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2. Reasons for non-feasibility of therapeutic drug monitoring of oral targeted therapies in oncology – an analysis of the closed cohorts of a multicentre prospective study

Author

van der Kleij, Maud B. A., Guchelaar, Niels A. D., Meertens, Marinda, Westerdijk, Kim, Giraud, Eline L., Bleckman, Roos F., Groenland, Stefanie L., van Eerden, Ruben A. G., Imholz, Alex L. T., Vulink, Annelie J. E., Otten, Hans-Martin, Fiebrich-Westra, Helle-Brit, Lubberman, Floor J. E., Desar, Ingrid M. E., Moes, Dirk-Jan A. R., Touw, Daan J., Koolen, Stijn L. W., Gelderblom, Hans, Reyners, An K. L., van Erp, Nielka P., Mathijssen, Ron H. J., Huitema, Alwin D. R., and Steeghs, Neeltje

Published
2024
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4. Evaluating the Clinical Impact and Feasibility of Therapeutic Drug Monitoring of Pazopanib in a Real-World Soft-Tissue Sarcoma Cohort

Author

Meertens, Marinda, Giraud, Eline L., van der Kleij, Maud B. A., Westerdijk, Kim, Guchelaar, Niels A. D., Bleckman, Roos F., Rieborn, Amy, Imholz, Alex L. T, Otten, Hans-Martin, Vulink, Annelie, Los, Maartje, Hamberg, Paul, van der Graaf, Winette T. A., Gelderblom, Hans, Moes, Dirk Jan A. R., Broekman, K. Esther, Touw, Daan J., Koolen, Stijn L. W., Mathijssen, Ron H. J., Huitema, Alwin D. R., van Erp, Nielka P., Desar, Ingrid M. E., and Steeghs, Neeltje

Published
2024
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12. Iron Deficiency and Nephrotoxic Heavy Metals: A Dangerous Interplay?

Author

Rawee, Pien, Kremer, Daan, Nolte, Ilja M, Leuvenink, Henri GD, Touw, Daan J, De Borst, Martin H, Bakker, Stephan JL, Hanudel, Mark R, and Eisenga, Michele F

Subjects
Biochemistry and Cell Biology, Biological Sciences, Medicinal and Biomolecular Chemistry, Chemical Sciences, Microbiology, Kidney Disease, Nutrition, 2.1 Biological and endogenous factors, Aetiology, Renal and urogenital, Humans, Metals, Heavy, Iron, Heavy Metal Poisoning, Iron Deficiencies, Renal Insufficiency, Chronic, iron deficiency, heavy metals, nephrotoxic, chronic kidney disease, metal transporters, Other Chemical Sciences, Genetics, Other Biological Sciences, Chemical Physics, Biochemistry and cell biology, Medicinal and biomolecular chemistry
Abstract

Heavy metals are common in our environment, and all individuals are exposed to them to some extent. These toxic metals have several harmful effects on the body, including the kidney, which is a very sensitive organ. Indeed, heavy metal exposure has been linked to an increased risk of chronic kidney disease (CKD) and its progression, which may be explained by the well-established nephrotoxic effects of these metals. In this hypothesis and narrative literature review, we will shed light on the potential role that another highly common problem in patients with CKD, iron deficiency, may play in the damaging effects of heavy metal exposure in this patient group. Iron deficiency has previously been linked with an increased uptake of heavy metals in the intestine due to the upregulation of iron receptors that also take up other metals. Furthermore, recent research suggests a role of iron deficiency in the retention of heavy metals in the kidney. Therefore, we hypothesize that iron deficiency plays a crucial role in the damaging effects of heavy metal exposure in patients with CKD and that iron supplementation might be a strategy to combat these detrimental processes.

Published
2023

17. Iron deficiency, anemia, and patient-reported outcomes in kidney transplant recipients

Author

Ranchor, Adelta V., Gomes Neto, Antonio W., Diepstra, Arjan, Hepkema, Bouke G., Tji Gan, C., Doorenbos, Caecilia S.E., te Velde-Keyzer, Charlotte A., van Leer-Buter, Coretta, Touw, Daan J., Hak, Eelko, Verschuuren, Erik A.M., Bodewes, Frank A.J.A., Klont, Frank, Dijkstra, Gerard, Nieuwenhuis-Moeke, Gertrude J., Blokzijl, Hans, Leuvenink, Henri G.D., Niesters, Hubert G.M., Cas Swarte, J., Sanders, Jan Stephan F., Damman, Kevin, Joost van Pelt, L., van Londen, Marco, de Boer, Marieke T., Siebelink, Marion J., van den Heuvel, Marius C., Vos, Michel J., Erasmus, Michiel E., Douwes, Rianne M., Slart, Riemer J.H.J.A., Weersma, Rinse K., Pol, Robert A., Porte, Robert J., de Meijer, Vincent E., Lexmond, Willem S., Kremer, Daan, Knobbe, Tim J., Vinke, Joanna Sophia J., Groothof, Dion, Post, Adrian, Annema, Coby, Abrahams, Alferso C., van Jaarsveld, Brigit C., de Borst, Martin H., Berger, Stefan P., Bakker, Stephan J.L., and Eisenga, Michele F.

