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Therapeutic monitoring of antipsychotics with a focus on lurasidone and its dosing

Czech version

Authors: Z. Strašilová 1;  M. Turjap 2;  J. Juřica 3
Authors‘ workplace: Farmakologický ústav LF MU, Brno Ústav laboratorní medicíny – Oddělení klinické biochemie FN, Brno 1;  Ústavní lékárna, FN Ostrava 2;  Ústav farmakologie a toxikologie FaF MU, Brno Ústavní lékárna, Masarykův onkologický ústav, Brno Kamenice 5, 625 00 Brno 3
Published in: Čes. slov. Farm., 2023; 72, 203-213
Category: Review Articles
doi: https://doi.org/10.5817/CSF2023-5-203

Overview

Dose-response relationships are not fully understood for antipsychotics. Especially in the case of multimodal antipsychotics, these relationships cannot be simplified to the level of dopaminergic receptor occupancy alone. In general, for most antipsychotics, there is no linear dose-response relationship. Reasons for this include, among others, pharmacokinetic factors affecting plasma levels. Based on meta-analyses, the doseresponse curve appears to be bell-shaped. However, in the case of some antipsychotics, it appears that even increasing the dose beyond the recommended range could yield further increases in efficacy. It should be stressed that this is an off-label procedure and cannot generally be recommended and there is not enough valid information for general conclusions for these antipsychotics either. Mini-invasive sampling and alternative matrices such as saliva or dry blood spots could open the way to more frequent monitoring of antipsychotics and a better understanding of doseresponse relationships.

Keywords:

Safety – Therapeutic drug monitoring – efficacy – lurasidone – dose- response relationship

Sources
  1. Tašková I. Lurasidon – rozšíření možností léčby schizofrenie s důrazem na kognitivní funkce a kardiometabolické cíle. Remedia 2020; 30(4), 454–459. Dostupné na: https://www.remedia.cz/rubriky/prehledy-nazory-di- skuse/lurasidon-rozsireni-moznosti-lecby-schizofre nie-s-durazem-na-kognitivni-funkce-a-kardiometabolicke-cile-11506/
  2. Hiemke C., Bergemann N., Clement H. W., Conca A., Deckert J., Domschke K., Eckermann G., Egberts K., Gerlach M., Greiner C., Gründer G., Haen E., Havemann-Reinecke U., Hefner G., Helmer R., Janssen G., Jaquenoud E., Laux G., Messer T., Mössner R., Müller M. J., Paulzen M., Pfuhlmann B., Riederer P., Saria A., Schoppek B., Schoretsanitis G., Schwarz M., Gracia M. S., Stegmann B., Steimer W., Stingl J. C., Uhr M., Ulrich S., Unterecker S., Waschgler R., Zernig G., Zurek G., Baumann P. Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017. Pharmacopsychiatry 2018; 51(1–02), 9–62. Available from: https://www.thieme-connect.com/products/ ejournals/abstract/10.1055/s-0043-116492
  3. Brozmanová H. Laboratorní metody v terapeutickém monitorování léků. Klin. Farmakol. Farm. 2020; 34(2), 56–62. Dostupné na: https://www.klinickafarmakologie. cz/pdfs/far/2020/02/03.pdf
  4. Šilhán P., Kacířová I., Hýža M., Uřinovská R., Češková E., Grundmann M. Terapeutické monitorování hladin léčiv v psychiatrii – možnosti a využití v praxi. Psychiatr. praxi 2016; 17(1), 10–14. Dostupné na: https://www. solen.cz/artkey/psy-201601-0003_terapeuticke_monitorovani_hladin_leciv_v_psychiatrii_-_moznosti_a_ vyuziti_v_praxi.php?back=%2Fsearch.php%3Fquery%3Dfarmakoterapie%252520v%252520t%2525C4%26sfrom%3D210%26spage%3D30
  5. Potkin S. G., Keator D. B., Kesler-West M. L., Nguyen D. D., van Erp T. G., Mukherjee J., Shah N., Preda D2 receptor occupancy following lurasidone treatment in patients with schizophrenia or schizoaffective disorder. CNS Spectr. 2014; 19(2), 176–181. Available from: https://www.cambridge.org/core/journals/ cns-spectrums/article/abs/d2-receptor-occupancy-following-lurasidone-treatment-in-patients-with-schizophrenia-or-schizoaffectivedisorder/D336FB84B34785122C531E2710EE0586
