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110. Quality Assessment of Dried Blood Spots from Tuberculosis Patients from Four Countries

Author

Zuur, Marlanka A., Veenhof, Herman, Aleksa, Alena, Boveneind-Vrubleuskaya, Natascha van ‘t, Darmawan, Endang, Hasnain, Md Golam, Heysell, Scott K., Jongedijk, Erwin M., Koster, Remco A., Magis-Escurra, Cecile, Martinez, Nilza, Molinas, Gladys, Mondal, Dinesh, Mulyani, Ully Adhie, Perwitasari, Dyah A., Tsivunchyk, Andrej, Touw, Daan J, and Alffenaar, Jan-Wilem C.

Published
2019
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113. Micronutrient deficiencies and new-onset atrial fibrillation in a community-based cohort: data from PREVEND

Author

Al-Mubarak, Ali A., primary, Grote Beverborg, Niels, additional, Zwartkruis, Victor, additional, van Deutekom, Colinda, additional, de Borst, Martin H., additional, Gansevoort, Ron T., additional, Bakker, Stephan J. L., additional, Touw, Daan J., additional, de Boer, Rudolf A., additional, van der Meer, Peter, additional, Rienstra, Michiel, additional, and Bomer, Nils, additional

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

Author

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

Published
2023
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115. Placenta-on-a-Chip as an In Vitro Approach to Evaluate the Physiological and Structural Characteristics of the Human Placental Barrier upon Drug Exposure: A Systematic Review

Author

Elzinga, Femke A., primary, Khalili, Behrad, additional, Touw, Daan J., additional, Prins, Jelmer R., additional, Olinga, Peter, additional, Leuvenink, Henri G. D., additional, van Goor, Harry, additional, Gordijn, Sanne J., additional, Nagelkerke, Anika, additional, and Mian, Paola, additional

Published
2023
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116. Clinical Validation of a Capillary Blood Home-Based Self-Sampling Technique for Monitoring of Infliximab, Vedolizumab, and C-Reactive Protein Concentrations in Patients With Inflammatory Bowel Disease

Author

Otten, Antonius T, primary, van der Meulen, Hedwig H, additional, Steenhuis, Maurice, additional, Loeff, Floris C, additional, Touw, Daan J, additional, Kosterink, Jos G W, additional, Frijlink, Henderik W, additional, Rispens, Theo, additional, Dijkstra, Gerard, additional, Visschedijk, Marijn C, additional, and Bourgonje, Arno R, additional

Published
2023
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118. Endobronchial Valve Treatment Does Not Cause Significant Nickel Deposition in Lung Tissue

Author

Roodenburg, Sharyn A, Pouwels, Simon D, Klooster, Karin, Touw, Daan J, Slebos, Dirk-Jan, Pharmaceutical Analysis, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Medicinal Chemistry and Bioanalysis (MCB), Groningen Research Institute for Asthma and COPD (GRIAC), and Biopharmaceuticals, Discovery, Design and Delivery (BDDD)

Abstract

Bronchoscopic lung volume reduction using endobronchial valves (EBVs) is a treatment option for patients with severe emphysema. These EBVs are made out of a nitinol mesh covered by a silicone layer. Nitinol is an alloy of nickel and titanium and is commonly used in implantable medical devices because of its biocompatibility and memory-shape properties. However, there are some concerns that nickel ions can be released from nitinol-containing devices which might cause adverse health effects, especially in patients with a known nickel hypersensitivity. In vitro, it was found that EBV release significant amounts of nickel in the first hours. Our aim was to assess the nickel concentration in lung tissue from a patient who previously underwent EBV treatment but, due to treatment failure, underwent lung volume reduction surgery and to compare this to a reference sample. We found no significant difference in the median nickel concentration between the EBV-treated patient and the non-EBV-treated patient (0.270 vs. 0.328 μg/g, respectively, p = 0.693) and these concentrations were also comparable to previously published nickel concentrations in human lung tissue samples not having any medically implanted devices in the lung. Our results suggest that there is no significant long-term nickel deposition in lung tissue after EBV treatment.

