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140 results on '"Bolhuis, Mathieu S."'

2. Repurposing SGLT2 inhibitors: Treatment of renal proximal tubulopathy in Fanconi‐Bickel syndrome with empagliflozin.

Author

Overduin, Ruben J., Grünert, Sarah C., Besouw, Martine T. P., Bolhuis, Mathieu S., Groen, Joost, Schreuder, Andrea B., Woidy, Mathias, Murko, Simona, Santer, René, and Derks, Terry G. J.

Abstract

Renal proximal tubulopathy in Fanconi‐Bickel syndrome is caused by impaired basolateral glucose transport via GLUT2 and consequently, intracellular accumulation of glucose and glycogen. SGLT2 inhibitors act on apical glucose reabsorption of renal proximal tubular cells. The purpose of this study was to retrospectively describe the first experiences with repurposing the SGLT2 inhibitor empagliflozin to treat the generalized tubulopathy in Fanconi‐Bickel syndrome. A case series was conducted of seven persons from five families (five males, two females; three children, who were 14y5m, 2y9m, and 1y6m old) with genetically confirmed Fanconi‐Bickel syndrome, off‐label treated with empagliflozin. Median (range) age at start of empagliflozin was 27 years (1y6m – 61y) and duration of follow‐up under empagliflozin treatment was 169 days (57–344). Under empagliflozin (up to 25 mg/d), biochemical parameters of tubular cell integrity (urinary N‐acetyl‐glucosaminidase) and/or tubular functions (including urinary α1‐microglobulin) improved in all persons with Fanconi‐Bickel syndrome, albeit to varying degrees. Clinically, supplementations (i.e., phosphate, alkali, carnitine, and alfacalcidol) could be completely discontinued in the three children, whereas results in the four adult patients were more variable and not as significant. Empagliflozin was well‐tolerated and no symptomatic hypoglycemia was observed. In conclusion, SGLT2 inhibitors such as empagliflozin shift the metabolic block in Fanconi‐Bickel syndrome, that is, they intervene specifically in the underlying pathophysiology and can thus attenuate renal proximal tubulopathy, especially when started in early childhood. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Repurposing empagliflozin in individuals with glycogen storage disease Ib: A value‐based healthcare approach and systematic benefit‐risk assessment

Author

Derks, Terry G. J., primary, Venema, Annieke, additional, Köller, Clara, additional, Bos, Eline, additional, Overduin, Ruben J., additional, Stolwijk, Nina N., additional, Hofbauer, Peter, additional, Bolhuis, Mathieu S., additional, van Eenennaam, Fred, additional, Groen, Henk, additional, Hollak, Carla E. M., additional, and Wortmann, Saskia B., additional

Published
2024
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9. Derivation and Clinical Utility of Safety Targets for Linezolid-Related Adverse Events in Drug-Resistant Tuberculosis Treatment

Author

Keutzer, Lina, Mockeliunas, Laurynas, Sturkenboom, Marieke G. G., Bolhuis, Mathieu S., Akkerman, Onno W., Simonsson, Ulrika S. H., Keutzer, Lina, Mockeliunas, Laurynas, Sturkenboom, Marieke G. G., Bolhuis, Mathieu S., Akkerman, Onno W., and Simonsson, Ulrika S. H.

Abstract

Long-term usage of linezolid can result in adverse events such as peripheral neuropathy, anemia and thrombocytopenia. Therapeutic drug monitoring data from 75 drug-resistant tuberculosis patients treated with linezolid were analyzed using a time-to-event (TTE) approach for peripheral neuropathy and anemia and indirect response modelling for thrombocytopenia. Different time-varying linezolid pharmacokinetic exposure indices (AUC0-24h,ss, Cav, Cmax and Cmin) and patient characteristics were investigated as risk factors. A treatment duration shorter than 3 months was considered dropout and was modelled using a TTE approach. An exposure-response relationship between linezolid Cmin and both peripheral neuropathy and anemia was found. The exposure index which best described the development of thrombocytopenia was AUC0-24h. The final TTE dropout model indicated an association between linezolid Cmin and dropout. New safety targets for each adverse event were proposed which can be used for individualized linezolid dosing. According to the model predictions at 6 months of treatment, a Cmin of 0.11 mg/L and 1.4 mg/L should not be exceeded to keep the cumulative probability to develop anemia and peripheral neuropathy below 20%. The AUC0-24h should be below 111 h center dot mg/L or 270 h center dot mg/L to prevent thrombocytopenia and severe thrombocytopenia, respectively. A clinical utility assessment showed that the currently recommended dose of 600 mg once daily is safer compared to a 300 mg BID dosing strategy considering all four safety endpoints.

