Advances in Therapy最新文献

{"title":"Real-World Persistence in Adults with HIV and Mental Health or Substance Use Disorders After Restarting Antiretroviral Therapy in the United States.","authors":"Amanda M Kong, Jacqueline Lucia, Mary J Christoph, Uche Mordi, Daisha Joseph, Gulce Askin, Daniela Yucuma, Neia Prata Menezes, Peter McMahon, Travis Lim","doi":"10.1007/s12325-025-03379-1","DOIUrl":"https://doi.org/10.1007/s12325-025-03379-1","url":null,"abstract":"<p><strong>Introduction: </strong>Lifelong antiretroviral therapy (ART) persistence prevents the progression of human immunodeficiency virus (HIV)-related illnesses and reduces HIV transmission. People with HIV who have a mental health disorder or substance use disorder (PWH-MHD/SUD) often face persistence challenges. This real-world study compared ART persistence among PWH-MHD/SUD who restarted various ART regimens after a treatment interruption.</p><p><strong>Methods: </strong>This observational, retrospective cohort study analyzed US claims data from the HealthVerity Marketplace from January 2015 through February 2024. PWH aged ≥ 18 years who restarted the same ART regimen they had previously discontinued for > 90 days were included. The population of PWH-MHD/SUD was analyzed. Pairwise comparisons were conducted for those who received bictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) versus dolutegravir (DTG)/lamivudine (3TC), DTG/abacavir (ABC)/3TC, and DTG-based multitablet regimens [MTRs; i.e., DTG + F/TAF or DTG + F/tenofovir disoproxil fumarate (TDF)]. Baseline characteristics were balanced using inverse probability of treatment weighting. Time to nonpersistence (i.e., ART regimen discontinuation or switching) was depicted using Kaplan-Meier plots. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using weighted Cox proportional hazards models.</p><p><strong>Results: </strong>Among all the PWH who restarted a previously discontinued ART regimen (n = 20,623), 43.4% had an MHD or SUD. Compared with PWH-MHD/SUD who received B/F/TAF, those receiving DTG/ABC/3TC and DTG-based MTRs were significantly more likely to be nonpersistent [weighted HR (95% CI) 1.18 (1.09-1.29) and 1.19 (1.06-1.34), respectively], while there was no significant difference for those receiving DTG/3TC. Compared with those receiving B/F/TAF, the risk of switching was significantly higher for PWH-MHD/SUD receiving DTG/3TC, DTG/ABC/3TC, or a DTG-based MTR [weighted HR (95% CI) 1.68 (1.08-2.63), 2.67 (2.23-3.19), and 2.88 (2.32-3.58), respectively]. These results were generally consistent among the broader population of restarters.</p><p><strong>Conclusion: </strong>For PWH-MHD/SUD who restarted ART after a treatment interruption, B/F/TAF was associated with longer persistence and the lowest risk of switch compared with other guideline-recommended therapies.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145367348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Value Contribution of Palopegteriparatide in Adult Patients with Chronic Hypoparathyroidism using Multicriteria Decision Analysis (MCDA).","authors":"Juan José Díez, Xavier Badia, Reyes Abad, Carmen Alerany, Mónica Climente Martí, Josep Maria Guiu, Isabel Martín, María Caballero, Manuel Muñoz Torres","doi":"10.1007/s12325-025-03396-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03396-0","url":null,"abstract":"<p><strong>Introduction: </strong>The study objective was to determine the value contribution of palopegteriparatide to the treatment of adults with chronic hypoparathyroidism, a rare endocrine disease, through a multi-criteria decision analysis (MCDA).</p><p><strong>Methods: </strong>The Orphar-SEFH group framework for evaluating orphan drugs was used, along with the weighting performed by 98 national and regional evaluators. A multidisciplinary panel of seven experts individually scored the evidence matrix. The scores were collected and analysed using Microsoft Excel software programmed for MCDA study analysis. The results were discussed in a reflective discussion session.