

AdolescentAdultAntimalarialsArea Under CurveArtemisininsBiological AvailabilityDietary FatsDrug CombinationsFemaleFollow-Up StudiesFood-Drug InteractionsHumansInfant, NewbornMalaria, FalciparumModels, StatisticalPapua New GuineaAntimalarialsArtemisininsartenimolDietary FatsDrug Combinationsfanasil, pyrimethamine drug combinationpiperaquinePiperazinesPyrimethamineQuinolinesSulfadoxine

Identifiers

PMID25963981
PMCPMC4468729
OpenAlexW1512181688

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.