  6. Hiemke C., Dragicevic A., Gründer G., Hätter S., Sachse J., Vernaleken I., Müller M. J. Therapeutic monitoring of new antipsychotic drugs. Ther. Drug. Monit. 2004; 26(2), 156–160. Available from: https://journals.lww.com/ drug-monitoring/abstract/2004/04000/therapeutic_ monitoring_of_new_antipsychotic_drugs.12.aspx
  7. Wong D. F., Kuwabara H., Brašić J. R., Stock T., Maini A., Gean E. G., Loebel A. Determination of dopamine D₂ receptor occupancy by lurasidone using positron emission tomography in healthy male subjects. Psychopharmacology 2013; 229(2), 245–252. Available from: https:// doi.org/10.1007/s00213-013-3103-z
  8. Kang J. S., Lee M. H. Overview of therapeutic drug monitoring. Korean J. Intern. Med. 2009; 24(1), 1–10. Available from: https://doi.org/10.3904/kjim.2009.24.1.1
  9. Jing J., Shan Y., Liu Z., Yan H., Xiang P., Chen P., Xu X. Automated online dried blood spot sample preparation and detection of anabolic steroid esters for sports drug testing. Drug. Test. Anal. 2022; 14(6), 1040–1052. Available from: https://doi.org/10.1002/dta.3226
  10. Deprez S., Stove Ch. Application of a Fully Automated Dried Blood Spot Method for Therapeutic Drug Monitoring of Immunosuppressants: Another Step Toward Implementation of Dried Blood Spot Analysis. Arch. Pathol. Lab. Med. 2022. Available from: https://doi.org/10.5858/ arpa.2021-0533-OA
  11. Gaugler S., Rykl J., Grill M., Cebolla V. L. Fully automated drug screening of dried blood spots using online LCMS/MS analysis. J. Appl. Bioanal. 2018; 4(1), 7–15. Available from: https://doi.org/10.17145/jab.18.003
  12. Luginbühl M., Gaugler S. The application of fully automated dried blood spot analysis for liquid chromatography-tandem mass spectrometry using the CAMAG DBS-MS 500 autosampler. Clin. Biochem. 2020; 82, 33–39. Available from: https://doi.org/10.1016/j.clinbiochem.2020.02.007
  13. Martial L. C., Aarnoutse R. E., Mulder M., Schellekens A., Brüggemann R. J. M., Burger D. M., Schene
    1. H., Batalla A. Dried Blood Spot sampling in psychiatry: Perspectives for improving therapeutic drug monitoring. Eur. Neuropsychopharmacol. 2017; 27(3), 205–216. Available from: https://doi.org/10.1016/j.euroneuro.2017.01.009
  14. Patteet L., Maudens K. E., Stove C. P., Lambert W. E., Morrens M., Sabbe, B., Neels, H. The use of dried blood spots for quantification of 15 antipsychotics and 7 metabolites with ultra-high performance liquid chromatography – tandem mass spectrometry. Drug. Test. Anal. 2015; 7(6), 502–511. Available from: https://doi. org/10.1002/dta.1698
  15. Niemiec A. Dried Blood Spot in Toxicology: Current Knowledge. Separations. 2021; 8(9), 145. Available from: https://doi.org/10.3390/separations8090145
  16. Antunes M. V., Charão M. F., Linden R. Dried blood spots analysis with mass spectrometry: Potentials and pitfalls in therapeutic drug monitoring, Clinical Biochemistry. 2016; 49(13–14), 1035–1046. Available from: https://doi.org/10.1016/j.clinbiochem.2016.05.004
  17. Ruggiero C., Ramirez S., Ramazzotti E., Mancini R., Muratori R., Raggi M. A., Conti M. Multiplexed therapeutic drug monitoring of antipsychotics in dried plasma spots by LCMS/MS. J. Sep. Sci. 2020; 43(8), 1440– 1449. doi: 10.1002/jssc.201901200
  18. Malsagova K., Kopylov A., Stepanov A., Butkova T., Izotov A., Kaysheva A. Dried Blood Spot in Laboratory: Directions and Prospects. Diagnostics (Basel). 2020; 10(4), 248. Available from: https://doi.org/10.3390/diagnostics10040248
  19. Fischer S., Obrist R., Ehlert U. How and when to use dried blood spots in psychoneuroendocrinological research. Psychoneuroendocrinology. 2019; 108, 190–196. Available from: https://doi.org/10.1016/j.psyneuen.2019.06.011
  20. The United States Food and Drug Administration. Pediatric Postmarketing Pharmacovigilance. Latuda 2019. Dostupné na: https://www.fda.gov/media/130835/ download
  21. European  Medicines  Agency.  Souhrn  údajů o přípravku. 2022. Dostupné na: https://www.ema.europa.eu/en/documents/product-information/latuda-epar-product-information_cs.pdf
  22. Státní ústav pro kontrolu léčiv. Latuda 74MG TBL FLM 28X1. Dostupné na: https://prehledy.sukl.cz/prehled_leciv.html#/leciva/0194921 (24. 06. 2023).
