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Hiroshi Yoshitani, Junko Ito, Hideki Kozono Pharmaceutical & Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, JapanCorrespondence: Hiroshi Yoshitani, Pharmaceutical & Medical Device Vigilance Department, Toray Industries, Inc., 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo, 103-8666, Japan, Tel +81 3 3245-8615, Email hiroshi.yoshitani.c2@mail.torayBackground: Nalfurafine (Remitch®, Toray Industries, Inc.) is a selective κ-receptor agonist approved in Japan for the improvement of pruritus in patients with chronic liver diseases (only when existing treatments bring insufficient efficacy) in May 2015.Methods: A post-marketing Specific Drug Use Survey was conducted in Japan (March 1, 2016 to June 30, 2020) of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver disease.Results: Among 1186 cases analyzed for safety, the incidence of adverse drug reactions was 9.4% (112/1186 cases), lower than 61.4% reported in pre-marketing surveillance (297/484 cases). No specific safety issues were found and no cases of concern for drug dependence identified. Efficacy (itch improvement) was demonstrated in 73.16% (815/1114 cases; 12-week analysis set) and in 85.67% (520/607; general assessment of itch improvement at 1-year analysis set). A significant difference was found in 4 items of itch improvement at 12 weeks and 8 items of itch improvement at 1 year. No noteworthy issues were identified. Mean Visual Analog Scale (VAS) values after 12 weeks and 1 year after the first dose were significantly lower than the baseline (p < 0.0001 for both treatment durations). Mean severity scores (Kawashima’s classification scheme) were significantly lower than the pretreatment score at 12 weeks and 1 year after the first dose (both p < 0.0001). No concerns were identified in the efficacy and safety of nalfurafine in patients with specific background, ie, the elderly (aged ≥ 65 years), those with renal impairment, and those on long-term treatment (≥ 365 days) compared with patients without corresponding background.Conclusion: No new safety issues of concern or cases of insufficient efficacy were identified in this Specific Drug Use Survey of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver diseases.Keywords: post-marketing surveillance, safety, efficacy, nalfurafine, pruritus, chronic liver disease

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0 mm (large group, n = 58) or < 3.0 mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995 days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels., (© 2024. Springer Nature Japan KK, part of Springer Nature.)

Background: There is a paucity of data regarding the optimal duration of drug-coated balloon (DCB) inflation for coronary lesions. We sought to explore the effect of DCB angioplasty with versus without long inflation time on residual stenosis and clinical outcomes in patients with coronary artery disease., Methods: This study included 314 consecutive patients with 445 lesions undergoing paclitaxel DCB angioplasty using different inflation time, divided according to whether the total inflation time of the DCB was ≥180 s (prolonged group) or <180 s (standard group). The primary clinical endpoint, defined as a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization, was examined in 92 propensity score matched pairs., Results: In the matched cohort, the median clinical follow-up period was 947 days. Postprocedural angiographic diameter stenosis was smaller in the prolonged group than in the standard group (30.0% [22.0-37.0] vs. 33.5% [25.5-40.5]; p = 0.042). Intravascular ultrasound measurements revealed that longer DCB inflation time resulted in smaller area stenosis (66.6 ± 7.8% vs. 69.4 ± 7.0%; p = 0.044) and a less mean increase in percent atheroma volume (-11.2 ± 7.1% vs. -7.4 ± 5.9%; p = 0.004) after angioplasty. The rate of the primary endpoint was lower in the prolonged group than in the standard group (log-rank p = 0.025). The efficacy of prolonged DCB inflation was prominent in patients with in-stent restenosis and longer lesions., Conclusion: Prolonged DCB inflation was associated with reduced residual stenosis and improved clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention. Prospective randomized trials are warranted to validate the benefits of DCB angioplasty with long inflation time., (© 2023 Wiley Periodicals LLC.)

Radiation can be visualized using a scintillator and a digital camera. If the amount of light emitted by the scintillator increases with dose, the dose estimation can be obtained from the amount of light emitted. In this study, the basic performance of the scintillator and digital camera system was evaluated by measuring computed tomography dose index (CTDI). A circular plastic scintillator plate was sandwiched between polymethyl methacrylate (PMMA) phantoms, and x-rays were irradiated to them while rotating the x-ray tube to confirm changes in light emission. In addition, CTDI was estimated from the amount of light emitted by the scintillator during the helical scan and compared with the value measured from dosimeter. The scintillator emitted light while changing its distribution according to the movement of the x-ray tube. The measured CTDI vol was 33.20 mGy, the CTDI vol estimated from the scintillation light was approximately 46 mGy, which was 40% larger. In particular, when the scintillator was directly irradiated, the dose was overestimated compared with the value measured from the dosimeter. This overestimation can be because of the reproducibility of the position and the difference between the sensitivity of the scintillator to detect light emission and the sensitivity of the dosimeter, and the non-uniformity of position sensitivity due to the wide-angle lens., (© 2022 IOP Publishing Ltd.)