Various neuropsychological or cognitive assessments are often conducted before rehabilitation to ascertain patients’ function, disability, and environment. However, adequate assessments are not conducted for persons with dementia under the assumption that assessments would burden them. Therefore, this study investigated the perceptions of persons with dementia and their family caregivers regarding cognitive function assessments during hospital rehabilitation and reconsidered the significance of such assessments according to the opinions of those involved.
Methods
This cross-sectional observational study was conducted over a 3-month period at a hospital-based rehabilitation center. We administered a semi-structured questionnaire to 31 older persons with dementia (13 men and 18 women; mean age [± SD]: 77 [± 5.7] (range: 66–87 years); mean years of education [± SD]: 12 [± 2.3]; (range: 9–16 years); Alzheimer's disease: 15; mild cognitive impairment (MCI): 15; corticobasal degeneration: 1) and 49 family caregiver dyads (24 men and 25 women, mean age [± SD]: 67 [± 11] years; age range: 46–90 years). The data were interpreted by employing descriptive statistics, and the χ2, Fisher's exact, and Kruskal–Wallis tests.
Findings
Both groups acknowledged the value of neuropsychological assessments, with 94% (95% CI 84.9–100%) of persons with MCI/dementia and 83% (95% CI 73.3–94.0%) of their family caregivers linking them directly to enhanced treatment and care quality. Their positive attitudes were significantly associated with the belief that such evaluations are integral for personalizing and optimizing rehabilitation strategies.
Implications
Most individuals with MCI/dementia and their caregivers value detailed neuropsychological assessments for understanding rehabilitation needs, highlighting the importance of integrating comprehensive evaluations into dementia care. However, the single-center nature of our study limits generalizability. Future research with diverse participants is needed to develop scalable, inclusive rehabilitation strategies.
目的在康复前经常进行各种神经心理学或认知评估，以确定患者的功能、残疾和环境。然而，没有对痴呆症患者进行充分的评估，认为评估会给他们带来负担。因此，本研究调查了痴呆症患者及其家庭照顾者对医院康复期间认知功能评估的看法，并根据相关人员的意见重新考虑这种评估的意义。方法本横断面观察性研究在一家医院康复中心进行了为期3个月的研究。我们对31名老年痴呆症患者(13名男性和18名女性；平均年龄[±SD]: 77[±5.7]（范围：66 ~ 87岁）；平均受教育年限[±SD]: 12[±2.3]；（范围：9-16岁）；阿尔茨海默病：15人；轻度认知障碍（MCI）： 15；皮质基底变性：1例)和49例家庭照顾者(男性24例，女性25例，平均年龄[±SD]: 67[±11]岁；年龄范围：46-90岁)。采用描述性统计、χ2、Fisher精确检验和Kruskal-Wallis检验对数据进行解释。两组都承认神经心理学评估的价值，94% （95% CI 84.9-100%）的轻度认知障碍/痴呆患者和83% （95% CI 73.3-94.0%）的家庭照顾者直接将其与提高治疗和护理质量联系起来。他们的积极态度与相信这些评估是个性化和优化康复策略的组成部分显著相关。大多数MCI/痴呆患者及其护理人员重视详细的神经心理学评估，以了解康复需求，强调将综合评估纳入痴呆护理的重要性。然而，本研究的单中心性质限制了通用性。未来的研究需要不同的参与者来制定可扩展的、包容性的康复策略。
{"title":"Unlocking the Value of Neuropsychological Assessments in Rehabilitation: Perspectives from Persons with Dementia and Their Caregivers","authors":"Takako Yoshimura , Aiko Osawa , Shiinchiro Maeshima , Iikue Ueda , Koki Kawamura , Masaki Kamiya , Naoki Itoh , Hidenori Arai","doi":"10.1016/j.curtheres.2025.100781","DOIUrl":"10.1016/j.curtheres.2025.100781","url":null,"abstract":"<div><h3>Purpose</h3><div>Various neuropsychological or cognitive assessments are often conducted before rehabilitation to ascertain patients’ function, disability, and environment. However, adequate assessments are not conducted for persons with dementia under the assumption that assessments would burden them. Therefore, this study investigated the perceptions of persons with dementia and their family caregivers regarding cognitive function assessments during hospital rehabilitation and reconsidered the significance of such assessments according to the opinions of those involved.</div></div><div><h3>Methods</h3><div>This cross-sectional observational study was conducted over a 3-month period at a hospital-based rehabilitation center. We administered a semi-structured questionnaire to 31 older persons with dementia (13 men and 18 women; mean age [± SD]: 77 [± 5.7] (range: 66–87 years); mean years of education [± SD]: 12 [± 2.3]; (range: 9–16 years); Alzheimer's disease: 15; mild cognitive impairment (MCI): 15; corticobasal degeneration: 1) and 49 family caregiver dyads (24 men and 25 women, mean age [± SD]: 67 [± 11] years; age range: 46–90 years). The data were interpreted by employing descriptive statistics, and the χ<sup>2</sup>, Fisher's exact, and Kruskal–Wallis tests.</div></div><div><h3>Findings</h3><div>Both groups acknowledged the value of neuropsychological assessments, with 94% (95% CI 84.9–100%) of persons with MCI/dementia and 83% (95% CI 73.3–94.0%) of their family caregivers linking them directly to enhanced treatment and care quality. Their positive attitudes were significantly associated with the belief that such evaluations are integral for personalizing and optimizing rehabilitation strategies.</div></div><div><h3>Implications</h3><div>Most individuals with MCI/dementia and their caregivers value detailed neuropsychological assessments for understanding rehabilitation needs, highlighting the importance of integrating comprehensive evaluations into dementia care. However, the single-center nature of our study limits generalizability. Future research with diverse participants is needed to develop scalable, inclusive rehabilitation strategies.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100781"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143684680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-04DOI: 10.1016/j.curtheres.2024.100768
Gang Ma MD , Song Zhang MD , Baozhong Yu MD
Background
Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) are highly prevalent diseases that constitute enormous public health problems. The efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors in blood glucose control in T2DM patients with NAFLD has been established, but little is known about its effect on liver enzyme levels.
