Clinical therapeutics最新文献

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Assessing the Role of Cannabis in Managing Spasticity in Multiple Sclerosis: A Systematic Review and Meta-Analysis. 评估大麻在多发性硬化症痉挛管理中的作用:一项系统综述和荟萃分析。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-08-01 DOI: 10.1016/j.clinthera.2025.07.009
Yazan AlHabil, Liza Saadeddin, Hana Ishkirat, Mariam Alqam, Obada Hossoon, Seema Hameedi, Hamzeh Yacoub, Diana Yasin, Anita Bahbah, Majd Oweidat, Hanadi Mosa
{"title":"Assessing the Role of Cannabis in Managing Spasticity in Multiple Sclerosis: A Systematic Review and Meta-Analysis.","authors":"Yazan AlHabil, Liza Saadeddin, Hana Ishkirat, Mariam Alqam, Obada Hossoon, Seema Hameedi, Hamzeh Yacoub, Diana Yasin, Anita Bahbah, Majd Oweidat, Hanadi Mosa","doi":"10.1016/j.clinthera.2025.07.009","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.009","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a complex, heterogeneous disease, and its management remains challenging due to varying symptoms and patient responses to treatments. While injectable therapies like glatiramer acetate and beta-interferon are common, they have limitations such as side effects and varying efficacy. Cannabis has garnered attention as a potential alternative treatment, particularly for symptoms like spasticity and pain.</p><p><strong>Objective: </strong>This study aims to evaluate the efficacy of cannabis-based therapies for managing MS-related spasticity.</p><p><strong>Methods: </strong>Nine clinical trials involving 2544 MS patients were included, with studies conducted between 2003 and 2021 across multiple countries. Cannabinoid therapies studied included whole-plant extracts, oils, and smoked cannabis containing delta-9-tetrahydrocannabinol and/or cannabidiol. Spasticity was assessed using standardized scales, including the Ashworth scale (AS), visual analog scale, and numeric rating scale (NRS). Effect sizes were pooled using random or fixed effects models, and heterogeneity and publication bias were evaluated using I², Tau², and funnel plots.</p><p><strong>Results: </strong>The overall meta-analysis revealed a standardized mean difference (MD) of 39.19 (95% CI: 34.32-44.05) in spasticity scores, indicating notable improvement post-treatment. Subgroup analyses showed a MD of 20.36 (95% CI: 20.35-20.37) for AS and 1.18 (95% CI: 1.16-1.21) for NRS. However, substantial heterogeneity (I² = 100% for overall and AS analyses; 91% for NRS) and asymmetry in funnel plots suggest possible publication bias and study variability. Short-term studies demonstrated modest changes (MD = 4.53, 95% CI: -0.06 to 9.12), while long-term studies yielded larger effects (MD = 75.81, 95% CI: 66.39-85.22). Adverse events were generally mild, including dizziness and dry mouth.</p><p><strong>Conclusion: </strong>Cannabis-based therapies are associated with clinically meaningful improvements in MS-related spasticity, particularly over longer durations. Despite the promising findings, high heterogeneity and suspected bias necessitate caution. Further high-quality randomized trials with standardized protocols and comprehensive safety assessments are warranted to validate efficacy and long-term outcomes.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of Older Patients with Acute Pain: A Complex Milieu 老年急性疼痛患者的治疗:复杂的环境。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-07-18 DOI: 10.1016/j.clinthera.2025.06.013
Paul Beninger MD, MBA
{"title":"Treatment of Older Patients with Acute Pain: A Complex Milieu","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.06.013","DOIUrl":"10.1016/j.clinthera.2025.06.013","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 533-535"},"PeriodicalIF":3.6,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Multilateral Qualitative Study of Perspectives on Enhancing Clinical Trial Diversity Among Historically Underrepresented Groups. 在历史上代表性不足的群体中加强临床试验多样性的多边定性研究。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-07-07 DOI: 10.1016/j.clinthera.2025.06.006
Matthew J DePuccio, Daniel Torrez, Elizabeth Hsu, Elizabeth B Lynch, Rachel S Bergmans, Robert J McCarthy
