Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Background/Aims: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. Methods: This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Results: Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred. Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

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: To identify factors affecting adherence to medication, a subjective questionnaire survey was administered to schizophrenia patients regarding the prescribed antipsychotic formulations. Methods: We evaluated the patients’ satisfaction and dissatisfaction with prescribed antipsychotic formulations, and patients answered the Drug Attitude Inventory-10 Questionnaire (DAI-10). Inclusion criteria for patients are as follows:age between 20 and 75 years and taking antipsychotic agents containing the same ingredients and formulations, for at least 1 month. Results: In total, 301 patients answered the questionnaire survey. Tablets were found to be the most commonly used antipsychotic formulations among schizophrenia patients (n = 174, 57.8%), followed by long-acting injections (LAIs, n = 93, 30.9%). No significant differences in the formulation satisfaction level and DAI-10 scores were observed between all formulations. Formulations, except for LAI, were selected by physicians in more than half of the patients.Patients who answered “Decided by consultation with physicians” had significantly higher satisfaction levels and DAI-10 scores compared to those who answered “Decided by physicians” (4.11 ± 0.77 vs. 3.80 ± 1.00, p = 0.0073 and 6.20 ± 3.51 vs. 4.39 ± 4.56, p ＜ 0.001, respectively). Satisfaction levels moderately correlated with DAI-10 scores (r = 0.48, p ＜ 0.001). Conclusion No formulation had a high satisfaction level in all patients, and it is important to be reflect the patients’ individual preferences in pharmacotherapy. Shared decision-making in the selection of the formulations is seen to be useful for improving medication adherence.

Objective：Currently, there is no reliable evidence on the usefulness of rehabilitation for idiopathic, normal-pressure hydrocephalus (iNPH）patients after cerebrospinal shunt surgery. Therefore, in this study we investigated the association between the duration of rehabilitation and outcomes.Methods：We evaluated the changes before and after cerebrospinal shunt surgery and rehabilitation by applying the 3-m timed up-and-go test (TUG), 10-m straight walk test, 180-degree turn, 30-seconds chair-stand test (CS-30), mini-mental state examination (MMSE), and frontal assessment battery (FAB) in 81 patients with iNPH. Clinical outcomes were classified as excellent, good, or unsatisfactory.Results：At discharge, TUG, 180-degree turn, and CS-30 were significantly improved in 38 patients who had been in rehabilitation for ≥2 weeks, compared to those with ＜2 weeks-rehabilitation after shunt surgery. However, there was no significant difference between MMSE and FAB tests in the two groups. Rehabilitation for ≥2 weeks significantly improved the patient outcome, especially for those patients with severe gait disturbance before treatment. In 53 patients whose initial TUG time was ≥13.5 s, rehabilitation for ≥2 weeks was effective, and resulted in an excellent outcome (odds ratio：4.52, 95％ confidence interval：1.22-18.7, P value：0.012).Conclusion：In-hospital rehabilitation after cerebrospinal shunt surgery was useful for patients with iNPH and severe disability in daily activities. Therefore, we suggest that these patients require in-hospital rehabilitation after shunt surgery until sufficient improvement of gait disturbance is achieved, in order to maximize activities of daily living.

Objective：Currently, there is no reliable evidence on the usefulness of rehabilitation for idiopathic, normal-pressure hydrocephalus (iNPH）patients after cerebrospinal shunt surgery. Therefore, in this study we investigated the association between the duration of rehabilitation and outcomes.Methods：We evaluated the changes before and after cerebrospinal shunt surgery and rehabilitation by applying the 3-m timed up-and-go test (TUG), 10-m straight walk test, 180-degree turn, 30-seconds chair-stand test (CS-30), mini-mental state examination (MMSE), and frontal assessment battery (FAB) in 81 patients with iNPH. Clinical outcomes were classified as excellent, good, or unsatisfactory.Results：At discharge, TUG, 180-degree turn, and CS-30 were significantly improved in 38 patients who had been in rehabilitation for ≥2 weeks, compared to those with ＜2 weeks-rehabilitation after shunt surgery. However, there was no significant difference between MMSE and FAB tests in the two groups. Rehabilitation for ≥2 weeks significantly improved the patient outcome, especially for those patients with severe gait disturbance before treatment. In 53 patients whose initial TUG time was ≥13.5 s, rehabilitation for ≥2 weeks was effective, and resulted in an excellent outcome (odds ratio：4.52, 95％ confidence interval：1.22-18.7, P value：0.012).Conclusion：In-hospital rehabilitation after cerebrospinal shunt surgery was useful for patients with iNPH and severe disability in daily activities. Therefore, we suggest that these patients require in-hospital rehabilitation after shunt surgery until sufficient improvement of gait disturbance is achieved, in order to maximize activities of daily living.

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.

Objective: To improve poor medication adherence in schizophrenic patients, long-acting injectable (LAI) antipsychotics are used. However, it has not yet become common in Japan. Recently, aripiprazole LAI was approved for alternative injection into the deltoid muscle in addition to the gluteal muscle. The acceptance for the proposal to switch from gluteal to deltoid injections of aripiprazole LAI was investigated. Methods: The subjects were 32 outpatients with schizophrenia who had continuously received aripiprazole LAI administration into the gluteal muscle for ≥ 6 months. In the patients who had continued deltoid injection for 3 months after switching, the changes in the pain and shame in comparison with gluteal injections were evaluated. Results: Switching to the deltoid injection was chosen by 17 out of 32 patients. Three months later, 9 patients were still receiving deltoid injections with highly rated satisfaction. The main reasons for switching to deltoid injections included the pain and shame associated with gluteal injections. The main reason for returning to the gluteal injection was the pain experienced from the injection in the deltoid. Conclusion The option to select the injected area was based on the amount of pain in the deltoid and gluteal sites, leading to the widespread use of aripiprazole LAI.

Idiopathic normal pressure hydrocephalus (iNPH) is a disorder observed in elderly patients causing gait disturbance, urinary incontinence and cognitive impairment. Due to the rapidly aging society, the number of patients with iNPH continues to increase yearly. However, iNPH is often overlooked because of its insidious and variable presentation. In the primary care setting, iNPH can be coincidentally discovered by neuroimaging findings, including disproportionately enlarged subarachnoid space hydrocephalus (DESH). We report two cases of iNPH in the elderly living alone that had different outcomes depending upon the availability of neurosurgery specialists. It is essential for primary care physicians to consult neurosurgeons without delay because prompt diagnosis and treatment can improve the patient's quality of life and prolong their duration of living at home.