Published
2023

119. Results From a Proficiency Testing Pilot for Immunosuppressant Microsampling Assays

Author

Veenhof, Herman, Koster, Remco A, Junier, Lenneke A T, Zweipfenning, Peter, Touw, Daan J, Pharmaceutical Analysis, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Medicinal Chemistry and Bioanalysis (MCB), Groningen Research Institute for Asthma and COPD (GRIAC), and Biopharmaceuticals, Discovery, Design and Delivery (BDDD)

Subjects
Pharmacology, Pharmacology (medical)
Abstract

BACKGROUND: Therapeutic Drug Monitoring (TDM) of immunosuppressive drugs is important for the prevention of allograft rejection in transplant patients. Several hospitals offer a microsampling service that provides patients the opportunity to sample a drop of blood from a fingerprick at home that can then be sent to the laboratory by mail. The aim of this study was to pilot an external quality control program.METHODS: Fourteen laboratories from seven countries participated (fully or partly) in three rounds of proficiency testing for the immunosuppressants tacrolimus, ciclosporin, everolimus, sirolimus and mycophenolic acid. The microsampling devices included the following: Whatman 903 and DMPK-C, HemaXis, Mitra and Capitainer-B. All assays were based on LC-MS/MS. In round 2, microsamples as well as liquid whole blood samples were sent, and one of these samples was a patient sample.RESULTS: Imprecision CV% values for the tacrolimus microsamples reported by individual laboratories ranged from 13.2% - 18.2%, 11.7% - 16.3%, and 12.2% - 18.6% for rounds 1, 2, and 3 respectively. For liquid whole blood (round 2), the imprecision CV% values ranged from 3.9% - 4.9%. For the other immunosuppressants, the results were similar. A great variety in analytical procedures was observed, especially the extraction method. For the patient sample, the microsample results led to different clinical decisions compared to that of the whole blood sample.CONCLUSIONS: Immunosuppressant microsampling methods show great interlaboratory variation compared to whole blood methods. This variation can influence clinical decision making. Thus, harmonization and standardization are needed. Proficiency testing should be performed regularly for laboratories that use immunosuppressant microsampling techniques in patient care.

Published
2022
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123. Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot–Based Methods for Therapeutic Drug Monitoring

Author

Capiau, Sara, Veenhof, Herman, Koster, Remco A., Bergqvist, Yngve, Boettcher, Michael, Halmingh, Otto, Keevil, Brian G., Koch, Birgit C.P., Linden, Rafael, Pistos, Constantinos, Stolk, Leo M., Touw, Daan J., Stove, Christophe P., and Alffenaar, Jan-Willem C.

Published
2019
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126. Micronutrient deficiencies and new-onset atrial fibrillation in a community-based cohort:data from PREVEND

Author

Al-Mubarak, Ali A., Grote Beverborg, Niels, Zwartkruis, Victor, van Deutekom, Colinda, de Borst, Martin H., Gansevoort, Ron T., Bakker, Stephan J.L., Touw, Daan J., de Boer, Rudolf A., van der Meer, Peter, Rienstra, Michiel, Bomer, Nils, Al-Mubarak, Ali A., Grote Beverborg, Niels, Zwartkruis, Victor, van Deutekom, Colinda, de Borst, Martin H., Gansevoort, Ron T., Bakker, Stephan J.L., Touw, Daan J., de Boer, Rudolf A., van der Meer, Peter, Rienstra, Michiel, and Bomer, Nils

Published
2023

127. 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, Swen, Jesse J, 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

Correction to: European Journal of Human Genetics https://doi.org/10.1038/s41431-022-01243-2, published online 28 November 2022

Published
2023

128. 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, Swen, Jesse J, 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 UGT1A1 gene) 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 UGT1A1 poor 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, UGT1A1 genotyping is considered "essential", indicating that UGT1A1 testing must be performed prior to initiating irinotecan treatment.

Published
2023

129. Needle spiking, het drogeren met een injectienaald

Author

NVIC, Other research (not in main researchprogram), Koppen, Hille, Gresnigt, Femke M J, van Ruyven, Paula, Balai, Majorie, Schippers, Emile F, Nugteren-van Lonkhuyzen, Annette, Touw, Daan J, NVIC, Other research (not in main researchprogram), Koppen, Hille, Gresnigt, Femke M J, van Ruyven, Paula, Balai, Majorie, Schippers, Emile F, Nugteren-van Lonkhuyzen, Annette, and Touw, Daan J

