Clinical Drug Investigation最新文献

{"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":"Same-Day Sedative and Night-Time Sleep Effects Following Combined Cannabinoid Formulations: A Randomised-Controlled Trial.","authors":"Andrea J Narayan, Brooke Manning, Blair Aitken, Luke A Downey, Amie C Hayley","doi":"10.1007/s40261-025-01455-6","DOIUrl":"10.1007/s40261-025-01455-6","url":null,"abstract":"<p><strong>Background and objectives: </strong>Cannabinoid treatments are commonly used for sleep conditions, but the direct sedating effects of daytime treatment consumption and indirect effects on night-time sleep are unclear. This study measures the direct effects of low-dose cannabinoid treatments on daytime sleepiness and potential indirect night-time sleep effects in healthy adult, novice cannabis users.</p><p><strong>Methods: </strong>Using a double-blind, randomised, placebo-controlled cross-over design, participants were orally administered a standardised dose of 1 mL oil containing THC:CBD ratios of either 1:1, 1:16 or a placebo over five weekly in-lab visits. Daytime sleepiness was measured at 40, 135 and 265 min post-dosing using the Karolinska Sleepiness Scale (KSS). Indirect night-time sleep effects on total sleep time (TST), sleep-onset latency (SOL), and number of awakenings after onset were measured using daily wrist-actigraphy and sleep-diary entries during the 7-day washout period between treatments.</p><p><strong>Results: </strong>Final analyses (N = 20) showed subjective sleepiness (KSS score) significantly increased (mean difference = 1.9, SE 0.25) from 40 min to 265 min post-treatment (p < 0.001). No significant differences were observed between treatments for KSS. Indirect sleep measures (TST, SOL, number of awakenings) showed no differences between treatments or over time (all p > 0.05).</p><p><strong>Conclusion: </strong>Daytime consumption of low-dose cannabinoid oils did not induce direct sleepiness or indirect night-time effects post-dosing among adults. Future studies would benefit from exploring pharmacokinetics and the possibility of treatment amplification of daytime fatigue, mood and cognitive changes to assist the development of therapeutic guidelines for safe daytime medical cannabis use.</p><p><strong>Anctr trial registration number: </strong>ACTRN12622001539729, 13 December 2022, prospectively registered.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"417-429"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339885","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":"Author's Reply to Perera et al.: A Commentary on \"An Early Cost-Utility Model of mRNA-Based Therapies for the Treatment of Methylmalonic and Propionic Acidemia in the United Kingdom\".","authors":"Pablo E Bretos-Azcona, Matthew Wallace, Murvin Jootun, E Veljanoska, Ion Agirrezabal, Agota Szende","doi":"10.1007/s40261-025-01443-w","DOIUrl":"10.1007/s40261-025-01443-w","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"435-438"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981360","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":"Comment on: \"An Early Cost-Utility Model of mRNA-Based Therapies for the Treatment of Methylmalonic and Propionic Acidemia in the United Kingdom\".","authors":"Sue Perera, Geetanjoli Banerjee, Vanja Sikirica, Eliza Kruger, Emily Combe, Caroline Barwood, Sofie Czarnota-Bojarski, Stephanie Grunewald, Sufin Yap","doi":"10.1007/s40261-025-01442-x","DOIUrl":"10.1007/s40261-025-01442-x","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"431-433"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255541/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969314","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":"Correction: Diagnosis and Management of Drug-Induced Interstitial Lung Disease in the context of Anti-Cancer Therapy: a Multidisciplinary Viewpoint by Portuguese Experts.","authors":"Mário Fontes E Sousa, Sérgio Campainha, Inês Dias Marques, Rui Dinis, João Rodrigues Inácio, João João Mendes, Rita Luís, Ana Magalhães Ferreira, Ricardo Racha-Pacheco, Rui Rolo, Gabriela Sousa, Paulo Cortes","doi":"10.1007/s40261-025-01427-w","DOIUrl":"10.1007/s40261-025-01427-w","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"439"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191568","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":"Early Cost-Effectiveness Analysis of Intra-articular Delivery of a PBAE-DEX Conjugate for Osteoarthritis in a UK Population.","authors":"Stefano Perni, Swathika Subburaman, Polina Prokopovich","doi":"10.1007/s40261-025-01446-7","DOIUrl":"10.1007/s40261-025-01446-7","url":null,"abstract":"<p><strong>Background: </strong>Osteoarthritis affects the cartilage tissue lining the joint. Current management plans often require intra-articular injections to relieve symptoms. This approach is hindered by the difficulty in localising the drug released in the synovial fluid into the cartilage surrounding the affected joint. Drug delivery systems have been developed to support cartilage drug uptake, potentially reducing the number of injections required. We developed an approach to drug localisation that exploits the highly electrostatically charged nature of cartilage constituents through binding biologically active molecules to positively charged polymers, and demonstrated high efficacy and safety in ex vivo tests.