Ramy Ibrahim Elwaraky, Amira B. Kassem, Ahmed Fathi Elkeraie, Gamal Abdelhay Omran, Noha A. El‑Bassiouny
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引用次数: 0
Abstract
Background
Anemia is a prevalent complication in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), contributing to adverse clinical outcomes. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), including dapagliflozin, have demonstrated cardiovascular and renal benefits, with emerging evidence suggesting their role in erythropoiesis and anemia correction.
Methods
This was a prospective cohort study, including patients with T2DM and CKD (stages 3–4). Patients were classified into dapagliflozin and control groups, with further stratification based on baseline anemia status. Outcomes included incident anemia, hemoglobin increase, anemia correction, development of iron deficiency anemia (IDA), and erythropoiesis-stimulating agent (ESA) therapy initiation over a 12-month follow-up.
Results
A total of 255 patients (dapagliflozin: n = 155; control: n = 100) were included, with baseline anemia present in 109 dapagliflozin-treated and 66 control patients. IDA development was higher in dapagliflozin-treated patients (36.7% vs. 18.2%, p = 0.005), occurring exclusively in patients with baseline anemia and more frequently among females. Among non-anemic patients, incident anemia was observed in 11.8% of controls but none in the dapagliflozin group. In anemic patients, a hemoglobin increase ≥ 1 g/dL was more frequent in the dapagliflozin group (66.7% vs. 14.3%, p < 0.001), with a significantly shorter time to response (7.30 vs. 11.57 months, p < 0.001). Anemia correction—defined as achieving hemoglobin ≥ 13.0 g/dL in males or ≥ 12.0 g/dL in females, with a ≥ 1 g/dL increase—was achieved in 53.6% of dapagliflozin-treated patients versus 4.8% of controls (p < 0.001). These findings were consistent in the propensity score-matched cohort, reinforcing the robustness of the observed associations. ESA initiation was lower in the dapagliflozin group (7.3% vs. 24.2%, p = 0.002), with a longer time to therapy initiation.
Conclusions
Dapagliflozin was associated with significant improvements in hemoglobin levels and anemia correction in patients with T2DM and CKD. However, an increased risk of IDA, particularly in female patients, warrants careful monitoring. The protective effects of dapagliflozin against ESA initiation highlight its potential role in anemia management. However, due to the observational design, causality cannot be definitively inferred.
背景：贫血是2型糖尿病（T2DM）和慢性肾脏疾病（CKD）患者的常见并发症，会导致不良的临床结果。钠-葡萄糖共转运蛋白-2抑制剂（SGLT2i），包括达格列净，已显示出心血管和肾脏益处，新证据表明它们在红细胞生成和贫血纠正中的作用。方法：这是一项前瞻性队列研究，包括T2DM和CKD患者（3-4期）。患者被分为达格列净组和对照组，并根据基线贫血状态进一步分层。在12个月的随访中，结果包括贫血、血红蛋白升高、贫血纠正、缺铁性贫血（IDA）的发展和红细胞生成刺激剂（ESA）治疗的开始。结果共纳入255例患者（达格列净组155例，对照组100例），其中治疗组109例基线贫血，对照组66例基线贫血。达格列净治疗患者的IDA发生率更高（36.7% vs. 18.2%, p = 0.005），仅发生在基线贫血患者中，在女性中更常见。在非贫血患者中，11.8%的对照组发生贫血，但在达格列净组中没有发生贫血。在贫血患者中，达格列净组血红蛋白升高≥1 g/dL的频率更高（66.7% vs. 14.3%, p < 0.001），反应时间显著缩短（7.30个月vs. 11.57个月，p < 0.001）。贫血矫正——定义为男性血红蛋白≥13.0 g/dL或女性血红蛋白≥12.0 g/dL，且血红蛋白升高≥1 g/dL——在接受达格列净治疗的患者中达到53.6%，对照组为4.8% （p < 0.001）。这些发现在倾向评分匹配的队列中是一致的，加强了观察到的关联的稳健性。达格列净组ESA起始率较低（7.3% vs. 24.2%, p = 0.002），且起始治疗时间较长。结论帕格列净可显著改善T2DM和CKD患者的血红蛋白水平和贫血矫正。然而，IDA的风险增加，特别是在女性患者中，值得仔细监测。达格列净对ESA起始的保护作用突出了其在贫血管理中的潜在作用。然而，由于观察设计，因果关系不能被明确地推断出来。
期刊介绍：
Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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