Published
2023

130. Global estimates and determinants of antituberculosis drug pharmacokinetics in children and adolescents : a systematic review and individual patient data meta-analysis

Author

Gafar, Fajri, Wasmann, Roeland E., McIlleron, Helen M., Aarnoutse, Rob E., Schaaf, H. Simon, Marais, Ben J., Agarwal, Dipti, Antwi, Sampson, Bang, Nguyen D., Bekker, Adrie, Bell, David J., Chabala, Chishala, Choo, Louise, Davies, Geraint R., Day, Jeremy N., Dayal, Rajeshwar, Denti, Paolo, Donald, Peter R., Engidawork, Ephrem, Garcia-Prats, Anthony J., Gibb, Diana, Graham, Stephen M., Hesseling, Anneke C., Heysell, Scott K., Idris, Misgana I., Kabra, Sushil K., Kinikar, Aarti, Kumar, Agibothu K. Hemanth, Kwara, Awewura, Lodha, Rakesh, Magis-Escurra, Cecile, Martinez, Nilza, Mathew, Binu S., Mave, Vidya, Mduma, Estomih, Mlotha-Mitole, Rachel, Mpagama, Stellah G., Mukherjee, Aparna, Nataprawira, Heda M., Peloquin, Charles A., Pouplin, Thomas, Ramachandran, Geetha, Ranjalkar, Jaya, Roy, Vandana, Ruslami, Rovina, Shah, Ira, Singh, Yatish, Sturkenboom, Marieke G. G., Svensson, Elin M., Swaminathan, Soumya, Thatte, Urmila, Thee, Stephanie, Thomas, Tania A., Tikiso, Tjokosela, Touw, Daan J., Turkova, Anna, Velpandian, Thirumurthy, Verhagen, Lilly M., Winckler, Jana L., Yang, Hongmei, Yunivita, Vycke, Taxis, Katja, Stevens, Jasper, Alffenaar, Jan-Willem C., Gafar, Fajri, Wasmann, Roeland E., McIlleron, Helen M., Aarnoutse, Rob E., Schaaf, H. Simon, Marais, Ben J., Agarwal, Dipti, Antwi, Sampson, Bang, Nguyen D., Bekker, Adrie, Bell, David J., Chabala, Chishala, Choo, Louise, Davies, Geraint R., Day, Jeremy N., Dayal, Rajeshwar, Denti, Paolo, Donald, Peter R., Engidawork, Ephrem, Garcia-Prats, Anthony J., Gibb, Diana, Graham, Stephen M., Hesseling, Anneke C., Heysell, Scott K., Idris, Misgana I., Kabra, Sushil K., Kinikar, Aarti, Kumar, Agibothu K. Hemanth, Kwara, Awewura, Lodha, Rakesh, Magis-Escurra, Cecile, Martinez, Nilza, Mathew, Binu S., Mave, Vidya, Mduma, Estomih, Mlotha-Mitole, Rachel, Mpagama, Stellah G., Mukherjee, Aparna, Nataprawira, Heda M., Peloquin, Charles A., Pouplin, Thomas, Ramachandran, Geetha, Ranjalkar, Jaya, Roy, Vandana, Ruslami, Rovina, Shah, Ira, Singh, Yatish, Sturkenboom, Marieke G. G., Svensson, Elin M., Swaminathan, Soumya, Thatte, Urmila, Thee, Stephanie, Thomas, Tania A., Tikiso, Tjokosela, Touw, Daan J., Turkova, Anna, Velpandian, Thirumurthy, Verhagen, Lilly M., Winckler, Jana L., Yang, Hongmei, Yunivita, Vycke, Taxis, Katja, Stevens, Jasper, and Alffenaar, Jan-Willem C.