Objective
This meta-analysis aimed to evaluate the influences of DPP-4 inhibitors on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in patients with T2DM and NAFLD.
Methods
To identify the relevant studies, we searched PubMed, Embase, the Cochrane Library, Wanfang Data, and China National Knowledge Infrastructure. Means differences in liver enzymes and metabolic outcomes were meta-analyzed using a random-effects model, with subgroup analyses by gender, age, area, follow-up duration, and type of DPP-4 inhibitor. Quality assessment of the included studies was conducted using the revised Cochrane risk of bias tool.
Results
A total of 1323 patients from 16 studies were included in this meta-analysis. The results of analysis of DPP-4 inhibitors showed that the mean difference was –6.19 (95% confidence interval [CI]: –9.45 to –2.92) for ALT and –5.17 (95% CI: –8.10 to –2.23) for AST; this effect was statistically significant from the placebo group which indicates the beneficial effect on liver enzymes. Subgroup analysis revealed that while there were no significant gender differences in enzyme reductions, individuals over 55 years old experienced more pronounced decreases in ALT. Notably, Asian studies showed significant reductions in liver enzymes, contrasting with the minor variations observed in Euramerican regions, and the effectiveness of DPP-4 inhibitors was particularly pronounced during shorter follow-up periods, with effects diminishing over time. Regarding secondary outcomes, there was a notable improvement in gamma-glutamyl transpeptidase, with a mean reduction, and in HbA1c levels, indicating improved glycemic control. Homeostatic model assessment for insulin resistance levels also improved, reflecting better insulin sensitivity. Additionally, adverse event analysis confirmed that DPP-4 inhibitors were well-tolerated with a favorable safety profile.
Conclusions
DPP-4 inhibitors appear to enhance glycemic control and improve liver enzyme levels, suggesting a potentially effective therapeutic approach for managing T2DM/NAFLD and highlighting their broader metabolic benefits.
{"title":"Impact of Dipeptidyl Peptidase-4 Inhibitors on Aminotransferases Levels in Patients with Type 2 Diabetes Mellitus With Nonalcoholic Fatty Liver Disease: A Meta-Analysis of Randomized Controlled Trial","authors":"Gang Ma MD , Song Zhang MD , Baozhong Yu MD","doi":"10.1016/j.curtheres.2024.100768","DOIUrl":"10.1016/j.curtheres.2024.100768","url":null,"abstract":"<div><h3>Background</h3><div>Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) are highly prevalent diseases that constitute enormous public health problems. The efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors in blood glucose control in T2DM patients with NAFLD has been established, but little is known about its effect on liver enzyme levels.</div></div><div><h3>Objective</h3><div>This meta-analysis aimed to evaluate the influences of DPP-4 inhibitors on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in patients with T2DM and NAFLD.</div></div><div><h3>Methods</h3><div>To identify the relevant studies, we searched PubMed, Embase, the Cochrane Library, Wanfang Data, and China National Knowledge Infrastructure. Means differences in liver enzymes and metabolic outcomes were meta-analyzed using a random-effects model, with subgroup analyses by gender, age, area, follow-up duration, and type of DPP-4 inhibitor. Quality assessment of the included studies was conducted using the revised Cochrane risk of bias tool.</div></div><div><h3>Results</h3><div>A total of 1323 patients from 16 studies were included in this meta-analysis. The results of analysis of DPP-4 inhibitors showed that the mean difference was –6.19 (95% confidence interval [CI]: –9.45 to –2.92) for ALT and –5.17 (95% CI: –8.10 to –2.23) for AST; this effect was statistically significant from the placebo group which indicates the beneficial effect on liver enzymes. Subgroup analysis revealed that while there were no significant gender differences in enzyme reductions, individuals over 55 years old experienced more pronounced decreases in ALT. Notably, Asian studies showed significant reductions in liver enzymes, contrasting with the minor variations observed in Euramerican regions, and the effectiveness of DPP-4 inhibitors was particularly pronounced during shorter follow-up periods, with effects diminishing over time. Regarding secondary outcomes, there was a notable improvement in gamma-glutamyl transpeptidase, with a mean reduction, and in HbA1c levels, indicating improved glycemic control. Homeostatic model assessment for insulin resistance levels also improved, reflecting better insulin sensitivity. Additionally, adverse event analysis confirmed that DPP-4 inhibitors were well-tolerated with a favorable safety profile.</div></div><div><h3>Conclusions</h3><div>DPP-4 inhibitors appear to enhance glycemic control and improve liver enzyme levels, suggesting a potentially effective therapeutic approach for managing T2DM/NAFLD and highlighting their broader metabolic benefits.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100768"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11741081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-04-15DOI: 10.1016/j.curtheres.2025.100794
Ya He M.D. , Liang’e Zhi M.Med , Yajin Feng B.Med , Shiyuan Li B.Med , Qian Liu B.Med , Zhendong Jiang M.D. , Cheng Zhong M.D.
