Advances in Therapy最新文献

{"title":"Disease Progression, Clinical Outcomes and Treatment Challenges in Patients with Chronic Kidney Disease and High-Risk Proteinuria.","authors":"Roberto Pecoits-Filho, Johan Bodegård, Phil Ambery, You-Seon Nam, Marcus Thuresson, Maria K Svensson","doi":"10.1007/s12325-025-03364-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03364-8","url":null,"abstract":"<p><strong>Introduction: </strong>A urine albumin-creatinine ratio (UACR) > 700 mg/g signifies severe kidney damage, and nephrology referral is recommended for intensified management. The impact of UACR ≥ 700 mg/g on outcomes and the efficacy of kidney protective therapies in patients have not been thoroughly examined.</p><p><strong>Methods: </strong>Using claims healthcare data from the USA, we identified prevalent patients with chronic kidney disease and a UACR measurement on 1 January 2022, and grouped them by UACR level. We also identified new users of sodium-glucose cotransporter 2 inhibitors (SGLT2i) between 2021 and 2023. Outcomes included estimated glomerular filtration rate (eGFR) slopes and risks of adverse outcomes and mortality.</p><p><strong>Results: </strong>Of the 46,626 patients with UACR ≥ 300 mg/g, 23,998 had UACR ≥ 700 mg/g. In the UACR ≥ 700 and UACR 300 to < 700 mg/g groups, mean age was 72 and 74 years, median eGFR was 42 and 50 mL/min/1.73 m², median UACR was 1376 and 437 mg/g at baseline and eGFR slopes were - 5.5 and - 3.1 mL/min/1.73 m² per year, respectively. Compared to the UACR < 10 mg/g group, adjusted hazard ratio of risk of cardiorenal hospitalizations was 5.83 (95% CI 5.55-6.12) and 3.53 (95% CI 3.34-3.73), atherosclerotic cardiovascular disease hospitalizations was 2.97 (95% CI 2.76-3.19) and 2.33 (95% CI 2.15-2.52), and all-cause death was 2.89 (95% CI 2.78-3.02) and 2.10 (95% CI 2.01-2.20) in the UACR ≥ 700 and UACR 300 to < 700 mg/g groups, respectively. Of the 5908 new users of SGLT2i with UACR ≥ 700 mg/g, UACR and eGFR slope improved as expected (to 720 mg/g and - 2.44 mL/min/1.73 m² per year, respectively).</p><p><strong>Conclusions: </strong>A UACR ≥ 700 mg/g identifies patients at high risk of accelerated kidney function decline and adverse outcomes. While emerging therapies such as SGLT2i had the expected benefits, the persistence of residual proteinuria/albuminuria and associated risks highlight an unmet need for optimized and new treatment strategies.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063084","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":"Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.","authors":"Naotaka Usui, Dong Zhou, Bing Qin, Somsak Tiamkao, Leonor Cabral-Lim, Kheng Seang Lim, Shih-Hui Lim, Jing-Jane Tsai, Jun Watanabe, Weiwei Sun, Najla Dickson, Brian Moseley, Dimitrios Bourikas, Yushi Inoue","doi":"10.1007/s12325-025-03357-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03357-7","url":null,"abstract":"<p><strong>Introduction: </strong>We assessed the time course of treatment-emergent adverse events (TEAEs) in adult Asian patients (in Thailand, Japan, China, Philippines, Malaysia, Singapore, and Taiwan) with focal-onset seizures (FOS) during adjunctive brivaracetam (BRV) treatment.</p><p><strong>Methods: </strong>Post hoc analysis of EP0083/NCT03083665, a Phase 3, randomized, double-blind, placebo (PBO)-controlled trial that evaluated BRV 50 and 200 mg/day in adult Asian patients (≥ 16-80 years) with FOS. Following an 8-week prospective baseline, patients were randomized 1:1:1 to PBO, BRV 50 mg, or BRV 200 mg and entered a 12-week treatment period.</p><p><strong>Results: </strong>Overall, 448 patients (mean age 34.5 years; 53.8% female) received ≥ 1 dose of trial medication (PBO/BRV 50 mg/BRV 200 mg: n = 149/151/148 [Safety Set]). The overall incidence of TEAEs was similar across treatment arms (53.6-58.1%), and most TEAEs were mild in intensity (45.0-48.3%). Patients discontinuing BRV because of TEAEs (1.3% BRV 50 mg; 2.7% BRV 200 mg) discontinued during the first 5 weeks of treatment (for PBO, discontinuations due to TEAEs [3.4%] took place between weeks 1-8). The incidence of drug-related TEAEs was 18.1% in patients receiving PBO, 24.5% in those on BRV 50 mg/day, and 39.2% for BRV 200 mg/day; however, most were of mild intensity and did not lead to BRV discontinuation. The incidence of TEAEs and drug-related TEAEs was highest during the first week of adjunctive BRV treatment and decreased thereafter. The onset of drug-related somnolence and dizziness occurred mainly during the first week of treatment.