Abstract

Background Suboptimal exposure to antituberculosis (anti-TB) drugs has been associated with unfavourable treatment outcomes. We aimed to investigate estimates and determinants of first-line anti-TB drug pharmacokinetics in children and adolescents at a global level. Methods We systematically searched MEDLINE, Embase and Web of Science (1990–2021) for pharmacokinetic studies of first-line anti-TB drugs in children and adolescents. Individual patient data were obtained from authors of eligible studies. Summary estimates of total/extrapolated area under the plasma concentration–time curve from 0 to 24 h post-dose (AUC0–24) and peak plasma concentration (Cmax) were assessed with random-effects models, normalised with current World Health Organization-recommended paediatric doses. Determinants of AUC0–24 and Cmax were assessed with linear mixed-effects models. Results Of 55 eligible studies, individual patient data were available for 39 (71%), including 1628 participants from 12 countries. Geometric means of steady-state AUC0–24 were summarised for isoniazid (18.7 (95% CI 15.5–22.6) h·mg·L−1), rifampicin (34.4 (95% CI 29.4–40.3) h·mg·L−1), pyrazinamide (375.0 (95% CI 339.9–413.7) h·mg·L−1) and ethambutol (8.0 (95% CI 6.4–10.0) h·mg·L−1). Our multivariate models indicated that younger age (especially <2 years) and HIV-positive status were associated with lower AUC0–24 for all first-line anti-TB drugs, while severe malnutrition was associated with lower AUC0–24 for isoniazid and pyrazinamide. N-acetyltransferase 2 rapid acetylators had lower isoniazid AUC0–24 and slow acetylators had higher isoniazid AUC0–24 than intermediate acetylators. Determinants of Cmax were generally similar to those for AUC0–24. Conclusions This study provides the most comprehensive estimates of plasma exposures to first-line anti-TB drugs in children and adolescents. Key determinants of drug exposures were identified. These may be relevant for population-specific dose adjustment or individualis

Published
2023
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131. Correction: Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction between UGT1A1 and irinotecan

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, 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, Swen, Jesse J, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, 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

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

Author

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., Bakker, Stephan J.L., 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., Bakker, Stephan J.L., 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., and Weersma, Rinse K.

Abstract

Rationale & Objective: Prior studies report that the use of proton pump inhibitors (PPIs) can adversely affect gut microbiota and gastrointestinal uptake of micronutrients, in particular iron and magnesium, and are used frequently by kidney transplant recipients. Altered gut microbiota, iron deficiency, and magnesium deficiency have been implicated in the pathogenesis of chronic fatigue. Therefore, we hypothesized that PPI use may be an important and underappreciated cause of fatigue and reduced health-related quality of life (HRQoL) in this population. Study Design: Cross-sectional study. Setting & Participants: Kidney transplant recipients (≥1 year after transplantation) enrolled in the TransplantLines Biobank and Cohort Study. Exposure: PPI use, PPI type, PPI dosage, and duration of PPI use. Outcome: Fatigue and HRQoL, assessed using the validated Checklist Individual Strength 20 Revised questionnaire and Short Form-36 questionnaire. Analytical Approach: Logistic and linear regression. Results: We included 937 kidney transplant recipients (mean age 56 ± 13 years, 39% female) at a median of 3 (1-10) years after transplantation. PPI use was associated with fatigue severity (regression coefficient 4.02, 95% CI, 2.18 to 5.85, P < 0.001), a higher risk of severe fatigue (OR 2.05, 95% CI, 1.48 to 2.84, P < 0.001), lower physical HRQoL (regression coefficient −8.54, 95% CI, −11.54 to −5.54, P < 0.001), and lower mental HRQoL (regression coefficient −4.66, 95% CI, −7.15 to −2.17, P < 0.001). These associations were independent of potential confounders including age, time since transplantation, history of upper gastrointestinal disease, antiplatelet therapy, and the total number of medications. They were present among all individually assessed PPI types and were dose dependent. Duration of PPI exposure was only associated with fatigue severity. Limitations: Residual confounding and inability to assess causal relationships. Conclusions: PPI use is in

Published
2023

133. Dutch pharmacogenetics working group (DPWG) guideline for the gene-drug interaction between UGT1A1 and irinotecan

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, 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, Swen, Jesse J, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, 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

134. Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients:Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC)

