Advances in Therapy最新文献

{"title":"Cost-Effectiveness of Tirzepatide Versus Liraglutide, Both Adjunct to Diet and Exercise, for Patients with Obesity or Overweight: A UK Perspective","authors":"Matthew Capehorn,&nbsp;Erin Johansson,&nbsp;Alun Davies,&nbsp;Jerome Evans,&nbsp;Fiona Godbeer,&nbsp;Naomi van Hest,&nbsp;Georgina Cotterill,&nbsp;Keith Tolley","doi":"10.1007/s12325-025-03288-3","DOIUrl":"10.1007/s12325-025-03288-3","url":null,"abstract":"<div><h3>Introduction</h3><p>This study estimated the cost-effectiveness from a UK healthcare system perspective of tirzepatide (5 mg, 10 mg, 15 mg) compared to liraglutide (3 mg) both adjunct to a reduced-calorie diet and increased physical activity in patients with a body mass index (BMI) ≥ 30 kg/m² (obesity), or with a BMI ≥ 27 to &lt; 30 kg/m² (overweight) + ≥ 1 obesity-related complication (‘trial population’). A subgroup analysis was performed in liraglutide’s National Institute of Health and Care Excellence (NICE) recommended population (patients with a BMI of ≥ 35 kg/m² with non-diabetic hyperglycaemia and a high risk of cardiovascular disease [CVD]).</p><h3>Methods</h3><p>A lifetime simulation model evaluated the costs and long-term clinical outcomes of each treatment. The base-case population was aligned to the population from the SURMOUNT-1 trial. The subgroup analysis included a 2-year stopping rule for liraglutide to reflect the NICE reimbursement criteria. Treatment efficacy was informed by a network meta-analysis. Patients were at risk of developing obesity-related complications such as diabetes and cardiovascular complications, calculated using published risk equations applied to modelled changes in risk factors. Incremental cost-effectiveness ratios (ICERs; cost/quality-adjusted life year [QALY]) were calculated.</p><h3>Results</h3><p>In the trial population, all doses of tirzepatide were dominant to liraglutide, with estimated cost savings and QALY gains. In liraglutide’s UK recommended population the estimated ICERs for tirzepatide vs liraglutide were £5401–7864/QALY gained across doses; the change in results is primarily due to the 2-year stopping rule for liraglutide in this population. In both populations, all doses of tirzepatide demonstrated reductions in at least five of seven complications compared to liraglutide, most notably for knee replacements (29–46% reduction) and diabetes (25–48% reduction).</p><h3>Conclusion</h3><p>On the basis of this simulation model, at the UK willingness-to-pay threshold (£20,000/QALY gained), tirzepatide is a cost-effective treatment compared to liraglutide for overweight and obesity, in both the full license SURMOUNT-1 trial population and in liraglutide’s specific NICE reimbursed population.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5055 - 5071"},"PeriodicalIF":4.0,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03288-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144815554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multi-specialty Physician Preferences and Perceptions in Treatment and Management of Polycystic Ovary Syndrome in China: Survey and Discrete Choice Experiment","authors":"Zhuowei Gu,&nbsp;Wei Chen,&nbsp;Jian Ming,&nbsp;Haijiao Liu,&nbsp;Hui Sun,&nbsp;Zhe Xu,&nbsp;Yijing Li,&nbsp;Yingyao Chen,&nbsp;Qinjie Tian","doi":"10.1007/s12325-025-03311-7","DOIUrl":"10.1007/s12325-025-03311-7","url":null,"abstract":"<div><h3>Introduction</h3><p>Polycystic ovary syndrome (PCOS) is one of the most common gynecological endocrine diseases in reproductive-aged women. Given the multifaceted nature of PCOS and the involvement of multiple disciplines, the diagnosis and treatment of PCOS vary among different specialties. Our study aimed to elicit preferences of physicians from multidisciplinary specialties for PCOS treatment and their perceptions of PCOS management to enhance the understanding of clinical practice in China.