</p><p><strong>Conclusion: </strong>In Asian adults with FOS, most drug-related TEAEs were mild in intensity, indicating that adjunctive BRV had a favorable tolerability profile when initiated at a potentially therapeutic dose without titration. The incidence of drug-related TEAEs including somnolence and dizziness was highest during the first week of adjunctive BRV treatment, abating thereafter. These tolerability data could help inform patient monitoring and treatment decisions when prescribing BRV.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03083665.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145051389","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":"Assessing the Benefits of Rapid Start Antiretroviral Therapy for Newly Diagnosed People with HIV in the United States.","authors":"Patrick S Sullivan, Cillian Copeland, James Jarrett, Uche Mordi, Nikos Kotsopoulos, Rui Martins, Hansel E Tookes","doi":"10.1007/s12325-025-03356-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03356-8","url":null,"abstract":"<p><strong>Introduction: </strong>International guidelines emphasize the need for earlier commencement of antiretroviral therapy (ART) among people with HIV (PWH). Reducing the time between HIV diagnosis and ART initiation can improve health outcomes, reduce healthcare utilization, and reduce HIV transmissions. This study evaluated the clinical and economic benefits associated with increasing uptake of rapid start ART among newly diagnosed PWH.</p><p><strong>Methods: </strong>A state transition disease model was developed in the United States setting to evaluate the benefits from earlier initiation of ART. The base case analysis compared two cohorts of 1000 newly diagnosed PWH: one following current patterns of ART initiation, and a counterfactual cohort where those receiving rapid start ART was doubled. Individuals were classified by different CD4 states at diagnosis and over time with viral suppression rates also being tracked. ART and CD4 state-specific healthcare costs were estimated over a 3-year time horizon. Averted HIV transmissions were calculated and used to estimate lifetime healthcare cost savings while CD4-specific mortality was also calculated. Several scenario analyses explored alternate assumptions related to the time at which PWH started ART after diagnosis.</p><p><strong>Results: </strong>Doubling the proportion of newly diagnosed PWH receiving rapid start ART averted 7 HIV transmissions and 0.3 deaths per 1000 people, corresponding to numbers needed to treat of 141 and 3502, respectively. This leads to cost savings resulting from reduced healthcare resource use and lifetime cost savings from preventing new HIV transmissions.</p><p><strong>Conclusion: </strong>Reducing the time between HIV diagnosis and ART initiation can provide clinical and economic benefits by eliminating transmissions that might occur while individuals are viremic but not on treatment. The additional costs of providing ART required for this increase achieve high levels of return when considering the lifetime healthcare cost burden of onward HIV transmissions potentially averted by early ART start.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038971","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":"Healthcare Costs Associated with Adverse Events in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder (ADHD): A Claims-Based Study.","authors":"Jeff Schein, Maryaline Catillon, Anaïs Lemyre, Alice Qu, Frederic Kinkead, Marjolaine Gauthier-Loiselle, Martin Cloutier, Ann Childress","doi":"10.1007/s12325-025-03345-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03345-x","url":null,"abstract":"<p><strong>Introduction: </strong>Adverse events (AEs) are common in pediatric patients receiving attention-deficit/hyperactivity disorder (ADHD) treatment; however, real-world studies on their costs from a payer's perspective are lacking. Therefore, this study investigated the healthcare costs associated with selected AEs among pediatric patients receiving ADHD treatment in the United States.