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209. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study

Author

Swen, Jesse J, van der Wouden, Cathelijne H, Manson, Lisanne EN, Abdullah-Koolmees, Heshu, Blagec, Kathrin, Blagus, Tanja, Böhringer, Stefan, Cambon-Thomsen, Anne, Cecchin, Erika, Cheung, Ka-Chun, Deneer, Vera HM, Dupui, Mathilde, Ingelman-Sundberg, Magnus, Jonsson, Siv, Joefield-Roka, Candace, Just, Katja S, Karlsson, Mats O, Konta, Lidija, Koopmann, Rudolf, Kriek, Marjolein, Lehr, Thorsten, Mitropoulou, Christina, Rial-Sebbag, Emmanuelle, Rollinson, Victoria, Roncato, Rossana, Samwald, Matthias, Schaeffeler, Elke, Skokou, Maria, Schwab, Matthias, Steinberger, Daniela, Stingl, Julia C, Tremmel, Roman, Turner, Richard M, van Rhenen, Mandy H, Dávila Fajardo, Cristina L, Dolžan, Vita, Patrinos, George P, Pirmohamed, Munir, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Buunk, Annemarie, Goossens, Hanneke, Baas, Gert, Algera, Maartje, Schuil-Vlassak, Evelyn, Ambagts, Thijs, De Hoog-Schouten, Leonie, Musaafir, Sara, Bosch, Roelof, Tjong, Carol, Steeman, Sanne, Van der Plas, Martine, Baldew, Glenn, Den Hollander, Iris, De Waal, Zacharias, Heijn, Aurele, Nelemans, Leen, Kouwen-Lubbers, Kirsten, Van Leeuwen, Maartje, Hoogenboom, Sacha, Van Doremalen, Jacobine, Ton, Célin, Beetstra, Bastien, Meijs, Veronique, Dikken, Jan, Dubero, Dasha, Slager, Mark, Houben, Tom, Kanis, Thomas, Overmars, Wietske, Nijenhuis, Marga, Steffens, Michael, Bergs, Ingmar, Karamperis, Kariofyllis, Siamoglou, Stavroula, Ivantsik, Ouliana, Samiou, Georgia-Chryssa, Kordou, Zoe, Tsermpini, Evira, Ferentinos, Panagiotis, Karaivazoglou, Aikaterini, Rigas, George, Gerasimou, Harilaos, Voukelatou, Georgia, Georgila, Eleni, Tsermpini, Evangelia Eirini, Mendrinou, Efrossyni, Chalikiopoulou, Konstantina, Kolliopoulou, Alexandra, Mitropoulos, Konstantinos, Stratopoulos, Apostolos, Liopetas, Ioannis, Tsikrika, Athina, Barba, Evangelia, Emmanouil, Georgia, Stamopoulou, Theano, Stathoulias, Andreas, Giannopoulos, Panagiotis, Kanellakis, Filippos, Bartsakoulia, Marina, Katsila, Theodora, Douzenis, Athanassios, Gourzis, Filippos, Assimakopoulos, Konstantinos, Bignucolo, Alessia, Dal Cin, Lisa, Comello, Francesco, Mezzalira, Silvia, Puglisi, Fabio, Spina, Michele, Foltran, Luisa, Guardascione, Michela, Buonadonna, Angela, Bartoletti, Michele, Corsetti, Serena, Ongaro, Elena, Da Ros, Lucia, Bolzonello, Silvia, Spazzapan, Simon, Freschi, Andrea, Di Nardo, Paola, Palazzari, Elisa, Navarria, Federico, Innocente, Roberto, Berretta, Massimiliano, D'Andrea, Mario, Angelini, Francesco, Diraimo, Tania, Favaretto, Adolfo, Dávila-Fajardo, Cristina Lucía, Díaz-Villamarín, Xando, Martínez-González, Luis Javier, Antúnez-Rodríguez, Alba, Moreno-Escobar, Eduardo, Fernández-Gonzalez, Ana Estefanía, García-Navas, Paloma, Bautista-Pavés, Alicia Bautista Pavés, Burillo-Gómez, Francisco, Villegas-Rodríguez, Inmaculada, Sánchez-Ramos, Jesús Gabriel, Antolinos-Pérez, Mª José, Rivera, Ricardo, Martínez-Huertas, Susana, Thomas-, Jesús, Carazo, Jose Julio, Yañez-Sanchez, Mª Isabel, Blancas-López-Navajas, Rocío, García-Orta, Beatriz, González-Astorga, Carlos José, Rodríguez-González, Francisco Javier, Ruiz-Carazo, Manuel, López-Pérez, Irene, Cano-Herrera, Rosa, Herrera, Teresa, Gil-Jiménez, Delgado-Ureña, Mª Teresa, Triviño-Juarez, Jose Matías, Campos-Velázquez, Salustiano, Alcántara-Espadafor, Silvia, Moreno Aguilar, Maria Rosario, Ontiveros-Ortega, Maria Carmen, Carnerero-Córdoba, Lidia, Guerrero-Jiménez, Margarita, Legeren-Álvarez, Marta, Yélamos-Vargas, Marisol, Castillo-Pérez, Isabel, Aomar-Millán, Ismael, Anguita-Romero, Manuel, Sánchez-García, María José, Sequero-Lopez, Silvia, Faro-Miguez, Naya, López-Fernández, Silvia, Leyva-Ferrer, Rosario Nieves, Herrera-Gómez, Norberto, Pertejo-Manzano, Laura, Pérez-Gutierrez, Eva Mª, Martín-de la Higuera, Antonio J., Plaza-Carrera, Jose, Baena-Garzón, Flor, Toledo-Frías, Pablo, Cruz-Valero, Inés, Chacón-McWeeny, Verónica, Gallardo-Sánchez, Isabel, Arrebola, Antonio, Guillén-Zafra, Lucía, Ceballos-Torres, Ángel, Guardia-Mancilla, Plácido, Guirao-Arrabal, Emilio, Canterero-Hinojosa, Jesús, Velasco-Fuentes, Sara, Sánchez-Cano, Daniel, Aguilar-Jaldo, Mª del Pilar, Caballero-Borrego, Juan, Praznik, Monika, Slapšak, Urška, Vončina, Blaz, Rajter, Branka, Škrinjar, Andrej, Marjetič Ulčakar, Angelika, Zidanšek, Anja, Stegne Ignjatvič, Tea, Mazej Poredoš, Barbara, Vivod Pečnik, Živka, Poplas Susič, Tonka, Juteršek, Milojka, Klen, Jasna, Skoporc, Janja, Kotar, Tjaša, Petek Šter, Marija, Zvezdana Dernovšk, Mojca, Klen, Jasna, Mlinšek, Gregor, Miklavčič, Petra, Plemenitaš Ilješ, Anja, Grašič Kuhar, Cvetka, Oblak, Irena, Stražišar, Branka, Štrbac, Danijela, Matos, Erika, Mencinger, Marina, Vrbnjak, Marko, Saje, Marko, Radovanovič, Mirjana, Jeras, Katja, Bukovec, Lucija, Terzič, Tea, Minichmayr, Iris, Nanah, Abdulaziz, Nielsen, Elisabet, Zou, Yuanxi, Lauschke, Volker, Johansson, Inger, Zhou, Yitian, Nordling, Åsa, Aigner, Christof, Dames-Ludwig, Marlies, Monteforte, Rossella, Sunder-Plassmann, Raute, Steinhauser, Corinna, Sengoelge, Guerkan, Winnicki, Wolfgang, Schmidt, Alice, Vasileios, Fragoulakis, Fontana, Vanessa, Hanson, Anita, Little, Margaret, Hornby, Rachael, Dello Russo, Cinzia, French, Stephanie, Hampson, Jamie, Gumustekin, Mukaddes, Anyfantis, George, Hampson, Lucy, Lewis, David, Westhead, Ruth, Prince, Clare, and Rajasingam, Arjunan

Abstract

The benefit of pharmacogenetic testing before starting drug therapy has been well documented for several single gene–drug combinations. However, the clinical utility of a pre-emptive genotyping strategy using a pharmacogenetic panel has not been rigorously assessed.

Published
2023
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210. Dutch pharmacogenetics working group (DPWG) guideline for the gene–drug interaction between UGT1A1and irinotecan

Author

Hulshof, Emma C., Deenen, Maarten J., Nijenhuis, Marga, Soree, Bianca, de Boer-Veger, Nienke J., Buunk, Anne-Marie, Houwink, Elisa J. F., Risselada, Arne, Rongen, Gerard A. P. J. M., van Schaik, Ron H. N., Touw, Daan J., van der Weide, Jan, van Westrhenen, Roos, Deneer, Vera H. M., Guchelaar, Henk-Jan, and Swen, Jesse J.

Abstract

The Dutch Pharmacogenetics Working Group (DPWG) aims to facilitate PGx implementation by developing evidence-based pharmacogenetics guidelines to optimize pharmacotherapy. This guideline describes the starting dose optimization of the anti-cancer drug irinotecan to decrease the risk of severe toxicity, such as (febrile) neutropenia or diarrhoea. Uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1 encoded by the UGT1A1gene) enzyme deficiency increases risk of irinotecan-induced toxicity. Gene variants leading to UGT1A1 enzyme deficiency (e.g. UGT1A1*6, *28 and *37) can be used to optimize an individual’s starting dose thereby preventing carriers from toxicity. Homozygous or compound heterozygous carriers of these allele variants are defined as UGT1A1poor metabolisers (PM). DPWG recommends a 70% starting dose in PM patients and no dose reduction in IM patients who start treatment with irinotecan. Based on the DPWG clinical implication score, UGT1A1genotyping is considered “essential”, indicating that UGT1A1testing must be performed prior to initiating irinotecan treatment.

Published
2023
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212. Safety and pharmacokinetic analysis of UGT1A1 genotype-guided dosing of irinotecan.

Author

Hulshof, Emma C., primary, de With, Mirjam, additional, de Man, Femke M., additional, Creemers, Geert-Jan, additional, Deiman, Birgit ALM, additional, Swen, Jesse J., additional, Houterman, Saskia, additional, Koolen, Stijn L.W., additional, Laven, Marjan, additional, Luelmo, Saskia, additional, van Schaik, Ron H.N., additional, Guchelaar, Henk-jan, additional, Mathijssen, Ron H.J., additional, Gelderblom, Hans, additional, and Deenen, Maarten J., additional

Published
2021
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214. Fixed dosing of tocilizumab in ICU admitted COVID-19 patients is a superior choice compared to bodyweight based dosing; an observational population pharmacokinetic and pharmacodynamic study

Author

Moes, Dirk Jan A.R., primary, van Westerloo, David J., additional, Arend, Sandra M., additional, Swen, Jesse J., additional, de Vries, Annick, additional, Guchelaar, Henk-Jan, additional, Joosten, Simone A., additional, de Boer, Mark G.J., additional, van Gelder, Teun, additional, and van Paassen, Judith, additional

Published
2021
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216. Diagnostic and Therapeutic Strategies for Fluoropyrimidine Treatment of Patients Carrying Multiple DPYD Variants

Author

Lunenburg, Carin A. T. C., Henricks, Linda M., van Kuilenburg, André, Mathijssen, Ron H. J., Schellens, Jan H. M., Gelderblom, Hans, Guchelaar, Henk-Jan, Swen, Jesse J., Cecchin, Erika, Stocco, Gabriele, CCA - Imaging and biomarkers, CCA - Cancer biology and immunology, Amsterdam Gastroenterology Endocrinology Metabolism, and Laboratory Genetic Metabolic Diseases

