Objective: Pharmaceutical manufacturers conduct drug use-results surveys (DUSs) for drug reexamination applications in Japan. However, most DUSs are single-cohort studies to confirm drug safety; therefore little information is obtained from a DUS for safety comparison with other drugs. Integrating DUS data is a novel method to compare drug safety profiles among drugs. This study examined the usefulness of integrating DUS data.
Design: Active surveillance
Methods: We integrated DUS data obtained from two DUSs of antihypertensive drugs-a calcium channel blocker (CCB), azelnidipine (CalblockR), and an angiotensin-receptor blocker (ARB), olmesartan medoxomil (OlmetecR)-with similar study protocols. Both studies were conducted by the same pharmaceuticalcompany. Matching patients using propensity scores, we examined whether the DUS results could be applied to pharmacoepidemiology data resources for hypothesis strengthening. Safety outcomes included vasodilation-related events, which are typical adverse drug reactions (ADRs) to CCB. The incidence of safety outcomes was compared by conditional logistic regression models. Two definitions for safetuoutcomes were employed: definition 1, physician-reported adverse events; and definition 2, physicianreported ADRs.
Results: In a total of 7196 patients included in the analysis, the propensity-matched patients were well balanced. Most safety outcomes were detected in the CCB group including a significant increase in vasodilation-related events (odds ratio for definition 1 versus ARB group, 1.75; 95% confidence interval,1.01-3.03).
Conclusion: Integrated DUS data collated by pharmaceutical manufacturers following clear criteria are potentially useful to commence pharmacoepidemiology studies designed to strengthen hypotheses.

BACKGROUND/AIMS: Both fecal immunochemical test (FIT) and fecal calprotectin (Fcal) results are useful biomarkers for ulcerative colitis (UC). However, the situations in which each marker should be used are largely unknown. METHODS: A total of 110 colonoscopy intervals of UC patients were assessed, and correlations between changes in colonoscopic findings and changes in the two aforementioned fecal markers were examined. RESULTS: Among patients with mucosal healing (MH) and negative FIT or Fcal results at the initial colonoscopy, FIT and Fcal findings exhibited accuracies of 93% (38/41) and 79% (26/33), respectively, for predicting the results of the subsequent examination. Among the 24 patients who showed endoscopic activity at the precedent colonoscopy and MH at the subsequent examination, positive-to-negative conversion of FIT and Fcal findings at the subsequent examination was observed in 92% (12/13) and 62% (8/13) of patients, respectively. Among the 43 patients who showed endoscopic activity at both the precedent and subsequent examinations, Fcal findings reflected the change in endoscopic activity better than FIT results (r=0.59, p<0.0001 vs r=0.30, p=0.054). CONCLUSIONS: The FIT is useful for confirming MH and the occurrence of relapse. In contrast, Fcal is useful for monitoring the mucosal status of patients with active inflammation.
Biomarkers ; Colitis ; Colitis, Ulcerative* ; Colonoscopy ; Humans ; Inflammation ; Leukocyte L1 Antigen Complex* ; Recurrence ; Ulcer*

BACKGROUND/AIMS: Although mucosal healing (MH) has been considered a treatment goal for patients with ulcerative colitis (UC), the risk factors predictive of relapse in patients who achieve MH are unknown. Because the platelet count has been shown to be a marker of inflammation in inflammatory bowel diseases, this study aimed to assess whether the platelet count could predict relapse in UC patients with MH. METHODS: A prospective observational study was performed. UC patients with MH were consecutively enrolled in the study and monitored for at least 2 years or until relapse. The correlation between the incidence of relapse and the platelet count at the time of study enrollment was examined. RESULTS: In total, 43 patients were enrolled, and 14 patients (33%) relapsed. The median platelet count at the time of enrollment in the patients who relapsed significantly differed from that in the patients who did not relapse (27.2×104/μL vs 23.8×104/μL, respectively; p=0.016). A platelet count >25.0×104/μL was a significant risk factor for relapse based on a multivariate analysis (hazard ratio, 4.85; 95% confidence interval, 1.07 to 25.28), and according to the Kaplan-Meier analysis, this cutoff could identify patients susceptible to relapse (p=0.041, log-rank test). CONCLUSIONS: The platelet count could be used as a predictor of relapse in UC patients with MH.
Blood Platelets* ; Colitis ; Colitis, Ulcerative* ; Humans ; Incidence ; Inflammation ; Inflammatory Bowel Diseases ; Kaplan-Meier Estimate ; Multivariate Analysis ; Observational Study ; Platelet Count* ; Prospective Studies ; Recurrence* ; Risk Factors ; Ulcer*