{"title":"A Multilateral Qualitative Study of Perspectives on Enhancing Clinical Trial Diversity Among Historically Underrepresented Groups.","authors":"Matthew J DePuccio, Daniel Torrez, Elizabeth Hsu, Elizabeth B Lynch, Rachel S Bergmans, Robert J McCarthy","doi":"10.1016/j.clinthera.2025.06.006","DOIUrl":"10.1016/j.clinthera.2025.06.006","url":null,"abstract":"<p><strong>Purpose: </strong>Clinical trial enrollment among underrepresented patient populations remains a critical challenge in biomedical research. This study was conducted for a clinical trial designed to identify biomarkers that would help predict the transition from acute to chronic pain. Specifically, the purpose of this study was to understand the perspectives of multiple stakeholders to characterize the factors that contribute to underrepresented patients' decisions to participate in the trial and inform actionable strategies that can improve trial recruitment and retention.</p><p><strong>Methods: </strong>Forty-seven participants from a Midwestern US city participated in one-on-one interviews, including 26 patients, 11 healthcare providers and staff, and 10 community-based healthcare organization employees. Interviews were recorded, transcribed, and analyzed inductively by an experienced health services researcher, with results organized into key themes.</p><p><strong>Findings: </strong>Analysis revealed six major themes about what influences underrepresented patients' participation: Practical barriers to participation, historical context and past experiences impacting research apprehensiveness, communication gaps, and information needs, adapting protocols to address participation barriers, opportunities for building rapport and trust, and motivations and perceived benefits of participating. Common barriers included logistical challenges (eg, distance to medical center), distrust toward medical institutions, and poor communication about clinical trial opportunities, while efforts to intentionally build rapport and trust with patients and community members were identified as opportunities to improve recruitment.</p><p><strong>Implications: </strong>The results of this study demonstrated that the barriers and enablers to underrepresented patient participation in a clinical trial were diverse and included both systemic and individual factors. These findings were supported across participant groups, suggesting that the engagement of multiple perspectives in the design and implementation of clinical trials play a role in mitigating barriers to clinical trial participation and enhancing participant diversity.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response to Letter Regarding Article “Epidemiology and Economic Burden of Diagnosed Congenital Cytomegalovirus Infection in the First 2 Years of Life among Commercially Insured and Medicaid-Insured Individuals in the United States” 关于“美国商业参保和医疗保险参保人群出生头2年确诊先天性巨细胞病毒感染的流行病学和经济负担”一文的回复。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-26 DOI: 10.1016/j.clinthera.2025.06.004
John Diaz-Decaro PhD, MS, Philip O. Buck PhD, MPH
{"title":"Response to Letter Regarding Article “Epidemiology and Economic Burden of Diagnosed Congenital Cytomegalovirus Infection in the First 2 Years of Life among Commercially Insured and Medicaid-Insured Individuals in the United States”","authors":"John Diaz-Decaro PhD, MS,&nbsp;Philip O. Buck PhD, MPH","doi":"10.1016/j.clinthera.2025.06.004","DOIUrl":"10.1016/j.clinthera.2025.06.004","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 659-660"},"PeriodicalIF":3.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
IMAAVY (nipocalimab-aahu)
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-24 DOI: 10.1016/j.clinthera.2025.06.002
Paul Beninger MD, MBA
{"title":"IMAAVY (nipocalimab-aahu)","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.06.002","DOIUrl":"10.1016/j.clinthera.2025.06.002","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 661-662"},"PeriodicalIF":3.6,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Cost-Effectiveness Analysis of Radiofrequency Ablation Compared to Hepatic Resection for Resectable Small Hepatocellular Carcinoma in Thailand 泰国射频消融与肝切除治疗可切除小肝癌的成本-效果分析。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-20 DOI: 10.1016/j.clinthera.2025.05.014
Nutcha Pinjaroen MD , Wantanee Kulpeng MSc , Pisit Tangkijvanich MD , Taya Kitiyakara MD