</p><p><strong>Methods: </strong>Using a retrospective cohort design, patients aged 6-17 years who received pharmacologic treatment for ADHD were identified from US claims data (October 1, 2015-September 30, 2023) and were categorized into AE and AE-free cohorts, separately for each studied AE. The eight selected AEs had statistically significant risk differences in a matching-adjusted indirect comparison of ADHD treatments and were identifiable from claims with ICD-10-CM codes. Entropy balancing was used to create cohorts with similar characteristics. Total excess healthcare costs and costs associated with AE-specific claims per patient per month (PPPM) were compared across balanced cohorts with vs. without a given AE.</p><p><strong>Results: </strong>Overall, 393,919 patients (mean age: 12.5 years; male: 65.4%; stimulant monotherapy: 71.8%) were included, among whom 13.6% had ≥ 1 studied AE that resulted in a medical encounter during their treatment episode. The most prevalent AEs were upper abdominal pain (5.2%), vomiting (3.4%), and insomnia (3.2%). All AEs were associated with substantial AE-specific costs PPPM (asthenia: $196; somnolence: $171; insomnia: $169; vomiting: $106; dizziness: $92; upper abdominal pain: $91; irritability: $75; decreased weight: $46) and total excess healthcare costs PPPM (asthenia: $1178; somnolence: $821; vomiting: $427; insomnia: $404; dizziness: $380; upper abdominal pain: $336; irritability: $231; decreased weight: $219; all p < 0.01).</p><p><strong>Conclusions: </strong>AEs were common during ADHD treatment episodes in pediatric patients and were associated with significant healthcare costs. ADHD treatments with a favorable safety profile could help alleviate the economic burden of AEs.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145032425","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":"Comparative Effectiveness of Valoctocogene Roxaparvovec and Efanesoctocog Alfa in the Treatment of Severe Hemophilia A: A Matching-Adjusted Indirect Comparison of Bleeding Frequency.","authors":"Thomas G Douglas, Sandra Santos, David R Hinds, Anthony J Hatswell, Kurt Taylor","doi":"10.1007/s12325-025-03339-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03339-9","url":null,"abstract":"<p><strong>Introduction: </strong>Hemophilia A, an X-linked recessive bleeding disorder, is characterized by reduced factor VIII (FVIII) activity. Hemophilia A can significantly impact a person's quality of life because of the risk of spontaneous bleeding. Treatment for hemophilia A aims to prevent bleeding from occurring. The innovation of gene therapies for use in hemophilia has the potential to replace prophylaxis treatment by enabling a single treatment infusion that sustains endogenous FVIII production for years. This analysis assessed the comparative effectiveness of valoctocogene roxaparvovec, a gene therapy, versus prophylactic FVIII replacement therapy with efanesoctocog alfa, given the current lack of comparative evidence between these treatments.</p><p><strong>Methods: </strong>Comparison between valoctocogene roxaparvovec and efanesoctocog alfa was conducted using matching-adjusted indirect comparison (MAIC). Patient-level data from the phase III GENEr8-1 trial of valoctocogene roxaparvovec were reweighted to align with baseline characteristics of aggregate-level data from XTEND-1, a phase III trial of efanesoctocog alfa. Matching variables included proportion of patients with zero treated bleeds and mean annualized bleed rate (ABR) for treated bleeds prior to initiating therapy. Following reweighting, the proportion of patients who had experienced zero bleeds after 52 weeks was compared, along with mean ABR-each population was assessed for treated bleeds, treated joint bleeds, and treated spontaneous bleeds.</p><p><strong>Results: </strong>Following MAIC weighting, patients treated with valoctocogene roxaparvovec had higher odds of experiencing zero treated bleeds (OR 2.68, 95% CI 1.18-6.14) and zero treated joint bleeds (OR 2.75, 95% CI 1.09-6.86) compared with efanesoctocog alfa. Odds of zero treated spontaneous bleeds were also higher for valoctocogene roxaparvovec, but not statistically significant. Mean ABRs for treated bleeds, treated joint bleeds, and treated spontaneous bleeds were similar between groups, with no statistically significant differences.</p><p><strong>Conclusion: </strong>This MAIC suggests that valoctocogene roxaparvovec provides a greater likelihood of patients experiencing zero treated bleeds compared with efanesoctocog alfa during the first year following treatment initiation.