Published
2020

217. A review of the bioanalytical methods for the quantitative determination of capecitabine and its metabolites in biological matrices

Author

Knikman, Jonathan E, Rosing, Hilde, Guchelaar, Henk-Jan, Cats, A, Beijnen, Jos H, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
Bioanalysis, bioanalysis, Clinical Biochemistry, Chemical Fractionation, 030226 pharmacology & pharmacy, 01 natural sciences, Biochemistry, Analytical Chemistry, Capecitabine, Mice, 03 medical and health sciences, 0302 clinical medicine, Drug Discovery, medicine, Animals, Humans, Molecular Biology, mass spectrometry, Pharmacology, Chromatography, Chemistry, capecitabine, 010401 analytical chemistry, Fluoropyrimidines, General Medicine, Anticancer drug, Quantitative determination, 0104 chemical sciences, chromatography, Chromatography, Liquid, medicine.drug
Abstract

The bioanalysis of the oral anticancer drug capecitabine and its metabolites has been investigated extensively over the past years. This paper reviews methods for the bioanalysis of capecitabine and its metabolites. The focus of this review will be on sample pre-treatment, chromatography and detection. Furthermore, the choice of standards and analytical problems encountered during analysis of capecitabine and its metabolites in biological matrices will be discussed. The major challenges in the bioanalysis of capecitabine and its metabolites are the simultaneous extraction and analysis due to the differences in polarity of the analytes. Furthermore we evaluate currently described methods for the quantification of capecitabine and its metabolites. Future wishes and perspectives are stated that could serve as an inspiration for further development of assays for the quantification of capecitabine and its metabolites.

Published
2020
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219. Translating pharmacogenomics: challenges on the road to the clinic

Author

Swen, Jesse J., Huizinga, Tom W., Gelderblom, Hans, de Vries, Elisabeth G.E., Assendelft, Willem J.J., Kirchheiner, Julia, and Guchelaar, Henk-Jan

Subjects
Pharmacogenetics -- Evaluation, Clinical medicine -- Evaluation
Abstract

FIVE KEY PAPERS IN THE FIELD Van den Akker-van Marle et al., 2006 [26] Provides evidence that TPMT genotyping prior to thiopurine treatment initation is cost effective in children with [...]

Published
2007

220. Generating evidence for precision medicine: considerations made by the Ubiquitous Pharmacogenomics Consortium when designing and operationalizing the PREPARE study

Author

van der Wouden, Cathelijne H, Böhringer, Stefan, Cecchin, Erika, Cheung, Ka-Chun, Dávila-Fajardo, Cristina Lucía, Deneer, Vera H M, Dolžan, Vita, Ingelman-Sundberg, Magnus, Jönsson, Siv, Karlsson, Mats O, Kriek, Marjolein, Mitropoulou, Christina, Patrinos, George P, Pirmohamed, Munir, Rial-Sebbag, Emmanuelle, Samwald, Matthias, Schwab, Matthias, Steinberger, Daniela, Stingl, Julia, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Turner, Richard M, van Rhenen, Mandy H, van Zwet, Erik, Swen, Jesse J, Guchelaar, Henk-Jan, van der Wouden, Cathelijne H, Böhringer, Stefan, Cecchin, Erika, Cheung, Ka-Chun, Dávila-Fajardo, Cristina Lucía, Deneer, Vera H M, Dolžan, Vita, Ingelman-Sundberg, Magnus, Jönsson, Siv, Karlsson, Mats O, Kriek, Marjolein, Mitropoulou, Christina, Patrinos, George P, Pirmohamed, Munir, Rial-Sebbag, Emmanuelle, Samwald, Matthias, Schwab, Matthias, Steinberger, Daniela, Stingl, Julia, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Turner, Richard M, van Rhenen, Mandy H, van Zwet, Erik, Swen, Jesse J, and Guchelaar, Henk-Jan