Published
2024
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23. Central Body Fat Distribution and Kidney Function after Living Kidney Donation

Author

Westenberg, Lisa B., Pol, Robert A., van der Weijden, Jessica, de Borst, Martin H., Bakker, Stephan J.L., van Londen, Marco, Annema, Coby, Berger, Stefan P., Blokzijl, Hans, Bodewes, Frank A.J.A., de Boer, Marieke T., Damman, Kevin, de Borst, Martin H., Diepstra, Arjan, Dijkstra, Gerard, Douwes, Rianne M., Doorenbos, Caecilia S.E., Eisenga, Michele F., Erasmus, Michiel E., Gan, C. Tji, Gomes Neto, Antonio W., Hak, Eelko, Hepkema, Bouke G., van den Heuvel, Marius C., Klont, Frank, Knobbe, Tim J., Kremer, Daan, van Leer-Buter, Coretta, Leuvenink, Henri G.D., van Londen, Marco, Lexmond, Willem S., de Meijer, Vincent E., Niesters, Hubert G.M., Nieuwenhuis-Moeke, Gertrude J., Joost van Pelt, L., Pol, Robert A., Porte, Robert J., Ranchor, Adelta V., Sanders, Jan Stephan F., Siebelink, Marion J., Slart, Riemer J.H.J.A., Swarte, J. Cas, Touw, Daan J., te Velde-Keyzer, Charlotte A., Verschuuren, Erik A.M., Vos, Michel J., Weersma, Rinse K., and Bakker, Stephan J.L.

Published
2024
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24. Biopharmaceutics

Author

Frijlink, Henderik, Lagarce, Frederic, Touw, Daan, Woerdenbag, Herman, Le Brun, Paul, editor, Crauste-Manciet, Sylvie, editor, Krämer, Irene, editor, Smith, Julian, editor, and Woerdenbag, Herman, editor

Published
2023
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25. Stability

Author

Touw, Daan, Thiesen, Judith, Vigneron, Jean, Le Brun, Paul, editor, Crauste-Manciet, Sylvie, editor, Krämer, Irene, editor, Smith, Julian, editor, and Woerdenbag, Herman, editor

Published
2023
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26. Irrigations and Dialysis Solutions

Author

Touw, Daan, Ragon, Alain, Mučicová, Olga, Le Brun, Paul, editor, Crauste-Manciet, Sylvie, editor, Krämer, Irene, editor, Smith, Julian, editor, and Woerdenbag, Herman, editor

Published
2023
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27. Muscle Mass, Muscle Strength, and Health-Related Quality of Life in Kidney Transplant Recipients: Results of the TransplantLines Biobank and Cohort Study

Author

Annema, Coby, Blokzijl, Hans, Bodewes, Frank AJA., de Boer, Marieke T., Damman, Kevin, de Borst, Martin H., Diepstra, Arjan, Dijkstra, Gerard, Doorenbos, Caecilia SE., Eisenga, Michele F., Erasmus, Michiel E., Gan, C Tji, Hak, Eelko, Hepkema, Bouke G., Leuvenink, Henri GD., Lexmond, Willem S., de Meijer, Vincent E., Niesters, Hubert GM., Joost van Pelt, L., Pol, Robert A., Porte, Robert J., Ranchor, Adelita V., Stephan F Sanders, Jan, Siebelink, Marion J., Slart, Riemer JHJA., Touw, Daan J., te Velde-Keyzer, Charlotte A., van den Heuvel, Marius C., van Leer-Buter, Coretta, van Londen, Marco, Verschuuren, Erik AM., Vos, Michel J., Weersma, Rinse K., Knobbe, Tim J., Lenis, Gijs M.M., van der Vossen, Dirk A.J., Wentink, Jory, Kremer, Daan, Quint, Evelien E., Gomes-Neto, Antonio W., Dullaart, Robin P.F., Berger, Stefan P., Franssen, Casper F.M., Bakker, Stephan.J.L., and Post, Adrian

Published
2024
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31. Correction: Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction between UGT1A1 and 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.