</p><h3>Methods</h3><p>A discrete choice experiment (DCE) was conducted to elicit the physicians’ preferences of PCOS treatment, and a cross-sectional survey was performed to understand the perceptions in management of PCOS. Physicians from three hospital specialties (general gynecology, gynecological endocrinology, and reproductive endocrinology) in China were included.</p><h3>Results</h3><p>Responses from a total of 123 physicians were eligible for the final analysis, with 41 from each specialty. In DCE, the physicians mainly preferred the anti-androgen effect, lower probability of irregular bleeding, and additional benefits when selecting treatment for PCOS, and the decision making was found to be highly dependent on the presence of clinical hyperandrogenism. Regarding diagnostic criteria, polycystic ovary morphology (PCOM) was the most frequently used (39.84%), followed by menstrual dysfunction (37.40%) and clinical hyperandrogenism (30.08%). Fertility and menstruation regulation were selected as the most important treatment goals for PCOS by physicians. Similar preferences across the three specialties were observed.</p><h3>Conclusion</h3><p>The decision making by physicians on PCOS treatment largely relies on the presence of clinical hyperandrogenism across all three specialties, indicating the significance of hyperandrogenism assessment in clinical practice, and the role of biochemical hyperandrogenism in PCOS treatment may require further elucidation in future clinical guidelines. Furthermore, the results emphasize the urgent need to bridge the gap between the clinical practice and guidance recommendations for the diagnosis and treatment of PCOS in China.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5042 - 5054"},"PeriodicalIF":4.0,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03311-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician’s Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma","authors":"Cyrille Touzeau,&nbsp;Brea Lipe,&nbsp;Abdullah M. Khan,&nbsp;Binod Dhakal,&nbsp;Sandhya Nair,&nbsp;Jianming He,&nbsp;João Mendes,&nbsp;Seina Lee,&nbsp;Carolina Lonardi,&nbsp;Ana Slaughter,&nbsp;Nikoletta Lendvai,&nbsp;Jordan M. Schecter,&nbsp;Diana Chen,&nbsp;Man Zhao,&nbsp;Tzu-min Yeh,&nbsp;Xavier Leleu,&nbsp;Noemí Puig,&nbsp;Dominik Dytfeld,&nbsp;Elena Zamagni,&nbsp;Katja Weisel,&nbsp;Lionel Karlin,&nbsp;Michel Delforge,&nbsp;Paolo Corradini,&nbsp;Roberto Mina,&nbsp;Wilfried Roeloffzen,&nbsp;Surbhi Sidana","doi":"10.1007/s12325-025-03308-2","DOIUrl":"10.1007/s12325-025-03308-2","url":null,"abstract":"<div><h3>Introduction</h3><p>Ciltacabtagene autoleucel (cilta-cel) is approved for relapsed or refractory multiple myeloma (RRMM). In the CARTITUDE-4 study (NCT04181827), cilta-cel demonstrated superior efficacy versus pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with RRMM after 1–3 prior lines of therapy (LOT). We conducted an indirect treatment comparison to understand the comparative efficacy of cilta-cel versus real-world (RW) physician’s choice of treatment for lenalidomide-refractory MM.</p><h3>Methods</h3><p>De-identified data from the Flatiron Health MM cohort registry (January 2020 to May 2024) were compared with data from CARTITUDE-4 (data cutoff May 1, 2024). Key eligibility criteria for CARTITUDE-4 were used to match patients from the Flatiron database. Baseline covariates of prognostic significance were adjusted using inverse probability of treatment weighting. Outcomes for comparative effectiveness included progression-free survival (PFS), RW PFS, time to next treatment (TTNT), and overall survival (OS). Sensitivity analyses were conducted.</p><h3>Results</h3><p>The CARTITUDE-4 cohort included data from 208 patients who received cilta-cel; the median follow-up was 33.6 months. The real-world cohort included 932 patients (1445 eligible LOT) from the Flatiron database; the median follow-up was 23.6 months. In base case analyses, compared with the Flatiron cohort, patients treated with cilta-cel had improved PFS (hazard ratio [HR] 0.29 [95% confidence interval (CI)] 0.22–0.36; <i>p</i> &lt; 0.001), RW-PFS (HR 0.29 [95% CI 0.23–0.37]; <i>p</i> &lt; 0.001), TTNT (HR 0.32 [95% CI 0.25–0.41]; <i>p</i> &lt; 0.001), and OS (HR 0.59 [95% CI 0.41–0.84]; <i>p</i> = 0.003). These findings were consistent across all sensitivity analyses.