TỔNG QUAN HỆ THỐNG VỀ HIỆU QUẢ VÀ AN TOÀN CỦA SEMAGLUTIDE TIÊM DƯỚI DA TRONG ĐIỀU TRỊ ĐÁI THÁO ĐƯỜNG TÍP 2 KÈM BÉO PHÌ
Nội dung chính của bài viết
Tóm tắt
Mục tiêu: Đánh giá hiệu quả và tính an toàn của semaglutide tiêm dưới da ở người bệnh đái tháo đường (ĐTĐ) típ 2 kèm béo phì.
Phương pháp: Tổng quan hệ thống được thực hiện theo hướng dẫn PRISMA trên ba cơ sở dữ liệu PubMed, Embase và Cochrane. Các nghiên cứu được lựa chọn theo tiêu chí xác định trước. Quá trình sàng lọc, trích xuất dữ liệu, đánh giá và phân tích kết quả được thực hiện độc lập bởi hai nghiên cứu viên.
Kết quả: Có 10 nghiên cứu được đưa vào phân tích. Semaglutide tiêm dưới da nhìn chung cho thấy xu hướng cải thiện HbA1c và cân nặng, mặc dù mức độ thay đổi khác nhau giữa các nghiên cứu. Một số nghiên cứu ghi nhận cải thiện BMI và số đo vòng eo. Dữ liệu về kết cục tim mạch – thận còn hạn chế. Về an toàn, các biến cố bất lợi được báo cáo nhiều nhất chủ yếu liên quan đến đường tiêu hóa.
Kết luận: Các bằng chứng hiện có gợi ý semaglutide tiêm dưới da có hiệu quả thuận lợi trên kiểm soát đường huyết và giảm cân ở người bệnh ĐTĐ típ 2 kèm béo phì, với hồ sơ an toàn nhìn chung chấp nhận được. Cần thêm các nghiên cứu có thiết kế chặt chẽ và thời gian theo dõi dài hơn để khẳng định hiệu quả và tính an toàn lâu dài của thuốc.
Chi tiết bài viết
Từ khóa
Semaglutide; đái tháo đường típ 2; béo phì; hiệu quả; an toàn; tổng quan hệ thống.
Tài liệu tham khảo
1. IDF. IDF Diabetes Atlas. Brussels, Belgium; 2025.
2. WHO. Mortality and global health estimates: WHO; 2025 [Available from: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates.
3. Cousin E, Schmidt MI, Ong KL, Lozano R, Afshin A, Abushouk AI, et al. Burden of diabetes and hyperglycaemia in adults in the Americas, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The lancet Diabetes & endocrinology. 2022;10(9):655-67. doi: 10.1016/S2213-8587(22)00186-3
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7. Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, Bain SC. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. The Lancet Diabetes and Endocrinology. 2017;5(4):251-60. doi: 10.1016/S2213-8587(17)30013-X
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10. Aroda VR, Bain SC, Cariou B, Piletič M, Rose L, Axelsen M, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. The Lancet Diabetes and Endocrinology. 2017;5(5):355-66. doi: 10.1016/S2213-8587(17)30085-2
11. Rodbard HW, Lingvay I, Reed J, De La Rosa R, Rose L, Sugimoto D, et al. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. Journal of Clinical Endocrinology and Metabolism. 2018;103(6):2291-301. doi: 10.1210/jc.2018-00070
12. Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes and Endocrinology. 2018;6(4):275-86. doi: 10.1016/S2213-8587(18)30024-X
13. Hoffmann K, Michalak M, Paczkowska A. Relative Effectiveness and Safety of the GLP-1 (Glucagon-Like Peptide 1) Receptor Agonists, Semaglutide and Liraglutide in the Treatment of Obese Type 2 Diabetics: A Prospective Observational Cohort Study in Poland. Diabetes Metab Syndr Obes. 2025;18:2723-38. doi: 10.2147/dmso.S531697
14. Pardo Lozano F, Rubio Marcos A, Casañ Fernández R, Bartual Rodrigo A, Martínez-Hervás S, Ampudia-Blasco FJ. Real-world evaluation of the efficacy and safety of switching from weekly dulaglutide to weekly semaglutide: The SEMA-SWITCH study. Endocrinol Diabetes Nutr (Engl Ed). 2025;72(6):501574. doi: 10.1016/j.endien.2025.501574
