Clinical Drug Investigation最新文献

{"title":"Pregabalin and Methadone Plasma Levels in Patients Receiving Methadone Maintenance Treatment: An Observational Study.","authors":"Anat Sason, Miriam Adelson, Shaul Schreiber, Einat Peles","doi":"10.1007/s40261-025-01460-9","DOIUrl":"10.1007/s40261-025-01460-9","url":null,"abstract":"<p><strong>Background and objectives: </strong>The combination of pregabalin and opioid usage is a known risk for fatalities. The pregabalin misuse rate among patients in methadone maintenance treatment (MMT) is reported to be high. However, pregabalin's risk among MMT patients, specifically concerning methadone dose and plasma level, is not yet determined. We aimed to study retention, survival, and whether pregabalin misuse is related to methadone dose and plasma level in MMT patients.</p><p><strong>Methods: </strong>An observational study was conducted on 273 patients at the MMT clinic in Tel Aviv, Israel. Inclusion criteria required having urine drug-screening results for pregabalin when evaluated for methadone plasma levels. Methadone dose and plasma level, drug in urine, sociodemographic, and addiction variables were taken from patients' records.</p><p><strong>Results: </strong>Patients with positive urine for pregabalin (n = 50) were comparable to 223 negative patients tested in methadone dose (124.3 ± 30.7 vs. 117.1 ± 42.5, p = 0.3) but had higher methadone plasma levels (693.8 ± 327.6 vs. 572.3 ± 286.5 ng/ml, p = 0.009) and QTc intervals on ECG (422.8 ± 31.8 vs. 412.1 ± 29.8 ms, p = 0.03). Logistic regression model found pregabalin tested positive as more likely to test positive for benzodiazepine (OR = 9.1), methylphenidate (OR = 5.5), and fentanyl (OR = 5.9), and to have higher methadone plasma levels (OR = 1.002). Cumulative retention (p < 0.001) and survival (p = 0.007) since admission to MMT were both shorter in the pregabalin group.</p><p><strong>Conclusions: </strong>Patients who tested positive for pregabalin presented high methadone plasma levels, even though they were treated with normal or low methadone doses. This phenomenon highlights the importance of monitoring methadone levels, which is not a routine procedure, to reduce patients' risk.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"575-582"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526686","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":"Memantine for the Treatment of Primary Negative Symptoms in Schizophrenia: A Meta-analysis of Randomized Controlled Trials.","authors":"Houlin Hong, Jack Donlon, Martin Schaefer, Susanne Sarkar, Dragana Bugarski-Kirola, Mujeeb U Shad, Wei Hou, Matthias Kirschner, Sajoy P Varghese, Ludmil Mitrev, Valentina Echeverria, John Dibato, Selene R T Veerman, Rohit Aiyer, Thomas N Ferraro, Gerardo Villarreal, Shafiqur Rahman, Trevor W Stone, Maju M Koola","doi":"10.1007/s40261-025-01465-4","DOIUrl":"https://doi.org/10.1007/s40261-025-01465-4","url":null,"abstract":"<p><strong>Background: </strong>Memantine is an N-methyl-D-aspartate (NMDA) receptor antagonist with favorable safety and side effect profiles. There is a growing body of evidence for memantine as an adjunctive therapy for the positive, negative, and cognitive symptoms of schizophrenia.</p><p><strong>Objective: </strong>This meta-analysis examined the efficacy of memantine as an add-on to treatment with antipsychotic(s) for the primary negative symptoms (PNS) of schizophrenia.</p><p><strong>Methods: </strong>We followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and searched for relevant publications in PubMed, Cochrane Library, PsycINFO, Embase, and China Journal Net databases from inception using the following search terms: memantine, schizophrenia, randomized controlled trials (RCTs), RCT, and clinical trial. Searches were limited to English- and Chinese-language articles to date. Standardized mean differences (SMDs) with 95% confidence intervals were calculated using RevMan 5.4 to assess the effect size. Risk of bias was assessed using RoB 2.0.</p><p><strong>Results: </strong>In total, 13 RCTs were identified (N = 681). Memantine was superior to placebo in treating negative symptoms, with an SMD of 0.79 (p = 0.0001, N = 631, 12 RCTs). Analysis of three studies whose corresponding authors provided original datasets showed an SMD of 2.16 (p = 0.25, N = 97) after adjusting for change in psychosis, depression, and extrapyramidal symptoms, suggesting that memantine is efficacious in treating PNS. Additionally, cognitive testing significantly improved, with an SMD of 0.66 (p = 0.0001, N = 395, eight RCTs). Positive symptoms were not significantly improved (SMD = 0.24, p = 0.1, N = 631, 12 RCTs).