  23. The United States Food and Drug Administration. Latuda (lurasidone hydrochloride) Tablets. Pharmacology reviews 2010. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000ClinPharmR.pdf
  24. The United States Food and Drug Administration. Highlights of Prescribing Information. Latuda 2022. Available from: https://www.latuda.com/LatudaPre- scribingInformation.pdf
  25. Suppes T., Silva R., Cucchiaro J., Mao Y., Targum S., Streicher C., Pikalov A., Loebel A. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study. Am. J. Psychiatry. 2016; 173(4), 400–407. Available from: https://doi.org/10.1176/appi.ajp.2015.15060770
  26. Pochiero I., Calisti F., Comandini A., Del Vecchio A., Costamagna I., Rosignoli M. T., Cattaneo A., Nunna S., Peduto I., Heiman F., Chang H. C., Chen C. C., Correll C. Impact of Lurasidone and Other Antipsychotics on Body Weight: Real-World, Retrospective, Comparative Study of 15,323 Adults with Schizophrenia. Int. J. Gen. Med. 2021; 14, 4081–4094. Available from: https://doi.org/10.2147/ IJGM.S320611
  27. Meyer J. M., Ng-Mak D. S., Chuang C. C., Rajagopalan K., Loebel A. Weight changes before and after lurasidone treatment: a real-world analysis using electronic health records. Ann. Gen. Psychiatry 2017; 16, 36. Available from: https://doi.org/10.1186/s12991-017-0159-x
  28. Caccia S., Pasina L., Nobili A. Critical appraisal of lurasidone in the management of schizophrenia. Neuropsychiatr. Dis. Treat. 2012; 8, 155–168. Available from: https://doi.org/10.2147/NDT.S18059
  29. Stahl S. M., Cucchiaro J., Simonelli, D., Hsu, J., Pikalov A., Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J. Clin. Psychiatry 2013; 74(5), 507–515. Available from: https://www.psychiatrist. com/jcp/schizophrenia/effectiveness-lurasidone-patients-schizophrenia-following/
  30. Meltzer H. Y., Cucchiaro J., Silva R., Ogasa M., Phillips D., Xu J., Kalali A. H., Schweizer E., Pikalov A., Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placeboand olanzapine-controlled study. Am. J. Psychiatry 2011; 168(9), 957–967. Available from: https://doi.org/10.1176/appi. ajp.2011.10060907
  31. Pompili M., Verzura C., Trovini G., Buscajoni A., Falcone G., Naim S., Nardella A., Sorice S., Baldessarini R. J., Girardi P. Lurasidone: efficacy and safety in the treatment of psychotic and mood disorders. Expert Opin. Drug. Saf. 2018; 17(2), 197–205. Available from: https:// doi.org/10.1080/14740338.2017.1379989
  32. European Medicines Agency. Assessment report – Latuda. 2014. Available from: https://www.ema.europa. eu/en/documents/assessment-report/latuda-epar-public-assessment-report_en.pdf
  33. Preskorn S., Ereshefsky L., Chiu Y. Y., Poola N., Loebel Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies. Hum. Psychopharmacol. 2013; 28(5), 495–505. Available from: https://doi.org/10.1002/hup.2338
  34. Greenberg W. M., Citrome L. Pharmacokinetics and Pharmacodynamics of Lurasidone Hydrochloride, a Second-Generation Antipsychotic: A Systematic Review of the Published Literature. Clin. Pharmacokinet. 2017; 56(5), 493–503. Available from: https://doi.org/10.1007/ s40262-016-0465-5
