Drugs - Real World Outcomes最新文献

{"title":"Evaluating the Effectiveness of Prophylactic Strategies for Hemophilia A Management: A Real-World, Longitudinal Observational Study.","authors":"Shyh-Shin Chiou, Ching-Yeh Lin, Te-Fu Weng, Jiaan-Der Wang, Sheng-Chieh Chou, Ching-Tien Peng, Pei-Chin Lin, Yu-Mei Liao, Leanne Lai, Ming-Ching Shen","doi":"10.1007/s40801-024-00452-z","DOIUrl":"https://doi.org/10.1007/s40801-024-00452-z","url":null,"abstract":"<p><strong>Background: </strong>Hemophilia A (HA) treatment strategies aim to manage bleeding episodes and improve patients' quality of life. This study investigates the effectiveness of a preventative approach using intermediate-dose prophylaxis with standard half-life FVIII products in reducing bleeding rates and enhancing the quality of life for patients with severe HA.</p><p><strong>Methods: </strong>A 4-year prospective longitudinal study followed 35 patients with severe HA (without FVIII inhibitors) who transitioned from a reactive treatment approach to intermediate-dose prophylaxis in Taiwan from 2014 until 2018. The study tracked annual bleeding rates (ABR) and annual joint bleeding rates (AjBR) alongside associated costs and patient-reported quality-of-life measures.</p><p><strong>Results: </strong>Prophylaxis significantly reduced both ABR and AjBR compared with the previous treatment. After one year, ABR and AjBR decreased by 76.9% and 72.5%, respectively, with further reductions to 91.0% and 90.8% after 4 years (p < 0.001). While the average annual cost of factor VIII concentrate increased by 41.0% in the first year, the incremental cost-effectiveness ratio demonstrated ongoing benefits from ABR avoidance over the 4 years. Additionally, patients reported significant improvements in quality-of-life measures following the switch to prophylaxis (p = 0.036).</p><p><strong>Conclusion: </strong>Intermediate-dose prophylaxis effectively reduced bleeding rates and improved quality of life in patients with severe HA. Despite initial cost increases, the intervention became cost effective over time. This study provides valuable data for healthcare policymakers, highlighting the long-term benefits of prophylaxis as a preventative approach for managing bleeding and improving overall well-being in patients with severe HA.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acknowledgement to Referees.","authors":"","doi":"10.1007/s40801-024-00466-7","DOIUrl":"https://doi.org/10.1007/s40801-024-00466-7","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Pharmacovigilance Study on Psychotropic Agent-Induced Urinary Retention Using the Japanese Adverse Drug Event Report Database.","authors":"Shusuke Uekusa, Keika Mogi, Yuki Ota, Yuki Hanai, Kohei Kitagawa, Takashi Yoshio, Kazuhiro Matsuo","doi":"10.1007/s40801-024-00465-8","DOIUrl":"https://doi.org/10.1007/s40801-024-00465-8","url":null,"abstract":"<p><strong>Introduction: </strong>Psychotropic drugs have been reported to cause urinary retention (UR) via anticholinergic and other mechanisms. However, UR has not received much attention because of its non-fatal symptoms. We investigated the occurrence of UR associated with psychotropic drugs using the Japanese Adverse Drug Event Report (JADER) database.</p><p><strong>Methods: </strong>Using the JADER database, we calculated reporting odds ratios for UR for 74 psychotropic drugs. Multivariate logistic regression analysis was used to adjust for the effects of sex, underlying disease, and age on UR. Variable selection included forced entry for sex, age, benign prostatic hyperplasia (BPH), depression, and backward-forward stepwise selection for each drug.</p><p><strong>Results: </strong>A total of 887,704 cases were reported, of which 4653 (0.52%) had UR. In terms of sex, 0.79% (3401/429,372 cases) and 0.43% (1797/415,358 cases) of male and female patients had UR. In terms of age, 0.31% (892/288,676 cases) and 0.68% (3463/506,907 cases) of patients aged < 60 years and 60 years or older had UR. Among the underlying diseases, 8.22% (930/11,316 cases) and 0.43% (3723/876,388 cases) of patients with BPH and without BPH had UR, respectively. Further, 1.99% (337/16,959 cases) and 0.50% (4316/870,745 cases) of patients with depression and without depression had UR, respectively. Overall, 38 psychotropic drugs met the criteria for signal detection. In logistic regression, a total of 783,083 patients of discernible age and sex were included. The selected variables were sex, age, BPH, depression, and 23 drugs, including quetiapine [adjusted reporting odds ratio (ROR) 95% confidence interval (CI): 1.46-2.81], chlorpromazine (adjusted ROR 95%CI: 1.29-3.13), etizolam (adjusted ROR 95%CI: 1.47-3.09), maprotiline (adjusted ROR 95%CI: 1.99-8.34), mirtazapine (adjusted ROR 95%CI: 1.37-2.88), and duloxetine (adjusted ROR 95%CI: 2.15-4.21).