Author

Meertens, Marinda, Muntinghe-Wagenaar, M Benthe, Sikkema, Barend J, Lopez-Yurda, Marta, Retèl, Valesca P, Paats, Marthe S, Ter Heine, Rob, Schuuring, Ed, Timens, Wim, Touw, Daan J, van Boven, Job F M, de Langen, Adrianus J, Hashemi, Sayed M S, Hendriks, Lizza E L, Croes, Sander, van den Heuvel, Michel M, Dingemans, Anne-Marie C, Mathijssen, Ron H J, Smit, Egbert F, Huitema, Alwin D R, Steeghs, Neeltje, van der Wekken, Anthonie J, Meertens, Marinda, Muntinghe-Wagenaar, M Benthe, Sikkema, Barend J, Lopez-Yurda, Marta, Retèl, Valesca P, Paats, Marthe S, Ter Heine, Rob, Schuuring, Ed, Timens, Wim, Touw, Daan J, van Boven, Job F M, de Langen, Adrianus J, Hashemi, Sayed M S, Hendriks, Lizza E L, Croes, Sander, van den Heuvel, Michel M, Dingemans, Anne-Marie C, Mathijssen, Ron H J, Smit, Egbert F, Huitema, Alwin D R, Steeghs, Neeltje, and van der Wekken, Anthonie J

Abstract

Background: Alectinib is first-line therapy in patients with stage IV non-small cell lung carcinoma (NSCLC) and an anaplastic lymphoma kinase (ALK) fusion. A shorter median progression-free survival (mPFS) was observed when alectinib minimum plasma concentrations during steady state (C min,SS) were below 435 ng/mL. This may suggest that patients should have an alectinib C min,SS ≥ 435 ng/mL for a more favorable outcome. This potential target could be attained by using therapeutic drug monitoring (TDM), i.e. adjusting the dose based on measured plasma trough concentrations. Hypothetically, this will increase mPFS, but this has not yet been evaluated in a randomized controlled trial (RCT). Therefore, the ADAPT ALEC trial is designed, with the primary objective to prolong mPFS in NSCLC patients treated with alectinib by using TDM. Methods: ADAPT ALEC is a multicenter, phase IV RCT, in which patients aged ≥ 18 years with advanced ALK positive (+) NSCLC eligible for alectinib in daily care are enrolled. Participants will be randomized (1:1 ratio) into intervention arm A (TDM) or B (control), stratified by brain metastases and prior ALK treatments. Starting dose in both arms is the approved flat fixed dose of alectinib 600 mg taken twice daily with food. In case of alectinib C min,SS < 435 ng/mL, arm A will receive increased doses of alectinib till C min,SS≥ 435 ng/mL when considered tolerable. The primary outcome is mPFS, where progressive disease is defined according to RECIST v1.1 or all-cause death and assessed by CT-scans and MRI brain. Secondary endpoints are feasibility and tolerability of TDM, patient and physician adherence, overall response rate, median overall survival, intracranial PFS, quality of life, toxicity, alectinib-M4 concentrations and cost-effectiveness of TDM. Exploratory endpoints are circulating tumor DNA and body composition. Discussion: The ADAPT ALEC will show whether treatment outcomes of patie

Published
2023

135. Correction: Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction between UGT1A1 and irinotecan (European Journal of Human Genetics, (2023), 31, 9, (982-987), 10.1038/s41431-022-01243-2)

Author

Apotheek Klinische Farmacie, 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, Swen, Jesse J, Apotheek Klinische Farmacie, 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

136. Dutch pharmacogenetics working group (DPWG) guideline for the gene–drug interaction between UGT1A1 and irinotecan

Author

Apotheek Klinische Farmacie, 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, Swen, Jesse J., Apotheek Klinische Farmacie, 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

137. Acute Effects of Insulin Infusion on Kidney Hemodynamic Function in People With Type 2 Diabetes and Normal Kidney Function

Author

MS Nefrologie, Regenerative Medicine and Stem Cells, Nefro Vasculaire Geneeskunde, van Baar, Michaël J.B., van Bommel, Erik J.M., Touw, Daan J., Nieuwdorp, Max, Joles, Jaap A., Krebber, Merle M., Bjornstad, Petter, van Raalte, Daniël H., MS Nefrologie, Regenerative Medicine and Stem Cells, Nefro Vasculaire Geneeskunde, van Baar, Michaël J.B., van Bommel, Erik J.M., Touw, Daan J., Nieuwdorp, Max, Joles, Jaap A., Krebber, Merle M., Bjornstad, Petter, and van Raalte, Daniël H.