Abstract

OBJECTIVES: Pharmacogenetic panel-based testing represents a new model for precision medicine. A sufficiently powered prospective study assessing the (cost-)effectiveness of a panel-based pharmacogenomics approach to guide pharmacotherapy is lacking. Therefore, the Ubiquitous Pharmacogenomics Consortium initiated the PREemptive Pharmacogenomic testing for prevention of Adverse drug Reactions (PREPARE) study. Here, we provide an overview of considerations made to mitigate multiple methodological challenges that emerged during the design.METHODS: An evaluation of considerations made when designing the PREPARE study across six domains: study aims and design, primary endpoint definition and collection of adverse drug events, inclusion and exclusion criteria, target population, pharmacogenomics intervention strategy, and statistical analyses.RESULTS: Challenges and respective solutions included: (1) defining and operationalizing a composite primary endpoint enabling measurement of the anticipated effect, by including only severe, causal, and drug genotype-associated adverse drug reactions; (2) avoiding overrepresentation of frequently prescribed drugs within the patient sample while maintaining external validity, by capping drugs of enrolment; (3) designing the pharmacogenomics intervention strategy to be applicable across ethnicities and healthcare settings; and (4) designing a statistical analysis plan to avoid dilution of effect by initially excluding patients without a gene-drug interaction in a gatekeeping analysis.CONCLUSION: Our design considerations will enable quantification of the collective clinical utility of a panel of pharmacogenomics-markers within one trial as a proof-of-concept for pharmacogenomics-guided pharmacotherapy across multiple actionable gene-drug interactions. These considerations may prove useful to other investigators aiming to generate evidence for precision medicine.

Published
2020

221. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction of DPYD and fluoropyrimidines

Author

Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., Guchelaar, Henk Jan, Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., and Guchelaar, Henk Jan

Abstract

Despite advances in the field of pharmacogenetics (PGx), clinical acceptance has remained limited. The Dutch Pharmacogenetics Working Group (DPWG) aims to facilitate PGx implementation by developing evidence-based pharmacogenetics guidelines to optimize pharmacotherapy. This guideline describes the starting dose optimization of three anti-cancer drugs (fluoropyrimidines: 5-fluorouracil, capecitabine and tegafur) to decrease the risk of severe, potentially fatal, toxicity (such as diarrhoea, hand-foot syndrome, mucositis or myelosuppression). Dihydropyrimidine dehydrogenase (DPD, encoded by the DPYD gene) enzyme deficiency increases risk of fluoropyrimidine-induced toxicity. The DPYD-gene activity score, determined by four DPYD variants, predicts DPD activity and can be used to optimize an individual’s starting dose. The gene activity score ranges from 0 (no DPD activity) to 2 (normal DPD activity). In case it is not possible to calculate the gene activity score based on DPYD genotype, we recommend to determine the DPD activity and adjust the initial dose based on available data. For patients initiating 5-fluorouracil or capecitabine: subjects with a gene activity score of 0 are recommended to avoid systemic and cutaneous 5-fluorouracil or capecitabine; subjects with a gene activity score of 1 or 1.5 are recommended to initiate therapy with 50% the standard dose of 5-fluorouracil or capecitabine. For subjects initiating tegafur: subjects with a gene activity score of 0, 1 or 1.5 are recommended to avoid tegafur. Subjects with a gene activity score of 2 (reference) should receive a standard dose. Based on the DPWG clinical implication score, DPYD genotyping is considered “essential”, therefore directing DPYD testing prior to initiating fluoropyrimidines.

Published
2020

223. Generating evidence for precision medicine: considerations made by the Ubiquitous Pharmacogenomics Consortium when designing and operationalizing the PREPARE study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van der Wouden, Cathelijne H, Böhringer, Stefan, Cecchin, Erika, Cheung, Ka-Chun, Dávila-Fajardo, Cristina Lucía, Deneer, Vera H M, Dolžan, Vita, Ingelman-Sundberg, Magnus, Jönsson, Siv, Karlsson, Mats O, Kriek, Marjolein, Mitropoulou, Christina, Patrinos, George P, Pirmohamed, Munir, Rial-Sebbag, Emmanuelle, Samwald, Matthias, Schwab, Matthias, Steinberger, Daniela, Stingl, Julia, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Turner, Richard M, van Rhenen, Mandy H, van Zwet, Erik, Swen, Jesse J, Guchelaar, Henk-Jan, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van der Wouden, Cathelijne H, Böhringer, Stefan, Cecchin, Erika, Cheung, Ka-Chun, Dávila-Fajardo, Cristina Lucía, Deneer, Vera H M, Dolžan, Vita, Ingelman-Sundberg, Magnus, Jönsson, Siv, Karlsson, Mats O, Kriek, Marjolein, Mitropoulou, Christina, Patrinos, George P, Pirmohamed, Munir, Rial-Sebbag, Emmanuelle, Samwald, Matthias, Schwab, Matthias, Steinberger, Daniela, Stingl, Julia, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Turner, Richard M, van Rhenen, Mandy H, van Zwet, Erik, Swen, Jesse J, and Guchelaar, Henk-Jan

Published
2020

224. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction of DPYD and fluoropyrimidines

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., Guchelaar, Henk Jan, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., and Guchelaar, Henk Jan

Published
2020

225. A review of the bioanalytical methods for the quantitative determination of capecitabine and its metabolites in biological matrices

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Knikman, Jonathan E, Rosing, Hilde, Guchelaar, Henk-Jan, Cats, A, Beijnen, Jos H, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Knikman, Jonathan E, Rosing, Hilde, Guchelaar, Henk-Jan, Cats, A, and Beijnen, Jos H

Published
2020

226. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction of DPYD and fluoropyrimidines

Author

Apotheek Klinische Farmacie, Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., Guchelaar, Henk Jan, Apotheek Klinische Farmacie, Lunenburg, Carin A.T.C., van der Wouden, Cathelijne H., Nijenhuis, Marga, Crommentuijn-van Rhenen, Mandy H., de Boer-Veger, Nienke J., Buunk, Anne Marie, Houwink, Elisa J.F., Mulder, Hans, Rongen, Gerard A., van Schaik, Ron H.N., van der Weide, Jan, Wilffert, Bob, Deneer, Vera H.M., Swen, Jesse J., and Guchelaar, Henk Jan

Published
2020

235. Fixed Dosing of Tocilizumab in ICU Admitted COVID-19 Patients Is a Superior Choice Compared to Bodyweight Based Dosing; An Observational Population Pharmacokinetic and Pharmacodynamic Study

Author

Moes, Dirk Jan, primary, van Westerloo, David, additional, Arend, Sandra, additional, Swen, Jesse, additional, De Vries, Annick, additional, Guchelaar, Henk-Jan, additional, Joosten, Simone, additional, De Boer, Mark, additional, Van Gelder, Teun, additional, and van Paassen, Judith, additional

Published
2021
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239. Genome-wide association analysis of anti-TNF drug response in patients with rheumatoid arthritis

Author

Umiċeviċ Mirkov, Maša, Cui, Jing, Vermeulen, Sita H, Stahl, Eli A, Toonen, Erik J M, Makkinje, Remco R, Lee, Annette T, Huizinga, Tom W J, Allaart, Renee, Barton, Anne, Mariette, Xavier, Miceli, Corinne Richard, Criswell, Lindsey A, Tak, Paul P, de Vries, Niek, Saevarsdottir, Saedis, Padyukov, Leonid, Bridges, S Louis, van Schaardenburg, Dirk-Jan, Jansen, Tim L, Dutmer, Ellen A J, van de Laar, Mart A F J, Barrera, Pilar, Radstake, Timothy R D J, van Riel, Piet L C M, Scheffer, Hans, Franke, Barbara, Brunner, Han G, Plenge, Robert M, Gregersen, Peter K, Guchelaar, Henk-Jan, and Coenen, Marieke J H