{"title":"The Cost-Effectiveness Analysis of Radiofrequency Ablation Compared to Hepatic Resection for Resectable Small Hepatocellular Carcinoma in Thailand","authors":"Nutcha Pinjaroen MD ,&nbsp;Wantanee Kulpeng MSc ,&nbsp;Pisit Tangkijvanich MD ,&nbsp;Taya Kitiyakara MD","doi":"10.1016/j.clinthera.2025.05.014","DOIUrl":"10.1016/j.clinthera.2025.05.014","url":null,"abstract":"<div><h3>Background</h3><div>Hepatocellular carcinoma (HCC) is a leading cause of cancer death in Thailand. For early-stage HCC patients with preserved liver function, hepatic resection (HR) or radiofrequency ablation (RFA) are considered curative options. RFA is suitable for small tumors, ideally ≤3 cm and up to ≤5 cm. and can be performed in patients who are unfit for surgery. However, the cost of ablative devices like the RFA electrode is not covered by the National Health Security Office (NHSO), limiting access for many patients. Thus, this study evaluates the cost-effectiveness of RFA compared to HR for single resectable HCC in Thailand.</div></div><div><h3>Methodology</h3><div>A cost-utility analysis using a Markov model was conducted from a societal perspective, simulating a cohort of 40-year-old patients with compensated cirrhosis (Child-Pugh A or B) and resectable HCC. Two patient subgroups were compared: those with single HCC sized 3.1-5 cm and those with single HCC ≤3 cm. Costs and outcomes were assessed over a lifetime horizon and measured in quality-adjusted life years (QALYs), with a 3% annual discount rate applied. Data sources included systematic reviews, national databases, and local hospitals.</div></div><div><h3>Results</h3><div>For tumors ≤3 cm, RFA proved more cost-effective than HR, with an incremental cost-effectiveness ratio (ICER) of THB 11,015 (USD 350) per QALY gained, significantly below the Thai threshold of THB 160,000 (USD 5,079) per QALY gained. RFA provided 7.55 QALYs versus 5.92 QALYs for HR, with an additional lifetime cost of THB 24,922 (USD 791)per patient. The discount rate and cost of follow-up significantly impacted the ICER. For tumors 3.1–5 cm, HR was more effective (1.25 QALYs) and costly (THB 21,294 or USD 676) than RFA, making HR a favorable option.</div></div><div><h3>Conclusion</h3><div>RFA should be considered a primary treatment for HCC ≤3 cm in Thailand, with policy changes to support device reimbursement. For HCCs sized 3.1–5 cm, HR remains the preferred treatment due to better survival outcomes and cost-effectiveness unless surgery is not feasible.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 602-609"},"PeriodicalIF":3.6,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Indirect Comparison of Maralixibat and Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis. 马拉利西他与奥维西他治疗进行性家族性肝内胆汁淤积症的间接比较。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-06-20 DOI: 10.1016/j.clinthera.2025.05.011
Guy Lacey, Toby Gosden, Oliver Darlington, Elise Evers, Robin Howard, Lucia Quadrado
{"title":"Indirect Comparison of Maralixibat and Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis.","authors":"Guy Lacey, Toby Gosden, Oliver Darlington, Elise Evers, Robin Howard, Lucia Quadrado","doi":"10.1016/j.clinthera.2025.05.011","DOIUrl":"10.1016/j.clinthera.2025.05.011","url":null,"abstract":"<p><strong>Purpose: </strong>Recent clinical trials provide evidence of the efficacy and safety of 2 ileal bile acid transporter inhibitors, maralixibat and odevixibat, for the treatment of children with progressive familial intrahepatic cholestasis (PFIC). However, no head-to-head trial currently exists assessing the efficacy of these 2 treatments. The objective of this study was to generate estimates of comparative efficacy and safety between maralixibat and odevixibat to inform optimal practices for the treatment of children with PFIC.</p><p><strong>Methods: </strong>Two phase 3 randomized placebo-controlled trials, MARCH-PFIC (maralixibat: n = 16; placebo: n = 19) and PEDFIC-1 (odevixibat: n = 42; placebo: n = 20), were included in an indirect treatment comparison (ITC) anchored by the placebo arms of each trial. Using patient-level data from MARCH-PFIC and published aggregate data from PEDFIC-1, we generated estimates of comparative efficacy for endpoints that were consistent between trials, including the proportion of patients achieving a serum bile acid (sBA) response and change from baseline in sBA concentration.</p><p><strong>Findings: </strong>Comparisons of the proportion of sBA responders indicated that maralixibat was significantly more efficacious than odevixibat (120 µg/kg), with an estimated treatment difference of 32.3% (95% CI, 1.1% to 63.4%, P = 0.043). In addition, point estimates for change from baseline in sBA concentration and total bilirubin trended in favor of maralixibat. These findings were robust to adjustments for imbalances in patient demographic characteristics between trials. No statistically significant differences were observed for alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase. The safety profiles of maralixibat and odevixibat were comparable, although adverse events associated with maralixibat were typically milder than those with odevixibat (mild: 75% vs 45%; moderate: 25% vs 31%; severe: 0% vs 7%).</p><p><strong>Implications: </strong>These findings suggest that maralixibat provides additional clinical benefit for children with PFIC compared with odevixibat in terms of increasing the proportion of sBA responders. Further studies are needed to compare the ability of maralixibat and odevixibat to reduce pruritus and improve long-term outcomes, including patients' quality of life.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of Loading Dose Adherence and Long-term Anti-VEGF Persistence on Diabetic Macular Edema Outcomes in a Korean Cohort Study 韩国队列研究中负荷剂量依从性和长期抗vegf持久性对糖尿病黄斑水肿结局的影响
