Population pharmacokinetics analysis of olanzapine for Chinese psychotic patients based on clinical therapeutic drug monitoring data with assistance of meta-analysis

Yin, Anyue; Shang, Dewei; Wen, Yuguan; Li, Liang; Zhou, Tianyan; Lu, Wei

doi:10.1007/s00228-016-2040-2

Cited by 13 publications

(18 citation statements)

References 36 publications

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“…We found that the population pharmacokinetic model parameters agreed with a previous meta-analysis, which covered multiple age groups. 22 All estimates of parameters were relatively accurate (relative standard errors < 40%). Given the lack of data for the absorption phase, and because the estimated Ka was not reliable, we decided to fix the Ka from a previously reported value.…”

Section: Discussionmentioning

confidence: 91%

“…Finally, a one-compartment pharmacokinetic model, with the first-order absorption, was identified as the best fitting model to describe the olanzapine data. Based on a previously published meta-analysis, 22 Ka of olanzapine was fixed at 0.868 h −1 . Typical CL/F and V/F were 18 L/h and 785 L, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…In adults, previous TDM data analysis revealed a significant impact for smoking on the elimination of olanzapine; the CL/F of male smokers was 1.53-fold higher than that of non-smokers. 22 Furthermore, gender has also been found to be a significant factor that is able to influence the clearance of olanzapine. Compared to females, male patients generally smoke more excessively; consequently, smoking and gender may have an interactive effect on the concentration of olanzapine in the serum.…”

Section: Discussionmentioning

confidence: 99%

“…The absorption rate constant (Ka) was fixed to values that were published in the previous literature because of the lack of serum samples around the absorption phase. 22 Similarly, the absorption lag time could not be evaluated. We did not use the algebraic equation, and differential equation.…”

Section: Methodsmentioning

confidence: 99%

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What to Do About Missed Doses? A Retrospective Study of Olanzapine in the Elderly

Xiao

Wang

et al. 2021

DDDT

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Background Schizophrenia is characterized by a high disease burden. Olanzapine is a common drug used in antipsychotic medication. Little is known about the population pharmacokinetics of olanzapine in elderly patients. Missed doses are a common and unavoidable issue during the treatment of psychiatric diseases, especially in elderly patients. This study aimed to identify what an elderly person should do if doses are inadvertently missed. Methods Data were collected from 140 elderly psychiatric patients (aged ≥65 years) who received olanzapine therapy. Olanzapine concentrations were determined by high pressure liquid chromatographic tandem mass spectrometry (HPLC-MS/MS) and a population-based approach was used to quantify the characteristics of elderly patients. A non-linear mixed-effects model was used for data analysis. Simulations based on the final model were applied to predict situations involving a single missed dose or three consecutive missed doses under several remedial regimens. Results A total of 474 samples from 140 elderly patients were included in the therapeutic drug monitoring (TDM) data analysis. A one-compartment model, with no significant covariates, was developed to describe the population pharmacokinetics of olanzapine in elderly patients. The population predicted systematic clearance (CL/F) and volumes of distribution (V/F) were 18 L/h and 785 L, respectively. The simulation demonstrated that in a missed dose situation, elderly patients should take the regular dose immediately; the refill dose used at the second remedial time point depends on the length of the time delay. Conclusion Here, we used a simulation to provide a remedial regimen for missed doses of olanzapine in the elderly population. Our simulation can provide valuable suggestions for individualized therapy in elderly patients.

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Section: Discussionmentioning

confidence: 91%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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What to Do About Missed Doses? A Retrospective Study of Olanzapine in the Elderly

Xiao

Wang

et al. 2021

DDDT

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“…Several population PK models for OLZ have been published recently, but they are specific for certain populations (e.g. adolescents, Chinese, patients who have overdosed, patients taking sertraline as comedication), and have not been applied to predict OLZ exposure in patients [14,[18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

Prediction of olanzapine exposure in individual patients using physiologically based pharmacokinetic modelling and simulation

Polasek

Tucker

Sorich

et al. 2018

Brit J Clinical Pharma

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Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions

Lin

Zhang²,

Zheng

et al. 2020

Clinical Pharm in Drug Dev

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To assess the bioequivalence of two 5‐mg olanzapine orally disintegrating tablet (ODT) products, 2 randomized, open‐label, single‐dose, 2‐way crossover studies were carried out under fasting or fed conditions. Blood samples were collected at scheduled times according to the study protocol. Statistical analysis of area under the concentration‐time curve from time 0 to 168 hours (AUC0‐t), area under the curve from time zero to infinity (AUC0‐∞), and peak plasma concentration (Cmax) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC0‐t, AUC0‐∞, and Cmax were within the range of 0.80‐1.25. Adverse events were recorded and evaluated throughout the studies. A total of 48 subjects with 24 in each study completed the 2 studies. In fasted subjects, the 90%CIs for the test product versus the reference product were 97.28%‐105.13% for AUC0‐t, 97.57%‐105.54% for AUC0‐∞, and 90.94%‐103.97% for Cmax. In fed subjects, the 90%CIs for AUC0‐t, AUC0‐∞ and Cmax were 99.73%‐122.63%, 99.56%‐121.75%, and 99.46%‐120.46%, respectively. No serious adverse events were reported in the studies. The reference and the test product of 5‐mg olanzapine ODT show comparable pharmacokinetic profiles under both fed and fasted conditions and were considered bioequivalent.

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Population pharmacokinetics analysis of olanzapine for Chinese psychotic patients based on clinical therapeutic drug monitoring data with assistance of meta-analysis

Abstract: The population PK model, built using meta-analysis, could facilitate the modeling of TDM data collected from Chinese psychotic patients. The factors that significantly influence olanzapine disposition were determined and the final model could be used for individualized treatment.

Cited by 13 publications

References 36 publications

What to Do About Missed Doses? A Retrospective Study of Olanzapine in the Elderly

What to Do About Missed Doses? A Retrospective Study of Olanzapine in the Elderly

Prediction of olanzapine exposure in individual patients using physiologically based pharmacokinetic modelling and simulation

Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions

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