</p><p><strong>Conclusions: </strong>To our knowledge, this is the first study showing a large effect size for treating PNS with memantine. Although statistical significance was not reached because of the small sample size (N = 97), the results were as expected because drugs such as memantine that act at NMDA receptors are unlikely to be effective as stand-alone treatments. Future RCTs should evaluate NMDAergic drugs in combination with complementary medications to optimize therapeutic effects for all three domains of schizophrenia psychopathology.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759333","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-Effectiveness of Pembrolizumab Monotherapy for High Programmed Death Ligand 1 Advanced or Metastatic Non-small Cell Lung Cancer Depends on Long-Term Survivors.","authors":"Zakile A Mfumbilwa, Janneke A Wilschut, Harry J M Groen, Valesca P Retèl, Bram Ramaekers, Manuela Joore, Veerle M H Coupé","doi":"10.1007/s40261-025-01456-5","DOIUrl":"10.1007/s40261-025-01456-5","url":null,"abstract":"<p><strong>Background: </strong>Pembrolizumab shows effectiveness in treating metastatic non-small cell lung cancer (metNSCLC), with a subgroup of patients experiencing long-term survival (LTS) benefits. The existence of a LTS subgroup may influence the cost-effectiveness of pembrolizumab monotherapy compared with platinum-based chemotherapy. This study aims to assess the potential implications of such a subgroup on the cost-effectiveness for patients with non-squamous metNSCLC and PD-L1 ≥ 50% who are ineligible for targeted therapies.</p><p><strong>Methods: </strong>This study used a decision analytic model based on Dutch real-world data (2008-2014). Two strategies were simulated: (1) a chemotherapy strategy: patients receive chemotherapy in the first-, second-, and third-line; and (2) a pembrolizumab strategy: patients receive first-line pembrolizumab followed by chemotherapy for those progressing to second- and third-lines. The pembrolizumab strategy is evaluated with and without the assumption that there is a LTS subgroup. The LTS subgroup is assumed to be free from metNSCLC-related progression after treatment. Costs (2022 €), including drug costs, other direct medical costs, family costs, and healthcare costs in life years gained, are considered from first-line treatment to death. Effects are measured in quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) is assessed using an €80,000/QALY threshold. Threshold analyses are performed on the size and mortality rate of the LTS subgroup and on the price of pembrolizumab.</p><p><strong>Results: </strong>QALYs per patient were 0.65 for chemotherapy, 1.24 for pembrolizumab without LTS, and 3.52 for pembrolizumab with LTS. Average costs per patient were €58,800 for chemotherapy, €154,600 for pembrolizumab without LTS, and €178,600 for pembrolizumab with LTS. Pembrolizumab without LTS was not cost-effective compared with chemotherapy (ICER €167,600/QALY), but pembrolizumab with LTS (30% of simulated population) was cost effective (ICER of €43,100/QALY). Threshold analyses showed that a LTS subgroup size of at least 10% or halving the price of pembrolizumab was needed for pembrolizumab to be cost-effective.</p><p><strong>Conclusions: </strong>Pembrolizumab is a cost-effective first-line treatment for patients with metNSCLC and PD-L1 ≥ 50% in the Netherlands when at least 10% of patients are long-term survivors. Without long-term survivors, this treatment is not cost-effective. Therefore, it is crucial to consider long-term survivors in assessing the cost-effectiveness of immunotherapy in metNSCLC.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"583-598"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12307520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590538","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":"Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis.","authors":"Gerd Burmester, Jakub Trefler, Artur Racewicz, Janusz Jaworski, Agnieszka Zielińska, Marek Krogulec, Sławomir Jeka, Rafał Wojciechowski, Katarzyna Kolossa, Anna Dudek, Magdalena Krajewska-Włodarczyk, Paweł Hrycaj, Piotr Adrian Klimiuk, SungHyun Kim, JeeHye Suh, GoEun Yang, YunAh Kim, YooBin Jung, GaHee Park, Josef S Smolen","doi":"10.1007/s40261-025-01453-8","DOIUrl":"10.1007/s40261-025-01453-8","url":null,"abstract":"<p><strong>Background and objective: </strong>This phase III study conducted in 22 centres in Poland assessed the efficacy equivalence of candidate tocilizumab biosimilar, CT-P47, and European Union-approved reference tocilizumab (r-TCZ) in rheumatoid arthritis. We report 1-year data, including switching from r-TCZ to CT-P47.</p><p><strong>Methods: </strong>This active-controlled, double-blind, multicentre trial randomised (1:1) adults (aged 18-75 years) with moderate-to-severe rheumatoid arthritis diagnosed for ≥ 24 weeks and treated with methotrextate for ≥ 12 weeks before the first study drug administration, to receive CT-P47 or r-TCZ every 4 weeks (8 mg/kg, intravenous) up to week 20. At week 24, those on CT-P47 continued maintenance treatment; those on r-TCZ were re-randomised (1:1) to continue r-TCZ (r-TCZ maintenance) or to switch to CT-P47 (CT-P47 switched) until week 48 (Treatment Period 2). After week 48, patients were followed up until week 52 (end of study). Efficacy, pharmacokinetics, safety and immunogenicity were evaluated.