</p><p><strong>Conclusions: </strong>Many psychotropic drugs induce UR, which may be owing to their pharmacological effects. Appropriate monitoring is needed, especially in patients with other risk factors for UR.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Pilot Study on the Collection of Adverse Event Data from the Patient Using an Electronic Platform in a Cancer Clinical Trial Unit.","authors":"Minna Grahvendy, Bena Brown, Laurelie R Wishart","doi":"10.1007/s40801-024-00461-y","DOIUrl":"https://doi.org/10.1007/s40801-024-00461-y","url":null,"abstract":"<p><strong>Background and objective: </strong>Accurate and robust adverse event (AE) data collection is crucial in cancer clinical trials to ensure participant safety. Frameworks have been developed to facilitate the collection of AE data and now the traditional workflows are facing renewal to include patient-reported data, improving completeness of AE data. We explored one of these workflows in a cancer clinical trial unit.</p><p><strong>Methods: </strong>The study was a single-site study conducted at a tertiary hospital located in Australia. Patients consenting to a clinical trial were eligible for inclusion in this study. Participants used an electronic platform-My Health My Way (MHMW)-to report their symptomatic data weekly for 24 weeks. A symptom list was included within the platform, along with a free text field. Data reported via the platform was compared with data recorded in the patient's medical chart. Time taken to compile data from each source was recorded, along with missing data points. Agreement between patient-reported data and data recorded in the medical notes was assessed using Kappa and Gwet's AC₁; time taken to compile data and missing data points were assessed using a Wilcoxon signed rank test.</p><p><strong>Results: </strong>Low agreement was found between patient- and clinician-reported data (- 0.482 and - 0.159 by Kappa and Gwet's AC₁ respectively). Only 127 (30%) of the total 428 AEs were reported by both MHMW and medical notes. Patients reported higher rates of symptoms from the symptom list, while clinicians reported higher rates of symptoms outside of the symptom list. Time taken to compile the data from MHMW was significantly less than that taken to review medical notes (2.19 min versus 5.73 min respectively; P <  0.001). There were significantly less missing data points from the MHMW data compared with the medical notes (1.4 versus 7.8; P < 0.001).</p><p><strong>Conclusions: </strong>This study confirms previous reports that patient- and clinician-reported adverse event data show low agreement. This study also shows that clinical trial sites could significantly reduce the work performed by research staff in the collection of adverse event data by implementing an electronic, patient-reported platform.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"US Clinical Practice Experience with Eculizumab in Myasthenia Gravis: Acute Clinical Events and Healthcare Resource Utilization.","authors":"Richard J Nowak, Ali A Habib, Andrew J Klink, Srikanth Muppidi, Anju Parthan, S Chloe Sader, Alexandrina Balanean, Ajeet Gajra, James F Howard","doi":"10.1007/s40801-024-00457-8","DOIUrl":"https://doi.org/10.1007/s40801-024-00457-8","url":null,"abstract":"<p><strong>Background and objective: </strong>The terminal complement inhibitor eculizumab is approved in the USA for the treatment of patients with acetylcholine receptor antibody-positive generalized myasthenia gravis (MG). The ELEVATE study aimed to examine clinical-practice outcome data on eculizumab effectiveness in US adults with MG (generalized or ocular). This paper reports the findings on MG exacerbations and crises and associated healthcare resource utilization, and the use of rescue therapy.