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145022677","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":"An Indirect Treatment Comparison of Avalglucosidase Alfa versus Cipaglucosidase Alfa Plus Miglustat in Patients with Late-Onset Pompe Disease.","authors":"Mark E Roberts, Irina Proskorovsky, Patricia Guyot, Pragya Shukla, Nathan Thibault, Alaa Hamed, Ruth Pulikottil-Jacob, Lasair O'Callaghan, Laurence Pollissard","doi":"10.1007/s12325-025-03301-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03301-9","url":null,"abstract":"<p><strong>Introduction: </strong>No head-to-head studies comparing the efficacy of avalglucosidase alfa (AVA) with cipaglucosidase alfa + miglustat (Cipa+mig) have been conducted in patients with late-onset Pompe disease (LOPD). Two indirect treatment comparisons (ITCs) were conducted to estimate the effects of AVA versus Cipa+mig.</p><p><strong>Methods: </strong>ITCs were conducted using simulated treatment comparisons (STCs), adjusting for differences in prognostic factors and treatment effect modifiers. An analysis of patients who were naïve to enzyme replacement therapy (ERT-naive) used anchored STC with individual patient data (IPD) from the Phase 3 COMET (NCT02782741) study of AVA versus alglucosidase alfa (ALG) and aggregate data from patients who were ERT-naïve in the Phase 3 PROPEL (NCT03729362) study of Cipa+mig versus ALG + placebo. For patients who were ERT-experienced, an analysis used unanchored STC with IPD for AVA from the COMET open-label extension, and from NEO-1 (NCT01898364)/NEO-EXT (NCT02032524) studies, and aggregate Cipa+mig data from PROPEL and ATB200-02 (NCT02675465).</p><p><strong>Results: </strong>In patients who were ERT-naïve, the difference (95% confidence interval, CI) in mean change from baseline (CFB) at Weeks 49-52 in forced vital capacity percent predicted (FVCpp) showed a numerical improvement for AVA versus Cipa+mig with values of 5.49% (- 0.87, 11.86) with mixed model repeated measures analysis (MMRM/MMRM) and 4.69% (- 3.22, 12.61) with MMRM/analysis of covariance (ANCOVA). For the 6-min walk test (6MWT), differences were 57.08 m (11.04, 103.12) with MMRM/MMRM and 41.88 m (- 5.46, 89.22) with MMRM/ANCOVA, the former being statistically significant (p < 0.02) and the latter numerically in favour of AVA. In patients who were ERT-experienced, at Weeks 48-52 differences for AVA versus Cipa+mig with MMRM/MMRM (CIs/p values unavailable) were 1.40% for FVCpp and 18.85 m for 6MWT; with MMRM/Mean CFB, differences of 1.16% (- 1.88, 4.19) for FVCpp and 7.67 m (- 21.67, 37.02) for 6MWT, indicating a numerical improvement in favour of AVA.</p><p><strong>Conclusions: </strong>ITCs suggest more favourable respiratory and mobility outcomes with AVA versus Cipa+mig in patients with LOPD, regardless of prior ERT-experience.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013645","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":"Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus.","authors":"Cristina Arriens, Eric F Morand, Anca D Askanase, Richard Furie, Ronald F van Vollenhoven, Yoshiya Tanaka, Kevin Connors, Monica Davey, Kimberly Young, Giovanni Franchin, Richard Meier, Vaishali Shah, Carolina Leite de Oliveria, Coburn Hobar","doi":"10.1007/s12325-025-03299-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03299-0","url":null,"abstract":"<p><strong>Background and objectives: </strong>Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, demonstrated efficacy across the primary endpoint and all key secondary endpoints in the phase 2 PAISLEY SLE trial in patients with active systemic lupus erythematosus (SLE). Here, we describe 2 phase 3 trials [POETYK SLE-1 (NCT05617677), POETYK SLE-2 (NCT05620407)] which will assess the efficacy and safety of deucravacitinib in patients with active SLE. These phase 3 trials have been designed to replicate the successful elements of the phase 2 trial, including its glucocorticoid-tapering strategy and disease activity adjudication.</p><p><strong>Methods: </strong>In these global, phase 3, randomized, double-blind, placebo-controlled trials, patients aged 18-75 years with active SLE receiving background standard-of-care treatment will be randomized 3:2 to receive deucravacitinib or placebo for 52 weeks of double-blind treatment. Patients receiving glucocorticoids will be instructed to taper, unless significant disease activity is present, to a threshold dose level during the double-blind treatment period. At week 52, eligible patients may continue to an optional 104-week open-label extension phase, in which all patients will receive deucravacitinib.