Agibothu Kupparam Hemanth Kumar, Abhijit Kadam, Ramesh Karunaianantham, Manoharan Tamizhselvan, Chandrasekaran Padmapriyadarsini, Anant Mohan, B Jeyadeepa, Ammayappan Radhakrishnan, Urvashi B Singh, Shraddha Bapat, Aarti Mane, Pradeep Kumar, Megha Mamulwar, Perumal Kannabiran Bhavani, Hemalatha Haribabu, Nibedita Rath, Randeep Guleria, Abdul Mabood Khan, Jaykumar Menon
BACKGROUND: To evaluate the effect of metformin on the plasma levels of rifampicin, isoniazid, and pyrazinamide in patients with drug-sensitive pulmonary tuberculosis being treated with first-line antituberculosis treatment (ATT) and to assess the influence of gene polymorphisms on the metabolic pathway of metformin and plasma levels of antitubercular drugs. METHODS: Nondiabetic adults aged 18-60 years with pulmonary tuberculosis were randomized to either the standard ATT (ATT group) or ATT plus metformin (METRIF group) groups in a phase IIB clinical trial...
November 28, 2023: Therapeutic Drug Monitoring
Nisha Chandrakant Bhavsar, Julie Ann Dopheide, Timothy Eugene Botello, Mengxi Wang
BACKGROUND: The American Psychiatric Association guidelines for the treatment of patients with schizophrenia state that the utility of antipsychotic therapeutic drug monitoring (TDM) remains unclear, except for clozapine or assessing adherence. The aim of this study was to investigate the extent and impact of antipsychotic TDM in inpatient practice to improve its utilization. METHODS: Patients with antipsychotic blood levels drawn between May 1, 2021 and January 31, 2023 were invited to consent for retrospective chart data analysis to determine the influence of antipsychotic blood levels on their treatment...
November 28, 2023: Therapeutic Drug Monitoring
Rekha Pai Mangalore, Andrew Alexander Udy, Trisha Nicole Peel, Anton Yariv Peleg, Darshini Ayton
BACKGROUND: Therapeutic drug monitoring (TDM) of beta-lactam antibiotics (beta-lactams) is increasingly recommended for optimizing antibiotic exposure in intensive care patients with sepsis. However, limited data are available on the implementation of beta-lactam TDM in complex health care settings. Theory-based approaches were used to systematically explore barriers and enablers perceived by key stakeholders in the implementation of beta-lactam TDM in the intensive care unit. METHODS: In this qualitative descriptive study, the authors interviewed key stakeholders (n = 40): infectious disease physicians, intensive care unit physicians, pharmacists, clinical leaders, scientists, and nurses...
November 28, 2023: Therapeutic Drug Monitoring
Rebecca A Hermans, Alaya E M Storm, Sanne M Kloosterboer, Manon H J Hillegers, Birgit C P Koch, Bram Dierckx, Brenda C M de Winter
BACKGROUND: Risperidone is an atypical antipsychotic drug used to treat irritability and aggression in children and adolescents with autism spectrum disorder. In an earlier study, the sum trough concentration of risperidone and its metabolite (9-hydroxyrisperidone) was positively correlated with weight gain and effectiveness. The aim of this study was to determine the therapeutic window for risperidone sum trough concentrations that balances weight gain with treatment effectiveness in this population...
November 27, 2023: Therapeutic Drug Monitoring
Amani Abderahmene, Marith I Francke, Louise M Andrews, Dennis A Hesselink, Dorra Amor, Wissal Sahtout, Marwa Ajmi, Hayfa Mastouri, Ali Bouslama, Dorsaf Zellama, Asma Omezzine, Brenda C M De Winter
BACKGROUND: Tacrolimus is the most frequently used immunosuppressive drug for preventing renal rejection. However, its use is hampered by its narrow therapeutic index and large intra and interpatient variability in pharmacokinetics. The objective of this study was to externally validate a tacrolimus population pharmacokinetic model developed for the Dutch population and adjust the model for the Tunisian population for use in predicting the starting dose requirement after kidney transplantation...
November 27, 2023: Therapeutic Drug Monitoring
Nunzia La Maida, Alessandro Di Giorgi, Simona Pichini, Manuela Pellegrini, Annagiulia Di Trana, Maria Giuseppa Elmo, Gian Marco Polselli, Pietro Casella, Adele Di Stefano, Giuseppe Ducci
BACKGROUND: The comprehensive monitoring of licit and illicit drug consumption plays a crucial role in understanding the complexities of patient conditions and designing effective treatment strategies. In this study, the prevalence of psychoactive prescription drugs, classical illicit drugs, and new psychoactive substances (NPS) were objectively assessed in individuals diagnosed with drug-related psychiatric disorders or episodes. METHODS: Blood, urine, and hair samples were collected from psychiatric patients admitted to the Mental Health Department and Drug Addiction Service of the North Rome Local Health Authority with declared or suspected psychoactive drug use...
