Evidence map›Paper›PMID 35171315›Full record

ArticleEuropean journal of clinical pharmacology2022

Assessing the binding interaction of polystyrene sulfonate with amitriptyline in healthy volunteers: a cross-over design - The BIND study.

I Prins-Can, I R F van Berlo-van de Laar, M Zeeman, C G Vermeij, E van 't Riet, K Taxis, F G A Jansman

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Article in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

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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

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No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

7 authors.

I Prins-Can *Department of Clinical Pharmacy, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands. ilonacan0@gmail.com.ORCID http://orcid.org/0000-0002-4252-4959
I R F van Berlo-van de Laar *Department of Clinical Pharmacy, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.
M ZeemanDepartment of Geriatrics, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.
C G VermeijDepartment of Nephrology, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.
E van 't RietDepartment of Research and Development, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.
K TaxisUnit of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.
F G A JansmanDepartment of Clinical Pharmacy, Deventer Teaching Hospital, Nico, Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePolystyrene sulfonate is used for binding potassium in patients with chronic kidney disease (CKD). Because of its binding properties, it can potentially bind other medications and thereby decrease their bioavailability and effectiveness. Amitriptyline, often used by CKD patients for neuropathic pain, shows significant binding to polystyrene sulfonate in vitro. The purpose of this study was to determine the effect of polystyrene sulfonate on the exposure of amitriptyline in vivo when taken concomitantly in healthy volunteers.

methodsWe performed a prospective cross-over study in nine healthy volunteers. Participants were 18 years of age or older, did not use any medication, and had no known allergy to amitriptyline or polystyrene sulfonate. Participants visited Deventer Teaching Hospital twice. Once they received a single dose of amitriptyline 50 mg and once they received a single dose of both polystyrene sulfonate 15 g and amitriptyline 50 mg taken concomitantly, with a wash out period of at least 1 week. After intake of the medication, six blood samples were collected, at 2, 3, 4, 5, 6, and 8 h. Blood samples were analysed to determine maximum concentration (Cmax) and area under the curve 0-8 h after intake (AUC

resultsOf the nine participants included, eight participants completed both visits to the hospital. Mean maximum concentration (Cmax) of amitriptyline was 35.61 µg l

conclusionThese results show a significant decrease in exposure of amitriptyline of approximately 75% when taken concomitantly with polystyrene sulfonate, thereby probably compromising therapy efficacy. Patients using both amitriptyline and polystyrene sulfonate should be informed to separate intake of these medications.

trial registrationNL8539 (17 April 2020).

Indexed as

AmitriptylineRenal Insufficiency, ChronicAdolescentAdultArea Under CurveCross-Over StudiesHealthy VolunteersHumansPolystyrenesProspective StudiesAmitriptylinePolystyrenespolystyrene sulfonic acidChronic kidney diseaseDrug interactionsDrug safetyPharmacokinetic-pharmacodynamicPharmacotherapy

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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.