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9. 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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16. Nutrimetric Validation of Solanidine as Dietary‐Derived CYP2D6 Activity Marker In Vivo.

Author

Müller, Julian Peter, Sarömba, Jens, Ziegler, Patrick, Tremmel, Roman, Rengelshausen, Jens, Schaeffeler, Elke, Just, Katja S., Schwab, Matthias, Kraus, Thomas, and Stingl, Julia C.

Subjects
METOPROLOL, CYTOCHROME P-450 CYP2D6, LIQUID chromatography-mass spectrometry, STEROIDAL alkaloids, POTATOES, DRUG metabolism, DRUG efficacy
Abstract

CYP2D6 is involved in the metabolism of many drugs. Its activity is affected by pharmacogenetic variability leading to highly polymorphic phenotypes between individuals, affecting safety and efficacy of drugs. Recently, solanidine, a steroidal alkaloid from potatoes, and its metabolites, has been identified as a dietary‐derived activity marker for CYP2D6. The intraday variability in plasma within individuals has not been studied yet in healthy subjects. As part of a CYP phenotyping cocktail study with 20 healthy participants, plasma concentrations of solanidine, 4‐OH‐solanidine and 3,4‐secosolanidine‐3,4‐dioic acid (SSDA) were determined using a sensitive liquid chromatography‐mass spectrometry method in urine and in plasma at timepoints 0, 2.5, 5, 8, and 24 hours after intake of test substances. The participants were phenotyped for CYP2D6 with oral metoprolol (12.5 mg) with 15 plasma sampling points over 24 hours (DRKS00028922). Metabolic ratios (MRs) of metabolite to parent plasma concentrations were formed from single timepoints and the area under the curve (AUC). All participants were genotyped for CYP2D6. The intra‐individual variability of the CYP2D6 metabolite SSDA was highly stable with a median SD of 11.62% over 24 hours. MR SSDA/solanidine was more variable (median SD 31.90%) but correlated significantly at all measured timepoints with AUC MR α‐OH‐metoprolol/metoprolol. The AUC MR SSDA/solanidine showed a significant linear relationship with the genetically predicted CYP2D6 activity score. This study substantiates the MR SSDA/solanidine as CYP2D6 activity marker. The high correlation with metoprolol MR indicates a valid prediction of the CYP2D6 phenotype at any timepoint during the study day. [ABSTRACT FROM AUTHOR]

Published
2024
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17. 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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24. Emergency Department Visits Due to Dyspnea: Association with Inhalation Therapy in COPD and Cases with Adverse Drug Reactions

Author

Bergs,Ingmar, Just,Katja S, Müller,Annegret, Stingl,Julia C, Dreher,Michael, Bergs,Ingmar, Just,Katja S, Müller,Annegret, Stingl,Julia C, and Dreher,Michael

Abstract

Ingmar Bergs,1 Katja S Just,2 Annegret Müller,1 Julia C Stingl,2,&ast; Michael Dreher1,&ast; 1Department of Pneumology and Internal Intensive Care Medicine, University Hospital RWTH Aachen, Aachen, Germany; 2Institute of Clinical Pharmacology, University Hospital RWTH Aachen, Aachen, Germany&ast;These authors contributed equally to this workCorrespondence: Ingmar Bergs, Department of Pneumology and Internal Intensive Care Medicine, University Hospital RWTH Aachen, Pauwelsstr. 30, Aachen, 52074, Germany, Tel +49 241/80 35443, Email ibergs@ukaachen.dePurpose: Dyspnea is a leading symptom of COPD that causes presentations in emergency departments or negatively impacts on them. Guideline-based inhalation therapies are intended to reduce dyspnea in COPD patients. This study analyzed how common guideline recommended inhalation therapy regimens are occurring in clinical practice among COPD patients presenting to emergency departments due to adverse drug reactions in polytherapy using data of the German ADRED database.Patients and Methods: In total, 269 COPD cases were identified. In a further analysis, all cases were analyzed for documented GOLD stage and guideline-recommended inhalation therapy for COPD. Dyspnea and other symptoms identified during ED presentation were analyzed and compared between patients who did and did not receive the guideline’s recommended inhalation therapy.Results: In this observation, 41% (n = 46) of all 112 cases with a documented COPD and GOLD stage received an underdosed therapy according to current guidelines. Dyspnea was the most common identified symptom (32%, n = 36) in this cohort and occurred more often in patients who received an underdosage of inhalation therapy (p < 0.01).Conclusion: Patients with COPD presenting to ED with ADRs show a high rate of non-guideline-recommended inhalation therapy and present more often with dyspnea compared to those COPD patients who received an adequate dosing of inhalation therapy.Keyw

Published
2022

25. Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)–Never Change a Running System?

