Evidence map›Paper›PMID 18420532›Full record

ArticleJournal of clinical pharmacology2008

Limitations of using a single postdose midazolam concentration to predict CYP3A-mediated drug interactions.

Scott R Penzak, Kristin H Busse, Sarah M Robertson, Elizabeth Formentini, Raul M Alfaro, Richard T Davey

Open access · greenAbstract readControlled Clinical Trial
In one paragraph

Article in Journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 6% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  5. Review
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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

6 authors at 2 institutions in 1 country.

Scott R PenzakClinical Pharmacokinetics Research Laboratory, National Institutes of Health, Clinical Center Pharmacy Department, Bldg 10, Room 1N 257, Bethesda, MD 20892, USA. spenzak@mail.cc.nih.gov
Kristin H Busse
Sarah M Robertson
Elizabeth Formentini
Raul M Alfaro
Richard T Davey
Cardinal Glennon Children’s Medical Center · USNational Institutes of Health · US

Funding

Immunologic/Virologic Approaches To HIV-1 TherapeuticsZ01AI000865 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI DAVEY, RICHARD · 2000 to 2008
$4.6M
The Influence of Herbal Supplements on Lopinavir/Ritonavir PharmacokineticsZ01CL005098 · CLC · CLINICAL CENTER · PI PENZAK, SCOTT R · 2005 to 2008
$61k
The Influence of Herbal Supplements on Lopinavir/Ritonavir PharmacokineticsZIACL005098 · CLC · CLINICAL CENTER · PI PENZAK, SCOTT · 2009 to 2012
$0k
Intramural NIH HHS Z01 CL005098
6 · The paper itself

Abstract

Midazolam is a common probe used to predict CYP3A activity, but multiple blood samples are necessary to determine midazolam's area under the concentration-time curve (AUC). As such, single sampling strategies have been examined. The purpose of this study was to assess the ability of single midazolam concentrations to predict midazolam AUC in the presence and absence of CYP3A modulation by Ginkgo biloba extract (GBE). Subjects received oral midazolam 8 mg before and after 28 days of GBE administration. Postdose blood samples were collected during both study periods and midazolam AUC determined. Linear regression was used to generate measures of predictive performance for each midazolam concentration. The geometric mean ratio (90% confidence intervals) of midazolam AUC(0-infinity) post-GBE/AUC(0-infinity) pre-GBE was 0.66 (0.49-0.84) (P = .03). Before and after GBE administration, optimal midazolam sampling times were identified at 3.5 to 5 hours and 2 to 3 hours, respectively. Single midazolam concentrations between 2 and 5 hours correctly predicted the reduction in midazolam AUC following GBE exposure, but confidence intervals were generally wide. Intersubject variability in CYP3A activity (either inherent or from drug administration) alters the prediction of optimal midazolam sampling times; therefore, midazolam AUC is preferred for assessing CYP3A activity in drug-drug interaction studies.

Indexed as

Herb-Drug InteractionsAdministration, OralAdultArea Under CurveCytochrome P-450 CYP3AFemaleForecastingGinkgo bilobaHumansLinear ModelsLongitudinal StudiesMaleMidazolamMiddle AgedPlant ExtractsTime FactorsCytochrome P-450 CYP3AMidazolamPlant Extracts

Identifiers

PMID18420532
PMCPMC2658757
OpenAlexW2136756293

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.