Background
Sudden deafness (SD) presents as rapid-onset sensorineural hearing loss within 72 hours, with unknown etiology. Current guidelines recommend systemic corticosteroids as first-line therapy, though high-dose regimens may increase risks of hypertension and hyperglycemia. No consensus exists on optimal SD treatment protocols.
Objective
To compare the treatment efficacy and side effects of different doses of glucocorticoids in patients with sudden deafness.
Methods
A total of 248 patients (from July 2020 to May 2022) with sudden deafness were divided into 3 groups based on their initial dexamethasone dosages: group A (adequate dose, 10 mg/d), group B (high dose, 15 mg/d), and group C (high dose, 20 mg/d). For treatment efficacy, the mean hearing threshold elevation was subsequently evaluated. For side effects, blood glucose and blood pressure were monitored in 14 patients with sudden deafness accompanied by diabetes and 20 patients with concomitant primary hypertension.
Results
There was no significant difference in the efficacy of various initial corticosteroid doses among different subgroups (all P > 0.05). Higher initial doses were associated with increased risk of rapid glucose in patients with diabetes, whereas no significant difference was observed in blood pressure fluctuation among the 3 groups.
Conclusions
The treatment efficacy of the 3 different corticosteroid doses in sudden deafness treatment was comparable; yet, an increased risk of rapid blood glucose increase was accompanied by the elevated dose of dexamethasone in patients with diabetes. Therefore, an adequate glucocorticoid (dexamethasone, 10 mg/d) could be the optimal regimen of patients with sudden deafness and diabetes.
{"title":"Efficacy and Side Effect of Different Doses of Glucocorticoids on Sudden Deafness","authors":"Ya He M.D. , Liang’e Zhi M.Med , Yajin Feng B.Med , Shiyuan Li B.Med , Qian Liu B.Med , Zhendong Jiang M.D. , Cheng Zhong M.D.","doi":"10.1016/j.curtheres.2025.100794","DOIUrl":"10.1016/j.curtheres.2025.100794","url":null,"abstract":"<div><h3>Background</h3><div>Sudden deafness (SD) presents as rapid-onset sensorineural hearing loss within 72 hours, with unknown etiology. Current guidelines recommend systemic corticosteroids as first-line therapy, though high-dose regimens may increase risks of hypertension and hyperglycemia. No consensus exists on optimal SD treatment protocols.</div></div><div><h3>Objective</h3><div>To compare the treatment efficacy and side effects of different doses of glucocorticoids in patients with sudden deafness.</div></div><div><h3>Methods</h3><div>A total of 248 patients (from July 2020 to May 2022) with sudden deafness were divided into 3 groups based on their initial dexamethasone dosages: group A (adequate dose, 10 mg/d), group B (high dose, 15 mg/d), and group C (high dose, 20 mg/d). For treatment efficacy, the mean hearing threshold elevation was subsequently evaluated. For side effects, blood glucose and blood pressure were monitored in 14 patients with sudden deafness accompanied by diabetes and 20 patients with concomitant primary hypertension.</div></div><div><h3>Results</h3><div>There was no significant difference in the efficacy of various initial corticosteroid doses among different subgroups (all <em>P</em> > 0.05). Higher initial doses were associated with increased risk of rapid glucose in patients with diabetes, whereas no significant difference was observed in blood pressure fluctuation among the 3 groups.</div></div><div><h3>Conclusions</h3><div>The treatment efficacy of the 3 different corticosteroid doses in sudden deafness treatment was comparable; yet, an increased risk of rapid blood glucose increase was accompanied by the elevated dose of dexamethasone in patients with diabetes. Therefore, an adequate glucocorticoid (dexamethasone, 10 mg/d) could be the optimal regimen of patients with sudden deafness and diabetes.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100794"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144130856","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}
Pub Date : 2025-01-01Epub Date: 2025-07-23DOI: 10.1016/j.curtheres.2025.100809
Mesnad S. Alyabsi PhD , Lolwah Almousa BS , Anwar H. Alqarni BS , Asma Aldawsari MS , Lubna Alnasser PhD , Adel F. Almutairi PhD
Background
Continuous updates in management guidelines for type 2 diabetes mellitus (T2DM) have affected treatment patterns. In this study, we aimed to identify the prevalence of initiating various antidiabetic medications and analyze differences in patient characteristics based on the type of treatment initiated.
Methods
This cross-sectional study used data retrieved from the electronic medical records of the National Guard Health Affairs for all patients diagnosed with T2DM who initiated any antidiabetic therapy between January 2018 and May 2022. Patient data were presented using frequencies, percentages, means, and standard deviations where applicable. The antidiabetic classes investigated include metformin, insulin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium–glucose cotransporter-2 inhibitors.
Results
In total, 433 patients with T2DM were included in this study, most of whom were females (55.66% vs 44.34%) and obese (61.20%), with a mean age of 53.29 years (SD ± 15.22). Monotherapy was the most commonly initiated approach (66.28%), with insulin being the most prescribed monotherapy (29.10%). The most frequent combination therapy was metformin and sulfonylureas (7.16%). Overall, the most initiated medication was metformin, accounting for 37.12% of all prescriptions. Additionally, there was an increasing trend in prescribing newer medications, such as GLP-1 receptor agonists (8.70%) and SGLT-2 inhibitors (11.11%), for newly diagnosed patients in 2021.
Conclusion
The initiation of novel antidiabetic medications has increased over the study period, reflecting recent updates in T2DM management guidelines. However, further understanding of their benefits is required for optimal patient care.