</p><h3>Conclusion</h3><p>Cilta-cel lengthened TTNT and demonstrated meaningful prolongation in PFS and OS compared with real-world physician’s choice for lenalidomide-refractory MM. These data highlight the value of cilta-cel as an effective therapy in earlier-line patients with relapsed, lenalidomide-refractory MM exposed to proteasome inhibitors and immunomodulatory drugs.</p><h3>Trial registration</h3><p>CARTITUDE-4: ClinicalTrials.gov ID NCT04181827.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5023 - 5041"},"PeriodicalIF":4.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03308-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144787989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Weight Loss Among Patients Initiating Semaglutide 2.4 mg and Enrolled in WeGoTogether, a Digital Self-Support Application","authors":"Joshua C. Toliver,&nbsp;Victoria Divino,&nbsp;Carmen D. Ng,&nbsp;Julia Wang","doi":"10.1007/s12325-025-03325-1","DOIUrl":"10.1007/s12325-025-03325-1","url":null,"abstract":"<div><h3>Introduction</h3><p>Semaglutide injection 2.4 mg (Wegovy^®; hereafter referred to as semaglutide) was approved by the US Food and Drug Administration in June 2021 for chronic weight management in adults with overweight or obesity. This study aimed to evaluate the real-world long-term effectiveness of semaglutide in combination with the WeGoTogether patient support program with a follow-up period of up to 24 months.</p><h3>Methods</h3><p>This retrospective, noninterventional cohort study included adults with overweight or obesity (body mass index [BMI] ≥ 25.0 kg/m²) who initiated semaglutide and enrolled in WeGoTogether during the study period (6/2021–4/2025). Semaglutide is administered as a once-weekly subcutaneous injection. Patients had ≥ 2 post-index weights, with ≥ 1 weight at 6, 12, 18, and/or 24 months (± 30 days) of follow-up. Self-reported, de-identified data from WeGoTogether were analyzed descriptively. Patient demographics were characterized, and changes in weight and BMI were compared from index to each follow-up time point.</p><h3>Results</h3><p>Overall, 8177 patients met the eligibility criteria, including 7604 (93.0%) patients with a BMI ≥ 30.0 kg/m². At baseline, the mean age was 49.5 years, mean weight was 234.1 lb, and mean BMI was 38.4 kg/m²; 83.6% of patients were female. Among patients with reported weight at the time points of interest, the mean (standard deviation) percent weight loss was − 13.4% (6.4) at 6 months (<i>n</i> = 6964), − 17.6% (10.2) at 12 months (<i>n</i> = 2050), − 20.3% (11.4) at 18 months (<i>n</i> = 491), and − 20.4% (11.3) at 24 months (<i>n</i> = 325). The proportions of patients achieving ≥ 20% weight loss were 13.1%, 43.3%, 52.5%, and 50.5% at 6, 12, 18, and 24 months, respectively. Similar results were observed for the subgroup with BMI ≥ 30.0 kg/m².</p><h3>Conclusion</h3><p>The study demonstrated substantial weight loss with semaglutide treatment, including over long-term 18- and 24-month follow-up periods, as reported in the WeGoTogether program. These data suggest patients can achieve clinically meaningful long-term (24 months) weight loss in real-world settings when treated with semaglutide and participating in the WeGoTogether patient support program.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5010 - 5022"},"PeriodicalIF":4.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03325-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Semaglutide 2.4 mg Clinical Outcomes in Patients with Obesity or Overweight: A Real-World Retrospective Comparative Cohort Study","authors":"Aleksandrina Ruseva,&nbsp;Wojciech Michalak,&nbsp;Anthony Fabricatore,&nbsp;Bríain Ó. Hartaigh,&nbsp;Zhenxiang Zhao,&nbsp;Devika Umashanker","doi":"10.1007/s12325-025-03320-6","DOIUrl":"10.1007/s12325-025-03320-6","url":null,"abstract":"<div><h3>Introduction</h3><p>This study compared the effectiveness of semaglutide 2.4 mg vs. no treatment with obesity medication (OM) for reducing weight and improving cardiometabolic risk factors among adults with obesity or overweight.