Objectives: This study aimed to assess the clinical burden, a critical determinant of medication adherence in patients with schizophrenia, after the administration of Aripiprazole once-monthly (AOM). Methods: This study was a retrospective, non-interventional, multicenter, naturalistic observational study conducted through the analysis of participants’ electronic medical records. Study participants were recruited from eight sites. Data were collected at baseline, defined as the time of AOM administration, and at 1, 3, 6, 9, and 12 months thereafter. The primary outcome measure was the change in the Clinical Global Impression-Clinical Benefit (CGI-CB) score over 12 months, and the secondary outcome measure was the change in the Clinical Global Impression-Improvement (CGI-I) score. Results: The data of 139 participants were analyzed, revealing a statistically significant decrease of 26.8% in CGI-CB scores and 13.4% in CGI-I scores over 12 months. Upon comparison between adjacent visit intervals, significant reductions were observed for both measures between month 3 and month 6. Conclusions This study is the first multicenter investigation to simultaneously evaluate the clinical efficacy and tolerability of transitioning to AOM in the context of polypharmacy. The study suggested that AOM may contribute to reducing the clinical burden, thereby improving the quality of life for patients with schizophrenia.

Objectives: This study aimed to assess the clinical burden, a critical determinant of medication adherence in patients with schizophrenia, after the administration of Aripiprazole once-monthly (AOM). Methods: This study was a retrospective, non-interventional, multicenter, naturalistic observational study conducted through the analysis of participants’ electronic medical records. Study participants were recruited from eight sites. Data were collected at baseline, defined as the time of AOM administration, and at 1, 3, 6, 9, and 12 months thereafter. The primary outcome measure was the change in the Clinical Global Impression-Clinical Benefit (CGI-CB) score over 12 months, and the secondary outcome measure was the change in the Clinical Global Impression-Improvement (CGI-I) score. Results: The data of 139 participants were analyzed, revealing a statistically significant decrease of 26.8% in CGI-CB scores and 13.4% in CGI-I scores over 12 months. Upon comparison between adjacent visit intervals, significant reductions were observed for both measures between month 3 and month 6. Conclusions This study is the first multicenter investigation to simultaneously evaluate the clinical efficacy and tolerability of transitioning to AOM in the context of polypharmacy. The study suggested that AOM may contribute to reducing the clinical burden, thereby improving the quality of life for patients with schizophrenia.

Objectives: This study aimed to assess the clinical burden, a critical determinant of medication adherence in patients with schizophrenia, after the administration of Aripiprazole once-monthly (AOM). Methods: This study was a retrospective, non-interventional, multicenter, naturalistic observational study conducted through the analysis of participants’ electronic medical records. Study participants were recruited from eight sites. Data were collected at baseline, defined as the time of AOM administration, and at 1, 3, 6, 9, and 12 months thereafter. The primary outcome measure was the change in the Clinical Global Impression-Clinical Benefit (CGI-CB) score over 12 months, and the secondary outcome measure was the change in the Clinical Global Impression-Improvement (CGI-I) score. Results: The data of 139 participants were analyzed, revealing a statistically significant decrease of 26.8% in CGI-CB scores and 13.4% in CGI-I scores over 12 months. Upon comparison between adjacent visit intervals, significant reductions were observed for both measures between month 3 and month 6. Conclusions This study is the first multicenter investigation to simultaneously evaluate the clinical efficacy and tolerability of transitioning to AOM in the context of polypharmacy. The study suggested that AOM may contribute to reducing the clinical burden, thereby improving the quality of life for patients with schizophrenia.

The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC’s initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC’s second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.

Objective: This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia. Methods: Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed. Results: Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea. Conclusion Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.