15. Seijas-Amigo J, Salgado-Barreira Á, Castelo-Dominguez R, Pérez-Álvarez MT, Ponce-Piñón B, Fernández-Silva M, et al. Differences in weight loss and safety between the glucagon-like peptide-1 receptor agonists: A non-randomized multicenter study from the titration phase. Prim Care Diabetes. 2023;17(4):366-72. doi: 10.1016/j.pcd.2023.05.004
16. Pérez-Velasco MA, Bernal-López MR, Trenas A, Ricci M, López-Carmona MD, García de Lucas MD, et al. Efficacy of once-weekly semaglutide in patients with heart failure with preserved ejection fraction, obesity and type 2 diabetes. Medicina clinica. 2025;165(3):107019. doi: 10.1016/j.medcli.2025.107019
17. Rodríguez Jiménez B, Rodríguez de Vera Gómez P, Belmonte Lomas S, Mesa Díaz Á M, Caballero Mateos I, Galán I, et al. Transforming body composition with semaglutide in adults with obesity and type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2024;15:1386542. doi: 10.3389/fendo.2024.1386542
18. Ferrulli A, Senesi P, Sonaglioni A, Cannavaro D, Massarini S, Macrì C, et al. Weight Loss With SGLT2 Inhibitors, Semaglutide, and Transcranial Magnetic Stimulation in Type 2 Diabetes and Obesity. Obesity. 2026;34(2):317-22. doi: 10.1002/oby.70105
19. Alarfaj SJ. The Effectiveness of Semaglutide on a Composite Endpoint of Glycemic Control and Weight Reduction and Its Effect on Lipid Profile Among Obese Type 2 Diabetes Patients. Medicina (Kaunas). 2025;61(8). doi: 10.3390/medicina61081393
20. Caballero-Mateos I, Morales-Portillo C, González Aguilera B. Once-Weekly Semaglutide Improves Body Composition in Spanish Obese Adults with Type 2 Diabetes: A 48-Week Prospective Real-Life Study. J Clin Med. 2025;14(15). doi: 10.3390/jcm14155434
21. Alenzi S, Alzahrani A, Aljaloud A, Alanazi K, Alarfaj SJ. The effectiveness of 0.5 mg and 1mg of semaglutide in patients with type two diabetes and predictors of response: a retrospective cohort study. Front Endocrinol (Lausanne). 2024;15:1395651. doi: 10.3389/fendo.2024.1395651
22. Pérez-Belmonte LM, Sanz-Cánovas J, García de Lucas MD, Ricci M, Avilés-Bueno B, Cobos-Palacios L, et al. Efficacy and Safety of Semaglutide for the Management of Obese Patients With Type 2 Diabetes and Chronic Heart Failure in Real-World Clinical Practice. Front Endocrinol (Lausanne). 2022;13:851035. doi: 10.3389/fendo.2022.851035
2. WHO. Mortality and global health estimates: WHO; 2025 [Available from: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates.
3. Cousin E, Schmidt MI, Ong KL, Lozano R, Afshin A, Abushouk AI, et al. Burden of diabetes and hyperglycaemia in adults in the Americas, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The lancet Diabetes & endocrinology. 2022;10(9):655-67. doi: 10.1016/S2213-8587(22)00186-3
4. Huang Q, Li Y, Yu M, Lv Z, Lu F, Xu N, et al. Global burden and risk factors of type 2 diabetes mellitus from 1990 to 2021, with forecasts to 2050. Frontiers in endocrinology. 2025;16:1538143. doi: 10.3389/fendo.2025.1538143
5. Pham HTK, Kieu TTM, Duong TD, Van Nguyen KD, Tran NQ, Tran TH, Ng JYS. Direct medical costs of diabetes and its complications in Vietnam: A national health insurance database study. Diabetes Research and Clinical Practice. 2020;162:108051. doi: 10.1016/j.diabres.2020.108051
6. IDF. Obesity and type 2 diabetes: A joint approach to halt the rise: International Diabetes Federation; 2022 [Available from: https://www.idf.org/media/uploads/2022/11/IDF-WOF-Obesity-and-type-2-diabetes_A-joint-approach-to-halt-the-rise-WEB-2.pdf.
7. Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, Bain SC. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. The Lancet Diabetes and Endocrinology. 2017;5(4):251-60. doi: 10.1016/S2213-8587(17)30013-X
8. Ahrén B, Masmiquel L, Kumar H, Sargin M, Karsbøl JD, Jacobsen SH, Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. The Lancet Diabetes and Endocrinology. 2017;5(5):341-54. doi: 10.1016/S2213-8587(17)30092-X
9. Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, et al. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018;41(2):258-66. doi: 10.2337/dc17-0417
10. Aroda VR, Bain SC, Cariou B, Piletič M, Rose L, Axelsen M, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. The Lancet Diabetes and Endocrinology. 2017;5(5):355-66. doi: 10.1016/S2213-8587(17)30085-2
11. Rodbard HW, Lingvay I, Reed J, De La Rosa R, Rose L, Sugimoto D, et al. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. Journal of Clinical Endocrinology and Metabolism. 2018;103(6):2291-301. doi: 10.1210/jc.2018-00070
12. Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes and Endocrinology. 2018;6(4):275-86. doi: 10.1016/S2213-8587(18)30024-X
13. Hoffmann K, Michalak M, Paczkowska A. Relative Effectiveness and Safety of the GLP-1 (Glucagon-Like Peptide 1) Receptor Agonists, Semaglutide and Liraglutide in the Treatment of Obese Type 2 Diabetics: A Prospective Observational Cohort Study in Poland. Diabetes Metab Syndr Obes. 2025;18:2723-38. doi: 10.2147/dmso.S531697
14. Pardo Lozano F, Rubio Marcos A, Casañ Fernández R, Bartual Rodrigo A, Martínez-Hervás S, Ampudia-Blasco FJ. Real-world evaluation of the efficacy and safety of switching from weekly dulaglutide to weekly semaglutide: The SEMA-SWITCH study. Endocrinol Diabetes Nutr (Engl Ed). 2025;72(6):501574. doi: 10.1016/j.endien.2025.501574
15. Seijas-Amigo J, Salgado-Barreira Á, Castelo-Dominguez R, Pérez-Álvarez MT, Ponce-Piñón B, Fernández-Silva M, et al. Differences in weight loss and safety between the glucagon-like peptide-1 receptor agonists: A non-randomized multicenter study from the titration phase. Prim Care Diabetes. 2023;17(4):366-72. doi: 10.1016/j.pcd.2023.05.004
16. Pérez-Velasco MA, Bernal-López MR, Trenas A, Ricci M, López-Carmona MD, García de Lucas MD, et al. Efficacy of once-weekly semaglutide in patients with heart failure with preserved ejection fraction, obesity and type 2 diabetes. Medicina clinica. 2025;165(3):107019. doi: 10.1016/j.medcli.2025.107019
17. Rodríguez Jiménez B, Rodríguez de Vera Gómez P, Belmonte Lomas S, Mesa Díaz Á M, Caballero Mateos I, Galán I, et al. Transforming body composition with semaglutide in adults with obesity and type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2024;15:1386542. doi: 10.3389/fendo.2024.1386542
18. Ferrulli A, Senesi P, Sonaglioni A, Cannavaro D, Massarini S, Macrì C, et al. Weight Loss With SGLT2 Inhibitors, Semaglutide, and Transcranial Magnetic Stimulation in Type 2 Diabetes and Obesity. Obesity. 2026;34(2):317-22. doi: 10.1002/oby.70105
19. Alarfaj SJ. The Effectiveness of Semaglutide on a Composite Endpoint of Glycemic Control and Weight Reduction and Its Effect on Lipid Profile Among Obese Type 2 Diabetes Patients. Medicina (Kaunas). 2025;61(8). doi: 10.3390/medicina61081393
20. Caballero-Mateos I, Morales-Portillo C, González Aguilera B. Once-Weekly Semaglutide Improves Body Composition in Spanish Obese Adults with Type 2 Diabetes: A 48-Week Prospective Real-Life Study. J Clin Med. 2025;14(15). doi: 10.3390/jcm14155434
21. Alenzi S, Alzahrani A, Aljaloud A, Alanazi K, Alarfaj SJ. The effectiveness of 0.5 mg and 1mg of semaglutide in patients with type two diabetes and predictors of response: a retrospective cohort study. Front Endocrinol (Lausanne). 2024;15:1395651. doi: 10.3389/fendo.2024.1395651
22. Pérez-Belmonte LM, Sanz-Cánovas J, García de Lucas MD, Ricci M, Avilés-Bueno B, Cobos-Palacios L, et al. Efficacy and Safety of Semaglutide for the Management of Obese Patients With Type 2 Diabetes and Chronic Heart Failure in Real-World Clinical Practice. Front Endocrinol (Lausanne). 2022;13:851035. doi: 10.3389/fendo.2022.851035