</p><h3>Methods</h3><p>This real-world, retrospective, observational cohort study included adults with obesity or overweight with ≥ 1 obesity-related complication treated with semaglutide 2.4 mg identified in a large US claims and medical record database (December 15, 2020, through May 30, 2024). Patients were matched 1:4 to non-treated patients using a propensity score (PS) model. Change in weight and body mass index (BMI) (primary outcomes) and changes in cardiometabolic risk factors (secondary outcomes; systolic blood pressure [SBP], diastolic blood pressure [DBP], glycated hemoglobin [HbA1c], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], and triglycerides) were assessed from baseline to 12 months. PS matching and generalized linear models were used to compare outcomes.</p><h3>Results</h3><p>A total of 8,857 semaglutide 2.4 mg-treated patients were matched to 35,428 non-treated patients. After matching, baseline characteristics between cohorts were well balanced in mean age (47.6 vs. 47.8 years), mean BMI (36.7 kg/m² in both cohorts), and gender (76% vs. 77% female). Weight data were available for 4,038 and 1,186 patients in the non-treated and semaglutide cohort, respectively. Estimated treatment differences between cohorts showed the semaglutide 2.4 mg cohort had significantly greater percentage (− 15.0%) and absolute reduction in weight (– 15.7 kg), greater reduction in BMI (– 4.2 kg/m²), and significantly greater improvements in cardiometabolic risk factors, including SBP (– 6.7 mmHg), DBP (– 2.7 mmHg), HbA1c (– 0.5%), HDL-C (1.2 mg/dl), LDL-C (– 10.4 mg/dl), and triglycerides (– 34.3 mg/dl) at 12 months.</p><h3>Conclusion</h3><p>In this real-world study, adults with obesity or overweight treated with semaglutide 2.4 mg had greater reductions in weight and improvements in cardiometabolic risk factors compared with patients not treated with OM at 12 months.</p><p>A Graphical Abstract is available for this article.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4993 - 5009"},"PeriodicalIF":4.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03320-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Glycemia Risk Index and Continuous Glucose Monitoring Outcomes Following the Transition to an Advanced Hybrid Closed-Loop System in Type 1 Diabetes","authors":"Ayman Al Hayek,&nbsp;Wael M. Alzahrani,&nbsp;Abdulghani H. Al Saeed,&nbsp;Malak Al Mashali,&nbsp;David C. Klonoff,&nbsp;Mohamed A. Al Dawish","doi":"10.1007/s12325-025-03326-0","DOIUrl":"10.1007/s12325-025-03326-0","url":null,"abstract":"<div><h3>Introduction</h3><p>Advanced hybrid closed-loop (AHCL) systems have shown promise in improving glycemic control in adults with type 1 diabetes (T1D), yet real-world evidence remains limited. This study evaluated the impact of transitioning from multiple daily injections (MDI) or conventional continuous subcutaneous insulin infusion (CSII) to the Tandem t:slim X2™ Control-IQ® AHCL system on glycemic outcomes in adults with T1D.</p><h3>Methods</h3><p>In this retrospective study, 56 non-pregnant adults with T1D were followed for 6 months. Primary outcomes were changes in the Glycemia Risk Index (GRI) and percentage time in the tight range (%TiTR_70-140). Secondary outcomes included other standardized ambulatory glucose profile metrics as well as additional glycemic, anthropometric, and insulin dosing measures.</p><h3>Results</h3><p>Transition to the Control-IQ system increased %TiTR_70-140 by 11.5 percentage points and reduced GRI by 23.5 points. Both components of the GRI, hypoglycemia risk (%Chypo) and hyperglycemia risk (%Chyper), improved significantly. Hemoglobin A1c decreased by 1.0%, time in range (%TIR_70-180) improved by 13.6 percentage points, and glycemic variability (CV%) showed marked improvement. Total daily insulin dose decreased by 34%, accompanied by modest weight loss. No diabetic ketoacidosis episodes were reported throughout the study period.