A 3-month alcoholism rehabilitation program at psychiatric hospitals is common in Japan for patients with alcohol use disorder (AUD). However, many AUD patients are often hospitalized for the treatment of digestive disorders due to alcohol-related liver diseases and pancreatitis. In this sense, AUD patients need to be better supported by professionals and departments in general hospitals. Here we analyzed the problems in alcohol-related medical care in Japan and examined the measures to be taken at general hospitals.

Background: No studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (BAE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) for emergent treatment of acute cholangitis (AC) in patients with upper gastrointestinal surgically altered anatomy (SAA). Methods: This study retrospectively evaluated consecutive patients who underwent emergent BAE-ERCP or EUS-BD for AC with SAA between January 2020 and March 2024. Technical success, clinical success, procedure time, and adverse events (AEs) were compared between the two groups. Results: This study included 23 patients in the BAE-ERCP group and 14 patients in the EUS-BD group. Technical success and clinical success rates did not significantly differ between the two groups (88% vs. 100%, P = 0.51 and 95% vs. 93%, P = 0.66). Similarly, the rate of AEs was comparable between the two groups (4% vs. 14%, P = 0.54). The median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [interquartile range; IQR, 28.8–52.5] minutes vs. 70.0 [IQR, 60.0–90.0] minutes, P < 0.01). In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and AEs did not significantly differ between the two groups. However, the median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [IQR, 28.8–52.5] minutes vs. 70 [IQR, 56.3–90.0] minutes, P < 0.01). Conclusion While both BAE-ERCP and EUS-BD can be performed safely and effectively in patients with AC and SAA, the procedure time is significantly shorter with EUS-BD than with BAE-ERCP.

Background: No studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (BAE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) for emergent treatment of acute cholangitis (AC) in patients with upper gastrointestinal surgically altered anatomy (SAA). Methods: This study retrospectively evaluated consecutive patients who underwent emergent BAE-ERCP or EUS-BD for AC with SAA between January 2020 and March 2024. Technical success, clinical success, procedure time, and adverse events (AEs) were compared between the two groups. Results: This study included 23 patients in the BAE-ERCP group and 14 patients in the EUS-BD group. Technical success and clinical success rates did not significantly differ between the two groups (88% vs. 100%, P = 0.51 and 95% vs. 93%, P = 0.66). Similarly, the rate of AEs was comparable between the two groups (4% vs. 14%, P = 0.54). The median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [interquartile range; IQR, 28.8–52.5] minutes vs. 70.0 [IQR, 60.0–90.0] minutes, P < 0.01). In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and AEs did not significantly differ between the two groups. However, the median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [IQR, 28.8–52.5] minutes vs. 70 [IQR, 56.3–90.0] minutes, P < 0.01). Conclusion While both BAE-ERCP and EUS-BD can be performed safely and effectively in patients with AC and SAA, the procedure time is significantly shorter with EUS-BD than with BAE-ERCP.

Background: No studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (BAE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) for emergent treatment of acute cholangitis (AC) in patients with upper gastrointestinal surgically altered anatomy (SAA). Methods: This study retrospectively evaluated consecutive patients who underwent emergent BAE-ERCP or EUS-BD for AC with SAA between January 2020 and March 2024. Technical success, clinical success, procedure time, and adverse events (AEs) were compared between the two groups. Results: This study included 23 patients in the BAE-ERCP group and 14 patients in the EUS-BD group. Technical success and clinical success rates did not significantly differ between the two groups (88% vs. 100%, P = 0.51 and 95% vs. 93%, P = 0.66). Similarly, the rate of AEs was comparable between the two groups (4% vs. 14%, P = 0.54). The median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [interquartile range; IQR, 28.8–52.5] minutes vs. 70.0 [IQR, 60.0–90.0] minutes, P < 0.01). In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and AEs did not significantly differ between the two groups. However, the median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [IQR, 28.8–52.5] minutes vs. 70 [IQR, 56.3–90.0] minutes, P < 0.01). Conclusion While both BAE-ERCP and EUS-BD can be performed safely and effectively in patients with AC and SAA, the procedure time is significantly shorter with EUS-BD than with BAE-ERCP.

