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Therapeutic Drug Monitoring

Masahiro Ohgami, Takayuki Kaburagi, Atsuhiko Kurosawa, Kosuke Doki, Toshihiro Shiozawa, Nobuyuki Hizawa, Masato Homma
BACKGROUND: Erlotinib is used for treating non-small cell lung cancer (NSCLC). Intestinal absorption of erlotinib is impaired under gastric pH elevation, therefore, co-administration of gastric acid suppressants may provide lower blood concentration of erlotinib. We investigated the effects of erlotinib co-administration with proton pump inhibitors (PPI) and histamine H2 receptor blockers (H2RB) on the plasma concentration of erlotinib and erlotinib-induced adverse reaction in NSCLC patients...
July 9, 2018: Therapeutic Drug Monitoring
Sarah Allegra, Antonello Di Paolo, Jessica Cusato, Giovanna Fatiguso, Elena Arrigoni, Romano Danesi, Silvia Corcione, Antonio D'Avolio
BACKGROUND: Several factors contribute to the high variability of linezolid plasma exposure in patients. Very recently, it has been suggested that linezolid could be an ABCB1 substrate. Therefore, the present clinical study was aimed at investigating whether ABCB1 polymorphisms could predict linezolid pharmacokinetics in 27 critically ill patients. METHODS: Genotypes were assessed through a real-time polymerase chain reaction allelic discrimination system, and linezolid plasma concentrations, considering trough concentration (Ctrough) and area under the time concentration curve (AUC), were analyzed through a nonlinear mixed-effects modeling approach...
July 3, 2018: Therapeutic Drug Monitoring
Natalia Alzueta, Ana Ortega, Azucena Aldaz
BACKGROUND: Levetiracetam (LEV) is a second-generation antiepileptic drug extensively used in therapeutics. The aim of this study was to evaluate the influence that sex, age and weight exert on LEV pharmacokinetics in clinical practice. METHODS: We conducted a 6-year retrospective observational study. Patients were classified in subgroups according to sex, weight (normal range, overweight and obese), and age (young adult: 16-30 years old, middle-aged adult: 31-50 years old, advanced adult: 51-64 years old and elderly adult: ≥65 years old)...
June 29, 2018: Therapeutic Drug Monitoring
Mami Iwasaki, Ikuko Yano, Sachio Fukatsu, Sachiyo Hashi, Yuki Yamamoto, Mitsuhiro Sugimoto, Masahide Fukudo, Satohiro Masuda, Shunsaku Nakagawa, Atsushi Yonezawa, Toshimi Kaido, Shinji Uemoto, Kazuo Matsubara
BACKGROUND: This study investigates the pharmacokinetics and pharmacodynamics of tacrolimus using the once-daily (OD) formulation in the early stage after living donor liver transplantation (LDLT) in comparison with those using the twice-daily (TD) formulation. METHODS: Nine patients undergoing primary LDLT and treated with the OD tacrolimus formulation were included. The trough blood concentration (C0) of tacrolimus was monitored every day for three weeks after LDLT...
June 29, 2018: Therapeutic Drug Monitoring
Jeroen G H P Verhoeven, Karin Boer, Ron H N Van Schaik, Olivier C Manintveld, Manon M H Huibers, Carla C Baan, Dennis A Hesselink
Despite modern immunosuppressive therapy, allograft rejection remains a major cause of solid organ transplant (SOT) dysfunction. For clinical care, organ transplant function is routinely monitored by measuring biomarkers that, depending on the organ transplanted, include serum creatinine, N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP) and aspartate aminotransferase (ASAT). All can be measured easily in clinical chemistry laboratories. The main problem with these biomarkers is that they have a low sensitivity for the detection of allograft damage and are non-specific for the detection of allograft rejection...
June 26, 2018: Therapeutic Drug Monitoring
Philip N Patsalos, Edgar P Spencer, Dave J Berry
BACKGROUNDS: Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Since 1989, 18 new AEDs have been licensed for clinical use and there are now 27 licensed AEDs in total for the treatment of patients with epilepsy. Furthermore, several AEDs are also used for the management of other medical conditions, e.g., pain and bipolar disorder. This has led to an increasingly widespread application of therapeutic drug monitoring (TDM) of AEDs, making AEDs among the most common medications for which TDM is performed...
