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Therapeutic Drug Monitoring

Sofie Colman, Veronique Stove, Jan J De Waele, Alain G Verstraete
BACKGROUND: Piperacillin is considered a moderately protein-bound antibiotic (20-40%), with albumin being an important binding protein. Although infrequently used in practice, different methods to measure the fraction unbound (fu) are available, but uncertainty remains as to what the most appropriate method is. The main goal of this study was to estimate the impact of the methodology used to measure unbound piperacillin in plasma on the fu of piperacillin; we compared ultrafiltration (UF) at 4°C and 37°C with the reference method, equilibrium dialysis (ED)...
September 1, 2019: Therapeutic Drug Monitoring
(no author information available yet)
No abstract text is available yet for this article.
February 12, 2019: Therapeutic Drug Monitoring
Margrete Larsen Burns, Marina Nikanorova, Arton Baftiu, Jan Borg Rasmussen, Svein I Johannessen, Cecilie Johannessen Landmark
BACKGROUND: The indication for the antiepileptic drug (AED) lacosamide (LCM) was recently extended to include children from the age of four. Real-life data on the use and serum concentrations of LCM in children and adolescents are limited. The purpose of this study was to investigate the use of LCM in this patient group in relation to age, co-medication, dose, serum concentrations and duration of treatment, and to examine pharmacokinetic variability. METHODS: Children and adolescents (<18 years) who had serum concentrations of LCM measured from January 2012 to June 2018 were retrospectively identified from the therapeutic drug monitoring (TDM) databases at two national epilepsy centers in Norway and Denmark...
January 25, 2019: Therapeutic Drug Monitoring
Anne-Grete Märtson, Daan Touw, Kevin Damman, Martijn Bakker, Annemieke Oude Lansink-Hartgring, Tjip van der Werf, Marjolein Knoester, Jan-Willem C Alffenaar
This paper presents three cases of immunocompromised patients for whom therapeutic drug monitoring (TDM) of ganciclovir in combination with cytomegalovirus (CMV) viral load measurement was used to guide treatment. The first patient is diagnosed with Thymoma A, the second is a heart transplant recipient and the third is an HIV positive patient. These patients were all diagnosed with CMV and treated with ganciclovir. Our case studies illustrate how TDM guided dosing can be helpful in the management of these complex cases...
January 25, 2019: Therapeutic Drug Monitoring
Ivana Kacirova, Milan Grundmann, Hana Brozmanova
BACKGROUND: Lamotrigine has become the most frequently prescribed drug in the treatment of pregnant women with epilepsy. Though some relevant studies have found a wide milk/maternal serum as well as infant/maternal serum concentration ratio, different infant ages at the time of sampling and small number of patients preclude comparison. The aim of this study was to provide a consistent evaluation. METHODS: Data of 43 nursing women treated by lamotrigine were evaluated retrospectively...
January 25, 2019: Therapeutic Drug Monitoring
Annachiara D'Urso, Giuliana Cangemi, Sebastiano Barco, Pasquale Striano, Antonio DʼAvolio, Ugo de Grazia
BACKGROUND: Therapeutic drug monitoring (TDM) of antiepileptic drugs (AEDs) is commonly performed on plasma or serum. The use of Dried Plasma Spots (DPS) could represent a useful tool to facilitate sample shipment to reference laboratories. In this paper, the authors describe the application of a commercially available UHPLC-MS/MS method for the determination of nine commonly prescribed AEDs (levetiracetam, lacosamide, topiramate, ethosuximide, lamotrigine, rufinamide, zonisamide, primidone, oxcarbazepine and its active metabolite 10-OH-monohydroxycarbazepine) to DPS collected on Dried Sample Spot Devices (DSSD)...
January 25, 2019: Therapeutic Drug Monitoring
Sarah Allegra, Antonello Di Paolo, Jessica Cusato, Giovanna Fatiguso, Elena Arrigoni, Romano Danesi, Silvia Corcione, Antonio DʼAvolio
No abstract text is available yet for this article.
January 9, 2019: Therapeutic Drug Monitoring
M S Bolhuis, O W Akkerman, M G G Sturkenboom, W C M de Lange, T S van der Werf, D J Touw, J W C Alffenaar
No abstract text is available yet for this article.
