Clinical therapeutics最新文献

{"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}

{"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}

{"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}

{"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}

{"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_max) 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}

{"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>I² =</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>I² =</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>I² =</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}

{"title":"Critical Insights Into Epidemiology and Economic Burden of Diagnosed Congenital Cytomegalovirus Infection in the First 2 Years of Life","authors":"Fathimathul Henna ,&nbsp;Zaryab Bacha ,&nbsp;Mahnoor Qasim ,&nbsp;Arooba Khitab","doi":"10.1016/j.clinthera.2025.05.005","DOIUrl":"10.1016/j.clinthera.2025.05.005","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 657-658"},"PeriodicalIF":3.6,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293436","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}

{"title":"Dexmedetomidine-Propofol Versus Propofol Alone for Sedation in Upper Gastrointestinal Endoscopic Ultrasound: A Randomized Comparative Study","authors":"Yuanming Liu MM ,&nbsp;Yi Shen MM ,&nbsp;Hai Zhong BM","doi":"10.1016/j.clinthera.2025.05.013","DOIUrl":"10.1016/j.clinthera.2025.05.013","url":null,"abstract":"<div><h3>Purpose</h3><div>Upper gastrointestinal endoscopic ultrasonography (EUS) necessitates well-balanced sedation to ensure patient safety while optimizing procedural conditions. This study evaluates the safety and efficacy of dexmedetomidine-propofol versus propofol-only sedation in terms of respiratory safety, sedation quality, and recovery outcomes.</div></div><div><h3>Methods</h3><div>This prospective randomized controlled trial enrolled 145 patients undergoing lower esophageal or gastric EUS from January 2022 to May 2023. All participants received standardized premedication with midazolam and tetracaine gel for mucosal topicalization. Participants were randomized into two groups: dexmedetomidine-propofol (n = 72) and propofol-only (n = 73). Continuous variables were analyzed using independent t-tests, and categorical data were compared with chi-square tests, with statistical significance set at <em>P &lt;</em> 0<em>.</em>05.</div></div><div><h3>Findings</h3><div>No significant difference was observed in patient satisfaction (<em>P</em> = 0.717), but endoscopist satisfaction was significantly higher in the dexmedetomidine-propofol group (<em>P &lt;</em> 0<em>.</em>05). This group also showed significantly fewer midazolam rescue doses, fewer respiratory adverse events, and reduced intra-procedural patient movement and cough reflexes (all <em>P &lt;</em> 0<em>.</em>05). Furthermore, recovery outcomes were improved, with higher modified Aldrete scores and faster achievement of a post-anesthesia discharge score ≥9 (<em>P &lt;</em> 0<em>.</em>05). However, induction time was longer and the incidence of hypotension and bradycardia was higher in the combination group (<em>P &lt;</em> 0<em>.</em>05).</div></div><div><h3>Implications</h3><div>Dexmedetomidine-propofol sedation enhances procedural conditions and recovery metrics in EUS but is associated with greater cardiovascular side effects. These findings suggest it is a valuable alternative to propofol alone, particularly when optimizing proceduralist satisfaction and minimizing respiratory complications.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 554-558"},"PeriodicalIF":3.6,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293437","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}

