{"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":""},"PeriodicalIF":2.9,"publicationDate":"2025-04-30","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}
Stevie Pope, Christopher Crean, Sarah Thrasher, Hanghang Xu, P J Chen, Lee Chen, DeeDee Hu, Erol Onel
{"title":"Correction: Comparison of Pharmacokinetics of Long-Acting Local Analgesics: CPL-01, a Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Exposure Compared with Liposomal Bupivacaine.","authors":"Stevie Pope, Christopher Crean, Sarah Thrasher, Hanghang Xu, P J Chen, Lee Chen, DeeDee Hu, Erol Onel","doi":"10.1007/s40261-025-01431-0","DOIUrl":"10.1007/s40261-025-01431-0","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"221"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11976360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572249","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}
Sylvia Hsu, Lawrence J Green, Mark G Lebwohl, Abby A Jacobson
{"title":"Summary of Research: Comparable Efficacy and Safety of Brodalumab in Obese and Nonobese Patients with Psoriasis: Analysis of Two Randomized Controlled Trials.","authors":"Sylvia Hsu, Lawrence J Green, Mark G Lebwohl, Abby A Jacobson","doi":"10.1007/s40261-025-01423-0","DOIUrl":"10.1007/s40261-025-01423-0","url":null,"abstract":"<p><p>Obesity is associated with increased psoriasis severity and reduced effectiveness of psoriasis treatments. This is a summary of a research article that reports a study evaluating the efficacy and safety of brodalumab (a subcutaneous injectable therapy) in participants with and without obesity who have moderate-to-severe psoriasis. Data were analyzed from two large, phase 3 clinical trials (AMAGINE-2 and AMAGINE-3) of participants with psoriasis who were treated with brodalumab or another subcutaneous injectable therapy, ustekinumab. After brodalumab treatment for 52 weeks, participants with obesity experienced similar rates of skin clearance to those without obesity (90% improvement: 88% versus 85%; 100% improvement: 65% versus 73%, respectively). Brodalumab safety profiles were generally similar between participants with and without obesity. This study demonstrated that brodalumab is effective and safe for treating moderate-to-severe psoriasis, regardless of obesity status.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"175-178"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11976330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742484","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}
Yue Liu, Xin Gao, Yang Li, Xuemei He, Zhe Shi, Ling Zhang, Yaolin Wang, Aixin Shi
{"title":"Effect of Food on the Pharmacokinetic Characteristics of a Single Oral Dose of D-1553, a Selective Inhibitor of KRAS<sup>G12C</sup>, in Healthy Chinese Subjects.","authors":"Yue Liu, Xin Gao, Yang Li, Xuemei He, Zhe Shi, Ling Zhang, Yaolin Wang, Aixin Shi","doi":"10.1007/s40261-025-01430-1","DOIUrl":"10.1007/s40261-025-01430-1","url":null,"abstract":"<p><strong>Background and objective: </strong>D-1553 (garsorasib) is a novel and selective oral KRAS<sup>G12C</sup> inhibitor. This study aims to evaluate the effect of food on the single-dose pharmacokinetics (PK) of D-1553 tablet in healthy Chinese subjects. Also the safety and tolerability of single-dose D-1553 in subjects are also evaluated.</p><p><strong>Methods: </strong>A randomized, open-label, single-dose, two-intervention (fed vs fasting), two-period, two-sequence crossover study was performed on 14 healthy Chinese subjects. Plasma concentrations of D-1553 were determined by the liquid chromatography-tandem mass spectrometry method. Safety evaluations were carried out during the study period. The main PK parameters of the two formulations of D-1553 were calculated by non-compartmental analysis using Phoenix WinNonlin (Version 8.3) software.</p><p><strong>Results: </strong>The geometric mean ratios (90% confidence interval [CI]) of AUC<sub>0-t</sub> and AUC<sub>0-∞</sub> in the high-fat meal condition versus the fasting condition were 86.19% (78.30%, 94.87%) and 83.30% (75.77%, 91.58%), respectively. The geometric mean ratio (90% CI) of C<sub>max</sub> values in high-fat meal condition to that observed in fasting condition were 109.74% (100.22%,120.15%). The p value of T<sub>max</sub> was 0.1484 (fed vs fasting). Two subjects (14.3%) reported 4 treatment-emergent adverse events (TEAEs) in the fasting condition, and no subjects reported TEAEs in the fed condition. All adverse reactions were mild and had recovered by the end of the study.