Hakar Abdulkareem Saeed, Nidhal Abdulkader Mohammed Ali, Ramadhan Tayeb Othman
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引用次数: 0
Abstract
Aims: To evaluate whether dapagliflozin attenuates early cardiac functional and biomarker changes during anthracycline-based chemotherapy.
Materials & methods: In this randomized, double-blind, placebo-controlled phase II trial, 94 adults were assigned 1:1 to dapagliflozin 10 mg once daily or placebo for 4 months; 90 completed follow-up. The primary endpoint was 4-month left ventricular ejection fraction (LVEF), analyzed using analysis of covariance (ANCOVA) adjusted for baseline LVEF. Secondary and exploratory outcomes included cardiac biomarkers and the early-to-late transmitral flow velocity ratio (E/A ratio).
Results: Dapagliflozin was associated with higher adjusted 4-month LVEF than placebo (adjusted mean difference, 2.40 percentage points; 95% confidence interval [CI], 1.25-3.54; p < 0.001). Change in LVEF was +0.13 ± 2.28 versus -2.31 ± 3.27 percentage points, respectively. E/A ratio decline was attenuated (p = 0.030). Galectin-3 decreased with dapagliflozin but increased with placebo (p < 0.001), while N-terminal pro-B-type natriuretic peptide (NT-proBNP) increased less (p = 0.004). No major safety signal was observed during the 4-month follow-up.
Conclusions: Dapagliflozin was associated with attenuation of early anthracycline-associated cardiac functional and biomarker changes. Larger, longer trials are needed to determine clinical benefit.
Clinical trial registration: www.clinicaltrials.gov identifier is NCT06888505. Retrospectively registered.
目的：评估达格列净是否能减轻蒽环类药物化疗期间早期心功能和生物标志物的变化。材料与方法：在这项随机、双盲、安慰剂对照的II期试验中，94名成年人按1:1的比例被分配到达格列净10mg每日一次或安慰剂组，持续4个月；90例完成随访。主要终点是4个月左心室射血分数（LVEF），使用协方差分析（ANCOVA）调整基线LVEF进行分析。次要和探索性结果包括心脏生物标志物和早期到晚期的透射血流速度比（E/A比）。结果：达格列净的校正4个月LVEF高于安慰剂（校正平均差为2.40个百分点；95%可信区间[CI]， 1.25-3.54; p = 0.030）。达格列净组半乳糖凝集素-3降低，安慰剂组升高（p p = 0.004）。在4个月的随访中未观察到主要的安全信号。结论：达格列净与早期蒽环类药物相关心功能和生物标志物变化的衰减有关。需要更大规模、更长期的试验来确定临床效益。临床试验注册：www.clinicaltrials.gov标识符：NCT06888505。回顾注册。
期刊介绍：
Future Science OA is an online, open access, peer-reviewed title from the Future Science Group. The journal covers research and discussion related to advances in biotechnology, medicine and health. The journal embraces the importance of publishing all good-quality research with the potential to further the progress of research in these fields. All original research articles will be considered that are within the journal''s scope, and have been conducted with scientific rigour and research integrity. The journal also features review articles, editorials and perspectives, providing readers with a leading source of commentary and analysis. Submissions of the following article types will be considered: -Research articles -Preliminary communications -Short communications -Methodologies -Trial design articles -Trial results (including early-phase and negative studies) -Reviews -Perspectives -Commentaries
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