Published
2023
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32. Proton Pump Inhibitor Use, Fatigue, and Health-Related Quality of Life in Kidney Transplant Recipients: Results From the TransplantLines Biobank and Cohort Study

Author

Blokzijl, Hans, Bodewes, Frank A.J.A., de Boer, Marieke T., Damman, Kevin, de Borst, Martin H., Diepstra, Arjan, Dijkstra, Gerard, Doorenbos, Caecilia S.E., Erasmus, Michiel E., Gan, C. Tji, Hak, Eelko, Hepkema, Bouke G., Leuvenink, Henri G.D., Lexmond, Willem S., de Meijer, Vincent E., Niesters, Hubert G.M., van Pelt, L. Joost, Pol, Robert A., Porte, Robert J., Ranchor, Adelta V., Sanders, Jan Stephan F., Siebelink, Marion J., Slart, Riemer J.H.J.A., Touw, Daan J., van den Heuvel, Marius C., van Leer-Buter, Coretta, van Londen, Marco, Verschuuren, Erik A.M., Vos, Michel J., Weersma, Rinse K., Knobbe, Tim J., Kremer, Daan, Douwes, Rianne M., Eisenga, Michele F., Gomes-Neto, António W., Annema, Coby, Swarte, J. Casper, Klont, Frank, Navis, Gerjan, Berger, Stefan P., and Bakker, Stephan J.L.

Published
2023
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40. Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial.

Author

van Veldhuisen, Dirk J., Rienstra, Michiel, Mosterd, Arend, Alings, A. Marco, van Asselt, Antoinette D.J., Bouvy, Marcel L, Tijssen, Jan G.P., Schaap, Jeroen, van der Wall, Ernst E., Voors, Adriaan A., Boorsma, Eva M., Lok, Dirk J.A., Crijns, Harry J.G.M., Schut, Astrid, Vijver, Marlene A.T., Voordes, Geert H.D., de Vos, Agaath H., Maas‐Soer, Ester L., Smit, Nicoline W., and Touw, Daan J.

Subjects
VENTRICULAR ejection fraction, DIGOXIN, HEART failure patients, ATRIAL fibrillation, HEART failure
Abstract

Aims: Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low‐dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment. Methods: The DECISION trial is a randomized, double‐blind, parallel‐group, placebo‐controlled event‐driven outcome trial which will investigate the efficacy and safety of low‐dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low‐dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5–0.9 ng/ml, dose adjustments are made throughout follow‐up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients. Conclusions: The DECISION trial will provide important evidence regarding the effect of (low‐dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03783429. [ABSTRACT FROM AUTHOR]

Published
2024
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41. Urine cotinine versus self-reported smoking and the risk of chronic kidney disease.

Author

Kunutsor, Setor K, Dey, Richard S, Touw, Daan J, Bakker, Stephan J L, and Dullaart, Robin P F

Subjects
DISEASE risk factors, CHRONIC kidney failure, COTININE, KIDNEY development, SMOKING
Abstract

Background and hypothesis Evidence on the role of smoking in the development of chronic kidney disease (CKD) has mostly relied on self-reported smoking status. We aimed to compare the associations of smoking status as assessed by self-reports and urine cotinine with CKD risk. Methods Using the PREVEND prospective study, smoking status was assessed at baseline using self-reports and urine cotinine in 4333 participants (mean age, 52 years) without a history of CKD at baseline. Participants were classified as never, former, light current, and heavy current smokers according to self-reports and comparable cutoffs for urine cotinine. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated for CKD. Results The percentages of self-reported and cotinine-assessed current smokers were 27.5% and 24.0%, respectively. During a median follow-up of 7.0 years, 593 cases of CKD were recorded. In analyses adjusted for established risk factors, the HRs (95% CI) of CKD for self-reported former, light current, and heavy current smokers compared with never smokers were 1.17 (0.95–1.44), 1.48 (1.10–2.00), and 1.48 (1.14–1.93), respectively. On further adjustment for urinary albumin excretion (UAE), the HRs (95% CI) were 1.07 (0.87–1.32), 1.26 (0.93–1.70), and 1.20 (0.93–1.57), respectively. For urine cotinine-assessed smoking status, the corresponding HRs (95% CI) were 0.81 (0.52–1.25), 1.17 (0.92–1.49), and 1.32 (1.02–1.71), respectively, in analyses adjusted for established risk factors plus UAE. Conclusion Self-reported current smoking is associated with increased CKD risk, but dependent on UAE. The association between urine cotinine-assessed current smoking and increased CKD risk is independent of UAE. Urine cotinine-assessed smoking status may be a more reliable risk indicator for CKD incidence than self-reported smoking status. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Impact of obesity and roux‐en‐Y gastric bypass on the pharmacokinetics of (R)‐ and (S)‐omeprazole and intragastric pH.