  35. Citrome L. Lurasidone for schizophrenia: a brief review of a new second-generation antipsychotic. Clin. Schizophr. Relat. Psychoses. 2011; 4(4), 251–257. Available from: https://pubmed.ncbi.nlm.nih.gov/21177242/
  36. Katteboina M. Y., Pilli N. R., Mullangi R., Seelam R. R., Satla S. R. LC-MS/MS assay for the determination of lurasidone and its active metabolite, ID-14283 in human plasma and its application to a clinical pharmacokinetic study. Biomed. Chromatogr. 2016; 30(7), 1065–1074. Available from: https://doi.org/10.1002/bmc.3651
  37. Kumar Talluri M. V. N, Dharavath S., Kalariya P. D., Prasanth B., Srinivas R. Structural characterization of alkaline and oxidative stressed degradation products of lurasidone using LC/ESI/QTOF/MS/MS. J. Pharm. Biomed. Anal. 2015; 105, 1–9. Available from: https://doi. org/10.1016/j.jpba.2014.11.035
  38. Patteet L., Maudens K. E., Sabbe B., Morrens M., De Doncker M., Neels H. High throughput identification and quantification of 16 antipsychotics and 8 major metabolites in serum using ultra-high performance liquid chromatography-tandem mass spectrometry. Clin. Chim. Acta 2014; 429, 51–58. Available from: https://doi. org/10.1016/j.cca.2013.11.024
  39. Ravisankar P., Rajyalakshmi G., Deva Dasu Ch., Srinivasa Babu P., Venkateswar Reddy P. Novel analytical method development and validation for the quantitative analysis of lurasidone hydrochloride in bulk and pharmaceuical dosage forms by RP-HPLC. World Journal of Pharmaceutical Research 2014; 3(7), 453–466. Available from: https://www.academia.edu/33538456/ NOVEL_ANALYTICAL_METHOD_DEVELOPMENT_AND_ VALIDATION_FOR_THE_QUANTITATIVE_ANALYSIS_OF_ LURASIDONE_HYDROCHLORIDE_IN_BULK_AND_PHARMACEUTICAL_DOSAGE_FORMS_BY_RP_HPLC
  40. Sangeetha R. K. Method development and validation for the estimation of lurasidone by RP-HPLC and HPTLC. European Journal of Pharmaceutical and medical research. 2020; 2(5), 529-540. Available from: https://www. academia.edu/33538456/NOVEL_ANALYTICAL_METHOD_DEVELOPMENT_AND_VALIDATION_FOR_THE_ QUANTITATIVE_ANALYSIS_OF_LURASIDONE_HYDROCHLORIDE_IN_BULK_AND_PHARMACEUTICAL_DOSAGE_FORMS_BY_RP_HPLC
  41. Atila Karaca S., Yeniceli Uğur D. Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals. Marmara Pharm. J. 2017; 21(4), 931–937. Available from: http://dx.doi.org/10.12991/mpj.2017.32
  42. Thota B., Adepu G. S., Galla R. Method development, validation and stability studies for the determination of lurasidone hydrochloride in bulk and tablet dosage form RP-HPLC. International Journal of Pharmacy and Pharmaceutical Sciences 2018; 10(12), 58–63. Available from: https://doi.org/10.22159/ijpps.2018v10i12.27895
  43. Polawar, A. R., Damle, M. C. Development and validation of RP-HPLC method for estimation of lurasidone hydrochloride in bulk and pharmaceutical dosage form. IJRPC 2014; 4(2), 327–332. Available from: http://www. ijrpc.com/files/14-457.pdf
  44. Vaja M. D., Patel R. R., Patel B. D., Chaudhary A. B. Development and Validation of RP-HPLC Method for Estimation of Lurasidone and its impurities Lurasidone 1 and Lurasidone 8. Research Journal of Pharmacy and Technology 2022; 15(11), 4999–5004. Available from: https://rjptonline.org/AbstractView.aspx?PID=2022-15-11-25