Published
2023
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12. Combining digital adherence technology and therapeutic drug monitoring for personalised tuberculosis care

Author

Ghimire, Samiksha, primary, Iskandar, Deni, additional, van der Borg-Boekhout, Roelina, additional, Zenina, Marina, additional, Bolhuis, Mathieu S., additional, Kerstjens, Huib A.M., additional, van Rossum, Marieke, additional, Touw, Daan J., additional, Zijp, Tanja R., additional, van Boven, Job F.M., additional, and Akkerman, Onno W., additional

Published
2022
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14. Model-Informed Precision Dosing of Linezolid in Patients with Drug-Resistant Tuberculosis

Author

Mockeliunas, Laurynas, Keutzer, Lina, Sturkenboom, Marieke G. G., Bolhuis, Mathieu S., Hulskotte, Lotte M. G., Akkerman, Onno W., Simonsson, Ulrika S. H., Mockeliunas, Laurynas, Keutzer, Lina, Sturkenboom, Marieke G. G., Bolhuis, Mathieu S., Hulskotte, Lotte M. G., Akkerman, Onno W., and Simonsson, Ulrika S. H.

Abstract

Linezolid is an efficacious medication for the treatment of drug-resistant tuberculosis but has been associated with serious safety issues that can result in treatment interruption. The objectives of this study were thus to build a population pharmacokinetic model and to use the developed model to establish a model-informed precision dosing (MIPD) algorithm enabling safe and efficacious dosing in patients with multidrug- and extensively drug-resistant tuberculosis. Routine hospital therapeutic drug monitoring data, collected from 70 tuberculosis patients receiving linezolid, was used for model development. Efficacy and safety targets for MIPD were the ratio of unbound area under the concentration versus time curve between 0 and 24 h over minimal inhibitory concentration (fAUC(0-24h)/MIC) above 119 and unbound plasma trough concentration (fC(min)) below 1.38 mg/L, respectively. Model building was performed in NONMEM 7.4.3. The final population pharmacokinetic model consisted of a one-compartment model with transit absorption and concentration- and time-dependent auto-inhibition of elimination. A flat dose of 600 mg once daily was appropriate in 67.2% of the simulated patients from an efficacy and safety perspective. Using the here developed MIPD algorithm, the proportion of patients reaching the efficacy and safety target increased to 81.5% and 88.2% using information from two and three pharmacokinetic sampling occasions, respectively. This work proposes an MIPD approach for linezolid and suggests using three sampling occasions to derive an individualized dose that results in adequate efficacy and fewer safety concerns compared to flat dosing.

Published
2022
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15. Influence of Receptor Polymorphisms on the Response to α-Adrenergic Receptor Blockers in Pheochromocytoma Patients

Author

Berends, Annika M. A., primary, Bolhuis, Mathieu S., additional, Nolte, Ilja M., additional, Buitenwerf, Edward, additional, Links, Thera P., additional, Timmers, Henri J. L. M., additional, Feelders, Richard A., additional, Eekhoff, Elisabeth M. W., additional, Corssmit, Eleonora P. M., additional, Bisschop, Peter H., additional, Haak, Harm R., additional, van Schaik, Ron H. N., additional, el Bouazzaoui, Samira, additional, Wilffert, Bob, additional, and Kerstens, Michiel N., additional

Published
2022
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17. Clinical Relevance of Rifampicin‐Moxifloxacin Interaction in Isoniazid-Resistant/Intolerant Tuberculosis Patients

Author

Vogensen, Vanessa B., primary, Bolhuis, Mathieu S., additional, Sturkenboom, Marieke G. G., additional, van der Werf, Tjip S., additional, de Lange, Wiel C. M., additional, Anthony, Richard M., additional, van Soolingen, Dick, additional, Alffenaar, Jan-Willem, additional, Kerstjens, Huib A. M., additional, and Akkerman, Onno W., additional

Published
2022
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18. Malnutrition assessment methods in adult patients with tuberculosis: a systematic review

Author

ter Beek, Lies, primary, Bolhuis, Mathieu S, additional, Jager-Wittenaar, Harriët, additional, Brijan, René X D, additional, Sturkenboom, Marieke G G, additional, Kerstjens, Huib A M, additional, de Lange, Wiel C M, additional, Tiberi, Simon, additional, van der Werf, Tjip S, additional, Alffenaar, Jan-Willem C, additional, and Akkerman, Onno W, additional

Published
2021
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27. Cross border, highly individualised treatment of a patient with challenging extensively drug-resistant tuberculosis