Published
2023

138. Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC)

Author

Arts-assistenten Radiologie, Apotheek O&O&O, Cancer, Externen Med. Onco, Meertens, Marinda, Muntinghe-Wagenaar, M. Benthe, Sikkema, Barend J., Lopez-Yurda, Marta, Retèl, Valesca P., Paats, Marthe S., Ter Heine, Rob, Schuuring, Ed, Timens, Wim, Touw, Daan J., van Boven, Job F.M., de Langen, Adrianus J., Hashemi, Sayed M.S., Hendriks, Lizza E.L., Croes, Sander, van den Heuvel, Michel M., Dingemans, Anne Marie C., Mathijssen, Ron H.J., Smit, Egbert F., Huitema, Alwin D.R., Steeghs, Neeltje, van der Wekken, Anthonie J., Arts-assistenten Radiologie, Apotheek O&O&O, Cancer, Externen Med. Onco, Meertens, Marinda, Muntinghe-Wagenaar, M. Benthe, Sikkema, Barend J., Lopez-Yurda, Marta, Retèl, Valesca P., Paats, Marthe S., Ter Heine, Rob, Schuuring, Ed, Timens, Wim, Touw, Daan J., van Boven, Job F.M., de Langen, Adrianus J., Hashemi, Sayed M.S., Hendriks, Lizza E.L., Croes, Sander, van den Heuvel, Michel M., Dingemans, Anne Marie C., Mathijssen, Ron H.J., Smit, Egbert F., Huitema, Alwin D.R., Steeghs, Neeltje, and van der Wekken, Anthonie J.

Published
2023

146. Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC)

Author

Meertens, Marinda, primary, Muntinghe-Wagenaar, M. Benthe, additional, Sikkema, Barend J., additional, Lopez-Yurda, Marta, additional, Retèl, Valesca P., additional, Paats, Marthe S., additional, Ter Heine, Rob, additional, Schuuring, Ed, additional, Timens, Wim, additional, Touw, Daan J., additional, van Boven, Job F. M., additional, de Langen, Adrianus. J., additional, Hashemi, Sayed M. S., additional, Hendriks, Lizza E. L., additional, Croes, Sander, additional, van den Heuvel, Michel M., additional, Dingemans, Anne-Marie C., additional, Mathijssen, Ron H. J., additional, Smit, Egbert F., additional, Huitema, Alwin D. R., additional, Steeghs, Neeltje, additional, and van der Wekken, Anthonie J., additional

Published
2023
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147. Tremor, Daily Functioning, and Health-Related Quality of Life in Solid Organ Transplant Recipients

Author

Riemersma, Niels L., Kremer, Daan, Knobbe, Tim J., Gan, C. Tji, Nolte, Svea, Gomes-Neto, António W., Blokzijl, Hans, de Meijer, Vincent E., Damman, Kevin, Eisenga, Michele F., Drost, Gea, Elting, Jan Willem J., Touw, Daan J., Berger, Stefan P., Bakker, Stephan J.L., van der Stouwe, A. M. Madelein, Cardiovascular Centre (CVC), Movement Disorder (MD), Pharmaceutical Analysis, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Groningen Research Institute for Asthma and COPD (GRIAC), Medicinal Chemistry and Bioanalysis (MCB), Groningen Kidney Center (GKC), and Groningen Institute for Organ Transplantation (GIOT)

Subjects
ADL impairment, health-related quality of life, calcineurin inhibitors, solid organ transplant recipient, tremor
Abstract

Solid organ transplant recipients (SOTR) frequently report tremor. Data concerning tremor-related impairment and its potential impact on health-related quality of life (HRQoL) are lacking. This cross-sectional study assesses impact of tremor on activities of daily living and HRQoL using validated questionnaires among SOTR enrolled in the TransplantLines Biobank and Cohort Study. We included 689 SOTR (38.5% female, mean [±SD] age 58 [±14] years) at median [interquartile range] 3 [1–9] years after transplantation, of which 287 (41.7%) reported mild or severe tremor. In multinomial logistic regression analyses, whole blood tacrolimus trough concentration was an independent determinant of mild tremor (OR per µg/L increase: 1.11, 95% CI: 1.02 to 1.21, p = 0.019). Furthermore, in linear regression analyses, severe tremor was strongly and independently associated with lower physical and mental HRQoL (β = −16.10, 95% CI: −22.23 to −9.98, p < 0.001 and β = −12.68, 95% CI: −18.23 to −7.14, p < 0.001 resp.). SOTR frequently report tremor-related impairment of activities of daily living. Tacrolimus trough concentrations appeared as a main determinant of tremor among SOTR. The strong and independent association of tremor-related impairment with lower HRQoL warrants further studies into the effects of tacrolimus on tremor. Clinical Trial Registration: ClinicalTrials.gov, Identifier NCT03272841.