</p><p><strong>Results: </strong>In Treatment Period 2, 225 patients continued CT-P47 maintenance, 109 continued r‑TCZ maintenance and 110 switched to CT-P47. During Treatment Period 2, efficacy findings were comparable between groups. At week 52, the mean change from baseline in Disease Activity Score in 28 joints-erythrocyte sedimentation rate was - 4.279, - 4.231 and - 4.376 in the CT-P47 maintenance, r-TCZ maintenance and CT-P47 switched groups, respectively. Joint damage progression over 1 year was minimal in all groups. Drug serum concentrations were relatively consistent throughout Treatment Period 2. The safety profile and antidrug antibody-positive conversion rate (< 5% in each group) were similar between groups.</p><p><strong>Conclusions: </strong>Week 52 results show maintained efficacy after switching from r-TCZ to CT-P47, and comparable efficacy, pharmacokinetics, safety and immunogenicity of CT-P47 versus r-TCZ over 1 year of treatment.</p><p><strong>Clinical trial registration: </strong>NCT05489224, 24 July 2022.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"551-563"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12307557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616551","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":"Cost-Effectiveness Analysis of Toripalimab Plus Axitinib for Patients with Advanced Renal Cell Carcinoma in the United States.","authors":"Ibrahim Alfayoumi, Asmita Priyadarshini Khatiwada, Surachat Ngorsuraches","doi":"10.1007/s40261-025-01464-5","DOIUrl":"10.1007/s40261-025-01464-5","url":null,"abstract":"<p><strong>Objective: </strong>The RENOTORCH trial found that toripalimab plus axitinib extended progression-free and overall survival in patients with advanced renal cell carcinoma (RCC), though its financial burden may limit widespread use. This study aimed to assess the cost-effectiveness of toripalimab plus axitinib compared with sunitinib monotherapy as a first-line therapy for patients with previously untreated or intermediate- or poor-risk advanced RCC from a US third-party payer perspective.</p><p><strong>Methods: </strong>A three-state partitioned survival model (progression-free, progression, death) was utilized, with clinical outcomes obtained from the RENOTORCH trial. Progression-free survival (PFS) and overall survival (OS) were modeled using various parametric functions over a 5-year horizon, applying a 3% annual discount rate. Costs of treatments, administration, monitoring, and management of grade 3/4 adverse events (≥ 5% occurrence) were sourced from Micromedex® and Centers for Medicare & Medicaid Services (CMS) databases. Life years (LY), quality-adjusted life years (QALY), and incremental costs per LY and QALY were estimated. One-way and probabilistic sensitivity analyses were conducted. Subgroup analyses for intermediate- and poor-risk patients, as classified by the International Metastatic RCC Database Consortium (IMDC) criteria, were performed using similar methods.</p><p><strong>Results: </strong>Toripalimab plus axitinib increased total costs by $332,359, gained 0.68 LY and 0.36 QALY compared with sunitinib, resulting in incremental costs of $489,747 per LY and $923,962 per QALY. One-way sensitivity analysis showed that the incremental cost per QALY was most sensitive to changes in toripalimab plus axitinib's cost. At a $150,000 willingness-to-pay threshold, probabilistic sensitivity analysis showed a nearly 0% probability of toripalimab plus axitinib being cost-effective. Similarly, toripalimab plus axitinib was still not cost-effective for intermediate- and poor-risk patients.</p><p><strong>Conclusions: </strong>Compared with sunitinib monotherapy, our study suggested that toripalimab plus axitinib was not cost-effective for patients with advanced renal cell carcinoma from a US third-party payer perspective. Further analyses are warranted when more data are available. Despite benefits across different risk groups, toripalimab plus axitinib was not cost-effective for intermediate- and poor-risk patients.