</p><p><strong>Methods: </strong>A retrospective chart review was conducted of US adults with MG who initiated eculizumab. Outcomes assessed for up to 2 years before and after eculizumab initiation included percentages and rates per patient per year (PPPY) of exacerbations and crises (the latter defined as intubation/impending intubation), healthcare resource utilization, and rescue therapy administration.</p><p><strong>Results: </strong>A total of 119 patients diagnosed with MG were enrolled in the study; 92 patients had ≥ 3 months of data both before and during eculizumab therapy and were included in the analyses. The mean rate of MG exacerbations decreased from 0.385 PPPY before eculizumab initiation to 0.152 PPPY during eculizumab treatment (p = 0.0034); the mean rate of MG crises decreased from 0.411 to 0.056 PPPY (p = 0.0018). Rates of healthcare resource utilization and rescue therapy use also decreased significantly during eculizumab treatment.</p><p><strong>Conclusions: </strong>This retrospective chart review analysis provides evidence for a beneficial impact of eculizumab treatment on the incidence of MG exacerbations and crises and associated healthcare resource utilization in clinical practice, and on rescue therapy use. These data further support the therapeutic benefits of eculizumab in patients with MG.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the Safety of Aspirin Monotherapy and Aspirin and P2Y12 Inhibitor Combination Therapy in Patients Post Coil Embolization During Admission: A Cross-Sectional Study Using a Nationwide Inpatient Database.","authors":"Hiroshi Magara, Yuri Nakamura, Takuaki Tani, Shinobu Imai, Anna Kiyomi, Kensuke Yoshida, Kiyohide Fushimi, Munetoshi Sugiura","doi":"10.1007/s40801-024-00464-9","DOIUrl":"https://doi.org/10.1007/s40801-024-00464-9","url":null,"abstract":"<p><strong>Background: </strong>Some aspects regarding the use of antiplatelet agents after coil embolization for subarachnoid hemorrhage during admission remain unclear. This study used diagnostic procedure combination (DPC) data to investigate the safety and prognostic effects of aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy on bleeding events.</p><p><strong>Methods: </strong>This cross-sectional study used Japanese DPC data to assess patients who were hospitalized with subarachnoid hemorrhage and received aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy between April 2016 and March 2020 (n = 4421). The aspirin monotherapy (A group, n = 2848) and aspirin and P2Y12 inhibitor combination therapy (AP group, n = 1573) groups were compared. The primary and secondary endpoints were the incidence of bleeding events and proportion of patients with a modified Rankin Scale (mRS) score ≤ 2 at discharge, respectively. Data was analyzed using multivariable adjusted logistic regression (significance level, 5%).</p><p><strong>Results: </strong>The adjusted odds ratio in AP group, with A group as the reference, for bleeding events and the proportion of patients with mRS score ≤ 2 at discharge were 0.97 (95% confidence interval [95% CI]: 0.75-1.26, p = 0.839) and 1.09 (95% CI: 0.92-1.29, p = 0.302), respectively.</p><p><strong>Conclusions: </strong>There are no differences in the incidence of bleeding events or good clinical outcomes (mRS score ≤ 2 at discharge) between aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Significance of Prior Ramucirumab Use on the Effectiveness of Nivolumab as the Third-Line Regimen in Gastric Cancer: A Multicenter Retrospective Study.","authors":"Yuka Obayashi, Shoichiro Hirata, Yoshiyasu Kono, Makoto Abe, Koji Miyahara, Masahiro Nakagawa, Michihiro Ishida, Yasuhiro Choda, Kenta Hamada, Masaya Iwamuro, Seiji Kawano, Yoshiro Kawahara, Motoyuki Otsuka","doi":"10.1007/s40801-024-00460-z","DOIUrl":"https://doi.org/10.1007/s40801-024-00460-z","url":null,"abstract":"<p><strong>Background and objective: </strong>Because vascular endothelial growth factor inhibition has been suggested to improve immune cell function in the cancer microenvironment, we examined whether using ramucirumab (RAM) before nivolumab usage is more effective in advanced gastric cancer.