Author

Akkerman, Onno W., primary, Grasmeijer, Floris, additional, de Lange, Wiel C.M., additional, Kerstjens, Huib A.M., additional, de Vries, Gerard, additional, Bolhuis, Mathieu S., additional, Alffenaar, Jan-Willem, additional, Frijlink, Henderik W., additional, Smith, Grace, additional, Gajraj, Roger, additional, de Zwaan, Rina, additional, Hagedoorn, Paul, additional, Dedicoat, Martin, additional, van Soolingen, Dick, additional, and van der Werf, Tjip S., additional

Published
2018
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29. Safety and tolerability of clarithromycin in the treatment of multidrug-resistant tuberculosis

Author

Van der Paardt, Anne-Fleur Louise, primary, Akkerman, Onno W., additional, Gualano, Gina, additional, Palmieri, Fabrizio, additional, Davies Forsman, Lina, additional, Aleksa, Alena, additional, Tiberi, Simon, additional, de Lange, Wiel C.M., additional, Bolhuis, Mathieu S., additional, Skrahina, Alena, additional, van Soolingen, Dick, additional, Kosterink, Jos G.W., additional, Migliori, Giovanni Battista, additional, van der Werf, Tjip S., additional, and Alffenaar, Jan-Willem C., additional

Published
2017
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32. Shorter treatment for multidrug-resistant tuberculosis: the good, the bad and the ugly

Author

van Altena, Richard, primary, Akkerman, Onno W., additional, Alffenaar, Jan-Willem C., additional, Kerstjens, Huib A.M., additional, Magis-Escurra, Cecile, additional, Boeree, Martin J., additional, van Soolingen, Dick, additional, de Lange, Wiel C.M., additional, Bolhuis, Mathieu S., additional, Hoefsloot, Wouter, additional, de Vries, Gerard, additional, and van der Werf, Tjip S., additional

Published
2016
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36. End TB with precision treatment!

Author

van der Burgt, Evelien P.M., primary, Sturkenboom, Marieke G.G., additional, Bolhuis, Mathieu S., additional, Akkerman, Onno W., additional, Kosterink, Jos G.W., additional, de Lange, Wiel C.M., additional, Cobelens, Frank G.J., additional, van der Werf, Tjip S., additional, and Alffenaar, Jan-Willem C., additional

Published
2016
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42. Efficacy and safety of meropenem–clavulanate added to linezolid-containing regimens in the treatment of MDR-/XDR-TB

Author

De Lorenzo, Saverio, primary, Alffenaar, Jan Wilem, additional, Sotgiu, Giovanni, additional, Centis, Rosella, additional, D'Ambrosio, Lia, additional, Tiberi, Simon, additional, Bolhuis, Mathieu S., additional, van Altena, Richard, additional, Viggiani, Piero, additional, Piana, Andrea, additional, Spanevello, Antonio, additional, and Migliori, Giovanni Battista, additional

Published
2012
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49. Population Pharmacokinetic Modelling and Limited Sampling Strategies for Therapeutic Drug Monitoring of Pyrazinamide in Patients with Tuberculosis.

Author

Abolhassani-Chimeh R, Akkerman OW, Saktiawati AMI, Punt NC, Bolhuis MS, Subronto YW, Sumardi, van der Werf TS, Kosterink JGW, Alffenaar JC, and Sturkenboom MGG

Subjects
Adult, Antitubercular Agents pharmacokinetics, Antitubercular Agents therapeutic use, Bayes Theorem, Drug Monitoring methods, Humans, Pyrazinamide pharmacokinetics, Pyrazinamide therapeutic use, Tuberculosis drug therapy
Abstract

Pyrazinamide is one of the first-line antituberculosis drugs. The efficacy of pyrazinamide is associated with the ratio of 24-h area under the concentration-time curve (AUC 24 ) to MIC. The objective of this study was to develop and validate a limited sampling strategy (LSS) based on a population pharmacokinetic (popPK) model to predict AUC 24 . A popPK model was developed using an iterative two-stage Bayesian procedure and was externally validated. Using data from 20 treatment-naive adult tuberculosis (TB) patients, a one compartment model with transit absorption and first-order elimination best described pyrazinamide pharmacokinetics and fed state was the only significant covariate for absorption rate constant (k a ). External validation, using data from 26 TB patients, showed that the popPK model predicted AUC 24 with a slight underestimation of 2.1%. LSS were calculated using Monte Carlo simulation ( n  = 10,000). External validation showed LSS with time points 0 h, 2 h, and 6 h performed best with RMSE of 9.90% and bias of 0.06%. Food slowed absorption of pyrazinamide, but did not affect bioavailability, which may be advantageous in case of nausea or vomiting in which food can be used to diminish these effects. In this study, we successfully developed and validated a popPK model and LSS, using 0 h, 2 h, and 6 h postdose samples, that could be used to perform therapeutic drug monitoring (TDM) of pyrazinamide in TB patients.

Published
2022
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