Clinical therapeutics最新文献

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Comparison of Combined Letrozole and Clomiphene Citrate With Gonadotropin Microstimulation Protocols on Fertility Outcomes. 来曲唑与枸橼酸克罗米芬联合应用与促性腺激素微刺激方案对生育结果的比较。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-27 DOI: 10.1016/j.clinthera.2025.07.025
Na Zhou, Jiao Xu, Ling Liu, Yichen Yang, Xuejiao Fan, Haiqin Ren
{"title":"Comparison of Combined Letrozole and Clomiphene Citrate With Gonadotropin Microstimulation Protocols on Fertility Outcomes.","authors":"Na Zhou, Jiao Xu, Ling Liu, Yichen Yang, Xuejiao Fan, Haiqin Ren","doi":"10.1016/j.clinthera.2025.07.025","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.025","url":null,"abstract":"<p><strong>Purpose: </strong>Large-scale data comparing the effects of combined letrozole (LE) and clomiphene citrate (CC) with gonadotropin (Gn) microstimulation protocols on pregnancy outcomes are lacking. This study aimed to compare the effects of CC + Gn and LE + Gn microstimulation protocols on fertility outcomes.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted to include infertile patients between January 1, 2018, and December 31, 2022. All patients underwent a microstimulation protocol and treatment was administered using either CC + Gn or LE + Gn. The main study outcomes included clinical pregnancy, miscarriage, and live birth rates.</p><p><strong>Findings: </strong>Of the 1697 included patients, 875 were treated with CC + Gn, while the remaining 822 were treated with LE + Gn. We noted that CC + Gn was associated with a lower clinical pregnancy rate (odds ratio (OR): 0.324; 95% confidence interval (CI): 0.127-0.829; P = 0.019) and live birth rate (OR: 0.332; 95% CI: 0.112-0.988; P = 0.048) than LE + Gn; however, there was no significant difference between CC + Gn and LE + Gn regarding the abortion rate (OR: 0.523; 95% CI: 0.028-9.720; P = 0.664). Moreover, there were significant differences between the CC + Gn and LE + Gn groups in the number of embryos transferred (P < 0.001), number of frozen embryos (P < 0.001), and number of embryos at the frozen cleavage stage (P = 0.002).</p><p><strong>Implications: </strong>LE + Gn microstimulation protocol was associated with better fertility outcomes than CC + Gn in terms of clinical pregnancy and live birth rates in patients with infertility.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comment on: The Effect of Intermittent Fasting Diet in Comparison With Low-Calorie Diet on Inflammation, Lipid Profile, Glycemic Index, Liver Fibrosis in Patients With Metabolic-Associated Fatty Liver Disease (MAFLD): A Randomized Controlled Trial. 评论:与低热量饮食相比,间歇性禁食饮食对代谢性脂肪性肝病(MAFLD)患者炎症、脂质谱、血糖指数、肝纤维化的影响:一项随机对照试验。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-26 DOI: 10.1016/j.clinthera.2025.08.002
Hongda Xu, Tuocen Fan, Yiyang Xu, Wenhao Li, Junrui Cui
{"title":"Comment on: The Effect of Intermittent Fasting Diet in Comparison With Low-Calorie Diet on Inflammation, Lipid Profile, Glycemic Index, Liver Fibrosis in Patients With Metabolic-Associated Fatty Liver Disease (MAFLD): A Randomized Controlled Trial.","authors":"Hongda Xu, Tuocen Fan, Yiyang Xu, Wenhao Li, Junrui Cui","doi":"10.1016/j.clinthera.2025.08.002","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.08.002","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Quadruple-Drug Fixed-Dose Single-Pill Combination Therapy for Hypertension and Dyslipidemia: A Prospective, Multicenter, Observational Study. 四药联合治疗高血压和血脂异常的疗效和安全性:一项前瞻性、多中心、观察性研究。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-25 DOI: 10.1016/j.clinthera.2025.07.023
Soohyung Park, Eun Jin Park, Moon-Hwa Park, Wonsang Chu, Dae-In Lee, Seung-Young Roh, Cheol Ung Choi, Dong Oh Kang
{"title":"Efficacy and Safety of Quadruple-Drug Fixed-Dose Single-Pill Combination Therapy for Hypertension and Dyslipidemia: A Prospective, Multicenter, Observational Study.","authors":"Soohyung Park, Eun Jin Park, Moon-Hwa Park, Wonsang Chu, Dae-In Lee, Seung-Young Roh, Cheol Ung Choi, Dong Oh Kang","doi":"10.1016/j.clinthera.2025.07.023","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.023","url":null,"abstract":"<p><strong>Purpose: </strong>Single-pill combination (SPC) therapy can reduce the pill burden in patients with hypertension and dyslipidemia, potentially improving medication adherence and clinical outcomes. This study aimed to evaluate the efficacy and safety of a quadruple-drug fixed-dose SPC (QFDC) therapy combining losartan, amlodipine, rosuvastatin, and ezetimibe (L/A/R/E) in these patients.