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"537-549"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12307552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667247","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":"A Cost-Effectiveness Analysis of Rivaroxaban Compared to Warfarin for the Management of Venous Thromboembolism in Western Kenya.","authors":"Emily T O'Neill, Andrew W Huang, Marta Wilson-Barthes, Imran Manji, Gabriel Kigen, Naftali Busakhala, Samuel Nyanje, Omar Galárraga, Sonak D Pastakia","doi":"10.1007/s40261-025-01454-7","DOIUrl":"10.1007/s40261-025-01454-7","url":null,"abstract":"<p><strong>Background and objective: </strong>Access to direct oral anticoagulants (DOACs) in sub-Saharan Africa is limited due to prohibitive upfront costs, making warfarin the standard of care for many patients, especially those relying on public-sector healthcare. This study evaluated the cost-effectiveness of using the DOAC, rivaroxaban, compared to warfarin for treating venous thromboembolism (VTE), a cardiovascular disorder caused by blood clots in the veins, in western Kenya.</p><p><strong>Methods: </strong>We developed a discrete-time individual state-transition Markov model to simulate a VTE patient's quality-adjusted life-years (QALYs) and annual treatment costs under a rivaroxaban or warfarin therapy strategy. Transition state probabilities were derived from real-world event-rate data observed in patients treated with rivaroxaban (n = 160) or warfarin (n = 116) for VTE at Moi Teaching and Referral Hospital in western Kenya. Base-case parameter values were obtained from cohort event rates, local costs, and literature-derived utility values. Cost-effectiveness was assessed over a 1-year time horizon using an incremental cost-effectiveness ratio (ICER) threshold of (US)$6020.40 per QALY gained (equivalent to three times Kenya's 2021 per capita GDP). Deterministic and probabilistic sensitivity analyses were conducted to assess parameter and model uncertainty.</p><p><strong>Results: </strong>After 12 months, total mean treatment costs per patient were $216.00 and $173.00 using warfarin and rivaroxaban, respectively. In the base-case analysis, rivaroxaban therapy resulted in an additional 0.023 QALYs per patient compared to warfarin, with an ICER of $- 1862.00 per QALY gained. Based on probabilistic sensitivity analysis with Monte Carlo simulation, when costs, utility values, and event rates were varied, rivaroxaban was cost-effective compared to warfarin in 84.1% of all simulations at a willingness-to-pay threshold of $6020.40 per QALY. One-way sensitivity analyses and scenario analyses were stable with rivaroxaban therapy, resulting in fewer costs and higher QALYs.</p><p><strong>Conclusions: </strong>In this study, rivaroxaban is a clinically and economically superior alternative to warfarin. This research may catalyze further discussions with policymakers and industry partners to scale up the appropriate use of rivaroxaban in resource-constrained settings.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"565-574"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12307563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526685","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":"Immunosuppressant Use in Infective Endocarditis-Associated Glomerulonephritis: A Systematic Review.","authors":"Reem Sayad, Ahmed Saad Elsaeidy, Muhammed Edib Mokresh, Mohamed Mohamed Shawqi, Yasmine Adel Mohammed, Eslam A Hawash, Ahmed Mostafa Ali, Danisha Kumar, Mostafa G Aly","doi":"10.1007/s40261-025-01461-8","DOIUrl":"10.1007/s40261-025-01461-8","url":null,"abstract":"<p><strong>Background: </strong>Patients with infective endocarditis can develop various renal diseases, including infective endocarditis-associated glomerulonephritis. Antibiotics are essential for eradicating the infection. However, the prognosis for renal function remains poor. This systematic review examines the role of immunosuppressants in managing infective endocarditis-associated glomerulonephritis (GN).</p><p><strong>Methods: </strong>A comprehensive search was performed across four databases: PubMed, Scopus, MedLine, and Web of Science up to April 2024. We included studies that investigated patients with any type of GN due to infective endocarditis (IE) who were treated with immunosuppressants. Data extraction was conducted using a standardized sheet, and study quality was assessed using the Joanna Briggs Institute (JBI) critical appraisal tool.</p><p><strong>Results: </strong>The review incorporated 55 studies encompassing 84 cases, 65 of whom were male. The median age was 46.5 years. A total of 30 cases required kidney replacement therapy. Following immunosuppressive therapy, clinical improvement of IE was observed in 54 cases, while 9 patients experienced worsening conditions, 3 patients had no clinical change, and data were unavailable in 18 cases. Renal outcomes showed improvement in 67 patients, with 9 cases showing worsening conditions, 3 patients showing no change, 3 experiencing partial or residual impairment, and renal outcome was unavailable in 2 cases. A total of ten patients died, primarily owing to sepsis or infection-related complications (five cases), congestive or global heart failure (three cases), and renal failure with associated metabolic complications (two cases). Additional treatments included plasma exchange, with nine cases receiving plasmapheresis/plasma exchange. Of these, eight patients showed marked renal function improvement, and one patient showed partial improvement. Three patients also received intravenous immunoglobulin.