背景：2型糖尿病（T2DM）治疗指南的不断更新影响了治疗模式。在本研究中，我们旨在确定开始使用各种降糖药物的患病率，并根据开始使用的治疗类型分析患者特征的差异。方法：本横断面研究使用国民警卫队卫生事务电子病历中检索的数据，用于2018年1月至2022年5月期间开始任何降糖治疗的所有诊断为T2DM的患者。使用频率、百分比、平均值和标准偏差（如适用）来呈现患者数据。研究的抗糖尿病药物包括二甲双胍、胰岛素、磺脲类药物、噻唑烷二酮类药物、二肽基肽酶-4抑制剂、胰高血糖素样肽-1受体激动剂和钠-葡萄糖共转运蛋白-2抑制剂。结果共纳入T2DM患者433例，以女性（55.66% vs 44.34%）和肥胖（61.20%）居多，平均年龄53.29岁（SD±15.22）。单药治疗是最常见的方法（66.28%），胰岛素是最常用的单药治疗（29.10%）。最常见的联合治疗是二甲双胍和磺脲类药物（7.16%）。总体而言，最开始使用的药物是二甲双胍，占所有处方的37.12%。此外，2021年新诊断患者使用GLP-1受体激动剂（8.70%）和SGLT-2抑制剂（11.11%）等新药的趋势也在增加。在研究期间，新型抗糖尿病药物的使用有所增加，这反映了最近T2DM管理指南的更新。然而，为了获得最佳的患者护理，需要进一步了解它们的益处。
{"title":"Initiation of Type 2 Diabetes Mellitus Medications in the NGHA Healthcare System in Saudi Arabia: Contemporary Trends","authors":"Mesnad S. Alyabsi PhD , Lolwah Almousa BS , Anwar H. Alqarni BS , Asma Aldawsari MS , Lubna Alnasser PhD , Adel F. Almutairi PhD","doi":"10.1016/j.curtheres.2025.100809","DOIUrl":"10.1016/j.curtheres.2025.100809","url":null,"abstract":"<div><h3>Background</h3><div>Continuous updates in management guidelines for type 2 diabetes mellitus (T2DM) have affected treatment patterns. In this study, we aimed to identify the prevalence of initiating various antidiabetic medications and analyze differences in patient characteristics based on the type of treatment initiated.</div></div><div><h3>Methods</h3><div>This cross-sectional study used data retrieved from the electronic medical records of the National Guard Health Affairs for all patients diagnosed with T2DM who initiated any antidiabetic therapy between January 2018 and May 2022. Patient data were presented using frequencies, percentages, means, and standard deviations where applicable. The antidiabetic classes investigated include metformin, insulin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium–glucose cotransporter-2 inhibitors.</div></div><div><h3>Results</h3><div>In total, 433 patients with T2DM were included in this study, most of whom were females (55.66% vs 44.34%) and obese (61.20%), with a mean age of 53.29 years (SD ± 15.22). Monotherapy was the most commonly initiated approach (66.28%), with insulin being the most prescribed monotherapy (29.10%). The most frequent combination therapy was metformin and sulfonylureas (7.16%). Overall, the most initiated medication was metformin, accounting for 37.12% of all prescriptions. Additionally, there was an increasing trend in prescribing newer medications, such as GLP-1 receptor agonists (8.70%) and SGLT-2 inhibitors (11.11%), for newly diagnosed patients in 2021.</div></div><div><h3>Conclusion</h3><div>The initiation of novel antidiabetic medications has increased over the study period, reflecting recent updates in T2DM management guidelines. However, further understanding of their benefits is required for optimal patient care.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"103 ","pages":"Article 100809"},"PeriodicalIF":1.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144860591","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}
Pub Date : 2025-01-01Epub Date: 2025-07-30DOI: 10.1016/j.curtheres.2025.100808
Ke-peng Liu , Jing Dai , Fu-rong Huang , Hui-wei Deng , Qi Wang , Yun Liu , Yong Chen , Lilong Mo , Fangni Cao , Yan Zhang , Hua-jing Guo , Xian-xue Wang
Background
In patients undergoing gastrointestinal surgery, enhancing perioperative cognitive function and facilitating expedited postoperative recovery are critical components for achieving swift rehabilitation. Intravenous administration of lidocaine has been shown to mitigate the perioperative inflammatory response in surgical patients; however, its influence on postoperative cognitive performance remains unassessed. Consequently, this study was conducted to investigate the impact of intravenous lidocaine on postoperative cognitive function in participants undergoing laparoscopic surgery for colorectal cancer.
Methods
We performed a prospective, randomized controlled trial at The First People’s Hospital of Changde City and Zhongshan People’s Hospital to assess the impact of intravenous lidocaine on postoperative cognitive dysfunction (POCD) in patients undergoing laparoscopic radical resection for colorectal carcinoma. The primary endpoints of our investigation included Mini-Mental State Examination (MMSE) scores measured preoperatively and 7 days postoperatively, as well as the incidence of POCD at the 7-day mark following surgery. Secondary outcomes comprised an evaluation of recovery parameters in the postanesthesia care unit, overall length of hospitalization, and the prevalence of postoperative complications in both study cohorts.
