Clinical therapeutics最新文献

{"title":"ANDEMBRY (garadacimab-gxii)","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.07.020","DOIUrl":"10.1016/j.clinthera.2025.07.020","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 823-824"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945732","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 of Oral β-Blockers in Patients With Acute Myocardial Infarction with Preserved or Mildly Reduced Left Ventricular Systolic Function: A Systematic Review and Meta-Analysis","authors":"Yi Chen PhD ,&nbsp;Jin Qiu ,&nbsp;Tao Ai ,&nbsp;Yanqing Wu PhD","doi":"10.1016/j.clinthera.2025.06.007","DOIUrl":"10.1016/j.clinthera.2025.06.007","url":null,"abstract":"<div><h3>Purpose</h3><div>In patients with acute myocardial infarction (AMI) and preserved or mildly reduced left ventricular ejection fraction (LVEF), there is clinical uncertainty about the effectiveness of β-blockers in reducing mortality. We therefore investigated the effect of oral β-blockers on clinical benefit in patients with AMI with preserved or mildly reduced LVEF.</div></div><div><h3>Methods</h3><div>We conducted a comprehensive systematic search using PubMed, Embase, Cochrane Library, and ClinicalTrials.gov from January 1, 2000 to May 1, 2025, and finally included 16 observational studies and 2 randomized controlled trials (RCTs) to assess the β-blockers on patients with AMI with preserved or mildly reduced LVEF. The primary outcome was all-cause death, and the secondary outcomes were cardiac death, major adverse cardiovascular events, recurrent MI, hospitalization for heart failure, and stroke.</div></div><div><h3>Findings</h3><div>According to the search strategy, we finally included 18 studies, of which 16 were observational studies and 2 were RCTs. In the 5 studies without propensity score matching data, all-cause death was significantly lower in the β-blocker group than in the no β-blocker group (odds ratio [OR]: 0.65; 95% CI, 0.53–0.80). In the propensity score-matched 10 observational researches and 2 RCTs, there were no significant differences in all-cause death between the 2 groups. β-Blockers seemed to significantly reduce all-cause death in both non–ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction (OR = 0.44; 95% CI, 0.24–0.82; OR = 0.62; 95% CI, 0.40–0.98). β-Blockers seemed to be more effective in lowering all-cause death and cardiac death in patients with AMI and an LVEF of 40% to 50% (OR = 0.70; 95% CI, 0.50–0.97), and in the group with a follow-up time of ≥ 3 years, the use of β-blockers was significantly more effective in reducing cardiac death compared with the group with a follow-up time of &lt;3 years (OR = 0.45; 95% CI, 0.23–0.88).</div></div><div><h3>Implications</h3><div>β-Blockers did not significantly reduce all-cause death and cardiac death in patients with AMI with preserved or mildly reduced LVEF. However, it seemed that patients with an LVEF of 40% to 50% might experience significant benefits in terms of long-term efficacy.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 788-797"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552537","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":"Brexpiprazole Oral Soluble Film: A Randomized, Open-Label, Single-Dose, Crossover Bioequivalence Study in Healthy Chinese Volunteers","authors":"Tian Wang MM ,&nbsp;Lei Shang MS ,&nbsp;Yingxia He PhD ,&nbsp;Liyin Guo MM ,&nbsp;Xiaoyun Ruan MS ,&nbsp;Pan Han MS ,&nbsp;Wangping Wu BS ,&nbsp;Min Chen BS ,&nbsp;Fei Zhang BS ,&nbsp;Cailu Hu BS ,&nbsp;Jue Liu PhD","doi":"10.1016/j.clinthera.2025.07.001","DOIUrl":"10.1016/j.clinthera.2025.07.001","url":null,"abstract":"<div><h3>Purpose</h3><div>Brexpiprazole oral soluble film (OSF) is a novel dosage form under clinical development indicated for the treatment of schizophrenia in adults. This study aimed to investigate the bioequivalence, safety and tolerability of brexpiprazole OSF 2 mg compared with brexpiprazole orally disintegrating tablet (ODT) 2 mg (Rexulti®OD) in healthy Chinese adults.</div></div><div><h3>Methods</h3><div>A single-center, randomized, open-label, single-dose, crossover study was conducted, including a six-sequence three-period crossover intervention under fasting condition and a two-sequence two-period crossover intervention under postprandial condition. Pharmacokinetic sampling for brexpiprazole was carried out until 72 hours after dosing with a 28-day washout period. Participants were monitored for any adverse events throughout the study. The maximum plasma concentration (C_max) and the area under the plasma concentration-time curve (AUC) from time 0 to 72 hours (AUC_0-72h) were statistically analyzed using a linear mixed-effects model for bioequivalence evaluation.