</p><p><strong>Conclusions: </strong>Immunosuppressive therapy led to renal function improvement in the majority of cases, suggesting its potential benefit in managing infective endocarditis-associated glomerulonephritis. However, variability in response and significant mortality highlight the need for individualized treatment strategies and further research to optimize management.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"443-529"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12307529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667248","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":"Dronabinol Prescription Receipt and Refill Patterns in the US Military Health System.","authors":"Michael S Patzkowski, Maxwell Y Amoako, Christopher T Creedon, Michelle Miller, Germaine Herrera, Krista B Highland","doi":"10.1007/s40261-025-01463-6","DOIUrl":"10.1007/s40261-025-01463-6","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"531-535"},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616550","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":"SDZ-AFL: An Aflibercept Biosimilar.","authors":"Yahiya Y Syed","doi":"10.1007/s40261-025-01458-3","DOIUrl":"https://doi.org/10.1007/s40261-025-01458-3","url":null,"abstract":"<p><p>SDZ-AFL (SOK583A1; Afqlir^®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor. SDZ-AFL has been approved in the EU for the treatment of the same indications in adults as reference aflibercept: neovascular age-related macular degeneration (nAMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. SDZ-AFL has similar physicochemical and pharmacodynamic properties to those of reference aflibercept, and pharmacokinetic similarity has been demonstrated in patients with nAMD. SDZ-AFL demonstrated clinical efficacy equivalent to that of reference aflibercept in patients with nAMD and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of SDZ-AFL were similar to those of reference aflibercept. The role of reference aflibercept in the management of neovascular retinal diseases is well established, and SDZ-AFL provides an effective biosimilar alternative for patients requiring ophthalmic aflibercept therapy.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144697805","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-Effectiveness of Adding Dapagliflozin and Empagliflozin to Standard Treatment for Diabetic Kidney Disease in China.","authors":"Tingting Qiu, Ping Li, Dan Yan","doi":"10.1007/s40261-025-01462-7","DOIUrl":"https://doi.org/10.1007/s40261-025-01462-7","url":null,"abstract":"<p><strong>Background: </strong>Dapagliflozin and empagliflozin are emerging as promising treatment options for diabetic kidney disease (DKD).</p><p><strong>Objective: </strong>This study sought to evaluate the cost effectiveness of incorporating dapagliflozin and empagliflozin into the standard treatment for DKD in China.</p><p><strong>Methods: </strong>A Markov model was constructed to evaluate the cost-effectiveness of dapagliflozin and empagliflozin plus standard treatment versus standard treatment alone for DKD treatment from a healthcare perspective. Costs and utility data was obtained from published literatures within the Chinese context. The primary outcome included total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). GDP per capita of 2023 in China (¥89,358) was utilized as the willingness-to-pay threshold.</p><p><strong>Results: </strong>Compared to standard treatment alone, add-on therapy of dapagliflozin or empagliflozin resulted in a higher total cost than those solely receiving standard treatment (+¥19,203.56 and +¥9496.92, respectively). However, both dapagliflozin and empagliflozin also yielded more life-years (+1.72 vs. +1.40) and QALYs (+1.40 vs. +0.88). The ICER per life-year and ICER per QALY was ¥11,178.52 and ¥18,192.50 for dapagliflozin and ¥6773.10 and ¥10,811.64 for empagliflozin, respectively. The incremental net monetary benefit was ¥75,120.54 and ¥68,994.90 for dapagliflozin and empagliflozin, respectively. Sensitivity analysis supported the main findings of the base-case analysis as the cost-effectiveness of dapagliflozin or empagliflozin was sustained for most plausible ranges of parameter values.</p><p><strong>Conclusions: </strong>Considering that the ICER falls below the predefined willingness-to-pay threshold, incorporating dapagliflozin and empagliflozin into standard treatment for DKD is likely to be a cost-effective strategy in China.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625482","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}