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Background and Aim: Elobixibat is a triple mode of action laxative that increases water secretion into the colon, promotes colonic motility, and reestablishes the defecation desire. This study aims to evaluate the effectivity and safety of elobixibat in chronic constipation (CC) patients refractory to conventional laxatives. Methods: A single‐center retrospective observational study was conducted in refractory CC patients diagnosed according to the Rome IV criteria and received elobixibat between April 2018 and June 2022 at Osaka Saiseikai Nakatsu Hospital. Data were collected for spontaneous bowel movement (SBM), Bristol stool form scale (BSFS) scores, abdominal symptoms, and adverse events. Results: Eligible 311 patients were selected for the analysis. Two‐week Elobixibat treatment significantly increased SBM (times/week) from 2.9 ± 1.9 to 4.3 ± 1.9 (P < 0.0001). The BSFS score improved significantly from 3.2 ± 1.7 to 4.4 ± 1.4 (P < 0.0001). The percentages of patients with hard stool were decrease and that with normal stools were increase. Improvements in abdominal symptoms (sensation of incomplete bowel evacuation, straining, abdominal pain and distention, and difficulty defecating) were also significant (P < 0.05). These constipation symptoms were improved irrespective of patient characteristics or previous laxatives. The 43.9% of previous laxatives were discontinued at the start of or after starting elobixibat treatment. A few adverse events were observed, elobixibat was well tolerated. Conclusion: Elobixibat was effective in patients who were refractory to other laxatives, irrespective of previous therapy or patient characteristics. Elobixibat may contribute to resolving polypharmacy with single mode of action laxatives. [ABSTRACT FROM AUTHOR]

Background and Aim: Recombinant thrombomodulin (rhTM) is potentially effective in the treatment of disseminated intravascular coagulation (DIC). Several studies related to drugs for the treatment of acute cholangitis have shown negative results in improvement of overall survival (OS) with rhTM. The aim of this multicenter study was to evaluate the clinical effectiveness of rhTM in patients with acute cholangitis and sepsis‐induced DIC who underwent biliary drainage. Methods: A total of 284 consecutive patients, who were complicated with sepsis‐induced DIC due to severe acute cholangitis, were included (rhTM group, n = 173; non‐rhTM, n = 111) in this study. The primary outcome was the DIC resolution rate at 7 days after starting treatment. The 28‐day survival rate was secondarily evaluated. Results: DIC scores in the rhTM group improved significantly compared with the non‐rhTM group on day 7 (P =.020). According to multivariate analysis, etiology of cholangitis (malignant, HR 2.28), rhTM (non‐administration, HR 4.13), and DIC score (≥5, HR 2.46) were significant factors associated with failed DIC resolution on day 7. Propensity score matching created 103 matched pairs. Survival rate at day 28 was significantly higher in rhTM group (94.3%) compared with non‐rhTM group (82.6%; P =.048) after propensity score matching. rhTM (non‐administration, HR 2.870), DIC score (≥5, HR 2.751), and APACHE II score (≥20, HR 9.310) were significant factors associated with decreasing survival rate at day 28. Conclusion: In conclusion, rhTM seemed to improve patient survival, but future studies should only include patients with benign or malignant disease and should be performed according to APACHE II scores. [ABSTRACT FROM AUTHOR]

Introduction: Elobixibat is a new laxative, but its efficacy and adverse events (AEs) are insufficiently examined compared with those of other laxatives. Hence, by propensity score (PS) matching, we compared the effects and AEs between elobixibat and lubiprostone. Methods: We retrospectively analyzed 1,887 Japanese patients with chronic constipation (CC) treated at our hospital between October 2013 and April 2020. Enrolled patients were divided into three treatment groups, namely, elobixibat (10 mg daily) (E10 group, n = 293), lubiprostone (24 μg daily) (L24 group, n = 772), and lubiprostone (48 μg daily) (L48 group, n = 822), as their first treatment. We then investigated the changes on the weekly average number of spontaneous bowel movements, stool consistency scores (SCSs), and AEs starting from the baseline until the end of the 2-week treatment. To adjust for patients' background, we performed one-to-one nearest neighbor matching without replacement between elobixibat- and lubiprostone-treated patients according to the individual estimated PSs. Results: After treatment, for SCSs, both the L24 and L48 groups significantly improved compared with the E10 group (p < 0.05), but their stools were soft (Bristol Stool Form Scale: 4.8). Notably, the E10 group had less frequent AEs than the L24 group (26 [9.0%] vs. 43 [14.8%], p = 0.03). Particularly, nausea was significantly less in the E10 group than that in the L48 group (2 [0.7%] vs. 7 [2.4%], p = 0.01). Conclusion: Elobixibat is a beneficial drug for patients with mildly symptomatic CC and is safe to use, given its few AEs. [ABSTRACT FROM AUTHOR]