</p><p><strong>Methods: </strong>This was a multicenter retrospective observational study. We analyzed patients who received nivolumab monotherapy as the third-line regimen for unresectable advanced or recurrent gastric cancer between October 2017 and December 2022. They were divided into the RAM (RAM-treated) group and the non-RAM (non-treated) group according to the RAM usage in the second-line regimen. The primary outcome was to compare the overall survival after nivolumab administration in the third-line regimen between the RAM and non-RAM groups.</p><p><strong>Results: </strong>Fifty-two patients were included in the present study: 42 patients in the RAM group and ten patients in the non-RAM group. The median overall survival was significantly longer in the RAM group than in the non-RAM group (8.5 months vs 6.9 months, p < 0.05). In the RAM group, patients without peritoneal metastasis had significantly better median overall survival than those with peritoneal metastasis (23.8 months vs 7.7 months, p = 0.0033). Multivariate Cox-proportional hazards analyses showed that the presence of peritoneal metastasis (hazard ratio, 2.4; 95% confidence interval 1.0-5.7) alone was significantly associated with overall survival in the RAM group.</p><p><strong>Conclusions: </strong>The use of RAM prior to nivolumab monotherapy may contribute to prolonged survival in patients with gastric cancer, especially those without peritoneal metastasis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.","authors":"Bruno Fautrel, Yoram Bouhnik, Carine Salliot, Franck Carbonnel, Mathurin Fumery, Christophe Bernardeau, Yves Maugars, Mathurin Flamant, Fabienne Coury, Ben Braithwaite, Salima Hateb, Janet Addison","doi":"10.1007/s40801-024-00459-6","DOIUrl":"https://doi.org/10.1007/s40801-024-00459-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims database, SNDS) in addressing data gaps.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;PERFUSE is a 12-month, observational, multi-centre cohort study of patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs) who initiated routine SB5 treatment between October 2018 and October 2020, either as their first ADL (naïve) or transitioning from another ADL (switched). Clinical data, including disease activity scores, C-reactive protein levels, and dosing information, were collected as available from patient records captured during routine visits to specialist physicians. Persistence data were supplemented with data from the French national healthcare claims database (SNDS). Analyses of clinical data were descriptive, while persistence was assessed using a Kaplan-Meier survival analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Overall, 911 patients were included: 507 from rheumatology centres [116 with rheumatoid arthritis (RA), 78 psoriatic arthritis (PsA), and 313 ankylosing spondylitis (AS)] and 404 from gastroenterology centres [316 with Crohn's disease (CD) and 88 ulcerative colitis (UC)]. Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p &lt; 0.05). Switched patients' remission rates remained stable between baseline and month 12 (M12) for all indications (p &gt; 0.05). Persistence (95% CI) at M12 among naïve patients was 59% (46.5, 68.8) for RA, 65% (49.7, 77.1) for PsA, 56% (48.3, 62.6) for AS, 70% (63.0, 75.7) for CD, and 42% (30.7, 53.1) for UC, compared to 60% (42.7, 73.7) for RA, 57% (37.3, 72.1) for PsA, 55% (45.8, 64.0) for AS, 63% (53.4, 71.7) for CD, and 56% (27.2, 77.6) for UC among switched patients. No significant differences were observed between naïve and switched patients (p &gt; 0.05). SNDS pairing provided information on 68 of the 132 patients (52%) who were lost to follow-up in the clinical database, of whom 57 (84%) were confirmed persistent at M12 and 11 (16%) non-persistent. Primary treatment failure (naïve patients) and patient decision (switched patients) were the most common reasons stated for treatment discontinuation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Costs of Intravenous Push Waste in Intraoperative Areas Through Observation: A Multi-site Study.","authors":"John B Hertig, Les Louden, Blake Shay, Armando Soto, Garrett Robbins, Tatyana Kornilova, Prachi Arora","doi":"10.1007/s40801-024-00456-9","DOIUrl":"https://doi.org/10.1007/s40801-024-00456-9","url":null,"abstract":"<p><strong>Introduction: </strong>The costs associated with proper disposal, management, and regulatory compliance of controlled substances in healthcare systems are substantial. In the context of the current opioid crisis, and given the high abuse potential of controlled substances, it is imperative that waste is minimized and waste procedures are followed to ensure safe disposal of controlled substances. This study aims to quantify the costs associated with fentanyl, hydromorphone, morphine, midazolam, and ketamine waste in intraoperative areas through a multi-site observational analysis.