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Background: Second-generation antipsychotics (SGAs) are commonly used to treat schizophrenia (SCZ), but SGAs may differ in the severity of side effects. Long-term studies are lacking, and previous observational studies have limitations, such as failure to account for confounding factors and short follow-up durations., Aims: To compare the long-term anthropometric and metabolic side effects of seven SGAs in a Chinese population, using a within-subject approach to reduce the risk of confounding., Method: We collected longitudinal data of SGA prescriptions, concomitant medications, fasting blood glucose (BG), lipid profiles, and BMI in a cohort of 767 patients with SCZ, with follow-up lasting up to 18.7 years (median ∼6.2 years). A total of 192,152 prescription records were retrieved, with 27,723 metabolic measures analysed. Linear mixed models were used to estimate the effects of SGA on BG, lipid profiles and BMI. Besides studying the effects of SGA medications (as binary predictors), we also investigated the effects of SGA dosage on metabolic profiles., Results: Considering SGA medications as binary predictors, clozapine and olanzapine were associated with the most substantial worsening of lipid profiles and BMI. A significant increase in BG was observed with clozapine only. Amisulpride, paliperidone and quetiapine were associated with worsened lipid profiles and increased BMI. Conversely, aripiprazole was associated with significant improvement in lipid profiles but a small increase in BMI. When SGA dosage was considered, the model showed consistent results overall. At the minimum effective dose, clozapine was associated with the most severe metabolic side effects, followed by olanzapine. Risperidone and aripiprazole showed the least metabolic side effects, with aripiprazole being significantly associated with lower lipids., Conclusions: This study clarified the long-term and dose-dependent effects of different SGAs on anthropometric and metabolic parameters in Chinese SCZ patients. Our findings may inform clinicians and SCZ patients of SGA choices., Competing Interests: Declaration of Competing Interest All authors declare no competing interests., (Copyright © 2024 Elsevier B.V. All rights reserved.)

To assess the bioequivalence of 2 formulations of aripiprazole orally disintegrating tablets and to monitor their safety and tolerability in Chinese subjects, a single-site, open-label, randomized, 2-preparation, single-dose, 2-period crossover design was conducted. All 60 subjects were randomly divided into the fasting group and the fed group. Blood samples were collected at scheduled times after a single oral dose of orodispersible tablets containing 10 mg of aripiprazole. In the fasting state, the geometric mean ratios (90% confidence intervals [CIs]) of the test/reference formulation were 92.22%-100.20% for the area under the concentration-time curve (AUC) from time zero to the last measured concentration (AUC 0-t ), 91.73%-100.14% for the AUC from administration to infinite time (AUC 0-∞ ), and 98.52%-112.52% for the maximum plasma concentration (C max ). In the fed state, AUC 0-t , AUC 0-∞ , and C max were 92.23%-100.20%, 91.73%-100.14%, and 95.91%-105.13%, respectively. The 90%CIs of the test/reference AUC ratio and C max ratio were within the acceptance range of 80.00%-125.00% for bioequivalence. Neither the maximum peak plasma concentration (t max ) nor the terminal elimination half-life (t 1/2 ) showed any significant difference. No serious adverse events) were encountered during the study. The test and reference formulations were bioequivalent under both fasting and fed conditions and were found to be safe and tolerated., (© 2021, The American College of Clinical Pharmacology.)

Background: Orally disintegrating tablet (ODT) formulation of antipsychotics is one of the innovative drug delivery systems developed to improve medication adherence. We aimed to evaluate the cost-effectiveness of aripiprazole ODT vs. aripiprazole standard oral tablet (SOT), as well as olanzapine SOT in China., Methods: We developed a discrete event simulation model from government payers' perspective. On the entry, 100,000 patients in each group were simulated for relapse, adverse events, changing adherence level, medication discontinuation, switching or quitting in response to three different medication adherence levels. The model projected quality adjusted life years (QALYs) and treatment costs over a 1-year time horizon. Parameter uncertainties were assessed through sensitivity analyses., Results: The QALYs per patient over 1-year treatment with aripiprazole ODT, aripiprazole SOT, or olanzapine SOT, were 0.7282, 0.7112, and 0.7218, respectively. The corresponding costs were $1,423, $2,215, and $1,493. In both comparisons, aripiprazole ODT was dominant. Compared with aripiprazole SOT and olanzapine SOT, the likelihood of aripiprazole ODT being cost-effective was 99.2% and 69.2%, respectively, using 3 times per capita GDP per QALY as willingness-to-pay threshold., Conclusions: The aripiprazole ODT is associated with more QALYs at lower costs compared with both aripiprazole SOT and olanzapine SOT in treating schizophrenia in China.