Published
2013
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242. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2C19 and CYP2D6 and SSRIs

Author

Brouwer, Jurriaan M. J. L., Nijenhuis, Marga, Soree, Bianca, Guchelaar, Henk-Jan, Swen, Jesse J., van Schaik, Ron H. N., Weide, Jan van der, Rongen, Gerard A. P. J. M., Buunk, Anne-Marie, de Boer-Veger, Nienke J., Houwink, Elisa J. F., van Westrhenen, Roos, Wilffert, Bob, Deneer, Vera H. M., and Mulder, Hans

Abstract

The Dutch Pharmacogenetics Working Group (DPWG) guideline presented here, presents the gene-drug interaction between the genes CYP2C19and CYP2D6and antidepressants of the selective serotonin reuptake inhibitor type (SSRIs). Both genes’ genotypes are translated into predicted normal metabolizer (NM), intermediate metabolizer (IM), poor metabolizer (PM), or ultra-rapid metabolizer (UM). Evidence-based dose recommendations were obtained, based on a structured analysis of published literature. In CYP2C19PM patients, escitalopram dose should not exceed 50% of the normal maximum dose. In CYP2C19IM patients, this is 75% of the normal maximum dose. Escitalopram should be avoided in UM patients. In CYP2C19PM patients, citalopram dose should not exceed 50% of the normal maximum dose. In CYP2C19IM patients, this is 70% (65–75%) of the normal maximum dose. In contrast to escitalopram, no action is needed for CYP2C19UM patients. In CYP2C19PM patients, sertraline dose should not exceed 37.5% of the normal maximum dose. No action is needed for CYP2C19IM and UM patients. In CYP2D6UM patients, paroxetine should be avoided. No action is needed for CYP2D6PM and IM patients. In addition, no action is needed for the other gene-drug combinations. Clinical effects (increase in adverse events or decrease in efficacy) were lacking for these other gene-drug combinations. DPWG classifies CYP2C19genotyping before the start of escitalopram, citalopram, and sertraline, and CYP2D6genotyping before the start of paroxetine as “potentially beneficial” for toxicity/effectivity predictions. This indicates that genotyping prior to treatment can be considered on an individual patient basis.

Published
2022
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243. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction between CYP2D6and opioids (codeine, tramadol and oxycodone)

Author

Matic, Maja, Nijenhuis, Marga, Soree, Bianca, de Boer-Veger, Nienke J., Buunk, Anne-Marie, Houwink, Elisa J. F., Mulder, Hans, Rongen, Gerard A. P. J. M., Weide, Jan van der, Wilffert, Bob, Swen, Jesse J., Guchelaar, Henk-Jan, Deneer, Vera H. M., and van Schaik, Ron H. N.

Abstract

The current Dutch Pharmacogenetics Working Group (DPWG) guideline, describes the gene–drug interaction between CYP2D6and the opioids codeine, tramadol and oxycodone. CYP2D6 genotype is translated into normal metaboliser (NM), intermediate metaboliser (IM), poor metaboliser (PM) or ultra-rapid metaboliser (UM). Codeine is contraindicated in UM adults if doses >20 mg every 6 h (q6h), in children ≥12 years if doses >10 mg q6h, or with additional risk factors. In PMs, an alternative analgesic should be given which is not or to a lesser extent metabolised by CYP2D6 (not tramadol). In IMs with insufficient analgesia, a higher dose or alternative analgesic should be given. For tramadol, the recommendations for IMs and PMs are the same as the recommendation for codeine and IMs. UMs should receive an alternative drug not or to a lesser extent metabolised by CYP2D6 or the dose should be decreased to 40% of the commonly prescribed dose. Due to the absence of effect on clinical outcomes of oxycodone in PMs, IMs and UMs no action is required. DPWG classifies CYP2D6genotyping for codeine “beneficial” and recommends testing prior to, or shortly after initiation of treatment in case of higher doses or additional risk factors. CYP2D6genotyping is classified as “potentially beneficial” for tramadol and can be considered on an individual patient basis.