  45. Enders J. R., Strickland E. C., McIntire G. L. Determination of the Relative Prevalence of Lurasidone Metabolites in Urine Using Untargeted HRMS. Spectroscopy 2019; 17(2), 8–15. Available from: https://www.chromatographyonline.com/view/determination-relative-prevalence-lurasidone-metabolites-urine-using-untargeted-hrms
  46. Feng S., Enders J. R., Cummings O. T., Strickland E. C., McIntire T., McIntire G. A Dilute and Shoot LC-MS/MS Method for Antipsychotics in Urine. J. Anal. Toxicol. 2020; 44(4), 331–338. Available from: https://doi.org/10.1093/ jat/bkz098
  47. Prokeš M., Suchopár J. Lékové interakce v psychiatrii teorie a praxe. Psychiatr. praxi 2015; 16(2), 51–55. Dostupné na: https://www.psychiatriepropraxi.cz/pdfs/ psy/2015/02/04.pdf
  48. Lucas C., Martin J. Smoking and drug interactions. Aust. Prescr. 2013; 36, 102–104. doi: 10.18773/austprescr.2013.037
  49. Loebel A., Cucchiaro J., Sarma K., Xu L., Hsu C., Kalali A. H., Pikalov A., Potkin S. G. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placeboand active-controlled trial. Schizophr Res. 2013; 145, 101–109. Available from: https://doi.org/10.1016/j. schres.2013.01.009
  50. Shin Y. S., Kim S. N., Shin N. Y., Jung W. H., Hur J. W., Byun M. S., Jang J. H., An S. K., Kwon J. S. Increased intra-individual variability of cognitive processing in subjects at risk mental state and schizophrenia patients. PLOS One 2013; 8(11), e78354. Available from: https:// doi.org/10.1371/journal.pone.0078354
  51. Leucht S., Crippa A., Siafis S., Patel M. X., Orsini N., Davis J. M. Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia. Am. J. Psychiatry 2020; 177(4), 342–353. Available from: https://doi. org/10.1176/appi.ajp.2019.19010034
  52. Taylor D. M., Barnes T. R. E., Young, A. H. Schizophrenia and Related Psychoses. The Maudsley Prescribing Guidelines in Psychiatry 2021. Available from: https:// doi.org/10.1002/9781119870203.mpg001
  53. Billington S., Salphati L., Hop C. E. C. A., Chu X., Evers R., Burdette D., Rowbottom C., Lai Y., Xiao G., Humphreys W. G., Nguyen T. B., Prasad B., Unadkat J. D. Interindividual and Regional Variability in Drug Transporter Abundance at the Human Blood–Brain Barrier Measured by Quantitative Targeted Proteomics. Clin. Pharmacol. Ther. 2019; 106, 228–237. Available from: https://doi.org/10.1002/cpt.1373
  54. Leucht S., Leucht C., Huhn M., Chaimani A., Mavridis D., Helfer B., Samara M., Rabaioli M., Bächer S., Cipriani A., Geddes J. R., Salanti G., Davis J. M. Sixty Years of Placebo-Controlled Antipsychotic Drug Trials in Acute Schizophrenia: Systematic Review, Bayesian Meta-Analysis, and Meta-Regression of Efficacy Predictors. Am. J. Psychiatry 2017; 174(10), 927–942. Available from: https://doi.org/10.1176/appi.ajp.2017.16121358
  55. de Hert M., Detraux J., van Winkel R., Yu W., Correll C. U. Metabolic and cardiovascular adverse effects associated with antipsychotic drugs. Nat. Rev. Endocrinol. 2011; 8(2), 114–126. Available from: https://doi.org/10.1038/ nrendo.2011.156
  56. Sabe M., Zhao N., Crippa A., Kaiser S. Antipsychotics for negative and positive symptoms of schizophrenia: dose-response meta-analysis of randomized controlled acute phase trials. NPJ Schizophr. 2021; 7(1), 43. Available from: https://doi.org/10.1038/s41537-02100171-2
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