Evidence map›Paper›PMID 25801554›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Exposure to total and protein-unbound rifampin is not affected by malnutrition in Indonesian tuberculosis patients.

L H M te Brake, R Ruslami, H Later-Nijland, F Mooren, M Teulen, L Apriani, J B Koenderink, F G Russel, D M Burger, B Alisjahbana and 3 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report 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 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 5% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Protein Binding of First-Line Antituberculosis Drugs.Antimicrobial agents and chemotherapy · 2018
    Article
  10. 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

13 authors at 5 institutions in 3 countries.

L H M te BrakeDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands Department of Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands Lindsey.teBrake@radboudumc.nl.
R RuslamiDepartment of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia.
H Later-NijlandDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
F MoorenDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
M TeulenDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
L AprianiHealth Research Unit, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia.
J B KoenderinkDepartment of Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands.
F G RusselDepartment of Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands.
D M BurgerDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
B AlisjahbanaHealth Research Unit, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia.
F WieringaInstitut de Recherche pour le Developpement, UMR Nutripass IRD-UM2-UM1, Montpellier, France.
R van CrevelDepartment of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
R E AarnoutseDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Radboud University Medical Center · NLRadboud University Nijmegen · NLPadjadjaran University · IDDr. Hasan Sadikin General Hospital · IDInstitut de Recherche pour le Développement · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nutritional status may have a profound impact on the pharmacokinetics of drugs, yet only few data are available for tuberculosis (TB) drugs. As malnutrition occurs frequently among TB patients, we assessed the effect of malnutrition on the steady-state pharmacokinetics of total and protein-unbound rifampin during the intensive phase of TB treatment. In a descriptive pharmacokinetic study in Bandung, Indonesia, patients received a fixed standard rifampin dose of 450 mg once daily during the intensive phase of TB treatment. A full pharmacokinetic curve for rifampin was recorded, and total and unbound concentrations of rifampin were analyzed in all samples. Rifampin pharmacokinetic parameters were compared between severely malnourished (BMI of <16.0 kg/m(2)), malnourished (BMI of <18.5 kg/m(2)), and well-nourished (BMI of ≥18.5 kg/m(2)) individuals. No difference in total and protein-unbound pharmacokinetic parameters between severely malnourished (n = 7), malnourished (n = 11), and well-nourished (n = 25) patients could be demonstrated. In addition, no significant correlation between BMI and exposure (area under the concentration-time curve from 0 to 24 h [AUC0-24] and maximum concentration of drug in serum [Cmax]) was found. Females had significantly higher total AUC0-24 (geometric mean, 59.2 versus 48.2 h · mg/liter; P = 0.02) and higher unbound AUC0-24 (geometric mean, 6.2 versus 4.8 h · mg/liter; P = 0.02) than males. Overall, a marked 2-fold interindividual variation in the free fraction was observed (7.6 to 15.0%; n = 36). Nutritional status and BMI do not appear to have a major effect on total and protein-unbound pharmacokinetic parameters of rifampin in Indonesian subjects. The large interindividual variability in the free fraction of rifampin suggests that protein-unbound rather than total rifampin concentrations should preferably be used to study exposure-response relationships.

Indexed as

AdolescentAdultAntitubercular AgentsBody Mass IndexDrug Administration ScheduleFemaleHumansIndonesiaMaleMalnutritionMiddle AgedRifampinTuberculosisYoung AdultAntitubercular AgentsRifampin

Identifiers

PMID25801554
PMCPMC4432135
OpenAlexW1982802963

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.