Author

Just, Katja S., primary, Scholl, Catharina, additional, Boehme, Miriam, additional, Kastenmüller, Kathrin, additional, Just, Johannes M., additional, Bleckwenn, Markus, additional, Holdenrieder, Stefan, additional, Meier, Florian, additional, Weckbecker, Klaus, additional, and Stingl, Julia C., additional

Published
2021
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28. Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)–Never Change a Running System?

Author

Just, Katja S., Scholl, Catharina, Boehme, Miriam, Kastenmüller, Kathrin, Just, Johannes M., Bleckwenn, Markus, Holdenrieder, Stefan, Meier, Florian, Weckbecker, Klaus, Stingl, Julia C., Just, Katja S., Scholl, Catharina, Boehme, Miriam, Kastenmüller, Kathrin, Just, Johannes M., Bleckwenn, Markus, Holdenrieder, Stefan, Meier, Florian, Weckbecker, Klaus, and Stingl, Julia C.

Abstract

The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95%CI 1.02–2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05–3.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63–3.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.

Published
2021

29. 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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30. CYP2D6 in the Brain: Potential Impact on Adverse Drug Reactions in the Central Nervous System—Results From the ADRED Study

Author

Just, Katja S., primary, Dormann, Harald, additional, Freitag, Mathias, additional, Schurig, Marlen, additional, Böhme, Miriam, additional, Steffens, Michael, additional, Scholl, Catharina, additional, Seufferlein, Thomas, additional, Graeff, Ingo, additional, Schwab, Matthias, additional, and Stingl, Julia C., additional

Published
2021
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31. Additional file 5 of Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Author

Dubrall, Diana, Just, Katja S., Schmid, Matthias, Stingl, Julia C., and Sachs, Bernhardt

Abstract

Additional file 5 Supplementary Table 4. The three drug substances most frequently suspected for the three most frequently reported ADRs in the ADR reports of antithrombotic agents of younger adults and older adults.

Published
2020
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32. Additional file 3 of Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Author

Dubrall, Diana, Just, Katja S., Schmid, Matthias, Stingl, Julia C., and Sachs, Bernhardt

Subjects
hemic and lymphatic diseases
Abstract

Additional file 3 Supplementary Table 2. The number of ADR reports of the potentially inappropriate medications (PIMs) contained in the PRISCUS list in older adults (> 65 years).

Published
2020
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33. Additional file 1 of Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Author

Dubrall, Diana, Just, Katja S., Schmid, Matthias, Stingl, Julia C., and Sachs, Bernhardt

Abstract

Additional file 1 Supplementary Figure 1. The number of ADR reports per year for younger adults, older adults, patients aged 66-75 years, patients aged 76-85 years, patients aged ≥ 86 years (absolute numbers). Supplementary Table 1. The calculated ratio “number of ADR reports for older adults/number of ADR reports for younger adults” per year.

Published
2020
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34. Additional file 6 of Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Author

Dubrall, Diana, Just, Katja S., Schmid, Matthias, Stingl, Julia C., and Sachs, Bernhardt

Abstract

Additional file 6 Supplementary Table 5. Characteristics, drug indications, and ADRs in the ADR reports of younger adults and older adults in which rivaroxaban was suspected before and after extension of the indication (01/13/2012).

Published
2020
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36. Additional file 2 of Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Author

Dubrall, Diana, Just, Katja S., Schmid, Matthias, Stingl, Julia C., and Sachs, Bernhardt

Abstract

Additional file 2 Supplementary Document 1. The average number of ADR reports per 100,000 inhabitants/males/females and estimation of the number of ADR reports per 100,000 assumed drug-exposed inhabitants/males/females per age group.