</p><p><strong>Conclusion: </strong>The study indicated that a high-calorie and high-fat meal has no clinically relevant impact on the PK and bioavailability of D-1553 in healthy Chinese subjects. D-1553 was generally safe and well-tolerated under both fasting and fed conditions. The findings suggest that D-1553 could be administered orally with or without food.</p><p><strong>Clinical trials: </strong>ClinicalTrials.gov Identifer CTR20212761; registered on 4 Nov 2021.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"201-206"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656278","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":"Guanfacine Use in the ICU for Management of Sedation Weaning.","authors":"Young R Lee, Alayna Garza, Laureen Kiama","doi":"10.1007/s40261-025-01434-x","DOIUrl":"10.1007/s40261-025-01434-x","url":null,"abstract":"<p><p>Recent evidence highlights the increasing utilization of guanfacine in the intensive care unit. While dexmedetomidine is a widely used sedative and anti-anxiety agent in the intensive care unit, prolonged use can lead to withdrawal effects when attempting to reduce the dosage. This has generated interest in using guanfacine to manage agitation in patients being weaned off dexmedetomidine. Clonidine has been used for dexmedetomidine weaning, but its use has been associated with adverse cardiovascular events. Some observational studies and case reports have explored the use of guanfacine and have shown its benefits and tolerability for patients taking dexmedetomidine experiencing adverse effects. Guanfacine is increasingly being used in the intensive care unit instead of clonidine and is commonly prescribed for the management of withdrawal effects. While there are limited data from observational studies, it holds promise for future clinical research and broader adoption of guanfacine in the intensive care unit.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"169-173"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613208","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}
Mitchell L Doucette, Dipak Hemraj, D Luke Macfarlan, Junella Chin, Emily Fisher
{"title":"The Cost Effectiveness of Adjunctive Medical Cannabis Therapy in the Treatment of Moderate Post-Traumatic Stress Disorder.","authors":"Mitchell L Doucette, Dipak Hemraj, D Luke Macfarlan, Junella Chin, Emily Fisher","doi":"10.1007/s40261-025-01424-z","DOIUrl":"10.1007/s40261-025-01424-z","url":null,"abstract":"<p><strong>Introduction: </strong>Research on the benefits of medical cannabis (MC) is emerging and supports its use as a treatment for post-traumatic stress disorder (PTSD). This study aimed to evaluate the cost effectiveness of MC as an adjunctive therapy for moderate PTSD under varying reimbursement scenarios.</p><p><strong>Methods: </strong>A cost-utility analysis was conducted from the US payor perspective, using pricing data from the largest multi-state MC producer and established literature on standard PTSD treatments. We analyzed eight MC product types: dried flower, oral solutions, tablets, and edibles, each available in low/moderate (LM) and high-cost formulations. Incremental cost-utility ratios (ICURs) were calculated for these products across reimbursement levels of 100%, 75%, 50%, and 25%. Probabilistic sensitivity analyses with 10,000 Monte Carlo simulations were conducted to assess cost-effectiveness acceptability across willingness-to-pay (WTP) thresholds of $0-$100,000 per quality-adjusted life year (QALY) gained.</p><p><strong>Results: </strong>Non-flower MC products (edibles, oral solutions, and tablets) consistently demonstrated cost-effectiveness under a WTP threshold of $50,000, even at 100% reimbursement. Dried flower products, while less cost effective due to higher costs, achieved cost effectiveness under 75% or lower reimbursement levels for LM cost formulations. Sensitivity analyses confirmed robust ICURs for non-flower products, with narrower variability compared to dried flower products.</p><p><strong>Conclusions: </strong>Medical cannabis products, particularly non-flower formulations, represent a cost-effective adjunctive therapy for moderate PTSD under various reimbursement scenarios. This analysis underscores the importance of evidence-based reimbursement policies to improve patient access to cost-effective treatments while ensuring financial sustainability for payors.