Introduction: Lubiprostone is an effective treatment of chronic constipation (CC). However, as with other stimulant or osmotic laxatives, adverse events (AEs) can make it difficult to continue treatment. This article investigates AE risk factors associated with lubiprostone. Methods: We retrospectively analyzed all 1,338 Japanese patients with CC treated at our hospital from October 2013 to July 2017. All patients were diagnosed with constipation as defined by the Roma III criteria. Enrolled patients received lubiprostone orally (24 or 48 μg daily), after which we investigated the incidence of AEs. The causative factors for diarrhea and nausea, the most common AEs, were examined by the backward logistic regression model. Results: Two hundred eight (15.5%) experienced at least 1 AE. No serious AEs were associated with the study drug. The AEs reported by >1% of patients overall were diarrhea (6.1%) and nausea (4.2%). We performed a multivariate logistic regression using a backward variable selection method to investigate AE risk factors. Factors associated with higher incidence of diarrhea were patient age of 65 years or more (odds ratio: [95% confidence interval]; p value) (2.09: [1.05–4.16]; 0.035). Factors associated with greater likelihood of nausea included female gender (1.99: [1.10–3.61]; 0.023), and the chief complaint was a patient complaining of abdominal pain and fullness (2.07: [1.01–4.22]; 0.046). Conclusions: Understanding AE risk factors can help avoid unnecessary AEs and promote more effective treatment. [ABSTRACT FROM AUTHOR]

Summary: Background: Vonoprazan, a potassium‐competitive acid blocker, is used for acid‐related diseases. Occasionally, small white protrusions called "stardust" gastric mucosa have been detected in the stomachs of some patients taking vonoprazan. Aims: To determine the incidence of, and risk factors for, stardust gastric mucosa potentially induced by vonoprazan Methods: In this study, we enrolled 19 503 patients who underwent endoscopy at our hospital between 2016 and 2019. Using propensity score matching, we retrospectively compared patients who received and did not receive vonoprazan. The two groups were matched for age, sex, history of proton pump inhibitor use, and atrophic gastritis. Results: After 1:1 propensity score matching, each group comprised 2516 patients. Stardust gastric mucosa was detected significantly more often in the stomachs of patients receiving vonoprazan than those who had not received vonoprazan (4.9% vs 0.2%, P < 0.001). Its location was 70.7% in the upper third of the stomach, 29.3% in the middle third and none in the lower third. Histologically, this lesion had a mucus pool within a dilated duct surrounded by flattened glandular epithelium. The cumulative incidence rate of stardust gastric mucosa at 1, 2 and 3 years was 4.6%, 16.5% and 26.2%, respectively. The factors independently associated with the presence of stardust gastric mucosa were >205 days of vonoprazan oral intake (odds ratio [OR]: 6.99, 95% confidence interval [CI]: 4.60‐10.88) and female sex (OR: 1.75, 95% CI: 1.20‐2.58). Conclusions: Stardust gastric mucosa appeared more frequently in the stomachs of patients taking vonoprazan. [ABSTRACT FROM AUTHOR]

Background and Aim: Recombinant thrombomodulin (rhTM) is potentially effective in the treatment of disseminated intravascular coagulation (DIC). Several studies related to drugs for the treatment of acute cholangitis have shown negative results in improvement of overall survival (OS) with rhTM. The aim of this multicenter study was to evaluate the clinical effectiveness of rhTM in patients with acute cholangitis and sepsis-induced DIC who underwent biliary drainage., Methods: A total of 284 consecutive patients, who were complicated with sepsis-induced DIC due to severe acute cholangitis, were included (rhTM group, n = 173; non-rhTM, n = 111) in this study. The primary outcome was the DIC resolution rate at 7 days after starting treatment. The 28-day survival rate was secondarily evaluated., Results: DIC scores in the rhTM group improved significantly compared with the non-rhTM group on day 7 (P = .020). According to multivariate analysis, etiology of cholangitis (malignant, HR 2.28), rhTM (non-administration, HR 4.13), and DIC score (≥5, HR 2.46) were significant factors associated with failed DIC resolution on day 7. Propensity score matching created 103 matched pairs. Survival rate at day 28 was significantly higher in rhTM group (94.3%) compared with non-rhTM group (82.6%; P = .048) after propensity score matching. rhTM (non-administration, HR 2.870), DIC score (≥5, HR 2.751), and APACHE II score (≥20, HR 9.310) were significant factors associated with decreasing survival rate at day 28., Conclusion: In conclusion, rhTM seemed to improve patient survival, but future studies should only include patients with benign or malignant disease and should be performed according to APACHE II scores., (© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background and Aim: Esophageal endoscopic submucosal dissection (ESD) is often technically difficult due to intraoperative body movements. The level of sedation can be increased to suppress body movements, but this may not be successful in all cases. Using local analgesics for submucosal injection during ESD may aid in conscious sedation. This study evaluated the feasibility of the lidocaine injection method (LIM) during esophageal ESD., Methods: Twenty-nine patients with superficial esophageal cancer were enrolled in this study at Osaka Saiseikai Nakatsu Hospital, and 1% lidocaine + 0.4% hyaluronate sodium was injected into the submucosa underneath the lesion during esophageal ESD. The main outcome was body movements that disturbed the procedure., Results: Most patients were male (90%), with a median age of 70 years (interquartile range [IQR]: 66-75 years old), and the median lesion size was 17 mm (IQR: 12-21 mm). The median injection volume of lidocaine was 70 mg (IQR: 55-79 mg). All lesions were successfully removed en bloc. In all cases, there were no body movements that disturbed the procedure. Regarding adverse events of sedation, five patients (17%) had hypotension, four patients (14%) had bradycardia, and seven patients (24%) had hypoxemia during ESD. Convulsions or arrhythmia as adverse events associated with lidocaine were not observed., Conclusions: Esophageal ESD with LIM did not cause body movements that disturbed the procedure. LIM may help create a stable conscious sedation method for esophageal ESD., (© 2019 The Authors. JGH Open: An open access journal of gastroenterology and hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)