Results
The occurrence of POCD at day 7 postsurgery was significantly lower in the lidocaine group compared to the placebo group (P < 0.05). When stratified by age, both elderly patients (≥65 years) and nonelderly patients in the lidocaine group exhibited a significantly reduced incidence of POCD on the seventh day postoperatively compared to the placebo group (P < 0.05). Preoperative MMSE scores were comparable between the two groups; however, on the seventh day after surgery, the lidocaine group had significantly higher MMSE scores than the placebo group (P < 0.05). In the nonelderly cohort, MMSE scores were also significantly elevated in the lidocaine group compared to the placebo group at day 7 postsurgery (P < 0.05). Mediation analysis indicated that lidocaine’s influence on the incidence of POCD on the seventh postoperative day was partially mediated by propofol. Furthermore, there were no significant differences observed in intraoperative medication, postoperative recovery, or perioperative adverse events between the groups (P > 0.05).
Conclusions
Perioperative administration of intravenous lidocaine has been shown to significantly enhance cognitive function on the seventh postoperative day following laparoscopic colorectal surgery. The mediating influence of propofol on the association between lidocaine and the occurrence of POCD at this time point was determined to be 10%.
{"title":"Effect of Intravenous Lidocaine on Postoperative Cognitive Dysfunction in Patients Undergoing Laparoscopic Colorectal Surgery: A Two-Center, Randomized, Double-Blind Controlled Trial","authors":"Ke-peng Liu , Jing Dai , Fu-rong Huang , Hui-wei Deng , Qi Wang , Yun Liu , Yong Chen , Lilong Mo , Fangni Cao , Yan Zhang , Hua-jing Guo , Xian-xue Wang","doi":"10.1016/j.curtheres.2025.100808","DOIUrl":"10.1016/j.curtheres.2025.100808","url":null,"abstract":"<div><h3>Background</h3><div>In patients undergoing gastrointestinal surgery, enhancing perioperative cognitive function and facilitating expedited postoperative recovery are critical components for achieving swift rehabilitation. Intravenous administration of lidocaine has been shown to mitigate the perioperative inflammatory response in surgical patients; however, its influence on postoperative cognitive performance remains unassessed. Consequently, this study was conducted to investigate the impact of intravenous lidocaine on postoperative cognitive function in participants undergoing laparoscopic surgery for colorectal cancer.</div></div><div><h3>Methods</h3><div>We performed a prospective, randomized controlled trial at The First People’s Hospital of Changde City and Zhongshan People’s Hospital to assess the impact of intravenous lidocaine on postoperative cognitive dysfunction (POCD) in patients undergoing laparoscopic radical resection for colorectal carcinoma. The primary endpoints of our investigation included Mini-Mental State Examination (MMSE) scores measured preoperatively and 7 days postoperatively, as well as the incidence of POCD at the 7-day mark following surgery. Secondary outcomes comprised an evaluation of recovery parameters in the postanesthesia care unit, overall length of hospitalization, and the prevalence of postoperative complications in both study cohorts.</div></div><div><h3>Results</h3><div>The occurrence of POCD at day 7 postsurgery was significantly lower in the lidocaine group compared to the placebo group (<em>P</em> < 0.05). When stratified by age, both elderly patients (≥65 years) and nonelderly patients in the lidocaine group exhibited a significantly reduced incidence of POCD on the seventh day postoperatively compared to the placebo group (<em>P</em> < 0.05). Preoperative MMSE scores were comparable between the two groups; however, on the seventh day after surgery, the lidocaine group had significantly higher MMSE scores than the placebo group (<em>P</em> < 0.05). In the nonelderly cohort, MMSE scores were also significantly elevated in the lidocaine group compared to the placebo group at day 7 postsurgery (<em>P</em> < 0.05). Mediation analysis indicated that lidocaine’s influence on the incidence of POCD on the seventh postoperative day was partially mediated by propofol. Furthermore, there were no significant differences observed in intraoperative medication, postoperative recovery, or perioperative adverse events between the groups (<em>P</em> > 0.05).</div></div><div><h3>Conclusions</h3><div>Perioperative administration of intravenous lidocaine has been shown to significantly enhance cognitive function on the seventh postoperative day following laparoscopic colorectal surgery. The mediating influence of propofol on the association between lidocaine and the occurrence of POCD at this time point was determined to be 10%.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"103 ","pages":"Article 100808"},"PeriodicalIF":1.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144866119","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}
Pub Date : 2025-01-01Epub Date: 2025-03-25DOI: 10.1016/j.curtheres.2025.100785
Pernille Vigand Hegner MSt , Anne Sofie Rysgaard MSt , Alma Holm Rovsing MD, PhD , Charlotte Suppli Ulrik MD, DMSc, FERS
Background and objective
Patients’ with allergy-driven symptoms of asthma may not achieve adequate symptom control on inhaled pharmacotherapy alone, therefore, allergen-immunotherapy may be a relevant add-on treatment. The aim of the present review is to provide an update on the current evidence of efficacy of sublingual immunotherapy (SLIT) for the treatment of house dust mite (HDM)-driven allergic asthma.
Methods
Systematic review performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses-Statement (PRISMA) guidelines.
Results
A total of 15 studies fulfilled the predefined criteria and were included, all assessing the efficacy of the HDM SLIT-tablet in patients with HDM-driven asthma. Of the 15 studies, 13 reported significant improvements in asthma symptoms, while 2 found no changes. Ten studies assessed lung function (that is FEV1, PEF and FEV1/FVC) with 6 reporting significant improvements and 4 reporting no significant changes. Eight of the 15 studies measured the impact on prescribed asthma controller medication, of which 6 studies reported a significant reduction in daily mean dose of inhaled corticosteroid (ICS) (up to a reduction of 300+ µg/day), 1 found a significant reduction in medication use (according to the GINA steps), while 1 showed no significant reduction.
Conclusion
In the majority of studies, HDM SLIT was associated with improvements in asthma symptom control and a reduction in daily dose of ICS. On the other hand, the findings addressing treatment induced changes in lung function are conflicting.
