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1. Correction: An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

Author

Jose de Leon, Georgios Schoretsanitis, Robert L. Smith, Espen Molden, Anssi Solismaa, Niko Seppälä, Miloslav Kopeček, Patrik Švancer, Ismael Olmos, Carina Ricciardi, Celso Iglesias-Garcia, Ana Iglesias-Alonso, Edoardo Spina, Can-Jun Ruan, Chuan-Yue Wang, Gang Wang, Yi-Lang Tang, Shih-Ku Lin, Hsien-Yuan Lane, Yong Sik Kim, Se Hyun Kim, Anto P. Rajkumar, Dinora F. González-Esquivel, Helgi Jung-Cook, Trino Baptista, Christopher Rohde, Jimmi Nielsen, Hélène Verdoux, Clelia Quiles, Emilio J. Sanz, Carlos De Las Cuevas, Dan Cohen, Peter F.J. Schulte, Aygün Ertuğrul, A. Elif Anıl Yağcıoğlu, Nitin Chopra, Betsy McCollum, Charles Shelton, Robert O. Cotes, Arun R. Kaithi, John M. Kane, Saeed Farooq, Chee H. Ng, John Bilbily, Christoph Hiemke, Carlos López-Jaramillo, Ian McGrane, Fernando Lana, Chin B. Eap, Manuel Arrojo-Romero, Flavian Ş. Rădulescu, Erich Seifritz, Susanna Every-Palmer, Chad A. Bousman, Emmanuel Bebawi, Rahul Bhattacharya, Deanna L. Kelly, Yuji Otsuka, Judit Lazary, Rafael Torres, Agustin Yecora, Mariano Motuca, Sherry K.W. Chan, Monica Zolezzi, Sami Ouanes, Domenico De Berardis, Sandeep Grover, Ric M. Procyshyn, Richard A. Adebayo, Oleg O. Kirilochev, Andrey Soloviev, Konstantinos N. Fountoulakis, Alina Wilkowska, Wiesław J. Cubała, Muhammad Ayub, Alzira Silva, Raphael M. Bonelli, José M. Villagrán-Moreno, Benedicto Crespo-Facorro, Henk Temmingh, Eric Decloedt, Maria R. Pedro, Hiroyoshi Takeuchi, Masaru Tsukahara, Gerhard Gründer, Marina Sagud, Andreja Celofiga, Dragana Ignjatovic Ristic, Bruno B. Ortiz, Helio Elkis, António J. Pacheco Palha, Adrián LLerena, Emilio Fernandez-Egea, Dan Siskind, Abraham Weizman, Rim Masmoudi, Shamin Mohd Saffian, Jonathan G. Leung, Peter F. Buckley, Stephen R. Marder, Leslie Citrome, Oliver Freudenreich, Christoph U. Correll, Daniel J. Müller, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Psychiatry and Mental health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Pharmacology (medical), General Medicine
Published
2022

2. An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

Author

Jose de Leon, Georgios Schoretsanitis, Robert L. Smith, Espen Molden, Anssi Solismaa, Niko Seppälä, Miloslav Kopeček, Patrik Švancer, Ismael Olmos, Carina Ricciardi, Celso Iglesias-Garcia, Ana Iglesias-Alonso, Edoardo Spina, Can-Jun Ruan, Chuan-Yue Wang, Gang Wang, Yi-Lang Tang, Shih-Ku Lin, Hsien-Yuan Lane, Yong Sik Kim, Se Hyun Kim, Anto P. Rajkumar, Dinora F. González-Esquivel, Helgi Jung-Cook, Trino Baptista, Christopher Rohde, Jimmi Nielsen, Hélène Verdoux, Clelia Quiles, Emilio J. Sanz, Carlos De Las Cuevas, Dan Cohen, Peter F.J. Schulte, Aygün Ertuğrul, A. Elif Anıl Yağcıoğlu, Nitin Chopra, Betsy McCollum, Charles Shelton, Robert O. Cotes, Arun R. Kaithi, John M. Kane, Saeed Farooq, Chee H. Ng, John Bilbily, Christoph Hiemke, Carlos López-Jaramillo, Ian McGrane, Fernando Lana, Chin B. Eap, Manuel Arrojo-Romero, Flavian Ş. Rădulescu, Erich Seifritz, Susanna Every-Palmer, Chad A. Bousman, Emmanuel Bebawi, Rahul Bhattacharya, Deanna L. Kelly, Yuji Otsuka, Judit Lazary, Rafael Torres, Agustin Yecora, Mariano Motuca, Sherry K.W. Chan, Monica Zolezzi, Sami Ouanes, Domenico De Berardis, Sandeep Grover, Ric M. Procyshyn, Richard A. Adebayo, Oleg O. Kirilochev, Andrey Soloviev, Konstantinos N. Fountoulakis, Alina Wilkowska, Wiesław J. Cubała, Muhammad Ayub, Alzira Silva, Raphael M. Bonelli, José M. Villagrán-Moreno, Benedicto Crespo-Facorro, Henk Temmingh, Eric Decloedt, Maria R. Pedro, Hiroyoshi Takeuchi, Masaru Tsukahara, Gerhard Gründer, Marina Sagud, Andreja Celofiga, Dragana Ignjatovic Ristic, Bruno B. Ortiz, Helio Elkis, António J. Pacheco Palha, Adrián LLerena, Emilio Fernandez-Egea, Dan Siskind, Abraham Weizman, Rim Masmoudi, Shamin Mohd Saffian, Jonathan G. Leung, Peter F. Buckley, Stephen R. Marder, Leslie Citrome, Oliver Freudenreich, Christoph U. Correll, and Daniel J. Müller

