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Pharmacometric modeling of drug adverse effects: an application of mixture models in schizophrenia spectrum disorder patients treated with clozapine.

التفاصيل البيبلوغرافية
العنوان: Pharmacometric modeling of drug adverse effects: an application of mixture models in schizophrenia spectrum disorder patients treated with clozapine.
المؤلفون: Albitar O; School of Pharmaceutical Sciences, Universiti Sains Malaysia, USM, 11800, Gelugor, Penang, Malaysia., Ghadzi SMS; School of Pharmaceutical Sciences, Universiti Sains Malaysia, USM, 11800, Gelugor, Penang, Malaysia. maisharah@usm.my., Harun SN; School of Pharmaceutical Sciences, Universiti Sains Malaysia, USM, 11800, Gelugor, Penang, Malaysia., Ahmad SNA; Psychiatric Department, Hospital Pulau Pinang, Ministry of Health Malaysia, Jalan Residensi, 10460, Georgetown, Penang, Malaysia., Kjellsson MC; Pharmacometrics Research Group, Department of Pharmacy, Uppsala University, Uppsala, Sweden.
المصدر: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2023 Feb; Vol. 50 (1), pp. 21-31. Date of Electronic Publication: 2022 Nov 15.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: United States NLM ID: 101096520 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-8744 (Electronic) Linking ISSN: 1567567X NLM ISO Abbreviation: J Pharmacokinet Pharmacodyn Subsets: MEDLINE
أسماء مطبوعة: Publication: New York : Springer
Original Publication: Bristol, England ; New York, N.Y. : Kluwer Academic/Plenum Publishers, c2001-
مواضيع طبية MeSH: Clozapine*/adverse effects , Schizophrenia*/drug therapy , Schizophrenia*/chemically induced , Antipsychotic Agents*/adverse effects, Humans ; Retrospective Studies ; Weight Gain
مستخلص: Clozapine has superior efficacy to other antipsychotics yet is underutilized due to its adverse effects, such as neutropenia, weight gain, and tachycardia. The current investigation aimed to introduce a pharmacometric approach to simultaneously model drug adverse effects, with examples from schizophrenia spectrum patients receiving clozapine. The adverse drug effects were represented as a function of time by incorporating a mixture model to describe individual susceptibility to the adverse effects. Applications of the proposed method were presented by analyzing retrospective data from patients' medical records in Psychiatric Clinic, Penang General Hospital. Tachycardia, weight gain, and absolute neutrophils count (ANC) decrease were best described by an offset, a piecewise linear, and a transient surge function, respectively. 42.9% of the patients had all the adverse effects, including weight gain (0.01 kg/m 2 increase every week over a baseline of 24.7 kg/m 2 until stabilizing at 279 weeks), ANC decrease (20% decrease from 4540 cells/µL week 12-20.8), and tachycardia (14% constant increase over a baseline of 87.9 bpm for a clozapine maintenance dose of 450 mg daily). 32.5% of the patients had only tachycardia, while the remaining 24.6% had none of the adverse effects. A new pharmacometric approach was proposed to describe adverse drug effects with examples of clozapine-induced weight gain, ANC drop, and tachycardia. The current approach described the longitudinal time changes of continuous data while assessing patient susceptibility. Furthermore, the model revealed the possible co-existence of ANC drop and weight gain; thus, neutrophil monitoring might predict future changes in body weight.
(© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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فهرسة مساهمة: Keywords: Adverse effects; Clozapine; Disease progression; Mixture model; Pharmacometrics
المشرفين على المادة: J60AR2IKIC (Clozapine)
0 (Antipsychotic Agents)
تواريخ الأحداث: Date Created: 20221115 Date Completed: 20230222 Latest Revision: 20230227
رمز التحديث: 20240628
DOI: 10.1007/s10928-022-09833-9
PMID: 36380133
قاعدة البيانات: MEDLINE
الوصف
تدمد:1573-8744
DOI:10.1007/s10928-022-09833-9