November 27, 2023: Therapeutic Drug Monitoring
Kenshiro Hirata, Takafumi Obara, Tokunori Ikeda, Hiroshi Watanabe, Issei Fujita, Hirokazu Furusho, Takako Ishiguro, Sachiko Jingami, Toru Maruyama, Katsuki Hirai, Shigeyuki Miyamura
BACKGROUND: Thiamylal exerts excellent sedative effects. However, it is not routinely used because of its serious adverse effects. This study aimed to clarify the target blood concentration range and infusion rate of thiamylal in children by measuring its blood concentration and evaluating its relationship with efficacy and adverse effects. METHODS: This study was approved by the Ethics Committee of Japanese Red Cross Kumamoto Hospital. The authors included 10 children aged between 1 and 7 years who had received continuous intravenous (IV) infusion of thiamylal for the management of refractory status epilepticus, excluding those who met the exclusion criteria...
November 27, 2023: Therapeutic Drug Monitoring
Xenia M Hart, Moritz Spangemacher, Hiroyuki Uchida, Gerhard Gründer
BACKGROUND: Positron emission tomography (PET) and single photon emission tomography (SPECT) of molecular drug targets (neuroreceptors and transporters) provide essential information for therapeutic drug monitoring-guided antipsychotic drug therapy. The optimal therapeutic windows for D2 antagonists and partial agonists, as well as their proposed target ranges, are discussed based on an up-to-date literature search. METHODS: This part I of II presents an overview of molecular neuroimaging studies in humans and primates involving the target engagement of amisulpride, haloperidol, clozapine, aripiprazole, olanzapine, quetiapine, risperidone, cariprazine, and ziprasidone...
November 27, 2023: Therapeutic Drug Monitoring
Jurjen S Kingma, Niels W L Peeters, Catherijne A J Knibbe, Mariette J Agterof, Wouter J M Derksen, Desirée M T Burgers, Marcel P H van den Broek
Obesity is associated with an increased risk of cancers, such as breast cancer. Roux-en-Y gastric bypass (RYGB) is a common surgical intervention used to induce weight loss, reduce comorbidities, and improve overall survival. Due to alterations in the gastrointestinal tract, RYGB is associated with changes in oral drug disposition, which can affect treatment outcomes. Oral antihormonal agents were monitored in 9 patients who previously underwent RYGB. The results of therapeutic drug monitoring and estradiol concentrations were analyzed, and a review of the relevant literature was performed...
November 27, 2023: Therapeutic Drug Monitoring
Rossella Barone, Matteo Conti, Beatrice Giorgi, Milo Gatti, Pier Giorgio Cojutti, Pierluigi Viale, Federico Pea
BACKGROUND: Fosfomycin is an antibiotic recently repurposed as a potential combination treatment for difficult-to-treat Gram-negative bacterial infections. The pharmacokinetic features of fosfomycin have demonstrated that different pathophysiologic alterations may affect its exposure. Therapeutic drug monitoring may improve real-time management of fosfomycin therapy in different clinical scenarios. OBJECTIVES: To develop and validate a fast and sensitive liquid chromatography - tandem mass spectrometry method for measuring fosfomycin in human plasma microsamples (3 µL)...
November 22, 2023: Therapeutic Drug Monitoring
Sara Jiménez-Fernández, Manuel Gurpegui, Christoph U Correll, Jose de Leon, Georgios Schoretsanitis
BACKGROUND: Therapeutic drug monitoring of clozapine in children and adolescents has received insufficient attention. Calculation of concentration-to-dose (C/D) ratios from trough steady-state concentrations estimate drug clearance. METHODS: A systematic electronic literature search was conducted in 3 article databases from inception until January 10, 2023, and articles reporting clozapine concentrations in children and adolescents were retrieved. The pharmacokinetic quality of the studies was assessed, and clozapine C/D ratios were calculated using the sample mean clozapine dose and concentration...
November 16, 2023: Therapeutic Drug Monitoring
Nicole F Maranchick, Cesar Trillo-Alvarez, Vidhu Kariyawasam, Veena Venugopalan, Awewura Kwara, Kenneth Rand, Charles A Peloquin, Mohammad H Alshaer
BACKGROUND: Antimicrobial resistance is a growing health concern worldwide. The objective of this study was to evaluate the effect of beta-lactam infusion on the emergence of bacterial resistance in patients with severe pneumonia in the intensive care unit. METHODS: Adult intensive care patients receiving cefepime, meropenem, or piperacillin-tazobactam for severe pneumonia caused by Gram-negative bacteria were randomized to receive beta-lactams as an intermittent (30 minutes) or continuous (24 hours) infusion...
November 15, 2023: Therapeutic Drug Monitoring
Fabian Sattaf, Maike Scherf-Clavel, Stefan Unterecker, Andreas Reif, Martina Hahn
BACKGROUND: Therapeutic reference ranges are essential for therapeutic drug monitoring to evaluate results and adjust pharmacotherapy. The measured serum concentrations of cariprazine-treated patients have frequently been found to lie beyond the currently used therapeutic reference range; furthermore, reliable data for establishing evidence-based therapeutic ranges are scarce. The current therapeutic reference ranges have only been estimated; however, real-world data on cariprazine are missing...