</p><p><strong>Results: </strong>The expert panel considered chronic hypoparathyroidism to be a moderate-to-severe disease (mean ± SD: 3.3 ± 0.5) due to its multiorgan impact and associated comorbidities, with significant unmet needs (3.6 ± 1.0), particularly related to the lack of the physiological effect due to insufficient levels of parathyroid hormone. The experts found palopegteriparatide as an add-on treatment to conventional therapy (calcium and active vitamin D) to be much more effective than placebo plus conventional therapy, with this criterion receiving the highest score. The safety profile was considered acceptable (1.6 ± 1.1). The participants highlighted the positive impact of palopegteriparatide on patient-reported outcomes (2.9 ± 0.9) compared to placebo because of improvements in quality of life (QoL). Palopegteriparatide was seen as a potentially disease-modifying treatment, which could lead to savings in \"other medical costs\" (3.1 ± 1.1) and \"non-medical/indirect costs\" (2.0 ± 0.8), although no evidence was available, especially in the long term. The quality of the evidence was perceived as high (3.6 ± 0.5). The overall value contribution of palopegteriparatide was 0.58 (+ 1 = maximum value) compared to placebo. The study has some limitations, including a relatively small panel size and the exclusion of treatment cost as a criterion due to lack of pricing information at the time of evaluation.</p><p><strong>Conclusion: </strong>According to MCDA, palopegteriparatide represents a valuable therapeutic option for chronic hypoparathyroidism treatment, particularly due to its demonstrated efficacy, which had an impact on patients' QoL, and the current unmet needs in this therapeutic area.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Visualizing Improvements in Airway Dysfunction After Inhaled Therapy in Patients With Uncontrolled Asthma: A Narrative Review.","authors":"Sam Tcherner, Ali Mozaffaripour, Cory Yamashita, Grace Parraga","doi":"10.1007/s12325-025-03392-4","DOIUrl":"https://doi.org/10.1007/s12325-025-03392-4","url":null,"abstract":"<p><p>Clinical trials investigating asthma therapies typically rely on pulmonary function tests including spirometry markers, such as forced expiratory volume in 1 s, to evaluate efficacy. While these measures provide insights into the action of bronchodilators on global lung function, their specific effects on the airways and the relationship between clinical improvements and airway dysfunction remains poorly understood. In recent years, pulmonary functional imaging methods, such as hyperpolarized ¹²⁹Xe magnetic resonance imaging (MRI), have enabled the analysis of airway dysfunction in patients with asthma utilizing ventilation defect percent (VDP). In this narrative review, we summarize clinical evidence about the impact of inhaled bronchodilator therapies on airway dysfunction in patients with asthma, focusing on studies that utilized ¹²⁹Xe MRI to visualize and quantify MRI VDP. ¹²⁹Xe MRI VDP has been shown to be a well-tolerated and sensitive technique for enabling the visualization and quantification of airway functional changes over time in patients with asthma. This has been shown not only in a controlled clinical trial environment but also in a real-world setting, in patients with both controlled and poorly controlled asthma. A recent study evaluating single-inhaler triple therapy in patients with uncontrolled moderate-severe asthma, despite inhaled corticosteroid/long-acting β₂-agonist maintenance therapy, demonstrated that daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 200/62.5/25 µg) led to significantly improved ¹²⁹Xe MRI VDP after only 6 weeks, which was in line with broader central/distal airway function and quality of life improvements. These results highlight the capacity of ¹²⁹Xe MRI VDP to detect early responses to treatment. In addition, the mechanistic insights provided by ¹²⁹Xe MRI VDP also indicated that these benefits are likely due to the combination of UMEC (a long-acting muscarinic antagonist) and an efficacious inhaled corticosteroid, addressing undertreated inflammatory bronchoconstriction, helping to restore airway caliber and function that more closely resemble the airways of a healthy individual.Videos available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of 48-Week Low-Dose Dienogest Treatment in Patients with Endometriosis-Associated Dysmenorrhea: A Randomized, Open-Label, Parallel-Group Trial.","authors":"Kyoko Kikuno, Ryuta Asada, Takuma Ishihara, Ken-Ichirou Morishige, Kenro Chikazawa, Tatsuro Furui, Masanori Isobe","doi":"10.1007/s12325-025-03397-z","DOIUrl":"https://doi.org/10.1007/s12325-025-03397-z","url":null,"abstract":"<p><strong>Introduction: </strong>Dienogest (DNG) is widely used to manage endometriosis-associated pain; however, long-term data comparing low and standard doses are limited. Therefore, this study aimed to evaluate the efficacy and safety of 48-week DNG treatment (1 mg/day vs. 2 mg/day) in patients with endometriosis-related dysmenorrhea (composite score).