Published
2023

148. Needle spiking, het drogeren met een injectienaald

Author

Koppen, Hille, Gresnigt, Femke M J, van Ruyven, Paula, Balai, Majorie, Schippers, Emile F, Nugteren-van Lonkhuyzen, Annette, Touw, Daan J, Farmaceutische Analyse, Critical care, Anesthesiology, Peri-operative and Emergency medicine, Biopharmaceuticals, Discovery, Design and Delivery, Groningen Research Institute for Asthma and COPD, and Synthesis and Analysis

Subjects
Male, Adult, Young Adult, Informed Consent, Ethanol, Humans, Female, Substance Abuse, Intravenous, Netherlands
Abstract

BACKGROUND: In the Netherlands therewereseveralreports on needlespiking: people have found themselvessubjectedtosurreptitiousinjections. CASE DESCRIPTION: A 23-year-old female was seenafterbeingsurroundedby a group of men andfeltwhatshethought was a jab. She was abletoevadethegroup. Several minutes later sheexperienceddizziness, nausea andvomiting. On physical examination, a bleedingpuncturewound was seen on her upper arm withaccompanying erythema. Toxicology on bloodand urine didnot show evidenceforintoxicationotherthan alcohol which was higherthanwouldbesuspectedbythenumber of drinks thevictimreported. CONCLUSION: There is evidencethatpeople are puncturedwithneedles in busy surroundings like thenightlife. Possiblealso drugs are injected. Experiencedsymptomsbyvictims (n=19) wereheterogeneousandnotlikelyattributedtooneandthesamecausal drug. Toxicologydidnotrevealanysubstanceuntilnow.

Published
2023

149. Standard ganciclovir dosing results in slow decline of cytomegalovirus viral loads

Author

Märtson, Anne-Grete, Sturkenboom, Marieke G. G., Knoester, Marjolein, van der Werf, Tjip S., Alffenaar, Jan-Willem C., Hope, William, Edwina, Angela E., Burgerhof, Johannes G. M., Berger, Stefan P., de Joode, Anoek, Damman, Kevin, Verschuuren, Erik A. M., Blokzijl, Hans, Bakker, Martijn, Touw, Daan J., rtson, Anne-Grete Mä, and Microbes in Health and Disease (MHD)

Subjects
Pharmacology, Microbiology (medical), Antiviral Agents/therapeutic use, viruses, virus diseases, Cytomegalovirus, Viral Load, Antiviral Agents, Editor's Choice, AcademicSubjects/MED00290, Infectious Diseases, Ganciclovir/therapeutic use, AcademicSubjects/MED00740, Humans, Valganciclovir, Pharmacology (medical), AcademicSubjects/MED00230, Ganciclovir, Original Research
Abstract

Background Cytomegalovirus (CMV) can cause severe disease, including rejection in transplant recipients. Ganciclovir and its oral prodrug valganciclovir have been used as first-line therapy for CMV disease in transplant recipients. The exposure targets of ganciclovir are not exactly known, and toxicity and resistance have interfered with ganciclovir therapy. Objectives To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ganciclovir in transplant recipients. Methods We used patient data from a previous observational study on ganciclovir therapeutic drug monitoring (TDM) in prophylaxis and therapy. The ganciclovir concentrations and CMV viral loads were determined during routine clinical care. The PK/PD population modelling and simulations were done with non-parametric methodology using the Pmetrics program. Results Eighty-five patients were included in the PK modelling. The final PK model was a two-compartment model with first-order absorption and elimination. A subset of 17 patients on CMV therapy were included in the PD modelling. A median of 4 (range 2–8) viral loads were obtained per patient. A simulation of 10 000 patients showed that an approximately 1 log10 reduction of CMV viral load will be observed after 12.5 days at the current recommended dose. Conclusions The developed linked PK/PD population model and subsequent PD simulations showed slow decline of CMV viral load and it appears that dosing of (val)ganciclovir in this study might have been inadequate to achieve fast reduction of viral load. It is clear that further studies are needed to specify the PD effects of ganciclovir by performing systematic measurements of both ganciclovir concentrations and CMV viral loads.

Published
2022

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