Health support activities for residents were held three times during a period from June, 2016 to November, 2017. The residents registered in order to participate through 11 community pharmacies. Participant’s blood pressure values were measured at the venue of health support activities by pharmacists. The blood pressure values in 66 of the 106 participants were analyzed, excluding 40 participants receiving medical treatment. The rate of participants with hypertension, systolic blood pressure (SBP)≧140 mmHg or diastolic blood pressure (DBP)≧90 mmHg, was 32% (21／66). Of those with hypertension, 43% (9／21) had hypertension of a high risk level, SBP≧160 mmHg or DBP≧100 mmHg. Pharmacists provided lifestyle counseling and encouraged them to make changes in order to achieve tighter blood pressure control. The data of their blood pressure values were provided to community pharmacies for continuing support of their blood pressure control. With the pharmacist’s support, the median value of blood pressure of participants who had hypertension decreased in the second event. In addition, 50% (3／6) of participants who attended the second event with hypertension of high risk level, visited the hospital for a consultation with a doctor after getting pharmacist’s advice. These results indicate that greater access to community pharmacists improved blood pressure control of residents with hypertension. However, there were many residents who consider it difficult to use pharmacies without a prescription. Hence, friendly relationship to residents on their utilizing pharmacies is needed for providing them lifestyle counseling such as preventing hypertension by pharmacists.

The questionnaire was distributed to caregivers regarding their management for home medication therapy. The purpose of this questionnaire was to clarify the role of community pharmacists in city “Z”, Hiroshima in supporting this activity. The results were compared among seven administrative zones. The percentage of caregivers who had routinely administered medications to dependent patients was 81%. Of these, the percentage of caregivers who had encountered difficulty in medication administration to dependent patients was 66%. Only 13% of these caregivers had sought assistance from pharmacists in dealing with issues they faced in the administration of medications. The percentage of caregivers who had easy access to pharmacists was 44%. The percentage of caregivers who received pharmacist-initiated information about patients was 23%. Among the 7 administrative zones in city “Z”, the 2 zones (H-zones) with the highest percentage of elderly citizens, 38.7%, were compared with the other 2 zones (L-zones) with the lowest percentage of elderly citizens, 25.7%, regarding medication management by caregivers. It was observed that the frequency of missing side effects or crushing medicines by caregivers was higher in H-zones as compared to L-zones. The results of this research suggest that close cooperation between pharmacists and caregivers improves the quality of medication therapy management. In an aging society, pharmacist intervention could be very beneficial to providing support and information that would improve the quality of patients’ medication therapy.

The questionnaire was distributed to caregivers regarding their management for home medication therapy. The purpose of this questionnaire was to clarify the role of community pharmacists in city “Z”, Hiroshima in supporting this activity. The results were compared among seven administrative zones. The percentage of caregivers who had routinely administered medications to dependent patients was 81%. Of these, the percentage of caregivers who had encountered difficulty in medication administration to dependent patients was 66%. Only 13% of these caregivers had sought assistance from pharmacists in dealing with issues they faced in the administration of medications. The percentage of caregivers who had easy access to pharmacists was 44%. The percentage of caregivers who received pharmacist-initiated information about patients was 23%. Among the 7 administrative zones in city “Z”, the 2 zones (H-zones) with the highest percentage of elderly citizens, 38.7%, were compared with the other 2 zones (L-zones) with the lowest percentage of elderly citizens, 25.7%, regarding medication management by caregivers. It was observed that the frequency of missing side effects or crushing medicines by caregivers was higher in H-zones as compared to L-zones. The results of this research suggest that close cooperation between pharmacists and caregivers improves the quality of medication therapy management. In an aging society, pharmacist intervention could be very beneficial to providing support and information that would improve the quality of patients’ medication therapy.