Published
2022
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244. Pharmacogenomics decision support in the U-PGx project: Results and advice from clinical implementation across seven European countries.

Author

Blagec, Kathrin, Swen, Jesse J., Koopmann, Rudolf, Cheung, Ka-Chun, Crommentuijn - van Rhenen, Mandy, Holsappel, Inge, Konta, Lidija, Ott, Simon, Steinberger, Daniela, Xu, Hong, Cecchin, Erika, Dolžan, Vita, Dávila-Fajardo, Cristina Lucía, Patrinos, George P., Sunder-Plassmann, Gere, Turner, Richard M., Pirmohamed, Munir, Guchelaar, Henk-Jan, and Samwald, Matthias

Subjects
CLINICAL decision support systems, PHARMACOGENOMICS, MEDICAL personnel, INDIVIDUALIZED medicine, DRUG labeling
Abstract

Background: The clinical implementation of pharmacogenomics (PGx) could be one of the first milestones towards realizing personalized medicine in routine care. However, its widespread adoption requires the availability of suitable clinical decision support (CDS) systems, which is often impeded by the fragmentation or absence of adequate health IT infrastructures. We report results of CDS implementation in the large-scale European research project Ubiquitous Pharmacogenomics (U-PGx), in which PGx CDS was rolled out and evaluated across more than 15 clinical sites in the Netherlands, Spain, Slovenia, Italy, Greece, United Kingdom and Austria, covering a wide variety of healthcare settings. Methods: We evaluated the CDS implementation process through qualitative and quantitative process indicators. Quantitative indicators included statistics on generated PGx reports, median time from sampled upload until report delivery and statistics on report retrievals via the mobile-based CDS tool. Adoption of different CDS tools, uptake and usability were further investigated through a user survey among healthcare providers. Results of a risk assessment conducted prior to the implementation process were retrospectively analyzed and compared to actual encountered difficulties and their impact. Results: As of March 2021, personalized PGx reports were produced from 6884 genotyped samples with a median delivery time of twenty minutes. Out of 131 invited healthcare providers, 65 completed the questionnaire (response rate: 49.6%). Overall satisfaction rates with the different CDS tools varied between 63.6% and 85.2% per tool. Delays in implementation were caused by challenges including institutional factors and complexities in the development of required tools and reference data resources, such as genotype-phenotype mappings. Conclusions: We demonstrated the feasibility of implementing a standardized PGx decision support solution in a multinational, multi-language and multi-center setting. Remaining challenges for future wide-scale roll-out include the harmonization of existing PGx information in guidelines and drug labels, the need for strategies to lower the barrier of PGx CDS adoption for healthcare institutions and providers, and easier compliance with regulatory and legal frameworks. [ABSTRACT FROM AUTHOR]

Published
2022
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245. Pharmacogenetics: optimising prescribing in primary care.

Author

Youssef, Essra, Thornley, Tracey, Guchelaar, Henk‐Jan, and Wright, David J

Subjects
PHARMACOGENOMICS, EVALUATION of medical care, GENETIC testing, PRIMARY health care, DRUGS, DRUG prescribing, DRUG interactions, HEALTH care teams, PHYSICIAN practice patterns, DRUG side effects, PATIENT safety
Abstract

Pharmacogenetic (PGx) testing to personalise prescribing of certain medicines can improve patient outcomes and reduce adverse drug reactions. This article summarises the key findings of the PGx Impact study, designed to estimate the impact of pre‐emptive genetic testing on prescribing, and discusses potential ways in which pharmacogenetic testing may optimise primary care prescribing in the near future. [ABSTRACT FROM AUTHOR]

Published
2022
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