</p><p><strong>Methods: </strong>Between September 2021 and September 2023, 2,150 patients (mean age: 61.58 ± 12.41 years; male: 56.33%) were enrolled in this prospective, multicenter, observational study conducted across 137 hospitals in South Korea. Patients were treated with one of six QFDC regimens, which combined losartan (50/100 mg), amlodipine (5 mg), rosuvastatin (5/10/20 mg), and ezetimibe (10 mg). The primary endpoint was the percentage of patients who achieved a target blood pressure (BP) of <140/90 mmHg and low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL 12 weeks post-treatment.</p><p><strong>Findings: </strong>Among the 1,965 eligible patients (efficacy analysis set), 73.15% (95% confidence interval [CI] 71.19-75.11) achieved the target BP after 12 weeks of QFDC therapy. Similarly, 71.11% (95% CI 68.33-73.89) reached the target LDL-C level. Additionally, 57.11% (95% CI 54.08-60.15) achieved both target BP and LDL-C levels. The mean changes from baseline to 12 weeks were -13.69 ± 17.04 mmHg for systolic BP and -37.55 ± 34.93 mg/dL for LDL-C (both P < 0.0001), with greater reductions noted in subgroups with higher baseline levels (BP ≥140/90 mmHg or LDL-C ≥100 mg/dL). No serious adverse events or adverse drug reactions were reported.</p><p><strong>Implications: </strong>The L/A/R/E QFDC regimen is an effective and safe treatment option for patients with concurrent hypertension and dyslipidemia.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Randomized, Double-Blind, Placebo-Controlled Phase II Trial of AYP-101 (Soybean Phosphatidylcholine) for Submental Fat Reduction in Asian Adults. 随机、双盲、安慰剂对照的大豆磷脂酰胆碱(AYP-101)治疗亚洲成人脑下脂肪减少的II期试验。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-23 DOI: 10.1016/j.clinthera.2025.07.016
Sun Young Choi, A M Abd El-Aty, Beom Joon Kim
{"title":"Randomized, Double-Blind, Placebo-Controlled Phase II Trial of AYP-101 (Soybean Phosphatidylcholine) for Submental Fat Reduction in Asian Adults.","authors":"Sun Young Choi, A M Abd El-Aty, Beom Joon Kim","doi":"10.1016/j.clinthera.2025.07.016","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.016","url":null,"abstract":"<p><strong>Purpose: </strong>Submental fat (SMF) accumulation can affect self-image and psychological well-being, leading to a demand for nonsurgical treatment. AYP-101, which contains soybean phosphatidylcholine (SPC), is under investigation for SMF reduction. This study aimed to compare 2 concentrations of AYP-101 to placebo injections to determine the optimal concentration and evaluate safety and efficacy in reducing moderate to severe SMF in an Asian population.</p><p><strong>Methods: </strong>This single-center, randomized, double-blind, placebo-controlled phase II trial enrolled 96 participants with moderate to severe SMF. Participants were randomly assigned to receive either a placebo or AYP-101 at either a low concentration (25 mg/mL) or a high concentration (50 mg/mL), administered every 2 weeks for up to 6 sessions. The primary endpoint was the proportion of participants achieving at least a 1-grade improvement in both the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and the Subject-Reported Submental Fat Rating Scale (SR-SMFRS) at 4 and 12 weeks after the final injection.</p><p><strong>Findings: </strong>At 4 weeks post-treatment, 69.70% of the low-concentration group and 48.39% of the high-concentration group exhibited improvement in the ER-SMFRS, compared to 22.58% in the placebo group. Significant differences were noted between the low-concentration and placebo groups (P = 0.0002), with similar results at 12 weeks.</p><p><strong>Implications: </strong>AYP-101, administered biweekly at a concentration of 25 mg/mL, appears to be a safe and effective nonsurgical option for reducing SMF in Asians.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety Profiles of Trofinetide in Pediatric Rett Syndrome Population: A Real-World Postmarketing Pharmacovigilance Analysis. Trofinetide在小儿Rett综合征人群中的安全性:一项现实世界上市后药物警戒分析。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-22 DOI: 10.1016/j.clinthera.2025.07.022
Jingjing Li, Zhiyue Zhang, Tao Yan
{"title":"Safety Profiles of Trofinetide in Pediatric Rett Syndrome Population: A Real-World Postmarketing Pharmacovigilance Analysis.","authors":"Jingjing Li, Zhiyue Zhang, Tao Yan","doi":"10.1016/j.clinthera.2025.07.022","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.022","url":null,"abstract":"<p><strong>Purpose: </strong>Trofinetide, a synthetic analog of glycine-proline-glutamate, is the only approved therapy for Rett syndrome. This study evaluated the safety profile of trofinetide in pediatric patients with Rett syndrome using real-world pharmacovigilance data.</p><p><strong>Methods: </strong>Adverse event (AE) reports were extracted from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from Q1 2023 to Q4 2024. Disproportionality analyses were conducted using ROR, PRR, BCPNN, and MGPS to detect AE signals associated with trofinetide use in individuals under 18 years. A Weibull distribution model was applied to assess time-to-onset patterns. Subgroup analyses by age and dose, as well as sensitivity analyses excluding common co-medications, were conducted to evaluate signal consistency.</p><p><strong>Findings: </strong>Most patients were female (95.4%), and all reports originated from the United States. Common labeled AEs were confirmed, including diarrhoea (n = 1,528; ROR = 38.1), vomiting (n = 434; ROR = 5.96), and seizures (n = 251; ROR = 5.30). Off-label signals included weight decreased (n = 135; ROR = 7.21), tremor (n = 39; ROR = 3.37), dystonia (n = 18; ROR = 4.39), and dyskinesia (n = 24; ROR = 4.53). Over 70% of AEs occurred within the first month. Hypersomnia was more frequently reported in younger children (ROR = 12.11), and higher doses were associated with psychiatric symptoms. Subgroup and sensitivity analyses confirmed the robustness of key signals.</p><p><strong>Implications: </strong>This study provides critical real-world safety data on trofinetide use in pediatric Rett syndrome, identifying both expected and emerging AEs. Findings highlight the importance of monitoring dose-related and age-specific adverse events in clinical settings.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a). 一项开放标签、单剂量研究,评估奥尔帕西兰在血清脂蛋白升高的中国参与者中的药代动力学、药效学、安全性和耐受性。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-21 DOI: 10.1016/j.clinthera.2025.07.021
Winnie Sohn, Kathryn C B Tan, Trupti Shah, Yinhao Du, Jingying Wang, Shuo Zhang, Stephen Flach, Jessica Ward
{"title":"An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a).","authors":"Winnie Sohn, Kathryn C B Tan, Trupti Shah, Yinhao Du, Jingying Wang, Shuo Zhang, Stephen Flach, Jessica Ward","doi":"10.1016/j.clinthera.2025.07.021","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.021","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiovascular disease (CVD) remains a major cause of premature mortality and disability worldwide, with China ranking among the highest in CVD deaths. Lipoprotein(a) (Lp(a)) is a circulating lipoprotein particle that, when elevated, may increase CVD risk. Reduced Lp(a) levels with existing cardiovascular treatments are modest, and evidence confirming whether lowering Lp(a) leads to cardiovascular benefit is lacking. Olpasiran (AMG 890), a liver cell-targeting small interfering RNA, has been shown to elicit profound Lp(a) reductions with an acceptable safety profile and is being evaluated in clinical trials worldwide. Therefore, investigating olpasiran's treatment potential for cardiovascular risk reduction in the Chinese population is important.</p><p><strong>Participants and methods: </strong>This is a phase 1, open-label, randomized, single-dose, parallel-group study in Chinese participants with elevated serum Lp(a). Participants with serum Lp(a) concentrations ≥70 nmol/L (or approximately ≥27 mg/dL) were randomized 1:1 to receive a single subcutaneous dose of olpasiran (75 or 225 mg). Olpasiran pharmacokinetic (PK) results were the primary endpoints; treatment-emergent adverse events (TEAEs), clinical laboratory tests, 12-lead electrocardiograms (ECGs), vital signs, lipids, and serum Lp(a) concentrations were the secondary endpoints.</p><p><strong>Results: </strong>Twenty-four participants (12 per dose group) were randomized, and 23 participants completed the study. After reaching maximal serum concentrations (75 mg: 167 ng/mL; 225 mg: 667 ng/mL) in ∼3 hours, olpasiran concentrations in both groups declined rapidly and were predominantly cleared from circulation within 3 days. Sustained reductions in Lp(a) concentrations from baseline were observed for both doses, with maximal reductions seen on day 57 (75 mg: -94.8%; 225 mg: -99.2%). All TEAEs associated with olpasiran were mild/moderate in severity, with four participants in the 225 mg dose group experiencing five mild TEAEs at the injection site. No notable treatment- or dose-related trends in clinical laboratory evaluations, vital signs, ECGs, physical examinations, or lipid panel results were identified, and no TEAEs leading to discontinuation or deaths were reported.