{"title":"Long-Term Outcomes of Balloon Dilation in Pediatric Distal Ureteral Stenosis Across Age Groups","authors":"Keyu Ouyang MS (Urology) ,&nbsp;Yikui Zhang MS (Urology) ,&nbsp;Sai Ma MS (Urology) ,&nbsp;Weijun Ma MS (Urology) ,&nbsp;Tong Shi MS (Urology) ,&nbsp;Xiewu Zhang MS (Urology) ,&nbsp;Jiayao Luo MS (Urology) ,&nbsp;Weihua Lao MS (Urology)","doi":"10.1016/j.clinthera.2025.05.009","DOIUrl":"10.1016/j.clinthera.2025.05.009","url":null,"abstract":"<div><h3>Purposes</h3><div>The gold standard for treating primary obstructive megaureter is ureteral reimplantation, with ongoing debate surrounding its use in patients under 1 year of age. In most primary obstructive megaureter cases requiring urinary diversion, ureterostomy is favored over pyelostomy and nephrostomy. Another described alternative would be the refluxing ureteral reimplantation. Balloon dilation, established as effective and safe in adults with ureteral strictures, may offer an alternative for pediatric patients. This study aims to evaluate pre- and postoperative parameters of balloon dilation in distal ureteral segment stenosis among pediatric patients across age groups and to identify independent parameters influencing treatment success.</div></div><div><h3>Methods</h3><div>The medical records of newborns (age, 0–28 days; n = 19), young infants (age, 28 days to 6 months; n = 29), and children (age, 6 months to 11 years; n = 29) of Han Chinese pediatric patients from the Guangdong Women and Children Hospital, Guangzhou, China, from December 8, 2020, to November 5, 2023, with distal ureteral segment stenosis who underwent balloon dilatation (size from 8 to 10.5 F) were included in the analysis.</div></div><div><h3>Findings</h3><div>The prevalence of distal ureteral segment stenosis is higher in males than females (58 vs 19) and that was higher on the left lateral side in both boys and girls than right or both lateral sides (<em>P</em> = 0.0375). The therapeutic effect of balloon dilation in distal ureteral segment stenosis is effective across all age groups (<em>P</em> &lt; 0.05 for all) and especially reported to be more effective in newborns, followed by young infants and children regarding anterior and posterior pelvic diameter, renal parenchymal thickness (thinnest point), ureter diameter (widest point), and urine white blood cells (<em>P</em> &lt; 0.05 for all). The treatment effect of balloon dilation correlated with age (<em>P</em> = 0.0412), hydronephrosis (<em>P</em> = 0.0481), renal cortical thickness (<em>P</em> = 0.0419), and ureteral dilation (<em>P</em> = 0.0491).</div></div><div><h3>Implications</h3><div>These findings suggest that balloon dilation may offer a manageable alternative for younger patients, especially newborns for distal ureteral segment stenosis, with age and specific anatomical factors influencing outcomes. Age, hydronephrosis, renal cortical thickness, and ureteral dilation were independent parameters for the treatment effect of balloon dilation in very young patients.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 610-623"},"PeriodicalIF":3.6,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274312","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}

{"title":"The Role, Potential Benefits and Cost-effectiveness of Digital Tools for Diabetes Management","authors":"Anders L. Carlson MD ,&nbsp;Sameer Badlani MD ,&nbsp;Viral N. Shah MD","doi":"10.1016/j.clinthera.2025.05.002","DOIUrl":"10.1016/j.clinthera.2025.05.002","url":null,"abstract":"<div><h3>Purpose</h3><div>Health and financial burdens associated with poorly managed diabetes are considerable both for individuals and for healthcare systems. The last decade has seen a significant increase in the use of automated insulin delivery systems, continuous glucose monitoring and insulin pumps. With this, digital healthcare tools — such as smart or connected insulin pens and wearable continuous glucose monitoring (CGM) sensors utilizing current digital smartphone and wireless technology have emerged — helping people with diabetes and their healthcare providers maximize treatment adherence and achieve optimal glycemic control. This article reviews the available literature to assess current unmet needs within diabetes care management, summarizes the efficacy and safety of the latest US Food and Drug Administration (FDA)-approved insulin delivery systems and digital diabetes healthcare tools, and investigate the economic and healthcare benefits of such FDA-approved digital healthcare tools for people with diabetes in the US.</div></div><div><h3>Methods</h3><div>Literature searches were conducted using PubMed for articles published between 2014 and 2023. Type of articles included were narrative reviews, systematic reviews, randomized controlled trials and cost-effectiveness analyses.</div></div><div><h3>Findings</h3><div>There are many insulin delivery systems and associated digital devices, CGMs and software applications that utilize wireless and smartphone technology available within the US that have published efficacy, safety and cost-benefit outcomes. The safety and efficacy of CGM and continuous subcutaneous insulin infusion (CSII) therapy are well established. In contrast, the evidence available for the most recent digital diabetes healthcare tools (e.g., smart or connected insulin pens) is relatively limited.</div></div><div><h3>Implications</h3><div>Despite the acknowledged cost-effectiveness of digital healthcare tools within diabetes care and potential associated cost savings for healthcare markets, there are limited numbers of clinical studies investigating the efficacy and safety of newer devices such as smart or connected insulin pens. Further research is needed to pave the way for integrating these devices more fully into diabetes management.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 638-648"},"PeriodicalIF":3.6,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265446","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}