{"title":"The Efficacy of Sublingual Immunotherapy in Patients With House Dust Mite Allergic Asthma—A Systematic Review","authors":"Pernille Vigand Hegner MSt , Anne Sofie Rysgaard MSt , Alma Holm Rovsing MD, PhD , Charlotte Suppli Ulrik MD, DMSc, FERS","doi":"10.1016/j.curtheres.2025.100785","DOIUrl":"10.1016/j.curtheres.2025.100785","url":null,"abstract":"<div><h3>Background and objective</h3><div>Patients’ with allergy-driven symptoms of asthma may not achieve adequate symptom control on inhaled pharmacotherapy alone, therefore, allergen-immunotherapy may be a relevant add-on treatment. The aim of the present review is to provide an update on the current evidence of efficacy of sublingual immunotherapy (SLIT) for the treatment of house dust mite (HDM)-driven allergic asthma.</div></div><div><h3>Methods</h3><div>Systematic review performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses-Statement (PRISMA) guidelines.</div></div><div><h3>Results</h3><div>A total of 15 studies fulfilled the predefined criteria and were included, all assessing the efficacy of the HDM SLIT-tablet in patients with HDM-driven asthma. Of the 15 studies, 13 reported significant improvements in asthma symptoms, while 2 found no changes. Ten studies assessed lung function (that is FEV<sub>1</sub>, PEF and FEV<sub>1</sub>/FVC) with 6 reporting significant improvements and 4 reporting no significant changes. Eight of the 15 studies measured the impact on prescribed asthma controller medication, of which 6 studies reported a significant reduction in daily mean dose of inhaled corticosteroid (ICS) (up to a reduction of 300+ µg/day), 1 found a significant reduction in medication use (according to the GINA steps), while 1 showed no significant reduction.</div></div><div><h3>Conclusion</h3><div>In the majority of studies, HDM SLIT was associated with improvements in asthma symptom control and a reduction in daily dose of ICS. On the other hand, the findings addressing treatment induced changes in lung function are conflicting.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100785"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143855507","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}
Colorectal cancer (CRC) is a type of cancer affecting the colon and rectum, primarily originating from intestinal polyps. Recently, increasing attention has been given to the role of dietary acid-base balance in cancer development. This study aimed to investigate the relationship between dietary acid load and the risk of metastatic colorectal cancer (mCRC).
Design/methodology/approach
This hospital-based case-control study was conducted on 120 adults with mCRC and 240 non-neoplastic adults in the control group, matched for age and gender. Dietary intake was assessed using a food frequency questionnaire. Net endogenous acid production (NEAP) and potential renal acid load (PRAL) were calculated using predetermined formulas. Odds ratios (ORs) were used to estimate the risk of mCRC across PRAL and NEAP tertiles.
Findings
There were no significant differences between the two groups in terms of demographic characteristics, anthropometric measures, smoking, and alcohol consumption. However, energy intake and energy-adjusted carbohydrate, fiber, potassium, magnesium, and calcium intake were significantly higher in the control group compared to the case group (P < 0.05). The mean PRAL in the case group (10.5 ± 1 mEq/day) was significantly higher than in the control group (5.2 ± 0.5 mEq/day) (P < 0.001). However, no significant difference was observed between the groups regarding NEAP (35 ± 7 mEq/day in the control group vs. 36 ± 5.5 mEq/day in the case group, P = 0.12). The second and third tertiles of PRAL were associated with an increased risk of mCRC compared to the first tertile (OR = 3.4, 95% CI: 1.6–7; OR = 4.1, 95% CI: 2–8.5, respectively) (P < 0.001).
Originality/value
High PRAL levels were associated with an increased risk of mCRC, whereas NEAP scores were not linked to mCRC risk.
{"title":"Relationship Between Dietary Acid Load and Risk of Metastatic Colorectal Cancer: A Case-Control Study","authors":"Fatemeh Babaee Kiadehi MSc , Niayesh Naghshi MSc , Fatemeh Farz MSc , Pedram pam PhD , Arash Tandorost MSc , Alireza Ostadrahimi MD, PhD , Reza Eghdam Zamiri MD","doi":"10.1016/j.curtheres.2025.100790","DOIUrl":"10.1016/j.curtheres.2025.100790","url":null,"abstract":"<div><h3>Purpose</h3><div>Colorectal cancer (CRC) is a type of cancer affecting the colon and rectum, primarily originating from intestinal polyps. Recently, increasing attention has been given to the role of dietary acid-base balance in cancer development. This study aimed to investigate the relationship between dietary acid load and the risk of metastatic colorectal cancer (mCRC).</div></div><div><h3>Design/methodology/approach</h3><div>This hospital-based case-control study was conducted on 120 adults with mCRC and 240 non-neoplastic adults in the control group, matched for age and gender. Dietary intake was assessed using a food frequency questionnaire. Net endogenous acid production (NEAP) and potential renal acid load (PRAL) were calculated using predetermined formulas. Odds ratios (ORs) were used to estimate the risk of mCRC across PRAL and NEAP tertiles.</div></div><div><h3>Findings</h3><div>There were no significant differences between the two groups in terms of demographic characteristics, anthropometric measures, smoking, and alcohol consumption. However, energy intake and energy-adjusted carbohydrate, fiber, potassium, magnesium, and calcium intake were significantly higher in the control group compared to the case group (<em>P</em> < 0.05). The mean PRAL in the case group (10.5 ± 1 mEq/day) was significantly higher than in the control group (5.2 ± 0.5 mEq/day) (<em>P</em> < 0.001). However, no significant difference was observed between the groups regarding NEAP (35 ± 7 mEq/day in the control group vs. 36 ± 5.5 mEq/day in the case group, <em>P</em> = 0.12). The second and third tertiles of PRAL were associated with an increased risk of mCRC compared to the first tertile (OR = 3.4, 95% CI: 1.6–7; OR = 4.1, 95% CI: 2–8.5, respectively) (<em>P</em> < 0.001).</div></div><div><h3>Originality/value</h3><div>High PRAL levels were associated with an increased risk of mCRC, whereas NEAP scores were not linked to mCRC risk.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100790"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143918424","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}
Pub Date : 2025-01-01Epub Date: 2025-02-05DOI: 10.1016/j.curtheres.2025.100776
In Mo Yoon MD, PhD , Kang-Yon Kim MD , Kwan-Haeng Lee MD , Duk-Woo Yoo DMD , Hojin Oh PharmD
Purpose
Proton pump inhibitors (PPIs) have been the mainstay treatment for gastric ulcer (GU) for over 30 years. However, since the discovery of a new class of acid suppressants, potassium-competitive acid blockers (P-CABs), the desire for a therapeutic agent has continued and the clinical trials on P-CABs have been conducted. In this regard, we aimed to assess whether P-CABs are noninferior to PPIs in patients with GU in terms of efficacy.