</p><p><strong>Planned outcomes: </strong>The primary endpoint of SLE Responder Index-4 response and all secondary endpoints will be assessed at week 52. Safety and tolerability will be assessed throughout the trials. In each trial, planned randomization includes patients in multiple countries across North and South America, Europe, and the Asia-Pacific region.</p><p><strong>Conclusions: </strong>The POETYK SLE-1 and SLE-2 trials in progress are important to the continued evaluation of deucravacitinib as a potential well-tolerated and effective therapy option for patients with SLE.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT05617677 and NCT05620407.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013720","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":"Switching Patients with Schizophrenia from Intramuscular Paliperidone Palmitate Once Monthly to TV-46000, a Long-Acting Subcutaneous Antipsychotic: Population Pharmacokinetic-Based Strategies.","authors":"Itay Perlstein, Jonathan Meyer, Ziqi Yue, Vijay Ivaturi, Kelli R Franzenburg, Mark Suett, Rolf Hansen, Avia Merenlender Wagner, Arti Phatak, Rajendra Singh","doi":"10.1007/s12325-025-03329-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03329-x","url":null,"abstract":"<p><strong>Introduction: </strong>Pharmacokinetic differences between long-acting injectable antipsychotic (LAI) formulations, combined with a lack of clinical switch studies, contribute to clinician uncertainty when transitioning between LAIs. This analysis employed a population pharmacokinetic (popPK) modeling approach to characterize dosing conversions and switching strategies from intramuscular paliperidone palmitate once monthly (PP1m) to TV-46000, a long-acting subcutaneous formulation of risperidone, once monthly (q1m), with a secondary analysis of PP1m to TV-46000 every 2 months (q2m).</p><p><strong>Methods: </strong>For PP1m and TV-46000, concentration-time profiles for paliperidone and TV-46000 total active moiety (TAM; risperidone + paliperidone) were simulated on the basis of published popPK models with virtual populations of 5000 patients. TAM exposure following oral administration served as a comparison benchmark.</p><p><strong>Results: </strong>When switching from PP1m 234 mg at steady state (comparable to 6 mg/day oral risperidone), the most comparable switch involved initiating TV-46000 125 mg q1m 4 weeks after the last PP1m dose. Ratios of TV-46000 to PP1m for maximum, minimum, and average plasma concentration (C_max, C_min, and C_avg, respectively) post switch ranged from 1.0 to 1.4 after the first dose and 1.0-1.3 at steady state. Switching from other PP1m doses to TV-46000 q1m (comparable to 2-4 mg daily oral risperidone) using a 4-week interval demonstrated comparable TAM exposures. When switching from PP1m 234 mg to TV-46000 250 mg q2m, C_max was higher and C_min lower than that of q1m, though C_avg remained comparable to 5/6 mg daily oral risperidone.</p><p><strong>Conclusion: </strong>Switching to TV-46000 125 mg q1m 4 weeks after the last PP1m 234-mg injection yielded generally comparable pharmacokinetic parameters at steady state. The same was true for other TV-46000 q1m or q2m dosages and equivalent dosages of PP1m. Clinician discretion will ultimately determine how to switch on the basis of factors such as patient preference, convenience, and concerns about tolerability or symptom breakthrough.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013689","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":"Patient Preferences and Understanding of Glaucoma Treatment: A Nationwide Survey by the French Glaucoma Society.","authors":"Paul Bastelica, Antoine Labbe, Marwan Sahyoun, Christophe Baudouin, Cédric Lamirel, Muriel Poli, Jean-Paul Renard, Antoine Rousseau, Cédric Schweitzer, Florent Aptel","doi":"10.1007/s12325-025-03353-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03353-x","url":null,"abstract":"<p><strong>Introduction: </strong>Glaucoma treatment predominantly involves the use of topical anti-glaucoma eye drops, with patient adherence influenced by individual preferences. This study aimed to assess these preferences and highlight the importance of personalized treatment approaches among ophthalmologists.