June 26, 2018: Therapeutic Drug Monitoring
Brady S Moffett, Jennifer Morris, Marianne Galati, Flor M Munoz, Ayse Akcan Arikan
BACKGROUND: Gentamicin pharmacokinetics may be altered in pediatric patients undergoing extracorporeal membrane oxygenation (ECMO). Description of gentamicin pharmacokinetics and relevant variables can improve dosing. METHODS: A retrospective population pharmacokinetic study was designed, and pediatric patients who received gentamicin while undergoing ECMO therapy over a period of 6 ½ years were included. Data collection included: patient demographics, serum creatinine, albumin, hematocrit, gentamicin dosing and serum concentrations, urine output, and ECMO circuit parameters...
June 26, 2018: Therapeutic Drug Monitoring
Jun Zhang, YongGang Luo, ZhenFeng Zhu, GuiWen Feng, Zhi Sun, XiaoJian Zhang
BACKGROUND: The aim of this study was to investigate and compare the pharmacokinetic (PK) characteristics of mycophenolate mofetil (MMF) capsule and MMF dispersible tablet by detecting the active metabolite of mycophenolic acid (MPA) in Chinese kidney transplant recipients. METHODS: In the prospective, randomized, open-label study, the renal transplant patients were given a multiple-dose of either MMF capsule or MMF dispersible tablet combination with tacrolimus (Tac)...
June 12, 2018: Therapeutic Drug Monitoring
Jaya Dwivedi, Kuldeep K Namdev, Deepak C Chilkoti, Surajpal Verma, Swapnil Sharma
BACKGROUND: Therapeutic drug monitoring (TDM) of anti-epileptic drugs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) is a suitable alternative to overcome these issues. METHODS: An improved, simple, rapid, and stability indicating method for quantification of pregabalin in human plasma and DPS has been developed and validated...
June 6, 2018: Therapeutic Drug Monitoring
Annop Phupradit, Somratai Vadcharavivad, Atiporn Ingsathit, Surasak Kantachuvesiri, Nutthada Areepium, Supasil Sra-Ium, Titinun Auamnoy, Chonlaphat Sukasem, Vasant Sumethkul, Chagriya Kitiyakara
BACKGROUND: Tacrolimus, a critical dose drug, is widely used in transplantation. Knowing the contribution of genetic factors, which significantly influence tacrolimus variability, is beneficial in the personalization of its starting dose. The significant impact of CYP3A5*3 polymorphisms on tacrolimus exposure has been reported. Conflicting results of the additional influence of POR*28 polymorphisms on tacrolimus pharmacokinetic inter-individual variability have been observed among different populations...
June 6, 2018: Therapeutic Drug Monitoring
T Plecko, K Berbalk, E Wieland, M Shipkova
BACKGROUND: Oral fluid (OF) is increasingly used as an alternative sample matrix in drug of abuse (DOA) screening. Screening is commonly performed by immunoassays and results confirmed using laborious GC-MS based methods. Therefore, an easy to operate ion trap mass spectrometric (IT-MS) commercial screening method (Toxtyper, Bruker Daltronik, Bremen, Germany) combined with a laboratory-developed sample preparation procedure have been evaluated for their application to OF. METHODS: Oral fluid samples were subjected to protein precipitation followed by HybridSPE-phospholipid extraction...
June 6, 2018: Therapeutic Drug Monitoring
Virginie Mistretta, Raphaël Denooz, Corinne Charlier
No abstract text is available yet for this article.
June 4, 2018: Therapeutic Drug Monitoring
Edwin A Basak, Annemarie J M Wijkhuijs, Ron H J Mathijssen, Stijn L W Koolen, Marco W J Schreurs
BACKGROUND: Treatment with monoclonal antibodies (mAbs) against programmed cell death protein 1 (PD-1) receptor is subject to high variation in treatment outcome among cancer patients. For these agents, no exposure-response (ER) relationships have been investigated in routine healthcare settings. However, ER relationships have been identified for several other mAbs used in oncology. Methods to conveniently measure serum concentrations of anti-PD-1 mAbs in routine healthcare may clarify possible ER relationships...
May 25, 2018: Therapeutic Drug Monitoring
Lu-Yang Xu, Zheng Jiao, Fei-Yan Liu, Xiao-Yan Qiu, Li Ji, Ming Zhang
BACKGROUND: The aim of this study was to characterize the pharmacokinetics of mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in Chinese renal transplant patients taking enteric-coated mycophenolate sodium (EC-MPS). Limited sampling strategies (LSS) were developed to estimate the area under the concentration curve from 0 to 12 h (AUC0-12h) of total and free MPA. Another objective was to investigate the correlation between high-performance liquid chromatography (HPLC) and enzyme multiplied immunoassay technology (EMIT) for total MPA determination...