January 9, 2019: Therapeutic Drug Monitoring
Karen van Hoeve, Erwin Dreesen, Ilse Hoffman, Gert Van Assche, Marc Ferrante, Ann Gils, Séverine Vermeire
BACKGROUND: Rising evidence demonstrates that there are no differences in efficacy and safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of inflammatory bowel diseases (IBD). However, most data are derived from adult patients and data on pharmacokinetics are limited. The authors evaluated long-term IFX trough levels, immunogenicity and remission rates in children with IBD who switched from IFX originator to biosimilar CT-P13. METHODS: In this single-center study, all children with Crohn's disease (CD) and ulcerative colitis (UC) receiving maintenance IFX therapy were switched from originator to biosimilar CT-P13...
January 9, 2019: Therapeutic Drug Monitoring
Tenorio-Cañamás Teresa, Grau Santiago, Luque Sonia, Fortún Jesús, Liaño Fernando, Roberts Jason A
BACKGROUND: An optimal antifungal therapy for invasive candidiasis in critically ill patients is essential to reduce the high mortality rates. Acute kidney injury is common and continuous renal replacement therapies are frequently used. Previous studies have demonstrated a lack of effect from different continuous renal replacement techniques on micafungin clearance. However, the use of high cut-off pore size membranes could potentially allow the loss of albumin and alter micafungin pharmacokinetics...
January 9, 2019: Therapeutic Drug Monitoring
Helena Edlund, Ana-Marija Grisic, Casper Steenholdt, Mark A Ainsworth, Jørn Brynskov, Wilhelm Huisinga, Charlotte Kloft
BACKGROUND: Circulating infliximab (IFX) concentrations correlate with clinical outcomes, forming the basis of the IFX concentration monitoring in patients with Crohn's disease. This study aims to investigate and refine the exposure-response relationship by linking the disease activity markers 'Crohn's disease activity index' (CDAI) and C-reactive protein (CRP) to IFX exposure. In addition, we aim to explore the correlations between different disease markers and exposure metrics. METHODS: Data from 47 Crohn's disease patients of a randomized controlled trial were analyzed post hoc...
December 26, 2018: Therapeutic Drug Monitoring
Eberhard Wieland, Maria Shipkova
For decades, oral anticoagulation has been based on vitamin K antagonist such as warfarin, which requires pharmacodynamic drug (PD) monitoring to guide the therapy. The drug effect is measured by the clotting test prothrombin time (PT) and expressed as international normalized ratio (INR). New direct oral anticoagulants (DOACs) are increasingly used in fixed dose regimens but are licensed without any therapy monitoring.However, extensive clinical experiences have demonstrated that inter-individual variations in the response to the therapy with DOACs do exist...
December 18, 2018: Therapeutic Drug Monitoring
Birgit M Wollmann, Hilde A Lunde, Lene K Støten, Niclas Lunder, Espen Molden
BACKGROUND: Drugs may potentially adsorb to blood collection tubes containing gel separators in the pre-analytical phase of therapeutic drug monitoring (TDM). The aim of this study was to compare measured concentrations of 28 psychoactive drugs and 13 metabolites in spiked serum samples stored on standard (plain) tubes vs. barrier gel tubes during a 2-6 days period at room temperature. METHODS: Drug-free ("blank") serum samples spiked with mixes of antidepressants, antipsychotics or mood stabilizers (valproic acid and lamotrigine), including relevant metabolites, were transferred to tubes with and without gel, i...
December 11, 2018: Therapeutic Drug Monitoring
Benjamin R Griffin, Sarah Faubel, Charles L Edelstein
Blood urea nitrogen (BUN) and serum creatinine are imperfect markers of kidney function because they are influenced by many renal and non-renal factors independent of kidney function. A biomarker that is released directly into the blood or urine by the kidney in response to injury may be a better early marker of drug-induced kidney toxicity than BUN and serum creatinine. Urine albumin and urine protein, as well as urinary markers kidney injury molecule-1 (KIM-1), β2-microglobulin (B2M), cystatin C, clusterin, and trefoil factor-3 (TFF-3) have been accepted by the Food and Drug Administration (FDA) and European Medicines Agency as highly sensitive and specific urinary biomarkers to monitor drug-induced kidney injury in preclinical studies and on a case-by-case basis in clinical trials...
