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

Author

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-Gómez, 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-Carazo, Jesús, Yañez-Sanchez, Jose Julio, Blancas-López-Barajas, Mª Isabel, García-Orta, Rocío, González-Astorga, Beatriz, Rodríguez-González, Carlos José, Ruiz-Carazo, Francisco Javier, Pérez-Campos, Manuel, Cano-Herrera, Irene, Herrera, Rosa, Gil-Jiménez, Teresa, 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, Voncina, Blaz, Rajter, Branka, Škrinjar, Andrej, Marjetic Ulcakar, Angelika, Zidanšek, Anja, Stegne Ignjatvic, Tea, Mazej Poredoš, Barbara, Vivod Pecnik, Živka, Poplas Susic, Tonka, Juteršek, Milojka, Klen, Jasna, Skoporc, Janja, Kotar, Tjaša, Petek Šter, Marija, Zvezdana Dernovšk, Mojca, Mlinšek, Gregor, Miklavcic, Petra, Plemenitaš Ilješ, Anja, Grašic Kuhar, Cvetka, Oblak, Irena, Stražišar, Branka, Štrbac, Danijela, Matos, Erika, Mencinger, Marina, Vrbnjak, Marko, Saje, Marko, Radovanovic, Mirjana, Jeras, Katja, Bukovec, Lucija, Terzic, 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, Rajasingam, Arjunan, 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, and Guchelaar, Henk-Jan

Published
2023
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3. A 12-gene pharmacogenetic panel to prevent adverse drug reactions : an open-label, multicentre, controlled, cluster-randomised crossover implementation study

Author

Swen, JesseJ, van der Wouden, Cathelijne H., Manson, Lisanne E. N., Abdullah-Koolmees, Heshu, Blagec, Kathrin, Blagus, Tanja, Böhringer, Stefan, Cambon-Thomsen, Anne, Cecchin, Erika, Cheung, Ka-Chun, Deneer, Vera H. M., Dupui, Mathilde, Ingelman-Sundberg, Magnus, Jönsson, Siv, Joefield-Roka, Candace, Just, Katja S., Karlsson, Mats, 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., Fajardo, Cristina L. Davila, Dolzan, Vita, Patrinos, George P., Pirmohamed, Munir, Sunder-Plassmann, Gere, Toffoli, Giuseppe, Guchelaar, Henk-Jan, Swen, JesseJ, van der Wouden, Cathelijne H., Manson, Lisanne E. N., Abdullah-Koolmees, Heshu, Blagec, Kathrin, Blagus, Tanja, Böhringer, Stefan, Cambon-Thomsen, Anne, Cecchin, Erika, Cheung, Ka-Chun, Deneer, Vera H. M., Dupui, Mathilde, Ingelman-Sundberg, Magnus, Jönsson, Siv, Joefield-Roka, Candace, Just, Katja S., Karlsson, Mats, 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., Fajardo, Cristina L. Davila, Dolzan, Vita, Patrinos, George P., Pirmohamed, Munir, Sunder-Plassmann, Gere, Toffoli, Giuseppe, and Guchelaar, Henk-Jan

Abstract

Background: 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. Methods: We conducted an open-label, multicentre, controlled, cluster-randomised, crossover implementation study of a 12-gene pharmacogenetic panel in 18 hospitals, nine community health centres, and 28 community pharmacies in seven European countries (Austria, Greece, Italy, the Netherlands, Slovenia, Spain, and the UK). Patients aged 18 years or older receiving a first prescription for a drug clinically recommended in the guidelines of the Dutch Pharmacogenetics Working Group (ie, the index drug) as part of routine care were eligible for inclusion. Exclusion criteria included previous genetic testing for a gene relevant to the index drug, a planned duration of treatment of less than 7 consecutive days, and severe renal or liver insufficiency. All patients gave written informed consent before taking part in the study. Participants were genotyped for 50 germline variants in 12 genes, and those with an actionable variant (ie, a drug-gene interaction test result for which the Dutch Pharmacogenetics Working Group [DPWG] recommended a change to standard-of-care drug treatment) were treated according to DPWG recommendations. Patients in the control group received standard treatment. To prepare clinicians for pre-emptive pharmacogenetic testing, local teams were educated during a site-initiation visit and online educational material was made available. The primary outcome was the occurrence of clinically relevant adverse drug reactions within the 12-week follow-up period. Analyses were irrespective of patient adherence to the DPWG guidelines. The primary analysis was done using a gatekeeping analysis, in which outcomes in people with an actionable drug-gene interaction in the study group versus the

Published
2023
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6. 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
Full Text
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