May 25, 2018: Therapeutic Drug Monitoring
John A Duley, Ming Ni, Catherine Shannon, Ross L Norris, Leslie Sheffield, David Cowley, Marion Harris, André B P van Kuilenburg, Nuala Helsby, Rani George, Bruce G Charles
BACKGROUND: Chemotherapy for colorectal, head and neck, and breast cancer continues to rely heavily upon 5-fluorouracil (5FU) and its oral prodrug capecitabine. Associations of serious fluoropyrimidine adverse effects have focused on inherited deficiency of the catabolic enzyme, dihydropyrimidine dehydrogenase. However, abnormal dihydropyrimidine dehydrogenase activity accounts for only about one-third of observed toxicity cases. Thus, the cause of the majority of fluorouracil toxicity cases remains unexplained...
May 24, 2018: Therapeutic Drug Monitoring
Ugo de Grazia, Annachiara D'Urso, Federica Ranzato, Valentina De Riva, Giorgia Contarato, Giuseppe Billo, Francesco Perini, Elisabetta Galloni
BACKGROUND: Perampanel is a novel non-competitive selective antagonist at the postsynaptic ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) glutamate receptor, approved as an adjunctive agent for the treatment of partial-onset seizure with or without secondary generalization and for primary generalized tonic-clonic seizure in patients with epilepsy who are at least 12 years of age. Limited information is available about the clinical utility of therapeutic drug monitoring of perampanel and therapeutic ranges are so far not established...
May 9, 2018: Therapeutic Drug Monitoring
So Won Kim, Sangmin Choe, Dong Jin Kim, Dae Young Zang, Dong-Hwan Lee
BACKGROUND: Dose adjustment is often required in patients with normal or enhanced renal function. The aim of this study is to investigate the pharmacokinetic (PK) properties of doripenem and explore optimal dosing regimens in patients with normal or enhanced renal function according to various minimum inhibitory concentrations (MIC). METHODS: The authors conducted a clinical trial and analyzed PK samples in 11 healthy Korean subjects applying non-compartmental analysis (NCA) and a population approach...
May 9, 2018: Therapeutic Drug Monitoring
Gabrielle R Russell, Stephanie J Phelps, Chasity M Shelton, James W Wheless
BACKGROUND: Clobazam (CLB) is approved as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in patients ≥2 years of age. It is converted to an active metabolite N-desmethylclobazam (NCLB) by CYP3A4, which is then broken down to an inactive metabolite by CYP2C19. This study characterizes the impact of CYP3A4 and CYP2C19 drug interactions on CLB and NCLB serum concentrations (Cp) and concentration/dose (Cp/D) ratios in pediatric patients with epilepsy. METHODS: This was a retrospective chart review including patients >1 month of age, who received CLB between April 2012 and March 2017...
May 4, 2018: Therapeutic Drug Monitoring
Elias David-Neto, Ana Heloisa Triboni, Fernanda Ramos, Fabiana Agena, Paschoalina Romano
BACKGROUND: Enteric-coated mycophenolate sodium (EC-MPS) is frequently used in renal transplantation. The pharmacokinetic profile of mycophenolic acid (MPA) shows a broad range of time-to-maximum-concentration (Tmax) that limits the use of a single MPA concentration to calculate the area under the time-concentration curve (AUC). For both research and clinical MPA monitoring, measuring a complete AUC is troublesome to the center and patients. METHODS: We obtained 171 complete MPA-AUC12h (0, 20,40,60,90,120, 180, 240, 360, 480, 600, 720 min) from 59 adult (54±16 years) patients (29 male, 43 whites) who have been receiving stable doses of Tacrolimus/EC-MPS and steroids...
May 4, 2018: Therapeutic Drug Monitoring
Joshua Preiskorn, Sophie Studer, Reinhold Rauh, Richard Lukačin, Christoph Geffert, Christian Fleischhaker, Hans-Willi Clement, Eberhard Schulz, Monica Biscaldi
BackgroundTherapeutic drug monitoring (TDM) is becoming increasingly important in psychiatric therapy; especially in children. However, for several reasons, it cannot yet be implemented as a daily routine in clinical or outpatient settings. To evaluate new, non-invasive procedures; blood and saliva (oral fluid) samples were collected from patients with attention-deficit/hyperactivity disorder (ADHD) who were also being administered methylphenidate (MPH). The study's main purposes were to correlate MPH concentrations in serum and saliva between subjects; and to analyze intraindividual variation of serum concentration...
May 3, 2018: Therapeutic Drug Monitoring
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