December 10, 2018: Therapeutic Drug Monitoring
Vincent Haufroid, Nicolas Picard
Conventional TDM refers to the individualization of drug dosage by maintaining plasma or blood drug concentrations within a targeted therapeutic range. Accordingly, an individualized dose is proposed to the clinician according to the drug plasma or blood concentration using an a posteriori approach. Pharmacogenetics (PGx) has recently emerged as an additional tool to refine dose selection or, more interestingly to select, a priori, the first dose to administer. To date, the vast majority of genes explored in the context of PGx are those coding for metabolizing enzymes or membrane drug transporters, which mainly influence drug pharmacokinetics (PK) parameters...
December 10, 2018: Therapeutic Drug Monitoring
Marieke van der Zwan, Dennis A Hesselink, Marian C Clahsen-van Groningen, Carla C Baan
BACKGROUND: There is an unmet need for reliable minimally invasive diagnostic biomarkers for immunological allograft monitoring and for the detection of acute kidney transplant rejection. Here, targeted proteomic analysis was applied to compare 92 proteins in sera of belatacept-treated patients who had biopsy-proven, acute T cell-mediated rejection (aTCMR) with patients without aTCMR. METHODS: Proximity extension immunoassay (PEA) was used to measure 92 inflammation-related protein concentrations in the pre-rejection and rejection sera of 11 patients with aTCMR and 9 patients without aTCMR...
December 4, 2018: Therapeutic Drug Monitoring
Mohammed Rahman, Lewis Couchman, Valentyna Povstyan, Verity Bainbridge, Karin Kipper, Toqa El-Nahhas, Atholl Johnston, David Holt
BACKGROUND: Measurement of flecainide is useful to optimize dosage and minimize risks of toxicity. Further, there is a need for urgent sample analysis when flecainide is used in transplacental therapy for fetal tachycardia. To this end, we have developed and validated a rapid assay for the measurement of flecainide in human plasma or serum, using a small sample volume (50 µL). METHOD: Following a simple deproteination with zinc sulfate and methanol, prepared samples were injected onto a short (30 mm) analytical column and eluted using a rapid gradient elution...
December 4, 2018: Therapeutic Drug Monitoring
Laurence Roosens, Hugo M Neels, Bernard G Sabbe
No abstract text is available yet for this article.
December 4, 2018: Therapeutic Drug Monitoring
Michaela J Roslawski, Rory P Remmel, Ashwin Karanam, Ilo E Leppik, Susan E Marino, Angela K Birnbaum
BACKGROUND: A sensitive, robust method was developed and validated to quantitate thirteen major natural cannabinoid parent and metabolite compounds in human plasma at or below 0.5 ng/mL. METHODS: A liquid chromatography-tandem mass spectrometry method was developed and validated to measure thirteen cannabinoid compounds: cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabinol (CBN), cannabigerol (CBG), cannabigerolic acid (CBGA), cannabichromene (CBC), Δ-tetrahydocannabinol (THC), Δ-tetrahydrocannabinolic acid A (THCA), Δ-tetrahydrocannabivarin (THCV), 11-hydroxy-Δ-tetrahydrocannbinol (11-OH-THC), 11-nor-9-carboxy-Δ-tetrahydrocannbinol (THC-COOH), and 11-nor-9-carboxy-Δ-tetrahydrocannabinol-glucuronide (THC-COOH-glu)...
December 4, 2018: Therapeutic Drug Monitoring
Xuebin Wang, Yunyun Yang, Zhengyue Liu, Chengwu Xiao, Lihong Gao, PhD Wenjing Zhang, Wenwen Zhang, Zhuo Wang
BACKGROUND: Kidney transplant recipients on long-term cyclosporine (CsA) therapy may develop multiple adverse drug events, and immunosuppression conversion from CsA to tacrolimus (Tac) is an option. Genetic variations, especially cytochrome P450 (CYP) 3A5*3 affects Tac dosing. However, little information is available to guide the conversion with regards to patients' pharmacogenomics. We aimed to investigate whether CYP3A5, CYP3A4 and ABCB1 genotyping could contribute to a more precise and individualized initial dosing of Tac at the time of immunosuppressant conversion...
December 4, 2018: Therapeutic Drug Monitoring
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