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口服司美格鲁肽治疗2型糖尿病女性的临床疗效:一项全国性、多中心、回顾性、观察性研究(Women_ENDO2S-RWD子研究)

Clinical Effectiveness of Oral Semaglutide in Women with Type 2 Diabetes: A Nationwide, Multicentre, Retrospective, Observational Study (Women_ENDO2S-RWD Substudy).

作者信息

Reyes-Garcia Rebeca, Moreno-Pérez Oscar, Guillen-Morote Cristina, Modrego-Pardo Inés, Doulatram-Gamgaram Viyey Kishore, Casado Cases Carlos, Arias Mendoza Nieves, Tejera-Pérez Cristina, Cárdenas-Salas Jersy, Martínez-Fuster Sandra, Lardiés-Sánchez Beatriz, Márquez-Pardo Rosa, Pinés Pedro, Tejera-Muñoz Antonio, Fernández-García José Carlos

机构信息

Endocrinology Unit, University Hospital of Torrecárdenas, 04009 Almería, Spain.

CIBER de Fragilidad y Envejecimiento Saludable "CIBERFES", Instituto de Salud Carlos III, 28029 Madrid, Spain.

出版信息

Nutrients. 2025 Jul 17;17(14):2349. doi: 10.3390/nu17142349.

DOI:10.3390/nu17142349
PMID:
40732973
Abstract

Sex differences in type 2 diabetes (T2D) are a growing area of diabetes research. No data have been reported on sex differences with oral semaglutide (oSEMA) in a real-world setting. : We included people with T2D who started treatment with oSEMA in routine clinical practice between November 2021 and November 2022, with at least one report of clinical follow-up (FU) data at 3 months. We evaluated in women with T2D (WWT2D) the clinical effectiveness of oSEMA and factors associated with clinical response and persistence. We also analyzed differences in baseline characteristics, clinical effectiveness, persistence rates and safety according to biological sex. : Of the 1018 subjects [median age: 63 years, body mass index (BMI): 33.8 kg/m, HbA1c: 7.8%], 469 were WWT2D. In WWT2D, oSEMA reduced HbA1c by 0.7% [-0.1 to -1.3] and 0.9% [-0.2 to -1.5] at the 6- and 12-month FU visits, while weight decreased by 4.6% [2.0 to 7.9] and 7.2% [2.5 to 10.9], respectively. Weight loss was >10% in 29.8% of WWT2D (95% CI 25.8 to 34.1); meanwhile, the combined endpoint (HbA1c decrease ≥ 1% + weight reduction ≥ 5%) was achieved in 23.5% (95% CI 19.8 to 27.5%) of WWT2D at the 12-month FU visit. Achievement of glycaemic targets was similar in women and men (59.3% vs. 61.1%). We found no sex differences in weight loss (6.9% vs. 6.8%), oSEMA maintenance dose, persistence rate (76.3% vs. 77.3%), or adverse events. : oSEMA was effective and safe in WWT2D in a real-world setting, with nearly one-third of patients reporting weight loss >10% and more than two-thirds achieving HbA1c < 7%. oSEMA showed no sex bias in terms of effectiveness and safety.

摘要

2型糖尿病(T2D)中的性别差异是糖尿病研究中一个不断发展的领域。在现实环境中,尚无关于口服司美格鲁肽(oSEMA)性别差异的数据。:我们纳入了2021年11月至2022年11月期间在常规临床实践中开始使用oSEMA治疗的T2D患者,且至少有一份3个月临床随访(FU)数据报告。我们评估了oSEMA在T2D女性患者(WWT2D)中的临床疗效以及与临床反应和持续治疗相关的因素。我们还根据生物学性别分析了基线特征、临床疗效、持续治疗率和安全性方面的差异。:在1018名受试者中[中位年龄:63岁,体重指数(BMI):33.8kg/m²,糖化血红蛋白(HbA1c):7.8%],469名是WWT2D。在WWT2D中,oSEMA在6个月和12个月FU访视时分别使HbA1c降低0.7%[-0.1至-1.3]和0.9%[-0.2至-1.5],而体重分别下降4.6%[2.0至7.9]和7.2%[2.5至10.9]。29.8%的WWT2D患者体重减轻>10%(95%CI 25.8至34.1);同时,在12个月FU访视时,23.5%(95%CI 19.8至27.5%)的WWT2D患者达到了联合终点(HbA1c降低≥1%+体重减轻≥5%)。女性和男性实现血糖目标的情况相似(59.3%对61.1%)。我们发现体重减轻(6.9%对6.

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本文引用的文献

1
Real-world sex differences in type 2 diabetes patients treated with GLP-1 receptor agonists.真实世界中接受 GLP-1 受体激动剂治疗的 2 型糖尿病患者的性别差异。
Diabetes Res Clin Pract. 2024 Jun;212:111689. doi: 10.1016/j.diabres.2024.111689. Epub 2024 May 1.
2
Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?对于2型糖尿病和慢性肾脏病患者,我们是否准备好采用以脂肪为中心的治疗方法?
Clin Kidney J. 2024 Feb 21;17(4):sfae039. doi: 10.1093/ckj/sfae039. eCollection 2024 Apr.
3
Phenotype-based targeted treatment of SGLT2 inhibitors and GLP-1 receptor agonists in type 2 diabetes.
基于表型的 SGLT2 抑制剂和 GLP-1 受体激动剂在 2 型糖尿病中的靶向治疗。
Diabetologia. 2024 May;67(5):822-836. doi: 10.1007/s00125-024-06099-3. Epub 2024 Feb 22.
4
Real-world effectiveness and safety of oral semaglutide in people living with type 2 diabetes: A nationwide multicentre retrospective observational study (ENDO S-RWD).口服司美格鲁肽在2型糖尿病患者中的真实世界有效性和安全性:一项全国多中心回顾性观察研究(ENDO S-RWD)
Diabetes Obes Metab. 2024 Apr;26(4):1519-1523. doi: 10.1111/dom.15431. Epub 2023 Dec 27.
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Sex differences in type 2 diabetes.2 型糖尿病的性别差异。
Diabetologia. 2023 Jun;66(6):986-1002. doi: 10.1007/s00125-023-05891-x. Epub 2023 Mar 10.
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Gender disparities in time-to-initiation of cardioprotective glucose-lowering drugs in patients with type 2 diabetes and cardiovascular disease: a Danish nationwide cohort study.性别差异在 2 型糖尿病和心血管疾病患者起始心脏保护降血糖药物的时间:一项丹麦全国队列研究。
Cardiovasc Diabetol. 2022 Dec 10;21(1):279. doi: 10.1186/s12933-022-01713-3.
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Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care.胰高血糖素样肽-1受体激动剂治疗反应中的性别差异:糖尿病和肥胖症个性化护理的机遇
J Pers Med. 2022 Mar 13;12(3):454. doi: 10.3390/jpm12030454.
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Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 analyses.患者特征对每周一次司美格鲁肽与度拉糖肽疗效和安全性的影响:SUSTAIN 7 分析。
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