Published
2020
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37. Adverse Drug Reactions in the Emergency Department: Is There a Role for Pharmacogenomic Profiles at Risk?—Results from the ADRED Study

Author

Just, Katja S., primary, Dormann, Harald, additional, Schurig, Marlen, additional, Böhme, Miriam, additional, Fracowiak, Jochen, additional, Steffens, Michael, additional, Scholl, Catharina, additional, Seufferlein, Thomas, additional, Gräff, Ingo, additional, Schwab, Matthias, additional, and Stingl, Julia C., additional

Published
2020
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38. The phenotype of adverse drug effects: Do emergency visits due to adverse drug reactions look different in older people? Results from the ADRED study

Author

Just, Katja S., primary, Dormann, Harald, additional, Schurig, Marlen, additional, Böhme, Miriam, additional, Steffens, Michael, additional, Plank‐Kiegele, Bettina, additional, Ettrich, Kristin, additional, Seufferlein, Thomas, additional, Gräff, Ingo, additional, Igel, Svitlana, additional, Schricker, Severin, additional, Jaeger, Simon U., additional, Schwab, Matthias, additional, and Stingl, Julia C., additional

Published
2020
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40. Personalising drug safety—results from the multi-centre prospective observational study on Adverse Drug Reactions in Emergency Departments (ADRED)

Author

Just, Katja S., primary, Dormann, Harald, additional, Böhme, Miriam, additional, Schurig, Marlen, additional, Schneider, Katharina L., additional, Steffens, Michael, additional, Dunow, Sandra, additional, Plank-Kiegele, Bettina, additional, Ettrich, Kristin, additional, Seufferlein, Thomas, additional, Gräff, Ingo, additional, Igel, Svitlana, additional, Schricker, Severin, additional, Jaeger, Simon U., additional, Schwab, Matthias, additional, and Stingl, Julia C., additional

Published
2019
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42. Adverse Drug Reactions (ADR) and Emergencies

Author

Schurig, A. Marlen, primary, Böhme, Miriam, additional, Just, Katja S., additional, Scholl, Catharina, additional, Dormann, Harald, additional, Plank-Kiegele, Bettina, additional, Seufferlein, Thomas, additional, Gräff, Ingo, additional, Schwab, Matthias, additional, and Stingl, Julia C., additional

Published
2018
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46. [Current Challenges in Pharmacotherapy].

Author

Just KS

Subjects
Aged, Drug Interactions, Humans, Cytochrome P-450 CYP2D6, Drug-Related Side Effects and Adverse Reactions epidemiology
Abstract

Analysis of preoperative medication is used to assess the benefit and risk associated with continuing or discontinuing medication before and during surgery. Identifying adverse drug reactions and assessing its risks often leads to uncertainty. Typical challenges are medication underuse, but also overuse occurs and is often more difficult to recognize, especially in the context of drug interactions and individual patient characteristics.Typical consequences of multi-medication and medical overuse may include an increased potential for drug interactions, an increased risk of adverse drug reactions and medication errors, and in particular in older adults, geriatric syndromes may occur or worsen. Adverse drug reactions may occur as a result of the dose administered and as an effect of time of exposure. Older, multi-morbid, and multi-medicated patients are often affected by adverse drug reactions. For drugs primarily metabolized via the phase I enzymes CYP2D6, CYP2C9, or CYP2C19, pharmacogenetically rapid or slow metabolism may result in altered drug exposures. Clinically relevant pharmacokinetic drug interactions frequently occur with drugs primarily metabolized via the phase I enzyme CYP3A4., Competing Interests: Erklärung zu finanziellen Interessen Forschungsförderung erhalten: nein; Honorar/geldwerten Vorteil für Referententätigkeit erhalten: nein; Bezahlter Berater/interner Schulungsreferent/Gehaltsempfänger: nein; Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an im Bereich der Medizin aktiven Firma: nein; Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an zu Sponsoren dieser Fortbildung bzw. durch die Fortbildung in ihren Geschäftsinteressen berührten Firma: nein. Erklärung zu nichtfinanziellen Interessen Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Published
2021
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