November 14, 2023: Therapeutic Drug Monitoring
Michael Philippe, Jérôme Guitton, Sylvain Goutelle, Yann Thoma, Bertrand Favier, Nour Chtiba, Mauricette Michallet, Amine Belhabri
BACKGROUND: Venetoclax (VNX)-based regimens have demonstrated significantly favorable outcomes in patients with acute myeloid leukemia (AML) and are now becoming the standard treatment. Tyrosine kinase inhibitors are administered at a fixed dose, irrespective of body surface area or weight. For such orally targeted therapies, real-world data have highlighted a larger pharmacokinetic (PK) interindividual variability (IIV) than expected. Even if VNX PKs have been well characterized and described in the literature, only 1 clinical trial-based PK study has been conducted in patients with AML...
November 8, 2023: Therapeutic Drug Monitoring
Guillaume Drevin, Stéphane Malbranque, Nathalie Jousset, Séverine Férec, Donca Zabet, Antoine Baudriller, Marie Briet, Chadi Abbara
Pharmacobezoars develop after an acute overdose or during routine drug administration. Here, the authors present a case of fatal multidrug overdose involving a 62-year-old woman. Her usual treatment included tramadol extended-release, citalopram, and mirtazapine. Furthermore, she self-medicated and misused her husband's medications. The autopsy revealed the presence of a voluminous medication bezoar in the stomach. No mechanical complication was noted. Toxicologic analyses were performed using gas chromatography with flame ionization detection, liquid chromatography with diode array detection, gas chromatography with mass spectrometry detection, and liquid chromatography coupled to tandem mass spectrometry...
November 8, 2023: Therapeutic Drug Monitoring
Xuemei Zhao, Rui Zhang, Wenjing Li
BACKGROUND: This report describes the successful rescue of a 12-year-old girl who ingested large quantities of clonazepam tablets. METHODS: The patient was promptly treated with flumazenil and hemoperfusion to alleviate the symptoms of central depression. Therapeutic drug monitoring was used to evaluate detoxification efficacy. The authors analyzed the rescue protocol for clonazepam poisoning based on the pathophysiology, clinical manifestations, and pharmacokinetics of clonazepam overdose...
October 23, 2023: Therapeutic Drug Monitoring
Cathy M Jacobs, Lea Wagmann, Markus R Meyer
BACKGROUND: Analytical monitoring of adherence using mass spectrometry (MS) plays an important role in clinical toxicology. Unambiguous detection of drugs (of abuse) and/or their metabolites in body fluids is needed to monitor intake of medication as prescribed or to monitor abstinence as a follow-up to detoxification procedures. This study focused on the advantages and disadvantages of different sample matrices used for MS-based adherence monitoring. METHODS: Relevant articles were identified through a literature search in the PubMed database...
October 5, 2023: Therapeutic Drug Monitoring
Mandy Elewa, Sarah S Alghanem, Jasem Al-Hashel, Anil Thussu, Yousef Al-Lanqawi, Kamal Matar
BACKGROUND: Topiramate (TPM) is used for the treatment of various epileptic seizures and the prevention of migraine. This study aimed to develop a population pharmacokinetic model and identify covariates that influence TPM behavior in patients with epilepsy in Kuwait. METHODS: Data were collected retrospectively from 108 patients (2 years old and above) with epilepsy who were treated with oral TPM and 174 TPM blood samples from 3 hospitals in Kuwait from 2009 to 2016...
October 4, 2023: Therapeutic Drug Monitoring
Alessia Cafaro, Giammarco Baiardi, Federica Pigliasco, Sebastiano Barco, Francesca Mattioli, Stefano Volpi, Roberta Caorsi, Marco Gattorno, Giuliana Cangemi
BACKGROUND: Janus kinase inhibitors are antirheumatic immunosuppressive drugs that target intracellular Janus kinases (JAKs). Baricitinib is a selective and reversible orally administered JAK1/JAK2 inhibitor approved for treating rheumatoid arthritis, atopic dermatitis, and alopecia areata in adult patients. Expanded access to baricitinib has been approved for treating pediatric patients affected by rare Mendelian autoinflammatory diseases with type I interferon-mediated damage. Knowledge of the pharmacokinetic properties and target plasma levels of baricitinib in pediatric patients is limited...
September 25, 2023: Therapeutic Drug Monitoring
Ting Zhao, Hong-Jian Li, Hui-Lan Zhang, Ji-Rong Feng, Jing Yu, Jie Feng, Ting-Ting Wang, Yan Sun, Lu-Hai Yu
BACKGROUND: Information on the efficacy and plasma concentration of perampanel (PER) in Chinese pediatric patients with epilepsy is limited. Therefore, this real-world retrospective study aimed to assess the efficacy, tolerability, and plasma concentration of the maximum dose of PER for epilepsy treatment in Chinese pediatric patients. METHODS: A total of 107 pediatric patients from 2 hospitals in China were enrolled in this study. The plasma concentration of PER was determined using ultrahigh-performance liquid chromatography...
September 25, 2023: Therapeutic Drug Monitoring
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