Evidence map›Paper›PMID 27066958›Full record

Observational studyEuropean journal of clinical pharmacology2016

Posaconazole plasma exposure correlated to intestinal mucositis in allogeneic stem cell transplant patients.

Kim Vanstraelen, Juergen Prattes, Johan Maertens, Katrien Lagrou, Hélène Schoemans, Nele Peersman, Pieter Vermeersch, Koen Theunissen, Raf Mols, Patrick Augustijns and 3 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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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

13 authors at 4 institutions in 3 countries.

Kim VanstraelenClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, University Hospitals Leuven, Leuven, Belgium. Kim_vanstraelen@hotmail.com.
Juergen PrattesDepartment of Internal Medicine, Section of Infectious Diseases and Tropical Medicine, Medical University of Graz, Graz, Austria. Juergen.prattes@medunigraz.at.
Johan MaertensDepartment of Hematology, Acute Leukemia and Stem Cell Transplantation Unit, University Hospitals Leuven, Leuven, Belgium.
Katrien LagrouDepartment of Microbiology and Immunology, Clinical Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
Hélène SchoemansDepartment of Hematology, Acute Leukemia and Stem Cell Transplantation Unit, University Hospitals Leuven, Leuven, Belgium.
Nele PeersmanDepartment of Microbiology and Immunology, Clinical Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
Pieter VermeerschDepartment of Microbiology and Immunology, Clinical Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
Koen TheunissenDepartment of Hematology, Jessa Hospital Hasselt, Hasselt, Belgium.
Raf MolsDepartment of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, University Leuven, Leuven, Belgium.
Patrick AugustijnsDepartment of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, University Leuven, Leuven, Belgium.
Pieter AnnaertDepartment of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, University Leuven, Leuven, Belgium.
Martin HoeniglDepartment of Internal Medicine, Section of Infectious Diseases and Tropical Medicine, Medical University of Graz, Graz, Austria.
Isabel SprietClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, University Hospitals Leuven, Leuven, Belgium.
KU Leuven · BEJessa Hospital · BEMedical University of Graz · ATUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLow posaconazole plasma concentrations (PPCs) are frequently encountered in allogeneic hematopoietic stem cell transplant (HSCT) patients, due to variable gastrointestinal absorption. In this study, the impact of intestinal mucositis on posaconazole exposure is investigated. PATIENTS AND

methodsA prospective pharmacokinetic study was performed including allogeneic HSCT patients receiving posaconazole prophylaxis with the oral suspension or tablets. Steady state PPCs were determined using high-performance liquid chromatography-fluorescence detection at the day of transplantation (=day 0), day +7, and +14. Citrulline was measured using liquid chromatography-tandem mass spectrometry to evaluate severity of mucositis, at baseline (day -7 or -6), and at day 0, +7 and +14. Additionally, citrulline plasma concentrations and steady state trough PPCs were determined in hematological patients without HSCT or mucositis.

resultsThirty-four HSCT patients received posaconazole oral suspension together with 25 cL of Coca Cola, 6 HSCT patients received posaconazole tablets and 33 hematological patients not receiving HSCT received posaconazole oral suspension. The median (interquartile range) average PPC was 0.26 mg/L (0.17-0.43), 0.67 mg/L (0.27-1.38), and 1.08 mg/L (0.96-1.38), with suspension in HSCT patients, suspension in hematological patients and tablets in HSCT patients, respectively. A higher trough PPC was encountered with the oral suspension when citrulline plasma concentrations were above 10 μmol/L compared to values below 10 μmol/L (p < 0.001), whereas for tablets, average PPCs remained high with citrulline plasma concentrations below or above 10 μmol/L (p = 0.64).

conclusionPosaconazole tablets should be preferred to suspension in HSCT patients immediately after transplantation to prevent insufficient plasma exposure due to intestinal mucositis.

Indexed as

Hematopoietic Stem Cell TransplantationAdministration, OralAdultAntifungal AgentsCitrullineFemaleHumansIntestinal MucosaMaleMiddle AgedMucositisMycosesSuspensionsTabletsTriazolesAntifungal AgentsCitrullineposaconazoleSuspensionsTabletsTriazolesAllogeneic HSCTCitrullineMucositisPosaconazole oral suspensionPosaconazole tablet

Identifiers

PMID27066958
OpenAlexW2317339228

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.