Evidence map›Paper›PMID 36568714›Full record

ArticleJournal of mass spectrometry and advances in the clinical lab2023

Validation of a quantitative multiplex LC-MS/MS assay of carvedilol, enalaprilat, and perindoprilat in dried blood spots from heart failure patients and its cross validation with a plasma assay.

Andre Joubert, Anton Joubert, Marthinus van der Merwe, Jennifer Norman, Sandra Castel, Paolo Denti, Karen Sliwa, Gary Maartens, Phumla Sinxadi, Lubbe Wiesner

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of mass spectrometry and advances in the clinical lab, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 52% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

10 authors at 2 institutions in 1 country.

Andre JoubertDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Anton JoubertDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Marthinus van der MerweDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Jennifer NormanDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Sandra CastelDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Karen SliwaCape Heart Institute, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Gary MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Phumla SinxadiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
University of Cape Town · ZAGroote Schuur Hospital · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Adherence to medication is an important determinant of outcomes in chronic diseases like heart failure. Drug assays provide objective adherence biomarkers. Dried blood spots (DBS) are appealing samples for drug assays due to less demanding transportation and storage requirements. Objectives: To analytically validate a LC-MS/MS method for the simultaneous quantification of carvedilol, enalaprilat, and perindoprilat in DBS and evaluate the feasibility of using the method as an adherence determining assay. To validate the assay further clinically by establishing correlation and agreement between plasma and DBS samples from a pharmacokinetic pilot study. Methods: The method was validated over a concentration range of 1.00-200 ng/mL according to FDA guidelines. Adherence tracking ability of the assay was evaluated using a pharmacokinetic pilot study. Correlation and agreement were evaluated through Deming regression and Bland-Altman analysis, respectively. Results: Accuracy, precision, selectivity, and sensitivity were proven with complete and reproducible extraction recovery at all concentrations tested. Stability of the analytes in the matrix and throughout sample processing was proven. The full range of concentrations of the pharmacokinetic pilot study could be quantified for enalaprilat, but not for carvedilol and perindoprilat. The difference between the observed and calculated plasma concentrations was less than 20 % of their mean for >67 % of samples for all analytes. Conclusions: The assay is suitable as a screening tool for carvedilol and perindoprilat, while suitable as an adherence determining assay for enalaprilat. Equivalence between observed and predicted plasma concentrations proves DBS and plasma concentrations can be used interchangeably.

Indexed as

ACE-I, Angiotensin-converting enzyme inhibitorsAdherenceALQ, Above the Limit of QuantitationBD, BidailyBMI, Body mass indexCarvedilolCHF, Chronic Heart FailureCID, Collision-induced dissociationCV, Co-efficient of variationDBS, Dried Blood SpotsDried blood spotsEMA, European Medicines AgencyEnalaprilatESI, Electrospray ionizationHF, Heart FailureISTD, Internal standardITP, Initial testing procedureLC-MS/MSLC-MS/MS, Liquid Chromatography with tandem mass spectrometryLLOQ, lower limit of quantitationLOD, Limit of detectionMRM, Multiple reaction monitoringNYHA FC, New York Heart Association Functional ClassificationOD, Once DailyPerindoprilatQC DIL, Quality control dilutionQCH, Quality control highQC LLOQ, Quality control lowest level of quantificationQCL, Quality control lowQCM, Quality control mediumQC, Quality ControlS/N, signal-to-noise ratioSOP, Standard operating procedureULOQ, upper limit of quantificationVAMS, volumetric absorptive micro sampling

Identifiers

PMID36568714
PMCPMC9772843
OpenAlexW4312209897

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.