</div></div><div><h3>Findings</h3><div>In the fasting trial, 30 eligible individuals were enrolled and completed the study. Compared to brexpiprazole ODT 2 mg administered without water, the geometric mean ratios for C_max and AUC_0-72h of brexpiprazole OSF 2 mg taken without or with water were all close to 100%, and the corresponding 90% confidence intervals were within the established bioequivalence limit of 80.00–125.00%. In the postprandial trial, 26 participants were randomized and 2 participants withdrew from the study during the washout period. The bioequivalence range of C_max and AUC_0-72h for brexpiprazole OSF and ODT 2 mg administered without water were both within 80.00–125.00%. Generally, both formulations of brexpiprazole displayed comparable safety profiles, with no serious or unexpected adverse events reported during the study.</div></div><div><h3>Implications</h3><div>Brexpiprazole OSF 2 mg is bioequivalent to brexpiprazole ODT 2 mg with favorable safety, tolerability and acceptability under fasting and postprandial conditions. Due to its ease of administration, brexpiprazole OSF 2 mg may be expected to improve medication adherence, and provide a viable treatment option for patients with schizophrenia.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 761-769"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752562","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":"Calcineurin Inhibitors and Risk of CNS Infections: A Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS)","authors":"Siming Ning ,&nbsp;Yanan Jin ,&nbsp;Yue Yang ,&nbsp;Ruixia Yang ,&nbsp;Xin Guan","doi":"10.1016/j.clinthera.2025.05.004","DOIUrl":"10.1016/j.clinthera.2025.05.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose&lt;/h3&gt;&lt;div&gt;Calcineurin inhibitors (CNIs) are widely used to prevent organ rejection and manage autoimmune disorders. Although post-marketing evidence suggests an increased risk of central nervous system (CNS) infections associated with CNIs, this association has not been sufficiently elucidated. To address this gap, we conducted a pharmacovigilance analysis using real-world data to systematically identify and characterize the safety profile of CNI-related CNS infections, thereby providing robust evidence to inform their potential clinical risks.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A total of 21,838,627 adverse event (AE) reports were extracted from the FDA Adverse Event Reporting System (FAERS), covering the period from Q1 2004 to Q3 2024. We conducted a comprehensive analysis of the clinical characteristics of CNS infection-related AEs associated with CNIs. To identify significant safety signals, disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC) methods. Furthermore, sex-specific differences, time-to-onset (TTO) patterns, and distinct infection profiles across different CNIs were thoroughly investigated. Statistical significance for sex-based comparisons was defined as &lt;em&gt;P&lt;/em&gt; value &lt; 0.05.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;We identified 687 CNI-related CNS infection cases, comprising 488 linked to tacrolimus and 199 to cyclosporine. Compared with all other drugs in the FAERS database, both agents demonstrated significantly elevated disproportionality signals, with tacrolimus exhibiting a notably stronger association. Sex-specific analyses revealed that brain abscess (ROR=2.21[1.50–3.27], &lt;em&gt;P&lt;/em&gt; &lt; 0.01) and encephalitis (ROR = 1.84[1.22–2.78], &lt;em&gt;P&lt;/em&gt; &lt; 0.01) were markedly more prevalent in male patients. Among tacrolimus users, male-specific CNS infection AEs with positive signals included cavernous sinus thrombosis, extradural abscess, neurosarcoidosis, spinal cord abscess, and others. In comparison, male patients receiving cyclosporine exhibited distinct signals for myelitis and myelitis transverse in addition to cavernous sinus thrombosis and extradural abscess. Notably, autoimmune encephalitis was reported exclusively in female patients treated with cyclosporine, suggesting potential sex-based immunological susceptibility. TTO analysis revealed median onset times of 181 days for tacrolimus and 83 days for cyclosporine. While most CNS infections emerged within the first month of therapy, a considerable proportion occurred beyond one year of treatment, underscoring the importance of sustained long-term surveillance in CNI-treated populations.