</p><p><strong>Methods: </strong>This French multicenter, cross-sectional study involved 21 ophthalmologists-members of the Board of Directors of the French Society of Glaucoma-from both public and private practices, who distributed a standardized questionnaire to their patients with glaucoma. The questionnaire collected data on demographics, treatment-related experiences, patient preferences, and the prioritization of six treatment criteria: cost, efficacy, dosing frequency, side effects, environmental impact, and ease of use.</p><p><strong>Results: </strong>A total of 798 patients with glaucoma participated. There was no strong preference between multi-dose bottles and single-dose units (32.0% vs. 37.4%, respectively, with 29.2% of patients showing no preference). Side effects were reported by 31.8% of patients, and the use of artificial tears was significantly higher among those with longer treatment durations (31.3% for ≤ 2 years vs. 65.6% for > 20 years, p = 0.001). Notably, 63% of patients were unaware that their eye drops could contain preservatives. Regarding generics, 29.9% of patients had previously used one, while only 25.6% were willing to switch from their prescribed brand to a generic equivalent. Adherence was suboptimal, with only 66.2% of patients reporting being compliant. Younger age (p < 0.001) and lack of awareness about preservatives (p < 0.001) were significantly associated with non-adherence. When ranking treatment criteria, patients prioritized efficacy, followed by side effects, ease of use, cost, and environmental impact.</p><p><strong>Conclusion: </strong>This nationwide survey conducted by the French Glaucoma Society underscores the diversity of patient preferences and the critical need for personalized glaucoma care. A substantial proportion of patients feels insufficiently informed about preservatives and generics, which may negatively impact adherence. Enhanced patient education and individualized treatment strategies are essential for improving outcomes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013712","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":"Obesity as a Chronic Disease: A Narrative Review of Evolving Definitions, Management Strategies, and Cardiometabolic Prioritization.","authors":"Vidhi Singh, Jia Sun, Susan Cheng, Alan C Kwan, Amanda Velazquez","doi":"10.1007/s12325-025-03352-y","DOIUrl":"https://doi.org/10.1007/s12325-025-03352-y","url":null,"abstract":"<p><p>Obesity is a multifactorial, complex disease that is driven by genetic, biological, environmental, and behavioral factors. In this review, we explain the key contributors to obesity, limitations in current definitions, its relationship with cardiometabolic health, and recent advancements in treatment. Obesity is characterized by the presence of excess and dysfunctional adipose tissue, driven by chronic inflammation and maladaptive energy homeostasis. Although body mass index (BMI) has historically been used to diagnose obesity, BMI provides a limited evaluation of individual patients because it fails to specifically quantify adiposity, which is the primary determinant of metabolic impact in these patients. There is an ongoing and necessary shift in treating obesity with a weight-inclusive approach that aims to address obesity upstream and prevent downstream cardiometabolic health complications. This approach is being supported by various treatment options, notably glucagon-like peptide-1 receptor agonists like semaglutide and tirzepatide, that also have promising effects on cardiovascular, renal, and liver health. Advances in precision medicine, gut microbiome research, and Multi-target therapies support personalized therapeutic approach. Despite these developments, less than 25% of individuals living with obesity are receiving evidence-based treatment. There is an urgent need to improve health care delivery to patients with obesity through timely, affordable, and multimodal treatments that promote sustainable and sustained weight loss. Increasing board certification of practicing physicians through the American Board of Obesity Medicine will be critical to improving access and quality of care.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999416","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}