Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia
المؤلفون المشاركون
Maldonado, Cecilia
Fagiolino, Pietro
Ibarra, Manuel
Giachetto, G.
Vázquez, Marta
Olmos, Ismael
المصدر
العدد
المجلد 2019، العدد 2019 (31 ديسمبر/كانون الأول 2019)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2019-03-06
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص EN
Clozapine (CZP) is an atypical antipsychotic agent commonly used in the treatment of schizophrenia.
It is metabolized primarily by CYP1A2 enzyme, yielding a pharmacologically active metabolite, norclozapine (NCZP).
Significant intra- and interindividual pharmacokinetic (PK) variability for CZP and NCZP has been observed in routine therapeutic drug monitoring.
So the goal of this study was to evaluate the magnitude and variability of concentration exposure to CZP and its active metabolite NCZP on pharmacokinetic parameters in Uruguayan patients with schizophrenia with a focus on covariates such as cigarette smoking, age, sex, caffeine consumption, brands available of CZP, and comedication using population PK (PPK) modeling methodologies.
Patients with a diagnosis of schizophrenia treated with brand-name CZP (Leponex®) for more than a year were included in the study.
Then these patients were switched to the similar brand of CZP (Luverina®).
Morning predose blood samples for determination of CZP and NCZP using a HPLC system equipped with a UV detector were withdrawn on both occasions at steady state and under the same comedication.
Ninety-eight patients, 22 women and 76 men, took part in the study.
Mean ± standard deviation for CZP and NCZP concentration was 421 ± 262 ng/mL and 275 ± 180 ng/mL, respectively.
After covariate evaluation, only smoking status remained significant in CZP apparent clearance, inducing a mean increment of 32% but with no clinical impact.
The results obtained with the two brands of CZP should ensure comparable efficacy and tolerability with the clinical use of either product.
Smoking was significantly associated with a lower exposure to CZP due to higher clearance.
The results obtained with the two brands commercialized in our country hint a bioequivalence scenario in the clinical setting.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Olmos, Ismael& Ibarra, Manuel& Vázquez, Marta& Maldonado, Cecilia& Fagiolino, Pietro& Giachetto, G.. 2019. Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia. BioMed Research International،Vol. 2019, no. 2019, pp.1-10.
https://search.emarefa.net/detail/BIM-1124407
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Olmos, Ismael…[et al.]. Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia. BioMed Research International No. 2019 (2019), pp.1-10.
https://search.emarefa.net/detail/BIM-1124407
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Olmos, Ismael& Ibarra, Manuel& Vázquez, Marta& Maldonado, Cecilia& Fagiolino, Pietro& Giachetto, G.. Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia. BioMed Research International. 2019. Vol. 2019, no. 2019, pp.1-10.
https://search.emarefa.net/detail/BIM-1124407
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1124407
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر