Pub Date : 2025-01-01Epub Date: 2024-12-14DOI: 10.1080/03007995.2024.2434083
Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara
Objective: Loss of sense of smell is a cardinal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP) and significantly impacts health-related quality-of-life. Dupilumab significantly improved smell outcomes (loss of smell [LoS] score; University of Pennsylvania Smell Identification Test [UPSIT]) versus placebo in the phase 3 SINUS-24/-52 studies (clinicaltrials.gov, NCT02898454/NCT02912468) in patients with severe CRSwNP. This post hoc analysis investigated the effect of dupilumab on olfaction using UPSIT smell impairment categories.
Methods: Patients with baseline smell impairment (UPSIT ≤34/≤33 [women/men; score range 0-40] AND LoS score ≥1 [0-3] AND smell/taste item of the 22-item Sinonasal Outcome Test >0 [SNOT-22; 0-5]) treated with dupilumab 300 mg or placebo once every 2 weeks on background intranasal corticosteroids were analyzed.
Results: Of 724 patients, 665 (91.9%) had smell impairment at baseline; most had anosmia (UPSIT 0-18) (dupilumab/placebo: 80.9%/79.8%). At week 24, the proportion of dupilumab-treated patients with anosmia decreased to 28.5%, while 14.9% achieved normosmia; most placebo-group patients (79.2%) remained anosmic and only 1.2% achieved normosmia (odds ratio = 17.3; 95% confidence interval = 5.1-59.0; p <.0001); results were similar at week 52. Improvements in Nasal Polyp Score, nasal congestion, and SNOT-22 total score were moderately correlated with improvements in UPSIT at weeks 24 and 52 (r = -.38 to -.50).
Conclusion: Most patients with severe CRSwNP had anosmia at baseline. Dupilumab treatment significantly improved smell versus placebo, with 14.9% achieving normosmia by week 24. There was a trend for better clinical outcomes in patients with greater smell improvement.
目的:嗅觉丧失是慢性鼻窦炎伴鼻息肉(CRSwNP)的主要症状,并显著影响与健康相关的生活质量。Dupilumab显著改善嗅觉预后(嗅觉丧失[LoS]评分;在严重CRSwNP患者的3期研究(clinicaltrials.gov, NCT02898454/NCT02912468)中,宾夕法尼亚大学嗅觉识别测试(University of Pennsylvania Smell Identification Test [UPSIT])与安慰剂进行了比较。这项事后分析使用UPSIT嗅觉损伤分类调查了dupilumab对嗅觉的影响。方法:基线嗅觉障碍患者(UPSIT≤34/≤33;评分范围0-40]和LoS评分≥1[0-3]和嗅觉/味觉项目的22项鼻窦结局测试>0 [SNOT-22;0-5]),每2周接受1次鼻内糖皮质激素背景治疗,分别使用dupilumab 300 mg或安慰剂。结果:724例患者中,665例(91.9%)在基线时存在嗅觉障碍;大多数患者有嗅觉缺失(UPSIT 0-18)(杜匹单抗/安慰剂:80.9%/79.8%)。在第24周,dupilumab治疗的嗅觉缺失患者比例降至28.5%,而14.9%的患者达到正常嗅觉;大多数安慰剂组患者(79.2%)仍然嗅觉缺失,只有1.2%达到正常嗅觉(优势比:17.3[95%置信区间:5.1,59.0];结论:大多数重度CRSwNP患者在基线时存在嗅觉缺失。与安慰剂相比,Dupilumab治疗显著改善了嗅觉,14.9%的患者在第24周达到正常嗅觉。嗅觉改善更大的患者有更好的临床结果的趋势。
{"title":"Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia.","authors":"Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara","doi":"10.1080/03007995.2024.2434083","DOIUrl":"10.1080/03007995.2024.2434083","url":null,"abstract":"<p><strong>Objective: </strong>Loss of sense of smell is a cardinal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP) and significantly impacts health-related quality-of-life. Dupilumab significantly improved smell outcomes (loss of smell [LoS] score; University of Pennsylvania Smell Identification Test [UPSIT]) versus placebo in the phase 3 SINUS-24/-52 studies (clinicaltrials.gov, NCT02898454/NCT02912468) in patients with severe CRSwNP. This post hoc analysis investigated the effect of dupilumab on olfaction using UPSIT smell impairment categories.</p><p><strong>Methods: </strong>Patients with baseline smell impairment (UPSIT ≤34/≤33 [women/men; score range 0-40] AND LoS score ≥1 [0-3] AND smell/taste item of the 22-item Sinonasal Outcome Test >0 [SNOT-22; 0-5]) treated with dupilumab 300 mg or placebo once every 2 weeks on background intranasal corticosteroids were analyzed.</p><p><strong>Results: </strong>Of 724 patients, 665 (91.9%) had smell impairment at baseline; most had anosmia (UPSIT 0-18) (dupilumab/placebo: 80.9%/79.8%). At week 24, the proportion of dupilumab-treated patients with anosmia decreased to 28.5%, while 14.9% achieved normosmia; most placebo-group patients (79.2%) remained anosmic and only 1.2% achieved normosmia (odds ratio = 17.3; 95% confidence interval = 5.1-59.0; <i>p</i> <.0001); results were similar at week 52. Improvements in Nasal Polyp Score, nasal congestion, and SNOT-22 total score were moderately correlated with improvements in UPSIT at weeks 24 and 52 (r = -.38 to -.50).</p><p><strong>Conclusion: </strong>Most patients with severe CRSwNP had anosmia at baseline. Dupilumab treatment significantly improved smell versus placebo, with 14.9% achieving normosmia by week 24. There was a trend for better clinical outcomes in patients with greater smell improvement.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"53-59"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767035","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}
Pub Date : 2025-01-01Epub Date: 2025-01-15DOI: 10.1080/03007995.2024.2436984
Daniel J Moore, Natasha I Leibel, William Polonsky, Henry Rodriguez
{"title":"Understanding the different stages of type 1 diabetes and their management: a plain language summary.","authors":"Daniel J Moore, Natasha I Leibel, William Polonsky, Henry Rodriguez","doi":"10.1080/03007995.2024.2436984","DOIUrl":"10.1080/03007995.2024.2436984","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"13-24"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142870834","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}
Pub Date : 2025-01-01Epub Date: 2025-01-06DOI: 10.1080/03007995.2024.2445142
Genevieve Chyrmang, Kangkana Bora, Anup Kr Das, Gazi N Ahmed, Lopamudra Kakoti
Breast cancer is a significant health challenge, with accurate and timely diagnosis being critical to effective treatment. Immunohistochemistry (IHC) staining is a widely used technique for the evaluation of breast cancer markers, but manual scoring is time-consuming and can be subject to variability. With the rise of Artificial Intelligence (AI), there is an increasing interest in using machine learning and deep learning approaches to automate the scoring of ER, PR, and HER2 biomarkers in IHC-stained images for effective treatment. This narrative literature review focuses on AI-based techniques for the automated scoring of breast cancer markers in IHC-stained images, specifically Allred, Histochemical (H-Score) and HER2 scoring. We aim to identify the current state-of-the-art approaches, challenges, and potential future research prospects for this area of study. By conducting a comprehensive review of the existing literature, we aim to contribute to the ultimate goal of improving the accuracy and efficiency of breast cancer diagnosis and treatment.
{"title":"Insights into AI advances in immunohistochemistry for effective breast cancer treatment: a literature review of ER, PR, and HER2 scoring.","authors":"Genevieve Chyrmang, Kangkana Bora, Anup Kr Das, Gazi N Ahmed, Lopamudra Kakoti","doi":"10.1080/03007995.2024.2445142","DOIUrl":"10.1080/03007995.2024.2445142","url":null,"abstract":"<p><p>Breast cancer is a significant health challenge, with accurate and timely diagnosis being critical to effective treatment. Immunohistochemistry (IHC) staining is a widely used technique for the evaluation of breast cancer markers, but manual scoring is time-consuming and can be subject to variability. With the rise of Artificial Intelligence (AI), there is an increasing interest in using machine learning and deep learning approaches to automate the scoring of ER, PR, and HER2 biomarkers in IHC-stained images for effective treatment. This narrative literature review focuses on AI-based techniques for the automated scoring of breast cancer markers in IHC-stained images, specifically Allred, Histochemical (H-Score) and HER2 scoring. We aim to identify the current state-of-the-art approaches, challenges, and potential future research prospects for this area of study. By conducting a comprehensive review of the existing literature, we aim to contribute to the ultimate goal of improving the accuracy and efficiency of breast cancer diagnosis and treatment.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"115-134"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142869406","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}
Pub Date : 2025-01-01Epub Date: 2025-01-02DOI: 10.1080/03007995.2024.2442045
Louise Olsbro Rosengaard, Mikkel Zola Andersen, Jacob Rosenberg, Siv Fonnes
Background: The number of systematic reviews is increasing rapidly. Several methodologies exist for systematic reviews. Cochrane Reviews follow distinct methods to ensure they provide the most reliable and robust evidence, ideally based on rigorous evaluations of randomized controlled trials and other high-quality studies. We aimed to examine the difference in citation patterns of Cochrane Reviews and other systematic reviews.
Methods: We conducted a bibliometric analysis of systematic reviews indexed in PubMed from 1993 to 2022. We collected data on citations from The Lens from 1993 to 2023, thus having at least 1-year follow-up on citations. The reviews were linked through their PubMed identifier. Comparisons between the Cochrane Reviews and other systematic reviews included total citations per review, reviews with zero citations, and the time window within which they receive citations.
Results: We included 10,086 Cochrane Reviews and 231,074 other systematic reviews. Other systematic reviews received significantly more citations than Cochrane Reviews from 1993 to 2007. From 1993 to 1997, the median difference was 80 citations (95% CI = 79.6-80.4). From 2008 and forward, the overall number of citations was similar between Cochrane Reviews and other systematic reviews (2018-2022: median difference = 5 [95% CI = 4.9-5.1] in favor of Cochrane Reviews; p = 0.83). Systematic reviews with zero citations were rare in both groups, but it was observed more often among other systematic reviews than Cochrane Reviews. Over the last 30 years, the time window in which all reviews received citations narrowed.
Conclusion: In recent years, Cochrane Reviews and other systematic reviews had similar citation patterns, but other systematic reviews received more citations from 1993 to 2007. Other systematic reviews were more often never cited than Cochrane Reviews, and potentially wasted. The time window in which systematic reviews received citations has been progressively decreasing, possibly indicating a trend toward quicker recognition and uptake of these reviews within the academic community. Cochrane reviews aim to provide robust evidence, but this is not reflected in the citation metrics compared to other systematic reviews.
背景:系统综述的数量正在迅速增加。存在几种用于系统审查的方法。Cochrane综述遵循独特的方法,以确保它们提供最可靠和最有力的证据,理想情况下是基于随机对照试验和其他高质量研究的严格评估。我们的目的是研究Cochrane综述和其他系统综述在引文模式上的差异。方法:对1993 - 2022年PubMed收录的系统综述进行文献计量学分析。我们收集了1993年至2023年《Lens》的引用数据,因此对引用进行了至少一年的随访。这些评论通过它们的PubMed标识符链接在一起。Cochrane综述与其他系统综述的比较包括每篇综述的总引用次数、零引用的综述以及它们收到引用的时间窗口。结果:我们纳入10086篇Cochrane综述和231074篇其他系统综述。从1993年到2007年,其他系统综述的引用量明显高于Cochrane综述。从1993年到1997年,中位差异为80次引用[95% CI 79.6-80.4]。从2008年及以后,Cochrane综述与其他系统综述的总被引次数相似(2018-2022年:中位数差异为5 [95% CI 4.9-5.1], Cochrane综述更有利;p = 0.83)。在两组中,零引用的系统评价都很少见,但在其他系统评价中比在Cochrane评价中更常见。在过去的30年里,所有评论被引用的时间窗口缩小了。结论:近年来,Cochrane综述与其他系统综述的被引模式相似,但1993 - 2007年其他系统综述的被引次数较多。与Cochrane综述相比,其他系统综述从未被引用的情况更多,而且可能被浪费。系统综述获得引用的时间窗口已经逐渐减少,这可能表明学术界对这些综述的认识和吸收越来越快。Cochrane综述旨在提供有力的证据,但与其他系统综述相比,这并没有反映在引用指标上。
{"title":"Citation patterns of Cochrane Reviews and other systematic reviews: a bibliometric analysis.","authors":"Louise Olsbro Rosengaard, Mikkel Zola Andersen, Jacob Rosenberg, Siv Fonnes","doi":"10.1080/03007995.2024.2442045","DOIUrl":"10.1080/03007995.2024.2442045","url":null,"abstract":"<p><strong>Background: </strong>The number of systematic reviews is increasing rapidly. Several methodologies exist for systematic reviews. Cochrane Reviews follow distinct methods to ensure they provide the most reliable and robust evidence, ideally based on rigorous evaluations of randomized controlled trials and other high-quality studies. We aimed to examine the difference in citation patterns of Cochrane Reviews and other systematic reviews.</p><p><strong>Methods: </strong>We conducted a bibliometric analysis of systematic reviews indexed in PubMed from 1993 to 2022. We collected data on citations from The Lens from 1993 to 2023, thus having at least 1-year follow-up on citations. The reviews were linked through their PubMed identifier. Comparisons between the Cochrane Reviews and other systematic reviews included total citations per review, reviews with zero citations, and the time window within which they receive citations.</p><p><strong>Results: </strong>We included 10,086 Cochrane Reviews and 231,074 other systematic reviews. Other systematic reviews received significantly more citations than Cochrane Reviews from 1993 to 2007. From 1993 to 1997, the median difference was 80 citations (95% CI = 79.6-80.4). From 2008 and forward, the overall number of citations was similar between Cochrane Reviews and other systematic reviews (2018-2022: median difference <b>=</b> 5 [95% CI <b>=</b> 4.9-5.1] in favor of Cochrane Reviews; <i>p</i> = 0.83). Systematic reviews with zero citations were rare in both groups, but it was observed more often among other systematic reviews than Cochrane Reviews. Over the last 30 years, the time window in which all reviews received citations narrowed.</p><p><strong>Conclusion: </strong>In recent years, Cochrane Reviews and other systematic reviews had similar citation patterns, but other systematic reviews received more citations from 1993 to 2007. Other systematic reviews were more often never cited than Cochrane Reviews, and potentially wasted. The time window in which systematic reviews received citations has been progressively decreasing, possibly indicating a trend toward quicker recognition and uptake of these reviews within the academic community. Cochrane reviews aim to provide robust evidence, but this is not reflected in the citation metrics compared to other systematic reviews.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"163-171"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834558","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}
Pub Date : 2025-01-01Epub Date: 2024-12-19DOI: 10.1080/03007995.2024.2443109
Hoda Gad, Jose Luis Dinamarca, Pablo Fletcher, Chih Hao Chen Ku, Ruy Lira, John Longa, Carlos Mendivil, Leonardo Palacios, Hermelinda Pedrosa, Luis Miguel Román Pintos, Carlos Solis, Rayaz A Malik
Peripheral Neuropathy (PN) can significantly impair quality of life, but often remains undiagnosed due to limited clinic time, lack of specialist expertise and lack of patient awareness. There are several validated questionnaires for diagnosing PN, but the time taken to administer them in busy primary care clinics limits their utilization. A new, simpler questionnaire was developed following an advisory board meeting in Southeast Asia and was further refined and translated to Portuguese and Spanish following a second advisory board meeting in Latin America. We consider current hurdles and propose a quick and reliable questionnaire that can be widely adopted to enable earlier diagnosis and improved management of PN in resource-limited settings in Latin America.
{"title":"Earlier diagnosis of peripheral neuropathy in primary care in Latin America using a simple screening tool (ACT).","authors":"Hoda Gad, Jose Luis Dinamarca, Pablo Fletcher, Chih Hao Chen Ku, Ruy Lira, John Longa, Carlos Mendivil, Leonardo Palacios, Hermelinda Pedrosa, Luis Miguel Román Pintos, Carlos Solis, Rayaz A Malik","doi":"10.1080/03007995.2024.2443109","DOIUrl":"10.1080/03007995.2024.2443109","url":null,"abstract":"<p><p>Peripheral Neuropathy (PN) can significantly impair quality of life, but often remains undiagnosed due to limited clinic time, lack of specialist expertise and lack of patient awareness. There are several validated questionnaires for diagnosing PN, but the time taken to administer them in busy primary care clinics limits their utilization. A new, simpler questionnaire was developed following an advisory board meeting in Southeast Asia and was further refined and translated to Portuguese and Spanish following a second advisory board meeting in Latin America. We consider current hurdles and propose a quick and reliable questionnaire that can be widely adopted to enable earlier diagnosis and improved management of PN in resource-limited settings in Latin America.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"93-104"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846008","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}
Objective: To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).
Methods: Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.
Results: At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both p < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both p < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.
Conclusion: Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.
{"title":"Efficacy and safety of lebrikizumab combined with topical corticosteroids in Japanese patients with moderate-to-severe atopic dermatitis: a phase 3, double-blind, placebo-controlled, randomized clinical trial (ADhere-J).","authors":"Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Ken Igawa","doi":"10.1080/03007995.2024.2436982","DOIUrl":"10.1080/03007995.2024.2436982","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).</p><p><strong>Methods: </strong>Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.</p><p><strong>Results: </strong>At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both <i>p</i> < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both <i>p</i> < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.</p><p><strong>Conclusion: </strong>Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767039","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}
Pub Date : 2025-01-01Epub Date: 2025-01-03DOI: 10.1080/03007995.2024.2440059
Zahinoor Ismail, Stine Rasmussen Meehan, Anja Farovik, Shivani Kapadia, Anton M Palma, Zhen Zhang, Roger S McIntyre
Objective: Patients with schizophrenia value improved life engagement, a term that describes positive health aspects across emotional, physical, social, and cognitive domains. This post hoc analysis of clinical trial data aimed to investigate the effect of brexpiprazole on patient life engagement in schizophrenia over the short and long term.
Methods: Data were pooled from three 6-week, randomized, double-blind, placebo-controlled clinical trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380; N = 1385) and two 52-week, open-label extension studies (NCT01397786, NCT01810783; N = 408) of brexpiprazole in adults with schizophrenia. Patient life engagement was measured using a subset of 14 Positive and Negative Syndrome Scale items (score range: 14 [best] to 98 [worst]) that has previously demonstrated content validity. Mean score changes and response rates (based on minimal clinically important difference estimates of ≥5 and ≥10 points) were calculated.
Results: Greater improvement in patient life engagement from baseline to Week 6 was observed for brexpiprazole 2-4 mg/day (least squares mean [standard error] change: -8.3 [0.3]; n = 868) versus placebo (-5.7 [0.4]; n = 517), with a least squares mean difference of -2.58 (95% confidence interval: -3.57 to -1.58; p < 0.001; Cohen's d effect size: 0.28). These improvements were maintained over 58 weeks on brexpiprazole 1-4 mg/day (n = 399). At Week 6, response rates among patients treated with brexpiprazole versus placebo were 71.6% versus 58.0% (≥5-point improvement; p < 0.001) and 43.5% versus 32.8% (≥10-point improvement; p < 0.001). At Week 58 (n = 179), response rates among patients treated with brexpiprazole were 90.5% (≥5-point improvement) and 78.2% (≥10-point improvement).
Conclusion: Beyond its efficacy on psychotic symptoms, brexpiprazole has the potential to improve patient life engagement - an important patient-centered outcome in schizophrenia.
{"title":"Effects of brexpiprazole on patient life engagement in schizophrenia: <i>post hoc</i> analysis of Positive and Negative Syndrome Scale data.","authors":"Zahinoor Ismail, Stine Rasmussen Meehan, Anja Farovik, Shivani Kapadia, Anton M Palma, Zhen Zhang, Roger S McIntyre","doi":"10.1080/03007995.2024.2440059","DOIUrl":"10.1080/03007995.2024.2440059","url":null,"abstract":"<p><strong>Objective: </strong>Patients with schizophrenia value improved life engagement, a term that describes positive health aspects across emotional, physical, social, and cognitive domains. This <i>post hoc</i> analysis of clinical trial data aimed to investigate the effect of brexpiprazole on patient life engagement in schizophrenia over the short and long term.</p><p><strong>Methods: </strong>Data were pooled from three 6-week, randomized, double-blind, placebo-controlled clinical trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380; <i>N</i> = 1385) and two 52-week, open-label extension studies (NCT01397786, NCT01810783; <i>N</i> = 408) of brexpiprazole in adults with schizophrenia. Patient life engagement was measured using a subset of 14 Positive and Negative Syndrome Scale items (score range: 14 [best] to 98 [worst]) that has previously demonstrated content validity. Mean score changes and response rates (based on minimal clinically important difference estimates of ≥5 and ≥10 points) were calculated.</p><p><strong>Results: </strong>Greater improvement in patient life engagement from baseline to Week 6 was observed for brexpiprazole 2-4 mg/day (least squares mean [standard error] change: -8.3 [0.3]; <i>n</i> = 868) versus placebo (-5.7 [0.4]; <i>n</i> = 517), with a least squares mean difference of -2.58 (95% confidence interval: -3.57 to -1.58; <i>p</i> < 0.001; Cohen's <i>d</i> effect size: 0.28). These improvements were maintained over 58 weeks on brexpiprazole 1-4 mg/day (<i>n</i> = 399). At Week 6, response rates among patients treated with brexpiprazole versus placebo were 71.6% versus 58.0% (≥5-point improvement; <i>p</i> < 0.001) and 43.5% versus 32.8% (≥10-point improvement; <i>p</i> < 0.001). At Week 58 (<i>n</i> = 179), response rates among patients treated with brexpiprazole were 90.5% (≥5-point improvement) and 78.2% (≥10-point improvement).</p><p><strong>Conclusion: </strong>Beyond its efficacy on psychotic symptoms, brexpiprazole has the potential to improve patient life engagement - an important patient-centered outcome in schizophrenia.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"145-153"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142920812","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}
Pub Date : 2025-01-01Epub Date: 2024-12-06DOI: 10.1080/03007995.2024.2433245
Lisa Hefti, Hanna Boëthius, Detlef Loppow, Nakisa Serry, Rocio Martin, Katrin Rupalla, Dietmar Krämer, Isabelle Juchler, Caitlin Masters, Verena Voelter
Background: Value-Based Health Care (VBHC) represents a pivotal shift from volume-based to outcome-driven quality metrics centered on patient-valued outcomes. This approach requires collaboration across all participants in the health care value chain; providers, payers, pharma, policymakers and patients (collectively known as the 5Ps). Despite substantial theoretical endorsement of VBHC's potential for improving health outcomes and system efficiency, empirical evidence detailing its practical implementation remains limited. This field study evaluates the real-word implementation of VBHC within a health care organization.
Methods: In 2022, a health care collaboration Think Tank initiated this investigation during a breakout session, gathering insights from 12 leading international organizations to construct an empirical VBHC transformation reference guide. Real-world data was collected through structured interviews over a 1-year period, covering the 5 P value chain in various healthcare settings. The VBHC initiatives were analyzed through four stages: initiation, data acquisition, collaborative frameworks, and results evaluation.
Results: The 12 interviews identified five key enablers for successful VBHC implementation: 1. Organizational Purpose: defining core motivators for change; 2. People: identifying pivotal roles and leadership to endorse change; 3. Resources: securing personnel and financial support; 4. Data Infrastructure: developing interoperable IT systems for effective data sharing and collection; 5. Execution: prioritizing sustained implementation processes.
Conclusion: The findings highlight that VBHC implementation and adoption is complex and requires incremental advancements, dedicated leadership, and resilient strategic framework spanning over multiple years. A comprehensive understanding of patient populations, risk stratification, and appropriate outcome metrics are essential to measure and deliver the VBHC transformation. Executive endorsement and transition funding during the transformation process are paramount to support this systemic shift. Collaboration among all 5 P stakeholders is essential for success. This field study underscores the importance of continuous learning and adaptation, providing a practical guide to enhance health care quality and efficiency that serves all stakeholders.
{"title":"The Tango to Modern Collaboration and Patient-Centric Value Generation in Health Care - a real-world guide from practitioners for practitioners.","authors":"Lisa Hefti, Hanna Boëthius, Detlef Loppow, Nakisa Serry, Rocio Martin, Katrin Rupalla, Dietmar Krämer, Isabelle Juchler, Caitlin Masters, Verena Voelter","doi":"10.1080/03007995.2024.2433245","DOIUrl":"10.1080/03007995.2024.2433245","url":null,"abstract":"<p><strong>Background: </strong>Value-Based Health Care (VBHC) represents a pivotal shift from volume-based to outcome-driven quality metrics centered on patient-valued outcomes. This approach requires collaboration across all participants in the health care value chain; providers, payers, pharma, policymakers and patients (collectively known as the 5Ps). Despite substantial theoretical endorsement of VBHC's potential for improving health outcomes and system efficiency, empirical evidence detailing its practical implementation remains limited. This field study evaluates the real-word implementation of VBHC within a health care organization.</p><p><strong>Methods: </strong>In 2022, a health care collaboration Think Tank initiated this investigation during a breakout session, gathering insights from 12 leading international organizations to construct an empirical VBHC transformation reference guide. Real-world data was collected through structured interviews over a 1-year period, covering the 5 P value chain in various healthcare settings. The VBHC initiatives were analyzed through four stages: initiation, data acquisition, collaborative frameworks, and results evaluation.</p><p><strong>Results: </strong>The 12 interviews identified five key enablers for successful VBHC implementation: 1. Organizational Purpose: defining core motivators for change; 2. People: identifying pivotal roles and leadership to endorse change; 3. Resources: securing personnel and financial support; 4. Data Infrastructure: developing interoperable IT systems for effective data sharing and collection; 5. Execution: prioritizing sustained implementation processes.</p><p><strong>Conclusion: </strong>The findings highlight that VBHC implementation and adoption is complex and requires incremental advancements, dedicated leadership, and resilient strategic framework spanning over multiple years. A comprehensive understanding of patient populations, risk stratification, and appropriate outcome metrics are essential to measure and deliver the VBHC transformation. Executive endorsement and transition funding during the transformation process are paramount to support this systemic shift. Collaboration among all 5 P stakeholders is essential for success. This field study underscores the importance of continuous learning and adaptation, providing a practical guide to enhance health care quality and efficiency that serves all stakeholders.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"31-41"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715513","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}
Pub Date : 2025-01-01Epub Date: 2024-12-17DOI: 10.1080/03007995.2024.2441340
Jaime A Teixeira da Silva, Jens C Türp, Timothy Daly
Biomedical research cannot function without the trust of peers and society. The truthfulness of claims made by knowledge-producing agents, such as authors of research, is a prerequisite for their trustworthiness, and violations of truthfulness are rightly seen as a threat to the existence and validity of such research. While most reflection on the lack of truthfulness has focused on fake research, little attention has been paid to how sting operations and hoaxes arguably pose an equally great risk to the ethical integrity of publishing. This paper posits that sting operations, like fake research, are examples of breaches of truthfulness. We also argue that for both fake research, as well as stings and hoaxes, the lack of respect for the ethical criterion of truthfulness makes those researchers who engage in them untrustworthy. Sting operations are akin to fighting fire with fire, further undermining trust in biomedical research. From a deontological perspective, we also argue that the reliance on anonymity in sting operations makes them just as bad, if not worse, than fake research. We advocate for critical scholarship as an alternative to hoaxes and sting operations to expose fake research, in order to promote truthfulness rather than violate it. Finally, we argue that journalists reporting on sting operations should insist less on their entertainment and sensationalist value, and focus more on their unethical nature.