</p><p><strong>Methods: </strong>In this randomized, open-label, parallel-group, trial, 88 patients with endometriosis were enrolled, all of whom had at least one ovarian endometriotic cyst confirmed by imaging. Other phenotypes of endometriosis, such as deep infiltrating or peritoneal lesions, were not systematically assessed and may have been present. Patients were randomized to receive either 1-mg/day or 2-mg/day DNG. The primary endpoint was the change in menstrual pain measured using a visual analog scale (VAS). Secondary endpoints included changes in the dysmenorrhea score, ovarian endometrioma volume, serum estradiol levels, bone mineral density (BMD), and menopausal symptoms.</p><p><strong>Results: </strong>Both groups demonstrated a significant reduction in menstrual pain (VAS). The mean VAS scores decreased by 44.63 and 54.19 mm in the 1-mg and 2-mg groups, respectively. However, the between-group difference (- 9.57 mm; 95% confidence interval: - 22.7 to 3.56) was not above the predefined non-inferiority margin of - 15 mm; thus, non-inferiority of the 1-mg dose could not be confirmed. Improvements in dysmenorrhea scores and endometrioma volume were also observed in both groups, although greater effects were noted in the 2-mg group than in the 1-mg group. Serum estradiol suppression was comparable between the groups, whereas BMD loss was less pronounced in the 1-mg group than in the 2-mg group.</p><p><strong>Conclusions: </strong>This study did not demonstrate statistical non-inferiority of 1-mg/day DNG treatment over 2-mg/day DNG treatment for pain relief. These results suggest that the 2-mg/day dose may offer more robust analgesic effects, particularly during the early treatment phase. However, 1-mg/day DNG still showed meaningful symptom improvement with fewer adverse events than 2-mg/day DNG, supporting its potential use in selected patients requiring long-term therapy. Trial Registration Japan Registry of Clinical Trials, trial registration number: jRCTs041210016.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mental Health Experiences and Challenges Among Individuals with Myasthenia Gravis: Insights from Patient-Centered, Qualitative Analyses.","authors":"Rachelle D Rodriguez, Ashley E L Anderson, Kelly G Gwathmey, Caroline R Brethenoux, Lisa M Shea, Raghav Govindarajan, Nizar Souayah, Wesley D Peters, Louis A Jackson, Zia U Choudhry","doi":"10.1007/s12325-025-03399-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03399-x","url":null,"abstract":"<p><strong>Introduction: </strong>Historically, anxiety and depression rates have been higher among individuals with myasthenia gravis (MG) than the general population, and self-reported sentiments and experiences of mental health impairment may be more common than formal diagnoses. Patient-centered research can provide insight into self-described anxiety and depressive symptoms and stressors experienced by those with MG in the United States (US) and improve understanding of the current prevalence of anxiety and depression.</p><p><strong>Methods: </strong>Insights were collected from three sources. First, a literature review of quantitative and/or real-world studies of anxiety/depression among individuals with gMG in the US. Second, a secondary, qualitative analysis of the transcripts from focus groups conducted with 12 individuals with self-reported generalized MG. Third, analysis of thousands of online conversations between people with self-reported ocular or generalized MG using search, data extraction, and artificial intelligence-powered algorithms. No statistical analyses were performed.