Methods
We performed a systematic review and network meta-analysis (NMA) based on randomized controlled trials (RCTs). Additionally, we used a new methodology of inference concept with the purpose of grouping between P-CABs and PPIs. Moreover, our quality management system was integrated throughout the research to ensure data accuracy.
Findings
We initially screened 438 studies and extracted 10 homogeneous GU RCTs with 6315 participants. The odds ratios (ORs) for the 4-week cure rate in Bayesian + frequentist NMA, tegoprazan 100 mg (OR = 4.14, 95% credible interval [CI] 0.56–26.3) and pantoprazole 40 mg (OR = 4.12, 95% CI 1.90–8.88) were the largest, respectively. The ORs for the 8-week cure rate in Bayesian + frequentist NMA, lansoprazole 30 mg (OR = 8.77, 95% credible interval [CI] 0.95–78.9) and lansoprazole 30 mg (OR = 7.91, 95% CI 2.60–24.03) was the largest, respectively.
Conclusions
The results of the NMA reveal that the cure rates of P-CABs in cases of GU were not inferior to those of PPIs. As the inference by grouping PPIs and P-CABs, the results showed similar trends in terms of effectiveness between the two therapeutic classes.
{"title":"Efficacy of Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors for Gastric Ulcers: Bayesian and Frequentist Network Meta-Analysis With Cross-Inference Through a Quality management System","authors":"In Mo Yoon MD, PhD , Kang-Yon Kim MD , Kwan-Haeng Lee MD , Duk-Woo Yoo DMD , Hojin Oh PharmD","doi":"10.1016/j.curtheres.2025.100776","DOIUrl":"10.1016/j.curtheres.2025.100776","url":null,"abstract":"<div><h3>Purpose</h3><div>Proton pump inhibitors (PPIs) have been the mainstay treatment for gastric ulcer (GU) for over 30 years. However, since the discovery of a new class of acid suppressants, potassium-competitive acid blockers (P-CABs), the desire for a therapeutic agent has continued and the clinical trials on P-CABs have been conducted. In this regard, we aimed to assess whether P-CABs are noninferior to PPIs in patients with GU in terms of efficacy.</div></div><div><h3>Methods</h3><div>We performed a systematic review and network meta-analysis (NMA) based on randomized controlled trials (RCTs). Additionally, we used a new methodology of inference concept with the purpose of grouping between P-CABs and PPIs. Moreover, our quality management system was integrated throughout the research to ensure data accuracy.</div></div><div><h3>Findings</h3><div>We initially screened 438 studies and extracted 10 homogeneous GU RCTs with 6315 participants. The odds ratios (ORs) for the 4-week cure rate in Bayesian + frequentist NMA, tegoprazan 100 mg (OR = 4.14, 95% credible interval [CI] 0.56–26.3) and pantoprazole 40 mg (OR = 4.12, 95% CI 1.90–8.88) were the largest, respectively. The ORs for the 8-week cure rate in Bayesian + frequentist NMA, lansoprazole 30 mg (OR = 8.77, 95% credible interval [CI] 0.95–78.9) and lansoprazole 30 mg (OR = 7.91, 95% CI 2.60–24.03) was the largest, respectively.</div></div><div><h3>Conclusions</h3><div>The results of the NMA reveal that the cure rates of P-CABs in cases of GU were not inferior to those of PPIs. As the inference by grouping PPIs and P-CABs, the results showed similar trends in terms of effectiveness between the two therapeutic classes.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100776"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2025-07-22DOI: 10.1016/j.curtheres.2025.100807
Vianney N. Ntabaza PhD , Antonelle Pardo PhD , Amandine Nachtergael PhD , Julien Bamps MSc , Salvius A. Bakari PhD , Pierre Duez PhD , Stephanie Patris PhD , Byanga Kahumba PhD
Background
Surgical Site Infections (SSIs) represent one of the most common post-operative complications and are the third most prevalent nosocomial infections.
Objective
The objective of this study was to analyze the conditions of using antibiotics in surgery at the University Clinics of Lubumbashi.