{"title":"Sting operations in biomedical publishing violate truthfulness and undermine trust in research.","authors":"Jaime A Teixeira da Silva, Jens C Türp, Timothy Daly","doi":"10.1080/03007995.2024.2441340","DOIUrl":"10.1080/03007995.2024.2441340","url":null,"abstract":"<p><p>Biomedical research cannot function without the trust of peers and society. The truthfulness of claims made by knowledge-producing agents, such as authors of research, is a prerequisite for their trustworthiness, and violations of truthfulness are rightly seen as a threat to the existence and validity of such research. While most reflection on the lack of truthfulness has focused on fake research, little attention has been paid to how sting operations and hoaxes arguably pose an equally great risk to the ethical integrity of publishing. This paper posits that sting operations, like fake research, are examples of breaches of truthfulness. We also argue that for both fake research, as well as stings and hoaxes, the lack of respect for the ethical criterion of truthfulness makes those researchers who engage in them untrustworthy. Sting operations are akin to fighting fire with fire, further undermining trust in biomedical research. From a deontological perspective, we also argue that the reliance on anonymity in sting operations makes them just as bad, if not worse, than fake research. We advocate for critical scholarship as an alternative to hoaxes and sting operations to expose fake research, in order to promote truthfulness rather than violate it. Finally, we argue that journalists reporting on sting operations should insist less on their entertainment and sensationalist value, and focus more on their unethical nature.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"155-162"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817472","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}
Pub Date : 2025-01-01Epub Date: 2024-12-20DOI: 10.1080/03007995.2024.2442040
Pamela Nogueira Cavalcante, Joaquim Barreto, Sheila T Kimura-Medorima, Ikaro Breder, Wilson Nadruz, Andrei C Sposito
Background: White coat effect (WCE) is a phenomenon linked to increased cardiovascular risk, where office blood pressure readings exceed home or ambulatory measurements. Excess weight and elevated blood pressure or glucose are associated with WCE in type 2 diabetes (T2D). This study compared dapagliflozin and glibenclamide on WCE in T2D patients under equivalent blood pressure and glucose control.
Methods: This post-hoc analysis of the ADDENDA-BHS2 trial enrolled T2D patients with high cardiovascular risk, defined by stable coronary artery disease or subclinical carotid atherosclerosis. This single-center, open-label, randomized trial included 98 participants, randomized to 12 weeks of dapagliflozin or glibenclamide, in addition to metformin. Baseline blood pressure and glucose control were adjusted to maintain equivalence. This analysis focused on 85 participants with pre- and post-treatment 24-h ambulatory blood pressure data.
Results: Despite blood pressure and glucose control, WCE was present in 28% of participants at baseline. Baseline-adjusted change in WCE on systolic BP showed median changes of -8.6 and 1.7 mmHg for dapagliflozin and glibenclamide groups, respectively (p = 0.048). This effect was not observed on diastolic blood pressure.
Conclusion: Dapagliflozin reduces WCE on systolic blood pressure compared to glibenclamide, even under equivalent blood pressure and glucose control.
Clinical trial registration: The trial was registered at the Clinicaltrials.gov (NCT: 02919345).
{"title":"Dapagliflozin reduces the white coat effect on systolic blood pressure of patients with type 2 diabetes: a <i>post-hoc</i> analysis from the ADDENDA-BHS 2 trial.","authors":"Pamela Nogueira Cavalcante, Joaquim Barreto, Sheila T Kimura-Medorima, Ikaro Breder, Wilson Nadruz, Andrei C Sposito","doi":"10.1080/03007995.2024.2442040","DOIUrl":"10.1080/03007995.2024.2442040","url":null,"abstract":"<p><strong>Background: </strong>White coat effect (WCE) is a phenomenon linked to increased cardiovascular risk, where office blood pressure readings exceed home or ambulatory measurements. Excess weight and elevated blood pressure or glucose are associated with WCE in type 2 diabetes (T2D). This study compared dapagliflozin and glibenclamide on WCE in T2D patients under equivalent blood pressure and glucose control.</p><p><strong>Methods: </strong>This <i>post-hoc</i> analysis of the ADDENDA-BHS2 trial enrolled T2D patients with high cardiovascular risk, defined by stable coronary artery disease or subclinical carotid atherosclerosis. This single-center, open-label, randomized trial included 98 participants, randomized to 12 weeks of dapagliflozin or glibenclamide, in addition to metformin. Baseline blood pressure and glucose control were adjusted to maintain equivalence. This analysis focused on 85 participants with pre- and post-treatment 24-h ambulatory blood pressure data.</p><p><strong>Results: </strong>Despite blood pressure and glucose control, WCE was present in 28% of participants at baseline. Baseline-adjusted change in WCE on systolic BP showed median changes of -8.6 and 1.7 mmHg for dapagliflozin and glibenclamide groups, respectively (<i>p</i> = 0.048). This effect was not observed on diastolic blood pressure.</p><p><strong>Conclusion: </strong>Dapagliflozin reduces WCE on systolic blood pressure compared to glibenclamide, even under equivalent blood pressure and glucose control.</p><p><strong>Clinical trial registration: </strong>The trial was registered at the Clinicaltrials.gov (NCT: 02919345).</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"25-29"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871625","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}