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"207-220"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491197","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":"Frequency of Acute Kidney Injury After the Initiation of Vitamin D Receptor Activators: A Multicenter Retrospective Observational Study.","authors":"Masanori Nakanishi, Tomohiro Mizuno, Shinya Sakai, Daiki Hira, Takenao Koseki, Takeshi Matsubara, Hideki Yokoi, Motoko Yanagita, Tomohiro Terada, Shigeki Yamada, Naotake Tsuboi","doi":"10.1007/s40261-025-01429-8","DOIUrl":"10.1007/s40261-025-01429-8","url":null,"abstract":"<p><strong>Background and objectives: </strong>Vitamin D receptor activators (VDRAs) are widely used in patients with osteoporosis; however, the frequency of acute kidney injury (AKI) due to VDRAs is unclear. This study aimed to investigate whether the incidence of AKI after VDRA initiation differed among patients with different renal functions.</p><p><strong>Methods: </strong>The medical records of Japanese patients who were newly prescribed with VDRAs for osteoporosis at the Fujita Health University Hospital or Kyoto University Hospital between April 2012 and March 2022 were retrospectively reviewed in this study. The RIFLE (Risk, Injury, Failure, Loss of function, End-stage kidney disease) criteria were used to assess the incidence of AKI within 7 days after initiation of VDRA therapy. Additionally, the AKI algorithm was used to assess the incidence of AKI from 8 to 365 days after initiation of VDRA therapy.</p><p><strong>Results: </strong>The incidence of AKI, as defined by the RIFLE criteria, was significantly higher in patients with normal renal function or end-stage renal failure than in those with mild renal decline (p < 0.05); the incidence of AKI, defined using the AKI algorithm, showed a similar trend. We found that the lack of serum calcium level monitoring before the initiation of VDRAs might be a risk factor for AKI defined by the RIFLE criteria (odds ratio = 2.004, p = 0.096).</p><p><strong>Conclusions: </strong>The incidence of AKI after the initiation of VDRA therapy was high, even if renal function was normal. Thus, our results suggest that monitoring serum calcium levels before the initiation of VDRA therapy is necessary, regardless of renal function.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"191-199"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613770","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}
Cheng Cui, Xiaoye Niu, Haiyan Li, Ruijie Zhang, Lei Geng, Wei Lin, Zichen Liu, Xiaohong Wang, Dongyang Liu
{"title":"Pharmacokinetics, Pharmacodynamics, and Safety Evaluation of the Novel HIF-PH Inhibitor Enarodustat: An Open-Label Phase I Study in Healthy Chinese Participants.","authors":"Cheng Cui, Xiaoye Niu, Haiyan Li, Ruijie Zhang, Lei Geng, Wei Lin, Zichen Liu, Xiaohong Wang, Dongyang Liu","doi":"10.1007/s40261-025-01428-9","DOIUrl":"10.1007/s40261-025-01428-9","url":null,"abstract":"<p><strong>Background and objectives: </strong>Enarodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor. We evaluated the pharmacokinetics, pharmacodynamics, and safety profile of domestic enarodustat (SAL-0951) and analyzed the influence of ethnic factors.</p><p><strong>Methods: </strong>In this phase I study, healthy Chinese participants received single and multiple oral doses (1, 5, and 15 mg) of SAL-0951 while in a fasted state. We monitored the pharmacokinetics, pharmacodynamics, and safety characteristics and analyzed the impact of ethnicity on pharmacokinetic characteristics.</p><p><strong>Results: </strong>In total, 33 healthy Chinese participants were enrolled; the mean age was 31.2 ± a standard deviation of 5.5 years. After single doses of 1, 5, and 15 mg were administered under fasted conditions, SAL-0951 was rapidly absorbed. Mean maximum plasma concentration and area under the plasma concentration-time curve from time 0 to the last quantifiable concentration increased dose proportionately from 0.14 to 2.54 μg/mL and from 0.63 to 9.50 h × μg/mL, respectively. The elimination half-life was 6.13, 6.32, and 6.74 h, respectively, in these three groups, and the mean value of apparent clearance ranged from 1.64 to 1.89 L/h. SAL-0951 was excreted mostly as the parent compound. It reached a stable concentration after 5 days of multiple-dose administration. We observed no drug accumulation or time-dependent pharmacokinetic characteristics and no significant difference in pharmacokinetic characteristics between Chinese and Japanese participants.