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Implications&lt;/h3&gt;&lt;div&gt;Our study provides novel real-world evidence on the safety profiles of CNIs in relation to CNS infections, highlighting differences in infection patterns across CNIs and sexes. Given the potential severity of these infections, clinicians should maintain heightened ","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 681-690"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186744","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":"Tranexamic Acid for Preventing Secondary Post-Tonsillectomy Bleeding: Insights From A Retrospective Cohort Study","authors":"Somaya Koraysh BSc (Pharm), PharmD ,&nbsp;Lina Naseralallah PharmD ,&nbsp;Zahra Noureddine MPharm ,&nbsp;Muna Al-Saadi BPharm ,&nbsp;Amr Elhakeem MBBS","doi":"10.1016/j.clinthera.2025.07.004","DOIUrl":"10.1016/j.clinthera.2025.07.004","url":null,"abstract":"<div><h3>Purpose</h3><div>Post-tonsillectomy bleeding (PTB) is the leading cause of re-operation and mortality following tonsillectomy. Tranexamic acid (TXA) has been widely utilized in various medical fields to manage bleeding. However, its efficacy in preventing bleeding after tonsillectomy remains uncertain. This study aimed to assess the effectiveness of systemic (intravenous or oral) TXA in reducing the incidence of secondary PTB post-tonsillectomy.</div></div><div><h3>Methods</h3><div>A retrospective cohort study at the Ambulatory Care Center in Qatar evaluated patients undergoing tonsillectomy from January 2021 to January 2024. Chi-square and multilogistic regression analyses were used to examine the relationship between TXA use and secondary PTB incidence.</div></div><div><h3>Findings</h3><div>A total of 2314 patients were evaluated, primarily pediatrics (89.1%), Arabic (89.3%), and male (57.5%). TXA was prescribed post-tonsillectomy for 233 patients (10.1%), with intraoperative use in 44 patients (1.9%). No significant difference in incidence of secondary PTB was observed between control group and TXA use post-tonsillectomy (5.0% vs 3.9%, <em>P</em> = 0.52). Among 114 secondary PTB cases, the mean hemoglobin drop was 1.7 (2.1) in the non-TXA group and 0.93 (1.2) in the TXA group (<em>P</em> = 0.23). Surgical intervention was needed in 24% of non-TXA patients (<em>P</em> = 0.11). Rates of blood transfusion, ICU admission, and significant hemoglobin drop were similar. TXA post-tonsillectomy did not significantly reduce PTB odds (OR 0.18, <em>P</em> = 0.13), but composite data of either intraoperative or discharge TXA administration significantly reduced PTB odds (OR 0.03, <em>P</em> = 0.004).</div></div><div><h3>Implications</h3><div>Post-tonsillectomy use of TXA did not significantly reduce secondary PTB but showed a nonsignificant trend towards less surgical reintervention. Composite of either intraoperative or discharge TXA significantly lowered PTB odds, suggesting potential benefits that warrant confirmation through larger studies.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages e7-e12"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764697","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":"Pegylated Liposomal Doxorubicin Confers a High Risk for Pneumocystis Jirovecii Pneumonia in Patients With Diffuse Large B-Cell Lymphoma","authors":"Siqian Wang MD ,&nbsp;Xi Xu MD ,&nbsp;Yongyong Ma MD ,&nbsp;Shanhu Qian MD ,&nbsp;Liyuan Tang MD ,&nbsp;Lan Sun MD ,&nbsp;Zhijian Shen MD ,&nbsp;Haige Ye MD ,&nbsp;Honglan Qian MD ,&nbsp;Songfu Jiang MD ,&nbsp;Shujuan Zhou MD","doi":"10.1016/j.clinthera.2025.06.016","DOIUrl":"10.1016/j.clinthera.2025.06.016","url":null,"abstract":"<div><h3>Purpose</h3><div>Pegylated liposomal doxorubicin (PLD) has emerged as an effective therapeutic option for diffuse large B-cell lymphoma (DLBCL). While demonstrating an improved safety profile compared to conventional doxorubicin, PLD has been associated with a potentially elevated risk of Pneumocystis jirovecii pneumonia (PJP), warranting clinical vigilance. This study aimed to evaluate the association between PLD administtion and PJP development in patients with diffuse large B-cell lymphoma (DLBCL).