Evidence map›Paper›PMID 19491317›Full record

Trial reportThe Annals of pharmacotherapy2009

Influence of clinical and demographic variables on mycophenolic acid pharmacokinetics in antineutrophil cytoplasmic antibody-associated vasculitis.

Melanie S Joy, Tandrea Hilliard, Yichun Hu, Susan L Hogan, Jinzhao Wang, Ronald J Falk, Philip C Smith

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in The Annals of pharmacotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.6field-weighted citation impact, top 30% 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, 16 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. The utility of trough mycophenolic acid levels for the management of lupus nephritis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2019
    Article
  6. Article
  7. Article
  8. Review
  9. 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

7 authors at 1 institution in 1 country.

Melanie S JoySchool of Medicine, University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC 27599, USA.
Tandrea Hilliard
Yichun Hu
Susan L Hogan
Jinzhao Wang
Ronald J Falk
Philip C Smith
University of North Carolina at Chapel Hill · US

Funding

Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
Translation of Knowledge on the Pathogenesis of ANCA Disease into NovelP01DK058335 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JENNETTE, CHARLES · 2000 to 2019
$25.9M
Pharmacokinetics &Genomics in Glomerular DiseasesK23DK064888 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 2004 to 2008
$609k
NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046NCRR NIH HHS U54RR024383NIDDK NIH HHS 5K23DK64888NIDDK NIH HHS K23 DK064888NIDDK NIH HHS P01 DK058335
6 · The paper itself

Abstract

backgroundMycophenolic acid (MPA) is used off-label to treat many forms of glomerulonephritis.

objectiveTo evaluate the pharmacokinetics of MPA and its glucuronide (MPAG) in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis patients with renal manifestations and to determine the effects of clinical (urinary protein excretion, serum albumin, creatinine clearance) and demographic (age, race, sex) variables on MPA and MPAG pharmacokinetics.

methodsTwenty-three patients taking MPA at steady-state were evaluated. Plasma and urine samples were collected over 24 hours. Analyses included noncompartmental pharmacokinetics and statistics including Mann-Whitney U test and univariate/multiple regression.

resultsMPA clearance (Cl/F 288 +/- 154 mL/min) was approximately 2-fold higher than previously reported from transplant patients and predicted by weight and race (ranked MPA Cl/F = -11.766 + 0.2035 [wt] + 4.9578 [race]; R(2) 41.8%; p = 0.005). Creatinine clearance (CrCl) less than 60 mL/min resulted in higher MPA exposure, total area under the curve (AUC)(0-12), and AUC(6-12), as well as unbound AUC(0-12). The metabolic ratio (MPAG(AUC)/MPA(AUC)) of 8.67 +/- 5.57 was lower than that previously reported in renal transplant recipients.

conclusionsDiminished kidney function (eg, CrCl <60 mL/min) demonstrated enhanced MPA and MPAG exposure in patients with ANCA vasculitis. However, unlike renal transplant recipients, patients with ANCA vasculitis had enhanced Cl/F and diminished metabolic ratio, suggesting the need to comprehensively evaluate the role of disease-specific factors on MPA pharmacokinetics.

Indexed as

AdultAgedAntibodies, Antineutrophil CytoplasmicArea Under CurveEnzyme InhibitorsFemaleGlucuronidesHumansKidney TransplantationMaleMiddle AgedMycophenolic AcidRegression AnalysisRenal InsufficiencyStatistics, NonparametricVasculitisAntibodies, Antineutrophil CytoplasmicEnzyme InhibitorsGlucuronidesMycophenolic Acidmycophenolic acid glucuronide

Identifiers

PMID19491317
PMCPMC2778272
OpenAlexW2096363861

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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.