</p><p><strong>Discussion: </strong>Results from this study, as well as previous studies, indicate that olpasiran effectively and safely reduces Lp(a) levels in a similar manner across different ethnic populations.</p><p><strong>Conclusions: </strong>Olpasiran administration (75 and 225 mg) was safe and well-tolerated in Chinese participants, and olpasiran PK and Lp(a) responses are generally consistent with those observed in East Asian/non-East Asian participants. Dose adjustments of olpasiran based on ethnicity are therefore not warranted, and work investigating the effects of olpasiran treatment on long-term cardiovascular risk in East Asian populations should continue.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advancing Decentralized and Pragmatic Clinical Trials as a Path Toward Improved Representativeness and Greater Generalizability of Clinical Trial Evidence. 推进分散和实用的临床试验,以提高临床试验证据的代表性和更大的普遍性。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-21 DOI: 10.1016/j.clinthera.2025.07.010
Caroline Marra, Krisda H Chaiyachati, Vindell Washington, Amy P Abernethy
{"title":"Advancing Decentralized and Pragmatic Clinical Trials as a Path Toward Improved Representativeness and Greater Generalizability of Clinical Trial Evidence.","authors":"Caroline Marra, Krisda H Chaiyachati, Vindell Washington, Amy P Abernethy","doi":"10.1016/j.clinthera.2025.07.010","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.010","url":null,"abstract":"<p><p>Despite efforts to improve research equity in clinical trials, a lack of representativeness continues to threaten the generalizability of clinical trial evidence and leads to several ethical and economic consequences. Decentralized clinical trials (DCTs) and pragmatic clinical trials (PCTs), novel clinical trial models that use technology to enable alternative data collection methods and integrate studies into clinical care, hold great promise for addressing representativeness challenges but also face several limitations. Leveraging technology and clinical care settings to conduct trial visits and collect trial data inherently limits participation from people without reliable access to technology and consistent medical care. Further, representativeness needs to be improved across the full spectrum of clinical trials, from trials conducted in early product development phases to trials conducted after a product is approved, but the DCT and PCT elements that can improve representativeness are more likely to be deployed after seminal evidence for a new medical product's regulatory approval has already been generated. We propose three solutions to help ensure the defining aspects of DCTs and PCTs increase representativeness and the generalizability of evidence generated in clinical trials conducted at all phases in the product lifecycle. We suggest that efforts should be centered around collaborative work with regulators to define data standards and validate outcomes when alternative data sources and collection methods are used, the creation of technical support resources and transparent processes for the conduct of trials facilitated by technology, and the incorporation of health equity principles into the design and deployment of technology-based tools used to facilitate DCTs and PCTs.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Leveraging Real-world Evidence for Antihypertensive Fixed-dose Combinations: A Multidimensional Narrative Review From European Industry Perspective. 利用真实世界的证据抗高血压固定剂量组合:从欧洲工业角度的多维叙事回顾。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-21 DOI: 10.1016/j.clinthera.2025.07.024
Mariusz Mogielnicki, Volodymyr Stus, Artur Banaszak