</div></div><div><h3>Methods</h3><div>We conducted a comparative analysis of 43 chemotherapy-treated DLBCL patients with PJP versus 195 contemporaneous DLBCL controls without PJP. The evaluation included PLD administration patterns and covariate-adjusted risk assessments.</div></div><div><h3>Fingdings</h3><div>The analysis revealed significant differences between PJP cases and controls. Patients who developed PJP were more likely to have received PLD-containing chemotherapy regimens (<em>p</em> = 0.001) and less likely to have received TMP-SMX prophylaxis (<em>p</em> = 0.001). The majority of PJP cases (51.2%) occurred after 3-4 chemotherapy cycles, with an 18.6% case-fatality rate (n = 8). Multivariable logistic regression identified 2 independent predictors, PLD-containing regimen (OR: 3.2, 95% CI: 1.5–6.8; <em>P</em> = 0.003) as a risk factor; TMP-SMX prophylaxis (OR: 0.4, 95% CI: 0.2–0.8; <em>P</em> = 0.003) as a protective factor. Notably, baseline characteristics including demographic parameters, disease stage, ECOG performance status, LDH levels, and IPI scores showed no significant intergroup differences (all <em>P</em> &gt; 0.05).</div></div><div><h3>Implications</h3><div>These findings demonstrate a clinically significant association between PLD-containing regimens and PJP development in DLBCL patients. Regular clinical and radiographic monitoring for PJP symptoms should be implemented and PJP prophylaxis should be strongly considered for all patients receiving PLD-based therapy.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 691-695"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803829","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":"Risk of Severe Outcomes From COVID-19 in Immunocompromised People During the Omicron Era: A Systematic Review and Meta-Analysis","authors":"Akvile Chapman MSc ,&nbsp;Francis Berenbaum MD, PhD ,&nbsp;Giuseppe Curigliano MD, PhD ,&nbsp;Triantafyllos Pliakas MSc ,&nbsp;Aziz Sheikh OBE, FRSE, FMedSci ,&nbsp;Sultan Abduljawad DPhil","doi":"10.1016/j.clinthera.2025.07.006","DOIUrl":"10.1016/j.clinthera.2025.07.006","url":null,"abstract":"<div><h3>Purpose</h3><div>COVID-19 imposes a high burden on people with immunocompromising/immunosuppressive (IC/IS) conditions. This is the first large-scale, comprehensive meta-analysis encompassing major IC/IS categories to assess the risks of severe outcomes from COVID-19 in people with IC/IS conditions during the Omicron era—the period dominated by the most recent major COVID-19 variant.</div></div><div><h3>Methods</h3><div>A systematic search of Embase, MEDLINE, PubMed, Europe PMC, Latin American and Caribbean Health Sciences Literature, Cochrane COVID-19 Study Register, and WHO COVID-19 database was performed to identify studies published between January 1, 2022, and March 13, 2024. Studies included people (all ages) with at least one of the following conditions: unspecified IC/IS, transplant, malignancy, autoimmune diseases, liver diseases, chronic or end-stage kidney disease, and advanced/untreated HIV. Studies were synthesized quantitatively using random-effects models. Evaluated outcomes were risks of death, hospitalization, intensive care unit (ICU) admission, and any combination of these outcomes.</div></div><div><h3>Findings</h3><div>Seventy-two studies were included, of which 66 were included in the meta-analysis. Minimum numbers of participants per IC/IS condition ranged from 12,634 to 3,287,816. Of all meta-analyzed IC/IS conditions, transplant recipients had the highest risk of death (pooled relative risk [RR], 6.78; 95% CI: 4.41–10.43; <em>P &lt;</em> 0.001), hospitalization (RR, 6.75; 95% CI 3.41–13.37; <em>P &lt;</em> 0.001), and combined outcomes (RR, 8.65; 95% CI 4.01–18.65; <em>P &lt;</em> 0.001), while participants in the unspecified IC/IS group had the highest risk of ICU admission (RR, 3.38; 95% CI 2.37–4.83; <em>P &lt;</em> 0.001) compared with participants without the respective IC/IS conditions or general population.</div></div><div><h3>Implications</h3><div>In the Omicron era, people with IC/IS conditions have a substantially higher risk of death and hospitalization from COVID-19.