</p><h3>Conclusion</h3><p>Transitioning to the Tandem t:slim X2 Control-IQ AHCL system led to significant improvements in tight glycemic control, glycemic risk reduction, and insulin efficiency, with a favorable safety profile. These findings support broader adoption of AHCL technology and underscore the need for prospective multicenter studies.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4977 - 4992"},"PeriodicalIF":4.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788000","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":"The Feasibility and Impact of Implementing Interventions to Reduce Short-Acting β2-Agonist Over-Reliance in Asthma: An Expert Opinion","authors":"Luis Nannini,&nbsp;Zaurbek Aisanov,&nbsp;Kurtuluş Aksu,&nbsp;Ashraf Alzaabi,&nbsp;Miguel Antúnez,&nbsp;Leonora Cañizares-Fernandez,&nbsp;Mark Cohen-Todd,&nbsp;Michael G. Crooks,&nbsp;Hisham Farouk,&nbsp;Suyapa Sosa Ferrari,&nbsp;Pin-Kuei Fu,&nbsp;Natalia Garcia,&nbsp;Ashraf Hatem,&nbsp;Truong Le Van Ngoc,&nbsp;Kittipong Maneechotesuwan,&nbsp;Walter Javier Mattarucco,&nbsp;John Mpe,&nbsp;Francesc Xavier Moranta Ribas,&nbsp;Jesús Javier Vázquez-Cortés,&nbsp;Faisal Yunus","doi":"10.1007/s12325-025-03293-6","DOIUrl":"10.1007/s12325-025-03293-6","url":null,"abstract":"<div><p>Asthma poses a significant global health problem. Despite the availability of effective treatments, management practices often fall short of current recommendations. The SABA use IN Asthma (SABINA) programme demonstrated that short-acting β₂-agonist (SABA) over-reliance significantly contributes to disease burden. A panel of 20 international healthcare practitioners (HCPs) invited to a summit meeting discussed five innovative interventions to reduce SABA over-reliance and assessed the feasibility of implementing them across countries. The interventions included the SABA rEductioN Through ImplemeNting Hull asthma guidELines (SENTINEL) quality improvement programme in the UK, the pay-for-performance (P4P) programme in Taiwan, the Asthma Right Care (ARC) programme in Spain, a SABA-free asthma clinic in Argentina, and a modified emergency department discharge protocol and SABA alert system in the United Arab Emirates. Following a review of the available clinical evidence from these five interventions, the HCPs proposed six themes to tackle SABA over-reliance: (1) consistent delivery of services across healthcare systems in individual countries to facilitate standardisation of optimal treatment approaches and resource allocation; (2) educational initiatives targeted at HCPs and patients to mitigate drivers of SABA over-reliance; (3) adopting a SABA-free treatment paradigm that provides concomitant anti-inflammatory therapy with a fast-acting bronchodilator for symptom relief; (4) regulating over-the-counter SABA purchase without a prescription; (5) engaging policymakers to integrate current evidence-based treatment recommendations into routine clinical practice; and (6) expanding use of digital technology as a key component of a patient-centric approach and monitoring prescribing practices. Since SABAs were the preferred reliever for &gt; 30 years, reducing SABA over-reliance will necessitate a considerable shift in asthma management practices. This transition requires coordinated efforts among clinicians, pharmacists, and policymakers to develop and tailor strategies for raising awareness of the clinical and economic burden of SABA overuse and address local/national barriers to integration of evidence-based recommendations in routine clinical practice.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4797 - 4823"},"PeriodicalIF":4.