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-20 DOI: 10.1016/j.clinthera.2025.05.010
Jihoo Shin , Jonghyun Jeong , Kyu-Nam Heo , Jaekyu Shin , Ju-Yeun Lee
{"title":"Impact of Loading Dose Adherence and Long-term Anti-VEGF Persistence on Diabetic Macular Edema Outcomes in a Korean Cohort Study","authors":"Jihoo Shin ,&nbsp;Jonghyun Jeong ,&nbsp;Kyu-Nam Heo ,&nbsp;Jaekyu Shin ,&nbsp;Ju-Yeun Lee","doi":"10.1016/j.clinthera.2025.05.010","DOIUrl":"10.1016/j.clinthera.2025.05.010","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the impact of adherence to the initial loading dose (LD) and 1-year persistence of anti-vascular endothelial growth factor (anti-VEGF) therapy on treatment failure in diabetic macular edema (DME).</div></div><div><h3>Methods</h3><div>This retrospective cohort study included patients receiving intravitreal anti-VEGF injections for DME between 2017 and 2021. Patients with prior anti-VEGF treatments or alternative therapies within one year before the index date were excluded. LD adherence was defined as completing three injections within 63 days of treatment initiation. Treatment failure was defined as the first occurrence of alternative treatments post-index date. Multivariable Cox proportional hazards models were performed.</div></div><div><h3>Findings</h3><div>Among 2,239 patients, the persistence rates of anti-VEGF therapy were 45.2%, 24.1%, and 16.8% at 1, 2, and 3 years, respectively. LD adherence was observed in 75.5% of patients. Compared to the LD adherent group, the LD incomplete group had a significantly higher risk of treatment failure (HR = 1.91; 95% CI: 1.06–3.43). However, extending the LD interval up to 180 days did not significantly impact treatment failure (HR = 1.04, 95% CI: 0.59–1.83; <em>P</em> = 0.90). Patients who discontinued treatment within the first year exhibited a 1.62-fold higher risk of treatment failure at three years (HR = 1.62; 95% CI: 1.01–2.60).</div></div><div><h3>Implications</h3><div>Adherence to the initial LD and sustained anti-VEGF therapy are crucial for reducing treatment failure risk in DME patients. Importantly, minor deviations from the standard LD schedule, with intervals extending to 180 days, may not adversely affect the treatment failure. These findings highlight the need for strategies to enhance patient adherence while individualized scheduling flexibility.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 566-571"},"PeriodicalIF":3.6,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Efficacy of Grapefruit Juice Combined With Low-Dose Venetoclax in AML Patients Ineligible for Intensive Chemotherapy 葡萄柚汁联合低剂量Venetoclax治疗不适合强化化疗的AML患者的安全性和有效性。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-13 DOI: 10.1016/j.clinthera.2025.05.008
Danchen Meng , YuXin Li , Min Ruan , ZhengFeng Hou , Xinyao Liu , Wei Wu , Jian Ge , Zhengqi Huang , Jichun Yang , Zhangbiao Long
{"title":"Safety and Efficacy of Grapefruit Juice Combined With Low-Dose Venetoclax in AML Patients Ineligible for Intensive Chemotherapy","authors":"Danchen Meng ,&nbsp;YuXin Li ,&nbsp;Min Ruan ,&nbsp;ZhengFeng Hou ,&nbsp;Xinyao Liu ,&nbsp;Wei Wu ,&nbsp;Jian Ge ,&nbsp;Zhengqi Huang ,&nbsp;Jichun Yang ,&nbsp;Zhangbiao Long","doi":"10.1016/j.clinthera.2025.05.008","DOIUrl":"10.1016/j.clinthera.2025.05.008","url":null,"abstract":"<div><h3>Purpose</h3><div>Venetoclax in combination with hypomethylating agents (HMAs) has become the standard treatment for acute myeloid leukemia (AML) patients ineligible for intensive chemotherapy. However, its high cost limits its accessibility in low- and middle-income countries. This study aims to evaluate the efficacy and safety of grapefruit juice combined with low-dose venetoclax and azacitidine as a feasible cost-reduction strategy.