</p><p><strong>Methods: </strong>The study used an observational design across various hospital procedural and post-procedural units in the Southwest Florida region of the United States. Automated and non-automated workflows for wasting controlled substances were compared. As with a previous study conducted by Hertig et al., waste was evaluated as (1) the quantity (mg/μg) of medication disposed defined as 'pharmaceutical waste' or 'product waste' (PW); and (2) workforce time associated with the waste disposal process defined as 'workforce time waste' (WTW). Secondary measures include workforce costs associated with the waste disposal process. The product waste analysis was conducted between October and December 2023. The workforce time waste analysis was examined over a 10-day period in January and February 2024. A yearly extrapolation model was applied to cost data.</p><p><strong>Results: </strong>The findings revealed substantial costs linked to both PW and WTW, emphasizing the financial burden of controlled substance waste. Study data validated previous literature describing the extent of fentanyl, hydromorphone, and morphine waste while documenting significant amounts of midazolam and ketamine waste. The combined annual waste cost for the two study hospitals was estimated at US$56,557, with workforce time accounting for 36%-50% of this total cost.</p><p><strong>Conclusion: </strong>This study provides vital insights into the financial and operational impact of medication waste in procedural and post-procedural areas, supporting ongoing efforts to minimize waste, ensuring the safe and effective use of controlled substances. Future research should explore the impact of medication waste across diverse healthcare settings and the cost implications associated with pharmacy professionals in the waste compliance process.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Clinical Outcomes of Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma: A Real-World Comparison with First-Line or Later-Line Treatment.","authors":"Yudai Fujiwara, Hidekatsu Kuroda, Tamami Abe, Keisuke Kakisaka, Ippeki Nakaya, Asami Ito, Takuya Watanabe, Kenji Yusa, Tomoaki Nagasawa, Hiroki Sato, Akiko Suzuki, Kei Endo, Yuichi Yoshida, Takayoshi Oikawa, Kei Sawara, Akio Miyasaka, Takayuki Matsumoto","doi":"10.1007/s40801-024-00458-7","DOIUrl":"https://doi.org/10.1007/s40801-024-00458-7","url":null,"abstract":"<p><strong>Background and objective: </strong>Durvalumab plus tremelimumab (Durva/Treme) has recently been approved as a first-line or later-line treatment for patients with unresectable hepatocellular carcinoma (u-HCC) in Japan. We assessed the real-world outcomes of Durva/Treme for u-HCC, with a focus on treatment efficacy and safety.</p><p><strong>Methods: </strong>We retrospectively evaluated 22 patients with u-HCC treated with Durva/Treme at Iwate Medical University during the period from 2023 to 2024, with a comparison of the clinical outcomes between patients who received Durva/Treme as first-line and later-line treatments. We further evaluated changes in the modified albumin-bilirubin (mALBI) grade during treatment.</p><p><strong>Results: </strong>There were 10 patients in the first-line group and 12 patients in the later-line treatment group. During the follow-up with a median duration of 7.6 months, the median progression-free survival (first-line versus later-line: 4.7 months versus 2.9 months, p = 0.85), the objective response rate (0.0% versus 16.7%, p = 0.48), the disease control rate (60.0% versus 58.4%, p = 1.00), and the incidence of any adverse event (50.0% versus 75.0%, p = 0.38) were not statistically different between the two groups. The changes in the mALBI scores were not statistically significant (p = 0.75).</p><p><strong>Conclusions: </strong>Durva/Treme may be effective and safe for patients with u-HCC, even in patients who receive Durva/Treme as a later-line treatment.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}