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 770-787"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945604","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":"Letter to the Editor Regarding \"The Safety and Efficacy of Intravenous Ibuprofen in Older Patients: A Retrospective Subgroup Analysis\"-Reframing Intravenous Ibuprofen Use in Geriatric Pain Management: Insights on Safety, Stratification, and Polypharmacy.","authors":"Schawanya K Rattanapitoon, Nav La, Phornpitcha Pechdee, Nathkapach K Rattanapitoon","doi":"10.1016/j.clinthera.2025.08.005","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.08.005","url":null,"abstract":"<p><p>We commend the retrospective subgroup analysis by Gan et al. for addressing a vital concern in geriatric pharmacotherapy-balancing analgesic efficacy with safety in older patients. Although their findings reinforce the utility of intravenous ibuprofen for acute postoperative pain, we offer further perspectives on patient selection, comorbid risk profiles, and polypharmacy, particularly in frail or polymorbid geriatric populations. This letter expands on practical and clinical considerations in translating these findings into real-world settings.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945496","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":"Effect of Epigallocatechin Gallate on Glycemic Index: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Mohamed J Saadh, Ibrahim Saeed Gataa, A S Hussam, Irwanjot Kaur, Abhishek Kumar, Pragati Godara, Rahadian Zainul, Khursheed Muzammil, Yousef Zahrani","doi":"10.1016/j.clinthera.2025.07.015","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.015","url":null,"abstract":"<p><strong>Purpose: </strong>Epigallocatechin gallate (EGCG), a major catechin found in green tea, has been suggested to influence glycemic control. This systematic review and meta-analysis aim to evaluate the effects of EGCG on the glycemic index (GI) and related glycemic parameters.</p><p><strong>Methods: </strong>Using predefined keywords, online databases (PubMed, Scopus, Web of Science Core Collection, and Google Scholar) were searched for relevant studies, published from inception up to May 2024. Initially 1994 studies were obtained out of which 41 RCTs were decided to be included for further analyses.</p><p><strong>Findings: </strong>The meta-analysis demonstrated that EGCG supplementation led to statistically significant, but modest, reductions in fasting blood glucose (FBG), HbA1c, and HOMA-IR. Notably, the reduction in HbA1c (WMD: -0.18%, 95% CI: -0.35, -0.02; P = 0.029) was small and may not equate to clinically meaningful benefits for all populations. Furthermore, the effect on fasting insulin was not statistically significant (WMD: -0.50; 95% CI: -1.46, 0.47; P = 0.313), indicating a lack of robust or consistent impact on this parameter across studies.</p><p><strong>Implications: </strong>Although EGCG supplementation is associated with improvements in some glycemic parameters, these effects especially for HbA1c and fasting insulin are modest and may not be clinically meaningful for most population. Therefore, current evidence does not strongly support the use of EGCG as a stand-alone intervention for glycemic control.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945561","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":"Measuring State Cannabis Policy Design Variation for Research and Policy: A Bundles Approach.","authors":"Daniel J Mallinson, Lilliard E Richardson","doi":"10.1016/j.clinthera.2025.07.027","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.07.027","url":null,"abstract":"<p><p>For understanding how cannabis legalization in the American states has affected public health, it is important to consider how policies vary by state. This commentary presents a policy bundles approach to measuring state cannabis policy variation. Measured from 1994 to 2023, three bundles-pharmaceutical, permissive, and fiscal-capture 36 different characteristics of state medical and recreational cannabis laws. The pharmaceutical bundle captures characteristics treating cannabis like a regulated pharmaceutical. The permissive bundle those that treat it like an easily accessed over-the-counter product. Finally, the fiscal bundle captures ways that states raise revenue from cannabis. Furthermore, measures are available capturing either policies as adopted or as implemented, allowing researchers to better link policy effects to actual implementation. The commentary demonstrates the bundle measures using the state of Massachusetts and concludes with future directions for using these publicly available measures for health research.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945672","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}