</p><p><strong>Results: </strong>The literature review identified three studies (precluding a meta-analysis): prevalence estimates for depression were 19% (diagnosed), 31% (receiving antidepressants), and 75% (self-reported sentiments), and for anxiety were 17%, 19% (both diagnosed), and 82% (self-reported sentiments). Unique stressors and triggers were identified, classified into four categories: experience of symptoms/uncontrolled symptoms; burden of medical care; daily life functioning, responsibilities, and aspirations; and social support needs. The relative prominence of each stressor and its induced emotion varied by stage in the disease journey: fear and anxiety were discussed more frequently prior to MG diagnosis, whereas hopelessness and depression became more prominent later, during ongoing disease monitoring and management. Patients felt that stress worsened symptoms in a positive feedback loop.</p><p><strong>Conclusion: </strong>This qualitative, hypothesis-generating study found that individuals with MG in the US were more likely to report experiencing anxiety and depression than the general population due, at least in part, to their MG-specific disease journey and the uncontrolled symptoms experienced.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145342583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Consequences of Adding Gliclazide Modified Release to Metformin in Patients with Uncontrolled Type 2 Diabetes in the United Arab Emirates.","authors":"Mohamed Farghaly, Olivier Cristeau, Fatheya A L Awadi, Sara Al Dallal","doi":"10.1007/s12325-025-03334-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03334-0","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes (T2D) is a chronic metabolic disease that is highly prevalent in the United Arab Emirates (UAE). This study aimed to assess the cost-consequences of adding gliclazide modified release (MR) to metformin in patients with inadequate glycaemic control on metformin alone and of switching patients currently receiving a combination of sitagliptin and metformin to a combination of gliclazide MR and metformin.</p><p><strong>Methods: </strong>We developed a cost-consequences decision-tree model comparing gliclazide MR and sitagliptin as second-line add-ons to metformin. Based on 2014-2023 Dubai Real World Claims Database data, the model estimated health outcomes (number of patients reaching HbA_1c targets of < 7% and ≤ 6.5% and cardiovascular [CV] events, i.e. myocardial infarction [MI] and hospitalisation for heart failure [HHF]), resource use (inpatient, emergency room, and outpatient visits, and hospital bed days), and costs (drug acquisition and medical costs) associated with the two therapies over a 1-year time horizon from the payer perspective.</p><p><strong>Results: </strong>Adding gliclazide MR to metformin in a cohort of 126,074 patients with inadequate glycaemic control on metformin alone was estimated to result in 535 CV events and 35 deaths avoided per year at a cost of USD 12,250 per CV event avoided or USD 189,415 per death avoided. Switching patients currently treated with sitagliptin as an add-on to metformin to gliclazide MR was estimated to avert 26 cardiovascular events (5 MI and 21 HHF) and 2 deaths per year while providing annual savings of USD 5.11 million, including USD 4.77 million in drug acquisition costs and USD 330,837 in medical costs.</p><p><strong>Conclusion: </strong>Initiating gliclazide MR as an add-on treatment to metformin could help to reduce the clinical and economic burden of poorly controlled T2D among patients in the UAE. Switching patients from sitagliptin to gliclazide MR as a second-line treatment option could generate substantial cost savings.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer.","authors":"Erwin De Cock, Sabine Oskar, Cecilia Lourdudoss, Renata Eiras, M Catherine Pietanza, Ashwini Arunachalam, Gustavo Alves, Gaston Lucas Martinengo, Enriqueta Felip","doi":"10.1007/s12325-025-03365-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03365-7","url":null,"abstract":"<p><strong>Introduction: </strong>Subcutaneous (SC) formulations of oncology therapies could provide time-saving benefits for both patients and healthcare professionals (HCPs) compared with intravenous (IV) delivery. This prospective observational study, conducted alongside the MK-3475A-D77 phase 3, open-label randomized clinical trial, quantifies HCP and patient time with pembrolizumab SC versus pembrolizumab IV among patients with metastatic non-small cell lung cancer.