评估司美格鲁肽在2型糖尿病控制不佳患者中的临床有效性和安全性。来自沙特阿拉伯的真实世界证据：观察性、多中心、为期15个月的EVOLUTION研究。
Evaluating the Clinical Effectiveness and Safety of Semaglutide in Individuals with Uncontrolled Type 2 Diabetes. Real-World Evidence from Saudi Arabia: The Observational, Multicenter, 15-Month EVOLUTION Study.
作者信息
Alsheikh Abdulrahman, Alshehri Ali, Alzahrani Saad, Jammah Anwar A, Alqahtani Fahad, Alotaibi Metib, Aldahash Raed, Alhozali Amani M, Alsabaan Fahad, Almehthel Mohammed, Aljuhani Naser, Aldabeis Ali, Alamri Moneer, Maghawry Waleed, Alzaman Naweed, Alshaikh Alshaima, M Alnozha Omar, Issak Emad R, Alsifri Saud
机构信息
King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Dr. Suliman Fakeeh Hospital, Jeddah, Saudi Arabia.
出版信息
Diabetes Ther. 2024 Feb;15(2):473-485. doi: 10.1007/s13300-023-01516-z. Epub 2023 Dec 19.
INTRODUCTION
This study aimed to assess the safety and effectiveness of semaglutide, administered either by weekly subcutaneous (SC) injection or orally, in real-life practice in Saudi Arabia in individuals with type 2 diabetes mellitus (T2DM).
METHODS
A retrospective chart review study was conducted at 18 Saudi Arabia centers. An accredited centralized institutional review board approved the study. Medical records were included for individuals of any age ≥ 18 years with uncontrolled T2DM. The primary outcome measure was the laboratory glycated hemoglobin (HbA1c) level. Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after 6 and 12 months of semaglutide initiation.
RESULTS
The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7%). The mean (SD) baseline HbA1c was 10.02% (1.17). HbA1c was reduced by an average of 3.02% (0.84) and 3.17% (0.84) at 6 and 12 months, respectively. Results of a repeated measure analysis of variance (ANOVA) indicated significant differences in HbA1c (p value < 0.001). HbA1c levels at 6 and 12 months were significantly lower, 7.00% (0.70) and 6.85% (0.69), than at baseline, 10.02% (1.17). About 193 patients (56.4%) of the 295 patients having HbA1c < 9% achieved HbA1c of 5.7% or less. The frequency of hypoglycemia events was 4.60 (1.10) in the 3 months before semaglutide was initiated. The frequency of hypoglycemia events in the last 3 months was 2.30 (0.80) events and 0.80 (0.50) events at 6-month and 12-month follow-up visits, respectively. The percent reduction in body mass index (BMI) was an average of 13.07% (1.53) and 19.89% (4.07) at 6 and 12 months, respectively. Lipid profile and blood pressure were improved at 6 and 12 months.
CONCLUSION
Semaglutide, administered either by SC injection or orally, provided substantial glycemic and weight-loss benefits in adults with T2DM.
引言
本研究旨在评估司美格鲁肽在沙特阿拉伯2型糖尿病（T2DM）患者的实际临床实践中，通过每周皮下注射或口服给药的安全性和有效性。
方法
在沙特阿拉伯的18个中心进行了一项回顾性病历审查研究。该研究获得了认可的中央机构审查委员会的批准。纳入了年龄≥18岁且T2DM控制不佳的个体的病历。主要结局指标是实验室糖化血红蛋白（HbA1c）水平。次要指标包括空腹血糖（FBG）、体重和低血糖。在开始使用司美格鲁肽6个月和12个月后检查所有变量。
结果
本研究分析纳入了1223例T2DM控制不佳（HbA1c>7%）的患者。平均（标准差）基线HbA1c为10.02%（1.17）。在6个月和12个月时，HbA1c分别平均降低了3.02%（0.84）和3.17%（0.84）。重复测量方差分析（ANOVA）结果表明HbA1c存在显著差异（p值<0.001）。6个月和12个月时的HbA1c水平分别为7.00%（0.70）和6.85%（0.69），显著低于基线水平10.02%（1.17）。在295例HbA1c<9%的患者中，约193例（56.4%）实现了HbA1c降至5.7%或更低。在开始使用司美格鲁肽前3个月，低血糖事件的发生率为4.60（1.10）。在6个月和12个月的随访中，最近3个月低血糖事件的发生率分别为2.30（0.80）次和0.80（0.50）次。在6个月和12个月时，体重指数（BMI）的降低百分比分别平均为13.07%（1.53）和19.89%（4.07）。在6个月和12个月时，血脂谱和血压均得到改善。
结论
皮下注射或口服司美格鲁肽在成人T2DM患者中带来了显著的血糖控制和体重减轻益处。
Zotero 插件