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03293-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global Incidence and Mortality of Myocardial Infarction in Multi-Modality Head and Neck Cancer Treatment: A Systematic Review and Meta-analysis","authors":"Ameya A. Asarkar,&nbsp;Srivatsa Surya Vasudevan,&nbsp;Veronica Fernandez-Alvarez,&nbsp;Jan B. Vermorken,&nbsp;Fernando López Álvarez,&nbsp;Karthik N. Rao,&nbsp;Nabil F. Saba,&nbsp;Remco de Bree,&nbsp;Carlos Suárez,&nbsp;Avraham Eisbruch,&nbsp;Sandra Nuyts,&nbsp;Carol Bradford,&nbsp;Alfio Ferlito","doi":"10.1007/s12325-025-03314-4","DOIUrl":"10.1007/s12325-025-03314-4","url":null,"abstract":"<div><h3>Introduction</h3><p>Myocardial infarction (MI) incidence and mortality vary following multi-modality treatment for head and neck cancer (HNC). This systematic review and meta-analysis evaluate these rates.</p><h3>Methods</h3><p>We searched PubMed, Embase, ScienceDirect, and Web of Science (inception to March 2025) for studies reporting MI incidence or mortality after HNC treatment. A random-effects meta-analysis yielded pooled proportions. Subgroup analyses examined variations by treatment modality, time period (pre-/post-2010), and geography.</p><h3>Results</h3><p>Of 680 studies, 53 were included, encompassing 85,948 patients with HNC. The global pooled MI incidence was 1.7% (95% CI 1.2–2.3%), decreasing from 2.6% (pre-2010) to 1.5% (post-2010). Incidence was lowest with upfront surgery alone (1.2%) and higher with surgery plus adjuvant therapy (2.7%), primary chemoradiotherapy (CRT) (2.3%), radiotherapy (RT) alone (2.4%), or chemotherapy (CT) alone (2.1%). Global pooled MI mortality was 42.1% (95% CI 15.3–74.6%), declining from 49.8% (pre-2010) to 36.0% (post-2010). Male sex (<i>p</i> = 0.01) and longer follow-up in the RT group (<i>p</i> = 0.01) were associated with higher MI incidence via meta-regression; longer follow-up was also linked to higher mortality (<i>p</i> = 0.028). </p><h3>Conclusion</h3><p>This systematic review (PROSPERO: CRD420251040579) estimated the global MI incidence post-HNC treatment to be 1.7%, with the lowest after surgery alone and no significant geographic variation. MI mortality is high (42.1%) but has decreased over time. These findings demonstrate significant cardiovascular burden associated with HNC treatment, particularly non-surgical modalities, highlighting the need for targeted cardiovascular surveillance strategies.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4768 - 4796"},"PeriodicalIF":4.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783252","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":"Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults","authors":"Abiraamasundari Ramapalaniappan,&nbsp;Vijayakrishnan Loganathan,&nbsp;Abhijeet Morde,&nbsp;Muralidhara Padigaru,&nbsp;Paras Patni,&nbsp;Lincy Joshua,&nbsp;Jestin V. Thomas","doi":"10.1007/s12325-025-03292-7","DOIUrl":"10.1007/s12325-025-03292-7","url":null,"abstract":"<div><h3>Introduction</h3><p>Ashwagandha has multiple medicinal properties and is widely used as a supplement to address various health conditions including stress and anxiety. The bioavailability of Ashwagandha bioactives provide critical information on the biological effects in humans after oral supplementation.</p><h3>Methods</h3><p>A randomized, double-blind, single-dose, cross-over comparative oral bioavailability study was conducted in 20 healthy, adult human subjects under fasting conditions. All subjects consumed single dose of ZEN 1.5 (Zenroot™ Ashwagandha 1.5% 125 mg), ASH 5 (Reference product 1—Ashwagandha 5% 600 mg) and ASH 10 (Reference product 2—Ashwagandha 10% 500 mg) as per a randomization schedule. Blood samples were collected at 0.00 h, and at 00.25, 00.50, 00.75, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 09.00, 12.00, and 24.00 h post-dose. Total withanolides (consisting of withanoside IV, withanolide A, 12-deoxywithastramonolide, and withaferin A) were quantified in plasma using the LC–MS/MS method and pharmacokinetics parameters like area under the curve, AUC_0-t, <i>C</i>_max, <i>T</i>_max, <i>t</i>_½ and test/reference (<i>T</i>/<i>R</i>) ratio for test product, ZEN 1.5, versus reference products, ASH 5 and ASH 10, were used for statistical comparisons.