</div></div><div><h3>Methods</h3><div>This prospective single-center study included 44 newly diagnosed elderly or unfit AML patients treated at our hospital between December 2020 and May 2024. Patients were assigned to two cohorts in parallel: 34 patients received standard-dose venetoclax combined with azacitidine (cohort 1), whereas 10 patients received low-dose venetoclax combined with grapefruit juice and azacitidine (cohort 2). The response to treatment, overall survival (OS), and progression-free survival (PFS) were evaluated. The peak venetoclax concentration (C<sub>max</sub>) and side effects of the patients were also monitored.</div></div><div><h3>Findings</h3><div>The median age of participants was 67.5 years (25 males and 19 females). The overall response rate (ORR) after the first treatment cycle was 85.3% in cohort 1 and 100% in cohort 2 (<em>P</em> = 0.5730), and the best ORR was 91.2% in cohort 1 and 100% in cohort 2 (<em>P</em> &gt; 0.9999). The median OS was 9 months in cohort 1 and 8.15 months in cohort 2 (<em>P</em> = 0.7103). The median PFS was 7 months in cohort 1 and 6.15 months in cohort 2 (<em>P</em> = 0.7068). The median Cmax of venetoclax in the whole cohort was 1664 ng/mL, with no significant difference between groups (<em>P</em> = 0.1614), and no significant correlation observed between venetoclax Cmax and age (<em>P =</em> 0.4575). The most common adverse events were thrombocytopenia, anemia, and neutropenia.</div></div><div><h3>Implications</h3><div>The combination of grapefruit juice with low-dose venetoclax demonstrates comparable efficacy and safety to the standard-dose regimen, while achieving a 75% reduction in drug costs. This approach offers a cost-effective treatment option for AML patients in resource-limited settings. Further large-scale, multicenter studies are required to validate the clinical feasibility of this regimen.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 595-601"},"PeriodicalIF":3.6,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cabotegravir Plus Rilpivirine Injection for Virally Suppressed Persons with HIV-1 infection: A Systematic Review and Meta-Analysis of Randomized Controlled Trials 卡波特韦加利匹韦林注射液治疗病毒抑制HIV-1感染者:随机对照试验的系统评价和荟萃分析。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-06-13 DOI: 10.1016/j.clinthera.2025.05.015
Erick Wesley Hedima B.Pharm, M.Pharm , John David Ohieku PharmD, MSc, PhD , Abdulrahman Nasir B.Pharm, MSc , Yahaya Mohammed Katagum B.Pharm, MSc, PhD
{"title":"Cabotegravir Plus Rilpivirine Injection for Virally Suppressed Persons with HIV-1 infection: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","authors":"Erick Wesley Hedima B.Pharm, M.Pharm ,&nbsp;John David Ohieku PharmD, MSc, PhD ,&nbsp;Abdulrahman Nasir B.Pharm, MSc ,&nbsp;Yahaya Mohammed Katagum B.Pharm, MSc, PhD","doi":"10.1016/j.clinthera.2025.05.015","DOIUrl":"10.1016/j.clinthera.2025.05.015","url":null,"abstract":"<div><h3>Purpose</h3><div>This study evaluated the efficacy and safety of cabotegravir/rilpivirine long-acting formulation compared to oral standard of care at 48 and 52 weeks.</div></div><div><h3>Method</h3><div>We conducted an electronic search (2005–2024) across databases for articles comparing the safety and efficacy of long-acting cabotegravir/rilpivirine with oral triple ART regimens. We analyzed efficacy and safety (treatment discontinuation and adverse effects). We used proportions of participants maintaining viral suppression, experiencing adverse drug effects or discontinuing treatment due to trial regimen, risk ratios, and 95% confidence intervals for pooled estimates.</div></div><div><h3>Findings</h3><div>Five RCTs with 2215 participants were analyzed, with 1390 receiving cabotegravir/rilpivirine injections. The analysis found long-acting cabotegravir/rilpivirine as effective as oral ART for viral load suppression (RR [<em>P = 0.</em>23, 0.99 95% CI; 0.97–1.01], <em>I<sup>2</sup> =</em> 0%) up to 52 weeks. However, more adverse effects were reported with the oral treatment [RR 1.32 (95% CI; 1.12–1.54), <em>I<sup>2</sup> =</em> 56%]. Pooled reports showed a significant an increased risk of treatment withdrawal in the oral group, [RR 3.61 (95% CI; 0.87–14.98), <em>I<sup>2</sup> =</em> 53</div></div><div><h3>Implication</h3><div>Findings from this meta-analysis emphasised the efficacy and safety of Cabotegravir/rilpivirine long-acting formulation in providing long-term maintenance of viral load suppression in HIV-1 infection with a tolerable safety profile.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 649-656"},"PeriodicalIF":3.6,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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