Author

Pippa, Leandro F., Vozmediano, Valvanera, Mitrov‐Winkelmolen, Lieke, Touw, Daan, Soliman, Amira, Cristofoletti, Rodrigo, Salgado Junior, Wilson, and de Moraes, Natalia Valadares

Subjects
GASTRIC bypass, OMEPRAZOLE, CYTOCHROME P-450 CYP2C19, PROTON pump inhibitors, CYTOCHROME P-450 CYP3A, SMALL intestine, WEIGHT loss
Abstract

This study employed physiologically‐based pharmacokinetic–pharmacodynamics (PBPK/PD) modeling to predict the effect of obesity and gastric bypass surgery on the pharmacokinetics and intragastric pH following omeprazole treatment. The simulated plasma concentrations closely matched the observed data from non‐obese, morbidly obese, and post‐gastric bypass populations. Obesity significantly reduces CYP3A4 and CYP2C19 activities, as reflected by the metabolic ratio [omeprazole sulphone]/[omeprazole] and [5‐hydroxy‐omeprazole]/[omeprazole]. The morbidly obese model accounted for the down‐regulation of CYP2C19 and CYP3A4 to recapitulate the observed data. Sensitivity analysis showed that intestinal CYP3A4, gastric pH, small intestine bypass, and the delay in bile release do not have a major influence on omeprazole exposure. Hepatic CYP3A4 had a significant impact on the AUC of (S)‐omeprazole, while hepatic CYP2C19 affected both (R)‐ and (S)‐omeprazole AUC. After gastric bypass surgery, the activity of CYP3A4 and CYP2C19 is restored. The PBPK model was linked to a mechanism‐based PD model to assess the effect of omeprazole on intragastric pH. Following 40 mg omeprazole, the mean intragastric pH was 4.3, 4.6, and 6.6 in non‐obese, obese, and post‐gastric bypass populations, and the daily time with pH >4 was 14.7, 16.4, and 24 h. Our PBPK/PD approach provides a comprehensive understating of the impact of obesity and weight loss on CYP3A4 and CYP2C19 activity and omeprazole pharmacokinetics. Given that simulated intragastric pH is relatively high in post‐RYGB patients, irrespective of the dose of omeprazole, additional clinical outcomes are imperative to assess the effect of proton pump inhibitor in preventing marginal ulcers in this population. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Infliximab in paediatric inflammatory bowel disease: External evaluation of population pharmacokinetic models.

Author

Heikal, Omnia Salah, van Rheenen, Patrick F., Touw, Daan J., Kosterink, Jos G. W., Maurer, Marina, Koomen, Jeroen V., Chelle, Pierre, and Mian, Paola

Subjects
INFLAMMATORY bowel diseases, PHARMACOKINETICS, INFLIXIMAB, NECROSIS, PEDIATRICS
Abstract

Aims: Use of infliximab (IFX) has improved outcomes in children with inflammatory bowel disease (IBD). However, a proportion of patients does not respond to IFX or loses response over time. Population pharmacokinetic (PopPK) modelling is a promising approach for IFX dose optimization, but with the increasing number of PopPK models in literature, model evaluation is essential. The aims of this study are: (i) to validate the predictive performance of existing IFX PopPK models using a cohort of children with IBD; and (ii) to perform a Bayesian estimation of the most suitable model to predict the next IFX concentrations. Methods: PubMed was searched for IFX PopPK models in children. Selected models were rebuilt and analysed using R. Model performance was assessed through goodness‐of‐fit‐plots, residuals against time, prediction error and prediction‐corrected visual predictive checks. The validation cohort consisted of 73 children with IBD who were treated with IFX in our centre between 2017 and 2023 (340 IFX measurements). Results: We identified 9 PopPK models. Model bias for individual predicted values ranged from −9.29% to 8.01% compared to bias for population predicted values. The model by Vande Casteele et al. demonstrated superior performance (individual predicted bias 2.13, population predicted bias −6.11); upon Bayesian estimation, it predicted induction trough levels with median error of 12.95% but had a median error of −69% predicting maintenance concentrations. Conclusion: The model by Vande Casteele et al. displayed superior performance in initial evaluations but had a high error in estimating next IFX levels and can only be used in practice to predict induction levels. [ABSTRACT FROM AUTHOR]

Published
2024
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