</p><p><strong>Objectives: </strong>We wanted to demonstrate the potential value of cartilage drug localisation technology beyond a clinical perspective, through health economic considerations and cost-effectiveness analysis, in order for these technologies to reach patients. We also conducted threshold analyses to determine, for different effectiveness levels of reducing injections, at what price the treatment will be cost-effective.</p><p><strong>Methods: </strong>We conducted an early health economic analysis of our technology, developing a cost-effectiveness model with a Markov structure. The analyses were conducted from an NHS perspective and the model was also used to estimate potential cost-effectiveness depending on target product profiles. The health states quality of life values were derived for a UK population through EQ-5D questionnaires collected and analysed in a Bayesian framework.</p><p><strong>Results: </strong>At the cost and effectiveness values set for the new treatment, it was cost-effective (increased costs of £16.28 and 0.001126 QALY per patient, resulting in an incremental cost-effectiveness ratios [ICER] of £14,459/QALY) but the results were highly uncertain (at a willingness-to-pay [WTP] of £20,000 and £30,000/QALY the probability of being cost-effective was 56.5% and 67.3%, respectively); while sensitivity analyses (one-way deterministic and probabilistic), within plausible ranges of model parameters, revealed that the efficacy of the technology in reducing intra-articular injections and its cost are the most influential parameters.</p><p><strong>Conclusions: </strong>Clinical trials are needed to validate the in vivo drug delivery system efficacy, but our study suggests that the system is likely to be a cost-effective use of NHS resources, also improving healthcare providers capacity.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"387-399"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983652","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":"Correction: Early Cost-Effectiveness Analysis of Intra-articular Delivery of a PBAE-DEX Conjugate for Osteoarthritis in a UK Population.","authors":"Stefano Perni, Swathika Subburaman, Polina Prokopovich","doi":"10.1007/s40261-025-01452-9","DOIUrl":"10.1007/s40261-025-01452-9","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"441"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215064","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":"Pharmacotherapy Considerations in Underweight Patients with Anorexia Nervosa: A Narrative Review.","authors":"William J Hayes, McCall Stegenga, John A Kappes, Joseph Berendse","doi":"10.1007/s40261-025-01457-4","DOIUrl":"10.1007/s40261-025-01457-4","url":null,"abstract":"<p><p>Given the severe and often enduring course of anorexia nervosa-where nearly half of patients may not reach full recovery-careful consideration of pharmacotherapy is essential, as pharmacokinetics can be significantly altered in the context of malnutrition, low body weight, and cachexia. Providers prescribing or preparing medications for patients who have anorexia nervosa as a comorbid condition need to consider what medications are unsafe for patients while treating these other disease states. The objective of this review article is to explore pharmacotherapeutic considerations for managing comorbid conditions in underweight patients with anorexia nervosa. This review will examine pharmacokinetic changes of underweight patients, assess each major organ system affected, and consider the implications of concomitant pharmacotherapy. Given the limited knowledge on the topic, the study applied broad criteria to include peer-reviewed research, expert commentary, and gray literature from 1969 to 2024. The search focused on pharmacotherapeutic considerations for underweight patients with anorexia nervosa, excluding studies solely addressing treatment. The search yielded 651 records, with 14 articles meeting the inclusion criteria after screening. Despite limited evidence, the review highlights literature on organ system complications in underweight patients with anorexia nervosa and offers considerations for medications on the basis of these affected systems. This article reviews treatment considerations, emphasizing the risks of medications such as bupropion and the need for further research to improve management strategies.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"373-386"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144483409","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}