Subjects
Adult, Male, CYP1A2, mortality/drug effects, clozapine/therapeutic use, American continental ancestry group, Asian continental ancestry group, clozapine/adverse effects, clozapine/blood, clozapine/metabolism, clozapine/toxicity, drug labeling, European continental ancestry group, infection, inflammation, Native, sex, smoking, Asian People, Humans, Pharmacology (medical), Clozapine, Valproic Acid, Native - American continental ancestry group - Asian continental ancestry group - clozapine/adverse effects - clozapine/blood - clozapine/metabolism - clozapine/therapeutic use - clozapine/toxicity - CYP1A2 - drug labeling - European continental ancestry group - infection - inflammation - mortality/drug effects - sex - smoking, General Medicine, Psychiatry and Mental health, C-Reactive Protein, Female, Antipsychotic Agents
Abstract

This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas’ original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300–600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75–150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175–300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100–200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250–400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150–300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300–600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.

Published
2021

3. European Whites May Need Lower Minimum Therapeutic Clozapine Doses Than Those Customarily Proposed

Author

Ismael Olmos, Niko Seppälä, Edoardo Spina, Robert Løvsletten Smith, Miloslav Kopecek, Ana Iglesias-Alonso, Patrik Švancer, Celso Iglesias-García, Georgios Schoretsanitis, Marta Vázquez, Anssi Solismaa, Jose de Leon, and Espen Molden

Subjects
Adult, Male, medicine.medical_specialty, Dose, clozapine, blood, pharmacokinetics, European continental ancestry group, sex, smoking, Antipsychotic Agents, Clozapine, Dose-Response Relationship, Drug, Female, Humans, Nomograms, Sex Factors, Smoking, Whites, White People, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Pharmacology (medical), Dosing, business.industry, Confounding, Nomogram, medicine.disease, Obesity, 030227 psychiatry, Psychiatry and Mental health, Smoking status, business, 030217 neurology & neurosurgery, European Whites, medicine.drug
Abstract

Purpose/background A nomogram from a British naturalistic study proposed that the clozapine dosing needed to reach a serum concentration of 350 ng/mL ranged from 265 mg/d (female nonsmokers) to 525 mg/d (male smokers). Some European reviews have used these dosing recommendations, which seem greater than what we found in an Italian White sample ranging from 245 mg/d (female nonsmokers) to 299 mg/d (male smokers). Five other published samples of European Whites were added to the Italian sample to estimate clozapine doses recommended for reaching 350 ng/mL. Methods/procedures Average clozapine metabolizers were obtained by eliminating outliers with confounding variables: (1) psychiatric inducers and inhibitors; (2) doses less than 100 mg/d; and (3) when possible, patients with inflammation, obesity, or using oral contraceptives. The study included 1363 average metabolizer European Whites: the Italian sample and 5 new samples. Mean averages that reached serum concentration levels of 350 ng/mL were calculated after stratification by sex and smoking status in each sample. Then, weighted mean averages were obtained by combining the 6 samples. Findings/results The estimated weighted mean clozapine dosages ranged from 236 to 368 mg/d (236 mg/d in 218 female nonsmokers, 256 mg/d in 340 male nonsmokers, 357 mg/d in 269 female smokers, and 368 mg/d in 546 male smokers). Implications/conclusions Our recommended dosages are less than those recommended in Europe. Future studies in European Whites need to replicate these recommended doses for average metabolizer patients after sex and smoking stratification and further explore clozapine dosing for those with relevant clinical confounders.

Published
2021

4. Hábitos dietéticos de una muestra de pacientes con esquizofrenia

Author

Aida Toimil, Ana Iglesias-Alonso, and Celso Iglesias-García

Subjects
03 medical and health sciences, Psychiatry and Mental health, 0302 clinical medicine, business.industry, Medicine, business, 030217 neurology & neurosurgery, 030227 psychiatry
Published
2016

5. Dietary habits of a sample of patients with schizophrenia

Author

Ana Iglesias-Alonso, Aida Toimil, and Celso Iglesias-García

Subjects
Adult, Male, Adolescent, Schizophrenia (object-oriented programming), Nutritional Status, Sample (statistics), Diet Surveys, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Text mining, Humans, Medicine, Retrospective Studies, Information retrieval, business.industry, Feeding Behavior, General Medicine, Middle Aged, Diet, 030227 psychiatry, Nutrition Assessment, Schizophrenia, Female, Schizophrenic Psychology, business, 030217 neurology & neurosurgery, Clinical psychology
Published
2016

6. An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels.

Author

de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppälä, Niko, Kopeček, Miloslav, Švancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, and Kim, Yong Sik

Subjects
DRUG side effects, CLOZAPINE, VOLUMETRIC analysis, C-reactive protein, PNEUMONIA-related mortality, AMISULPRIDE
Abstract

This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300–600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75–150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175–300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100–200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250–400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150–300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300–600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration. [ABSTRACT FROM AUTHOR]

Published
2022
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9. Correction: An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels.

Author

de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppälä, Niko, Kopeček, Miloslav, Švancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, and Kim, Yong Sik

Subjects
CLOZAPINE, VOLUMETRIC analysis, ADULTS
Abstract

Pharmacopsychiatry 2021 DOI: 10.1055/a-1625-6388 In the above-mentioned article, the spelling of 5 authors last names has been wrong and these names have been corrected. An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels References de Leon J, Schoretsanitis G, Smith RL et al. [Extracted from the article]

Published
2022
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