口服semaglutide对血糖控制和体重的疗效长达18个月:一项多中心回顾性真实世界研究。

IF 5.4 2区 医学 Q1 Medicine Journal of Endocrinological Investigation Pub Date : 2024-06-01 Epub Date: 2024-02-18 DOI:10.1007/s40618-024-02309-2
B M Bonora, G Russo, F Leonetti, M Strazzabosco, L Nollino, G Aimaretti, A Giaccari, F Broglio, A Consoli, A Avogaro, G P Fadini
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引用次数: 0

摘要

目的:口服塞马鲁肽是一种创新型口服 GLP-1 受体激动剂,用于治疗 2 型糖尿病(T2D):我们纳入了来自 18 个专科护理中心的口服塞马鲁肽新用户,并收集了有关基线临床特征的回顾性数据。采用重复测量混合模型分析了 HbA1c 和体重的最新值:研究纳入了 166 名 T2D 患者,其中男性占多数(64.5%),平均年龄为 64.4 岁,平均糖尿病病程为 10.1 年。大多数患者(68.3%)将口服塞马鲁肽作为二线药物使用,其中大部分与二甲双胍一起使用。基线时,平均体重指数为 28.9 kg/m2,HbA1c 为 7.5%。在 18 个月的观察期内,口服塞马鲁肽可显著降低 HbA1c,最大变化为-0.9%,42.1% 的患者 HbA1c 值低于 7.0%。此外,患者的体重也有大幅下降,18 个月时的估计变化为-3.4 千克,30.3% 的患者的基线体重下降了 5% 或更多。只有 24.2% 的患者达到了 14 毫克的剂量。亚组分析显示,基线 HbA1c > 7%、坚持服药、未使用过 DPP-4 抑制剂治疗以及初始体重减轻 5% 或更多与 HbA1c 降低幅度较大有关:本研究支持口服塞马鲁肽作为治疗 T2D 的有效选择,在实际环境中可改善血糖控制和体重管理。
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Effectiveness of oral semaglutide on glucose control and body weight up to 18 months: a multicenter retrospective real-world study.

Aim: Oral semaglutide, an innovative orally administered GLP-1 receptor agonist for type 2 diabetes (T2D) management was herein evaluated for its effectiveness in a multi-center retrospective real-world study.

Methods: We included new-users of oral semaglutide from 18 specialist care centres and collected retrospective data on baseline clinical characteristics. Updated values of HbA1c and body weight were analyzed using the mixed model for repeated measures.

Results: The study included 166 individuals with T2D, predominantly men (64.5%), with a mean age of 64.4 years and a mean diabetes duration of 10.1 years. In the majority of patients (68.3%) oral semaglutide was used as a second-line drug, mostly with metformin. At baseline, mean BMI was 28.9 kg/m2 and HbA1c was 7.5%. During the 18-month observation period, oral semaglutide demonstrated significant reductions in HbA1c, with a maximum change of - 0.9%, and 42.1% of patients achieved HbA1c values below 7.0%. Additionally, there was a substantial reduction in body weight, with an estimated change of - 3.4 kg at 18 months, and 30.3% of patients experienced a 5% or greater reduction in baseline body weight. Only 24.2% of patients reached the 14 mg dose. Subgroup analysis revealed that baseline HbA1c > 7%, persistence on drug, not being on a prior therapy with DPP-4 inhibitors, and loosing 5% or more the initial body weight were associated with greater HbA1c reductions.

Conclusion: This study supports oral semaglutide as an effective option for T2D treatment, offering improved glucose control and weight management in a real-world setting.

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来源期刊
Journal of Endocrinological Investigation
Journal of Endocrinological Investigation ENDOCRINOLOGY & METABOLISM-
CiteScore
8.10
自引率
7.40%
发文量
242
期刊介绍: The Journal of Endocrinological Investigation is a well-established, e-only endocrine journal founded 36 years ago in 1978. It is the official journal of the Italian Society of Endocrinology (SIE), established in 1964. Other Italian societies in the endocrinology and metabolism field are affiliated to the journal: Italian Society of Andrology and Sexual Medicine, Italian Society of Obesity, Italian Society of Pediatric Endocrinology and Diabetology, Clinical Endocrinologists’ Association, Thyroid Association, Endocrine Surgical Units Association, Italian Society of Pharmacology.
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