Evidence map›Paper›PMID 9333048›Full record

Trial reportAntimicrobial agents and chemotherapy1997

Pharmacokinetic profile of ABELCET (amphotericin B lipid complex injection): combined experience from phase I and phase II studies.

A Adedoyin, J F Bernardo, C E Swenson, L E Bolsack, G Horwith, S DeWit, E Kelly, J Klasterksy, J P Sculier, D DeValeriola and 5 more

Open access · bronzeAbstract readClinical TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 1997. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

  1. Antifungal pharmacodynamics: Latin America's perspective.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Pulmonary gene delivery-Realities and possibilities.Experimental biology and medicine (Maywood, N.J.) · 2021
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
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

15 authors at 1 institution in 1 country.

A AdedoyinCenter for Clinical Pharmacology, University of Pittsburgh Medical Center, Pennsylvania 15213-2582, USA.
J F Bernardo
C E Swenson
L E Bolsack
G Horwith
S DeWit
E Kelly
J Klasterksy
J P Sculier
D DeValeriola
E Anaissie
G Lopez-Berestein
A Llanos-Cuentas
A Boyle
R A Branch
University of Pittsburgh Medical Center · US

Funding

MECHANISMS OF AMPHOTERICIN B NEPHROTOXICITYR01GM047124 · NIGMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BRANCH, ROBERT A · 1991 to 1999
–
NIGMS NIH HHS GM47124
6 · The paper itself

Abstract

Amphotericin B (AmB) has been the most effective systemic antifungal agent, but its use is limited by the dose-limiting toxicity of the conventional micellar dispersion formulation (Fungizone). New formulations with better and improved safety profiles are being developed and include ABELCET (formerly ABLC), but their dispositions have not been well characterized; hence, the reason for their improved profiles remains unclear. This report details the pharmacokinetics of ABELCET examined in various pharmacokinetic and efficacy studies by using whole-blood measurements of AmB concentration performed by high-pressure liquid chromatography. The data indicated that the disposition of AmB after administration of ABELCET is different from that after administration of Fungizone, with a faster clearance and a larger volume of distribution. It exhibits complex and nonlinear pharmacokinetics with wide interindividual variability, extensive distribution, and low clearance. The pharmacokinetics were unusual. Clearance and volume of distribution were increased with dose, peak and trough concentrations after multiple dosings increased less than proportionately with dose, steady state appeared to have been attained in 2 to 3 days, despite an estimated half-life of up to 5 days, and there was no evidence of significant accumulation in the blood. The data are internally consistent, even though they were gathered under different conditions and circumstances. The pharmacokinetics of ABELCET suggest that lower concentrations in blood due to higher clearance and greater distribution may be responsible for its improved toxicity profile compared to those of conventional formulations.

Indexed as

Amphotericin BAntifungal AgentsAntineoplastic AgentsArea Under CurveChromatography, High Pressure LiquidDrug CombinationsDrug InteractionsHalf-LifeHIV InfectionsHumansKidney DiseasesLeishmaniasis, MucocutaneousMycosesNeutropeniaPhosphatidylcholinesPhosphatidylglycerolsAmphotericin BAntifungal AgentsAntineoplastic AgentsDrug Combinationsliposomal amphotericin BPhosphatidylcholinesPhosphatidylglycerols

Identifiers

PMID9333048
PMCPMC164093
OpenAlexW2140212092

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.