Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

OBJECTIVE: Suvorexant is a novel hypnotic drug that does not interact with the conventional γ-aminobutyric acid (GABA)-A receptor. We investigated the method by which suvorexant was introduced in insomnia patients who were taking benzodiazepine receptor agonists (BzRA). METHODS: This was a retrospective study. We extracted clinical data for patients who were prescribed suvorexant and were already using BzRA. The patients were assigned to two groups, the switching and add-on groups. We assessed the suvorexant discontinuation rate at one month after the prescription of the drug. RESULTS: One hundred and nineteen patients were assigned to the switching group, and 109 were assigned to the add-on group. The add-on group exhibited a significantly higher all-cause discontinuation rate than the switching group (odds ratio, 2.7; 95% confidence interval, 1.5 to 5.0; adjusted p < 0.001). Intolerability was a significantly stronger risk factor for suvorexant discontinuation in the add-on group (22.0% vs. 7.6%, p < 0.002), and the most common adverse effect was oversedation. CONCLUSION: Our results show that the add-on of suvorexant increases the frequency of oversedation compared with switching in insomnia patients that are taking BzRA. However, this was only a preliminary retrospective study, and further studies will be required to confirm our findings.
Benzodiazepines* ; Humans ; Methods ; Orexin Receptor Antagonists ; Prescriptions ; Receptors, GABA-A* ; Retrospective Studies* ; Risk Factors ; Sleep Initiation and Maintenance Disorders*

Methods: The study included patients with ASD aged >60 years who underwent spinal corrective fusion surgery from the lower thoracic spine to the pelvis. The intraoperative PS insertion torque was measured using a torque meter. Pearson correlation coefficients were calculated between the PS insertion torque and the BMD, HU, and VBQ score. Preoperative bone quality was compared between the proximal junctional failure (PJF) and non-PJF groups. Results: Thirty-one patients with 177 PS at T10, T11, and T12 were analyzed. The PS insertion torque showed a moderate positive correlation with lumbar spine BMD (r=0.59–0.69, p<0.01), total hip BMD (0.58–0.62, p<0.01), and HU value (r=0.58–0.66, p<0.01). However, the VBQ score did not show significant correlation (r=−0.28 to −0.23, p >0.05). Notably, a strong correlation was found between the PS insertion torque and the HU value for screws of the same size (r=0.71 and 0.74, p<0.01). The HU value at T12 and the PS insertion torque at T10 were significantly lower in the PJF group than in the non-PJF group. Conclusions This study demonstrates a positive correlation between the PS insertion torque and HU value in the lower thoracic spine and a moderate correlation with BMD but not the VBQ score. Preoperative assessment using DEXA and CT is crucial for optimizing bone health management in ASD surgery.

Methods: The study included patients with ASD aged >60 years who underwent spinal corrective fusion surgery from the lower thoracic spine to the pelvis. The intraoperative PS insertion torque was measured using a torque meter. Pearson correlation coefficients were calculated between the PS insertion torque and the BMD, HU, and VBQ score. Preoperative bone quality was compared between the proximal junctional failure (PJF) and non-PJF groups. Results: Thirty-one patients with 177 PS at T10, T11, and T12 were analyzed. The PS insertion torque showed a moderate positive correlation with lumbar spine BMD (r=0.59–0.69, p<0.01), total hip BMD (0.58–0.62, p<0.01), and HU value (r=0.58–0.66, p<0.01). However, the VBQ score did not show significant correlation (r=−0.28 to −0.23, p >0.05). Notably, a strong correlation was found between the PS insertion torque and the HU value for screws of the same size (r=0.71 and 0.74, p<0.01). The HU value at T12 and the PS insertion torque at T10 were significantly lower in the PJF group than in the non-PJF group. Conclusions This study demonstrates a positive correlation between the PS insertion torque and HU value in the lower thoracic spine and a moderate correlation with BMD but not the VBQ score. Preoperative assessment using DEXA and CT is crucial for optimizing bone health management in ASD surgery.

In Japan, drug therapy for schizophrenia is characterized by high-dose antipsychotic polypharmacy, which is an uncommon approach internationally. In this study, we reduced the number of antipsychotic agents in 5 patients using the Safety Correction of High-dose Antipsychotic Polypharmacy (SCAP) method and conducted a survey regarding treatment satisfaction. The switch from polypharmacy to monotherapy was achieved in all patients. There was no deterioration in psychiatric symptoms, and adverse reactions were reduced. Three of the subjects were satisfied with the decrease in the number of antipsychotic agents and dose-reduction. These results suggest that the SCAP method is a safe and useful method that can be applied in a clinical setting.

Methods: The study included patients with ASD aged >60 years who underwent spinal corrective fusion surgery from the lower thoracic spine to the pelvis. The intraoperative PS insertion torque was measured using a torque meter. Pearson correlation coefficients were calculated between the PS insertion torque and the BMD, HU, and VBQ score. Preoperative bone quality was compared between the proximal junctional failure (PJF) and non-PJF groups. Results: Thirty-one patients with 177 PS at T10, T11, and T12 were analyzed. The PS insertion torque showed a moderate positive correlation with lumbar spine BMD (r=0.59–0.69, p<0.01), total hip BMD (0.58–0.62, p<0.01), and HU value (r=0.58–0.66, p<0.01). However, the VBQ score did not show significant correlation (r=−0.28 to −0.23, p >0.05). Notably, a strong correlation was found between the PS insertion torque and the HU value for screws of the same size (r=0.71 and 0.74, p<0.01). The HU value at T12 and the PS insertion torque at T10 were significantly lower in the PJF group than in the non-PJF group. Conclusions This study demonstrates a positive correlation between the PS insertion torque and HU value in the lower thoracic spine and a moderate correlation with BMD but not the VBQ score. Preoperative assessment using DEXA and CT is crucial for optimizing bone health management in ASD surgery.

Methods: The study included patients with ASD aged >60 years who underwent spinal corrective fusion surgery from the lower thoracic spine to the pelvis. The intraoperative PS insertion torque was measured using a torque meter. Pearson correlation coefficients were calculated between the PS insertion torque and the BMD, HU, and VBQ score. Preoperative bone quality was compared between the proximal junctional failure (PJF) and non-PJF groups. Results: Thirty-one patients with 177 PS at T10, T11, and T12 were analyzed. The PS insertion torque showed a moderate positive correlation with lumbar spine BMD (r=0.59–0.69, p<0.01), total hip BMD (0.58–0.62, p<0.01), and HU value (r=0.58–0.66, p<0.01). However, the VBQ score did not show significant correlation (r=−0.28 to −0.23, p >0.05). Notably, a strong correlation was found between the PS insertion torque and the HU value for screws of the same size (r=0.71 and 0.74, p<0.01). The HU value at T12 and the PS insertion torque at T10 were significantly lower in the PJF group than in the non-PJF group. Conclusions This study demonstrates a positive correlation between the PS insertion torque and HU value in the lower thoracic spine and a moderate correlation with BMD but not the VBQ score. Preoperative assessment using DEXA and CT is crucial for optimizing bone health management in ASD surgery.