Methods
A retrospective study was conducted, collecting data from medical registers over a 3-year period, from 2017 to 2019. Parameters have been analyzed according to the European Centre for Disease Prevention and Control (ECDC), National Institute for Health and Care Excellence (NICE) and World Health Organization (WHO) guidelines.
Results
Shortcomings in registered data and the application of exclusion criteria allowed to include only 256 of the 977 retrospective procedures recorded during this period, with around 50% of the cases in 2019. A little more than half of them concerned men with a sex ratio of 1.28. Among these patients, 66% were aged between 16 and 40 years. Of these, 37.1% underwent visceral surgery. Over 38.7% of patients were hospitalized for more than 30 days, with 4.3% staying over 4 months. After the surgery, metronidazole 1.5 g, ceftriaxone 1 g and cefotaxime 1 g were the most used (89%) antibiotics followed by amoxicillin 1 g, all mainly parenterally. In 38,7% of cases, a series of other antibiotics were used in combination over a long period (7 days). A 32.8% rate of surgical site infection was recorded, with antibiotic-related costs of around 62,311 ± 30,417 CDF (31 ± 15 €). A comparison of the characteristics of patients with and without infections showed a significant influence of the sex and type of surgery. Men were 4.7 times more likely to develop a surgical site infection than women, and orthopedic surgery had a higher risk of infection than other surgeries.
Conclusion
These retrospective data suggest that the use of antibiotics before and after surgery at the University Clinics of Lubumbashi does not meet accepted standards (ECDC, NICE and WHO guidelines) and would not be efficient for their intended purpose.
{"title":"Surgical Antibiotic Prophylaxis Used in A University Clinics Hospital and Antibiotic Costs: A 3-year Survey","authors":"Vianney N. Ntabaza PhD , Antonelle Pardo PhD , Amandine Nachtergael PhD , Julien Bamps MSc , Salvius A. Bakari PhD , Pierre Duez PhD , Stephanie Patris PhD , Byanga Kahumba PhD","doi":"10.1016/j.curtheres.2025.100807","DOIUrl":"10.1016/j.curtheres.2025.100807","url":null,"abstract":"<div><h3>Background</h3><div>Surgical Site Infections (SSIs) represent one of the most common post-operative complications and are the third most prevalent nosocomial infections.</div></div><div><h3>Objective</h3><div>The objective of this study was to analyze the conditions of using antibiotics in surgery at the University Clinics of Lubumbashi.</div></div><div><h3>Methods</h3><div>A retrospective study was conducted, collecting data from medical registers over a 3-year period, from 2017 to 2019. Parameters have been analyzed according to the European Centre for Disease Prevention and Control (ECDC), National Institute for Health and Care Excellence (NICE) and World Health Organization (WHO) guidelines.</div></div><div><h3>Results</h3><div>Shortcomings in registered data and the application of exclusion criteria allowed to include only 256 of the 977 retrospective procedures recorded during this period, with around 50% of the cases in 2019. A little more than half of them concerned men with a sex ratio of 1.28. Among these patients, 66% were aged between 16 and 40 years. Of these, 37.1% underwent visceral surgery. Over 38.7% of patients were hospitalized for more than 30 days, with 4.3% staying over 4 months. After the surgery, metronidazole 1.5 g, ceftriaxone 1 g and cefotaxime 1 g were the most used (89%) antibiotics followed by amoxicillin 1 g, all mainly parenterally. In 38,7% of cases, a series of other antibiotics were used in combination over a long period (7 days). A 32.8% rate of surgical site infection was recorded, with antibiotic-related costs of around 62,311 ± 30,417 CDF (31 ± 15 €). A comparison of the characteristics of patients with and without infections showed a significant influence of the sex and type of surgery. Men were 4.7 times more likely to develop a surgical site infection than women, and orthopedic surgery had a higher risk of infection than other surgeries.</div></div><div><h3>Conclusion</h3><div>These retrospective data suggest that the use of antibiotics before and after surgery at the University Clinics of Lubumbashi does not meet accepted standards (ECDC, NICE and WHO guidelines) and would not be efficient for their intended purpose.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"103 ","pages":"Article 100807"},"PeriodicalIF":1.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827567","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}
Pub Date : 2025-01-01Epub Date: 2025-08-31DOI: 10.1016/j.curtheres.2025.100812
Francis Dodeller PhD , Peter Alliger PhD , Jens Heyn MD , Dragan Urosevic MD , Lisa Allmannsberger PhD , Cornelia Wersig PhD , Rufino Silva MD, PhD
<div><h3>Purpose</h3><div>Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data.</div></div><div><h3>Methods</h3><div>This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.</div></div><div><h3>Results</h3><div>Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities<em>,</em> including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was –0.3 letters (90% CI −1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent “in-use” studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.</div></div><div><h3>Conclusion</h3><div>This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologi
{"title":"Development of Biosimilar Aflibercept SDZ-AFL","authors":"Francis Dodeller PhD , Peter Alliger PhD , Jens Heyn MD , Dragan Urosevic MD , Lisa Allmannsberger PhD , Cornelia Wersig PhD , Rufino Silva MD, PhD","doi":"10.1016/j.curtheres.2025.100812","DOIUrl":"10.1016/j.curtheres.2025.100812","url":null,"abstract":"<div><h3>Purpose</h3><div>Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data.</div></div><div><h3>Methods</h3><div>This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.</div></div><div><h3>Results</h3><div>Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities<em>,</em> including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was –0.3 letters (90% CI −1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent “in-use” studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.</div></div><div><h3>Conclusion</h3><div>This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologi","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"103 ","pages":"Article 100812"},"PeriodicalIF":1.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154660","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}
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