</p><p><strong>Conclusion: </strong>SAL-0951 was safe and well tolerated in healthy Chinese participants and had a linear pharmacokinetic profile. We found no ethnic differences in the pharmacokinetic characteristics of the drug between Chinese and Japanese populations.</p><p><strong>Clinical trial registration: </strong>Registered at Chinadrugtrials.org.cn, registration number CTR2020245.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"179-189"},"PeriodicalIF":2.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613276","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":"Tebentafusp Versus Nivolumab Plus Ipilimumab for Metastatic Uveal Melanoma: An E-Value Sensitivity Analysis Assessing Effect of Unmeasured Confounders on Observational Associations.","authors":"Na Zhang, Yu-Wei Qiao, Dan Su, Guo Yu, Guo-Fu Li","doi":"10.1007/s40261-025-01422-1","DOIUrl":"10.1007/s40261-025-01422-1","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"165-168"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440022","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":"Age-Specific Plasma Concentration, Efficacy and Safety of Ciprofol (Cipepofol) for Induction and Maintenance of General Anesthesia in Pediatric Patients Undergoing Elective Surgery: A Single-Arm Prospective, Pragmatic Trial.","authors":"Zheng Chen, Tuochao Peng, Shuibing Zhang, Qiaoyun Yang, Shuangquan Qu, Yong Cao, Junxia Chen, Yiwei Mao","doi":"10.1007/s40261-025-01425-y","DOIUrl":"10.1007/s40261-025-01425-y","url":null,"abstract":"<p><strong>Background and objective: </strong>Ciprofol (Cipepofol) currently has well-established clinical research data in adult Chinese patients, but there is a lack of reliable research data in pediatric patients. This study aimed to assess the age-specific plasma concentration, efficacy and safety profiles of cipepofol in pediatric patients aged 2-17 years during the induction and maintenance of general anesthesia.</p><p><strong>Methods: </strong>This was a single-arm, open-label, prospective, pragmatic study conducted in the Hunan Children's Hospital from May 10, 2023 to August 25, 2023, that involved pediatric patients undergoing elective surgery after the induction and maintenance of general anesthesia. Cipepofol was administered as an intravenous bolus injection of 0.6 mg/kg (patients aged 2-11 years) or 0.5 mg/kg (12-17 years) for induction, followed by an initial maintenance infusion of 1.2 mg/kg/h or 1.4 mg/kg/h, respectively. The primary endpoint-plasma concentration of cipepofol was measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. The age-specific plasma concentration, efficacy and safety profiles of cipepofol are summarized using descriptive statistics.</p><p><strong>Results: </strong>All 38 enrolled patients completed the study, including 14 children aged 2-5 years, 12 children aged 6-11 years and 12 children aged 12-17 years. The trends of plasma concentration variations among patients in the three age groups were largely consistent. The success rates of anesthesia induction and maintenance for patients in the three groups were both 100%, and no patients required rescue medication. Children aged 2 to 5 years had the longest median durations of successful anesthetic induction (1.1 min) and eyelash reflection disappearance (1.2 min), while the median durations for patients aged 6-11 years and those aged 12-17 years (0.5 and 0.5 min) were similar. The median time to extubation and length of stay in the post-anesthesia care unit tended to be the longest in children aged 6-11 years (23.5 and 30.0 min) but were comparable for those aged 2-5 years (10.5 min and 20.0 min) and 12-17 years (11.0 and 20.0 min). The median time to full alertness tended to decrease with increasing age (33.7 vs 25.8 vs 22.7 min). A total of 4 (10.5%) patients experienced treatment-emergent adverse events in those aged 2-5 years or 12-17 years, with a severity of grade 1 or grade 2.</p><p><strong>Conclusion: </strong>Cipepofol had good safety for the induction and maintenance of general anesthesia in pediatric patients aged over 2 years. The dosing regimen with an intravenous bolus injection of 0.5 mg/kg for induction, followed by an initial maintenance infusion of 1.4 mg/kg/h was adequate for children aged 12-17 years; age-specific dose regimen for children aged 2-11 years should be improved by further large-scale prospective studies.</p><p><strong>Trial registration: </strong>ChiCTR2400085640, July","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"137-150"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439952","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}