</p><p><strong>Methods: </strong>Seventeen sites across eight countries in Europe (n = 4), South America (n = 3), and Asia (n = 1) were enrolled. Primary endpoints were active HCP time; patient time in the treatment chair, treatment room, and healthcare facility; and consumables usage. Descriptive statistics included weighted mean (WM), and a linear mixed model (LMM) was employed to explore differences in time measures between pembrolizumab SC and pembrolizumab IV per visit.</p><p><strong>Results: </strong>Overall, 212 observations were analyzed (153 SC and 59 IV). Total active HCP time was reduced by 45.6% with SC versus IV (WM, 14.0 vs 25.8 min); HCPs spent 44.3% less time on the drug preparation process with SC versus IV (WM, 5.1 vs 9.1 min) and 46.3% less time on the drug administration process with SC versus IV (WM, 8.9 vs 16.7 min). Patient chair time was reduced by 49.6% with SC versus IV (WM, 59.0 vs 117.2 min). Patients receiving SC spent less time in the treatment room than those receiving IV (WM, 66.7 vs 126.9 min; difference - 47.4%). Exploratory LMM showed considerable between-group differences for active HCP time and patient time in the treatment chair and treatment room.</p><p><strong>Conclusion: </strong>Pembrolizumab SC substantially reduces active HCP time and patient chair time versus pembrolizumab IV. Time liberated for HCPs could be reallocated toward additional patient care activities, while optimized chair utilization could improve overall healthcare efficiency.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular Outcomes Among Patients with COPD Prescribed with LABA or LAMA: A Real-World Territory Wide Study.","authors":"Chun Ka Wong, Eugene C C Cheng, Ali Choo, Chung Ki Tsui, Audrey Tsznam Ko, Ting Fung Ma, Hung-Fat Tse, James Chung Man Ho, Wang Chun Kwok","doi":"10.1007/s12325-025-03375-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03375-5","url":null,"abstract":"<p><strong>Introduction: </strong>This study aims to compare cardiovascular outcomes among patients who received long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA) and thereby better inform the choice of pharmacotherapy prescription for patients with chronic obstructive pulmonary disease (COPD).</p><p><strong>Method: </strong>A real-world territory-wide retrospective cohort study using electronic data patient databases in Hong Kong was conducted. Patients with COPD without cardiovascular disease who were new users of LABA or LAMA from public hospitals in Hong Kong between 2010 and 2019 were identified and were followed up for 3 years after treatment initiation. Incidences of cardiovascular events were compared. Propensity score matching was employed to match important patient characteristics and clinical features.</p><p><strong>Results: </strong>After the propensity score matching, 5020 patients were included: 2510 treated with LABA and 2510 with LAMA. At 3-year follow-up, 19.6% of patients experienced cardiovascular events. LAMA treatment was associated with a higher incidence of cardiovascular events compared to LABA (20.2% vs 19.0%, adjusted hazard ratio [aHR] 1.14, p = 0.04). This difference was primarily driven by increased risks of new-onset atrial fibrillation (7.93% vs 6.53%, aHR 1.30, p = 0.01). Incidence rates were similar between groups for ventricular tachycardia and fibrillation (0.52% vs 0.80%, p = 0.32), acute coronary syndrome (4.06% vs 3.82%, p = 0.33), ischemic stroke (2.39% vs 2.59%, p = 0.98), and heart failure hospitalization (10.8% vs 9.84%, p = 0.05).</p><p><strong>Conclusion: </strong>Patients with COPD treated with LAMA might have higher incidence of atrial fibrillation when compared with LABA but not other cardiovascular events.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145311925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fetal Surgery for Congenital Heart Diseases: A Systematic Review and Single-Arm Meta-analysis.","authors":"Larissa Keren de Azevedo Teixeira, Henrique Provinciatto, Gustavo Yano Callado, Caroline de Oliveira Nieblas, Roberta Granese, Edward Araujo Júnior","doi":"10.1007/s12325-025-03388-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03388-0","url":null,"abstract":"<p><strong>Introduction: </strong>Congenital heart diseases (CHD) are the most common congenital anomalies, and fetal cardiac interventions (FCI) have been developed to improve perinatal outcomes. We aimed to conduct a systematic review and meta-analysis of observational studies to evaluate the effects of FCI on CHD.