</p><h3>Results</h3><p>Subjects in the ZEN 1.5 group showed significantly (<i>P</i> &lt; 0.05) higher total withanolides concentration in plasma at all post-dose time points except 12.00 and 24.00 h compared to ASH 5. In addition, subjects in Ashwagandha ZEN 1.5 group showed significantly higher (<i>P</i> &lt; 0.05) total withanolides concentration in plasma at 0.25, 1.00, 2.00, 3.0, and 4.00 h compared to ASH 10. Further, ZEN 1.5 showed significantly higher bioavailability for total withanolides compared to ASH 5 and ASH 10 with significantly higher (<i>P</i> &lt; 0.05) <i>C</i>_max and AUC_0-t parameters, <i>T</i>/<i>R</i> ratio, and 90% CI. ZEN 1.5 at 125-mg dose showed 2.1-fold higher bioavailability compared to ASH 5 at 600 mg, and 1.3-fold higher bioavailability compared to ASH 10 at 500 mg. ZEN 1.5 was well tolerated during the study period.</p><h3>Conclusion</h3><p>A low dose of 125 mg of ZEN 1.5 showed greater total withanolides bioavailability compared to reference products. The <i>C</i>_max and AUC parameters were significantly higher than the 80–125% criteria established by the FDA for bioequivalence confirming superior bioavailability of ZEN 1.5. In addition, ZEN 1.5 was well tolerated by subjects throughout the study duration. Further studies are warranted for evaluating the health benefits of ZEN 1.5.</p><p><b>Trial Registration:</b> CTRI/2022/11/047039.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4964 - 4976"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03292-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144758951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and Humanistic Burden of Adult Obesity in Asia–Pacific: A Systematic Literature Review","authors":"Esther Artime,&nbsp;Sarah Zimner-Rapuch,&nbsp;Roger Chen,&nbsp;Qiuhe Ji,&nbsp;Ichiro Tatsuno,&nbsp;Rachel S. Newson,&nbsp;Tomotaka Shingaki,&nbsp;Si Si,&nbsp;Rachel Kewley,&nbsp;Sam Riley,&nbsp;Swarna Khare","doi":"10.1007/s12325-025-03324-2","DOIUrl":"10.1007/s12325-025-03324-2","url":null,"abstract":"<div><h3>Introduction</h3><p>Obesity continues to be an increasing global health concern. However, the burden of obesity within the Asia–Pacific (APAC) region is less well defined relative to Western countries.</p><h3>Methods</h3><p>A systematic literature review was conducted to characterise disease burden in people with obesity within the APAC region (defined as body mass index of ≥ 30 kg/m² in Australia and Taiwan, ≥ 28 kg/m² in China, and ≥ 25 kg/m² in Japan, Korea, and Hong Kong). The presence of obesity-related complications and impact of obesity on patient-reported outcomes is described.</p><h3>Results</h3><p>Complications were reported at significantly higher rates in people with obesity compared to people with a normal weight. Diabetes, hypertension, dyslipidaemia, and cardiovascular diseases were the most frequently reported obesity-related complications, and rates among people with obesity were as high as 57%, 72%, 65%, and 23% respectively. Low scores on patient-reported outcome measures indicated reduced health-related quality of life (HRQoL) among people with obesity, with lower HRQoL in those with a higher obesity class. Psychological distress was also elevated in people with obesity which persisted despite treatment.</p><h3>Conclusion</h3><p>Despite variation in the definition of obesity across countries in the APAC region, obesity was consistently associated with notable presence of related metabolic, cardiovascular, and psychological complications. Obesity substantially impacts psychosocial and emotional wellbeing and is associated with a reduced HRQoL in people with obesity. This highlights the need to proactively recognise and manage obesity as a chronic relapsing disease to improve the health of people with obesity. Further research is warranted to address identified evidence gaps in the APAC region.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4741 - 4767"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03324-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144758947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}