{"title":"Leveraging Real-world Evidence for Antihypertensive Fixed-dose Combinations: A Multidimensional Narrative Review From European Industry Perspective.","authors":"Mariusz Mogielnicki, Volodymyr Stus, Artur Banaszak","doi":"10.1016/j.clinthera.2025.07.024","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.024","url":null,"abstract":"<p><strong>Purpose: </strong>Real-world data (RWD) and real-world evidence (RWE) offer significant potential for clinical development and clinical evidence generation. This review addresses the complexity surrounding the use of RWD and RWE in drug repurposing, such as antihypertensive fixed-dose combinations of known compounds from the 5 major pharmacological classes.</p><p><strong>Methods: </strong>We performed a narrative review examining RWD and RWE use in the development and registration of antihypertensive fixed-dose combinations, covering their role as examples of value-added medicines, regulatory policies, scientific perceptions, application in hypertension research, regulatory use cases, and economic factors.</p><p><strong>Findings: </strong>Well-designed RWE studies can yield clinical performance data comparable with findings of randomized controlled trials while addressing certain limitations. However, current European Union (EU) legislation regarding the usability of RWD and RWE is conservative and needs to be updated. Divergent opinions among EU member states pose uncertainty and risk for industry in marketing authorization applications involving RWD and RWE.</p><p><strong>Implications: </strong>Real-world data and RWE offer a transformative opportunity through data sourced beyond traditional clinical trials. This approach can expedite regulatory decisions, reduce development timelines and costs, and accelerate the delivery of valuable therapies to patients. Discussions at the centralized EU regulatory level are needed to recognize and accept RWE as valid for demonstrating clinical efficacy and safety.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-World Utilization Patterns of Immune Checkpoint Inhibitors Based on the National Health Insurance Service Data in Korea. 基于韩国国民健康保险服务数据的免疫检查点抑制剂的实际使用模式。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-14 DOI: 10.1016/j.clinthera.2025.07.014
Eunji Kim, Yu-Seon Jung, Jongmin Lee, Dal Ri Nam, Seung-Hun You, Ju Won Lee, Sook Ryun Park, Ji Seon Oh, Ye-Jee Kim, Eun-Jung Jo, Nakyung Jeon, Won-Jung Jung, Sun-Young Jung
{"title":"Real-World Utilization Patterns of Immune Checkpoint Inhibitors Based on the National Health Insurance Service Data in Korea.","authors":"Eunji Kim, Yu-Seon Jung, Jongmin Lee, Dal Ri Nam, Seung-Hun You, Ju Won Lee, Sook Ryun Park, Ji Seon Oh, Ye-Jee Kim, Eun-Jung Jo, Nakyung Jeon, Won-Jung Jung, Sun-Young Jung","doi":"10.1016/j.clinthera.2025.07.014","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.014","url":null,"abstract":"<p><strong>Purpose: </strong>This study was conducted to comprehensively understand the utilization patterns of immune checkpoint inhibitors (ICIs) in Korea, including their use in combination with traditional anticancer therapies.</p><p><strong>Methods: </strong>We investigated the utilization of ICIs using claims data from Korea between 2017 and 2022. Patients with cancer were included in the study if they received at least one dose of ICIs, defined by drug codes in the claims data. We used descriptive statistics to identify patterns of ICIs use in combination with other anticancer therapies and ICIs use by year and cancer type.</p><p><strong>Findings: </strong>During the study period, 41,208 patients received at least one dose of ICIs. Lung cancer (66.6%), urinary tract cancer (11.3%), and liver/biliary tract cancer (10.6%) were the most frequent cancer types. The prescription of ICIs particularly surged between 2020 and 2022 for liver/biliary tract cancer. Between 2017 and 2022, the use of ICIs increased from 1,155 to 15,034, with an increase every year. Since 2020, the use of ICIs in combination with other anticancer therapies and concurrent use of ICIs has increased sharply.</p><p><strong>Implications: </strong>The number of patients utilizing ICIs in Korea has been steadily increasing. As regulatory approval of indications for ICIs has expanded, so has the range of indications for ICIs. In addition, the combination of ICIs with other anticancer therapies and the concurrent use of ICIs has increased in recent years, reflecting expanded treatment options for advanced cancers.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to "The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab" [Clin Ther. 2024;46:916-926]. “SDZ-deno的证据总数:参考Denosumab的生物仿制药”的勘误表[j].临床医学杂志,2024;46:916-926。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-14 DOI: 10.1016/j.clinthera.2025.07.019
Barbara Vogg, Johann Poetzl, Arnd Schwebig, Susmit Sekhar, Alan Kivitz, Natalia Krivtsova, Oliver Renner, Jean-Jacques Body, Richard Eastell
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