</p><p><strong>Methods: </strong>We searched PubMed/Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to April 2025 without language restrictions. References of included studies and prior reviews were also screened. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO; ID CRD42024599628). Eligible studies included observational cohorts evaluating intrauterine procedures for CHD. Data were synthesized using random effects models in RStudio (version 4.2.2), and study quality was assessed with the Newcastle-Ottawa Quality Assessment Form for Cohort Studies (NOS).</p><p><strong>Results: </strong>Twelve studies including 485 fetuses with CHD were analyzed. The pooled overall survival rate after fetal cardiac intervention was 57.4% (95% confidence interval [CI] 39.8-73.3), with survival ranging from 20.0% to 90.2% across studies. The pooled perinatal mortality rate was 31.5% (95% CI 21.0-44.2), with estimates ranging from 9.8% to 66.7%. Substantial heterogeneity was observed for both outcomes (I² > 75%).</p><p><strong>Conclusion: </strong>FCI for CHD are associated with moderate overall survival but substantial perinatal mortality. Standardized protocols, refined patient selection, and multicenter collaboration are needed to improve outcomes and guide clinical decision-making.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145311969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial.","authors":"Milos Jesenak, Elena Prokopova, Jan Bozensky, Branka Bonaci-Nikolic, Katarina Milosevic, Katarina Stankovic, Olivera Ostojic, Zorica Zivkovic, Zuzana Diamant, Peter Kunc, Kamil Janeczek, Juraj Majtan","doi":"10.1007/s12325-025-03393-3","DOIUrl":"https://doi.org/10.1007/s12325-025-03393-3","url":null,"abstract":"<p><strong>Introduction: </strong>Recurrent respiratory tract infections (RRTIs) are common in childhood and impose substantial socioeconomic burden. β-Glucans, particularly pleuran from Pleurotus ostreatus, demonstrate immunomodulatory properties through the pathogen-associated molecular pattern receptor interactions. This study evaluated a novel chewable pleuran-based supplement with vitamin D and zinc for preventing respiratory infections in children with RRTIs.</p><p><strong>Methods: </strong>This international, multicentre, randomised, double-blind, placebo-controlled trial enrolled 249 children with RRTIs from Slovakia, Czech Republic, and Serbia. Participants received either pleuran-based supplement (IMG® with vitamin D and zinc) or active placebo (vitamin D and zinc) for 3 months during respiratory infection season (October-March). Primary endpoint was total respiratory tract infections (RTIs). Secondary endpoints included RTI subtypes, RTI duration, missed school days, and safety evaluations.</p><p><strong>Results: </strong>In total, 217 children completed the study (104 active, 113 placebo). The active group experienced significantly fewer total RTIs versus placebo (2.35 ± 1.25 vs. 2.77 ± 1.78; P = 0.042), representing 15.2% reduction over 3 months. Common cold episodes were reduced by 18.6% (1.53 ± 1.22 vs. 1.88 ± 1.25; P = 0.040). Effects were pronounced in children over 6 years (P = 0.026 for total RTIs; P = 0.005 for common cold) and evident after the first month (P = 0.037). Tonsillopharyngitis showed significant reductions in frequency (P = 0.003) and duration (P = 0.009). Post hoc analysis of children enrolled at respiratory season onset confirmed significant reductions in common cold frequency (P = 0.004) and duration (P = 0.023). The supplement demonstrated excellent tolerability with 98.7% compliance and only mild adverse events.</p><p><strong>Conclusion: </strong>Chewable pleuran-based supplement with vitamin D and zinc significantly reduced respiratory tract infections in children with RRTIs, with rapid onset and favourable safety profile, demonstrating therapeutic potential in this vulnerable population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID NCT06974747.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145285461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}