Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Vị trí của Gliclazide trong bối cảnh ngày càng thay đổi và quá trình bệnh lý của ĐTĐ type 2: Một đồng thuận dựa trên khảo sát Delphi hợp tác từ Ấn Độ
Tóm tắt
Nghiên cứu Delphi này nhằm cung cấp ý kiến chuyên gia dựa trên chứng cứ về việc sử dụng và vị trí hiện tại của gliclazide trong quản lý bệnh đái tháo đường type 2 (T2DM) ở Ấn Độ. Phương pháp khảo sát Delphi đã được điều chỉnh một lần duy nhất được sử dụng để thu thập ý kiến về việc sử dụng gliclazide và vị trí của nó trong quản lý bệnh tiểu đường từ 338 bác sĩ nội tiết/đái tháo đường có kinh nghiệm lâm sàng với gliclazide. Các tham gia viên, sử dụng thang điểm 9 điểm, đã được yêu cầu đánh giá tám phát biểu gồm tổng cộng 52 mục liên quan. Sự đồng thuận của Delphi chỉ ra rằng trong các bệnh nhân chưa dùng thuốc với T2DM, không dung nạp với metformin hoặc trong trường hợp metformin bị chống chỉ định, liệu pháp kép với gliclazide/gliclazide thải từ từ (MR) cần được xem xét kết hợp với một chất ức chế dipeptidyl peptidase 4 (DPP4) nếu mức hemoglobin glycat A1c lớn hơn 7,5% và với insulin nếu mức A1c vượt quá 9%. Nếu bệnh nhân không được kiểm soát đầy đủ với metformin (mức A1c lớn hơn 6,5% sau 3 tháng điều trị), gliclazide/gliclazide-MR sẽ được thêm vào phác đồ điều trị để đạt được giảm và duy trì mức A1c thấp hơn. Tuy nhiên, nó không được ưa chuộng hơn các nhóm thuốc điều trị đái tháo đường khác trong các tình huống lâm sàng như vậy, ngoại trừ các chất ức chế alpha-glucosidase (AGI). Việc thêm sớm gliclazide/gliclazide-MR sẽ được ưu tiên hơn việc tăng liều metformin lên quá nửa liều tối đa để quản lý hiệu quả T2DM. Gliclazide/gliclazide-MR có thể được sử dụng an toàn ở những bệnh nhân mắc bệnh tiểu đường với các bệnh lý tim mạch và thận mãn tính. Nó có thể được sử dụng ở những bệnh nhân lớn tuổi mắc T2DM vì không có các chuyển hóa hoạt động và có nguy cơ hạ đường huyết thấp. Nhóm chuyên gia đã đề xuất xem xét liệu pháp đơn hoặc liệu pháp kép với gliclazide là lựa chọn lý tưởng cho các bệnh nhân mắc T2DM do hiệu quả của nó, kiểm soát đường huyết lâu dài, kết quả thận thuận lợi, độ an toàn tim mạch và hồ sơ an toàn tối ưu.
Từ khóa
#gliclazide #đái tháo đường type 2 #metformin #điều trị #thuốc điều trị đái tháo đường #khảo sát DelphiTài liệu tham khảo
Misra A, Gopalan H, Jayawardena R, et al. Diabetes in developing countries. J Diabetes. 2019;11(7):522–39.
Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the International Diabetes Federation Diabetes Atlas, 9(th) edition. Diabetes Res Clin Pract. 2019;157:107843.
Singla R, Bindra J, Singla A, Gupta Y, Kalra S. Drug prescription patterns and cost analysis of diabetes therapy in India: audit of an endocrine practice. Indian J Endocrinol Metab. 2019;23(1):40–5.
American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(Suppl 1):S98.
International Diabetes Federation. IDF clinical practice recommendations for managing type 2 diabetes in primary care. IDF. 2020. https://www.idf.org/e-library/guidelines/128-idf-clinical-practice-recommendations-for-managing-type-2-diabetes-in-primary-care.html. Accessed 16 Dec 2020.
Kalra S, Aamir AH, Raza A, et al. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: a consensus statement. Indian J Endocrinol Metab. 2015;19(5):577–96.
Chawla R, Madhu SV, Makkar BM, Ghosh S, Saboo B, Kalra S. RSSDI-ESI clinical practice recommendations for the management of type 2 diabetes mellitus 2020. Indian J Endocrinol Metab. 2020;24(1):1–122.
Rutten G, De Grauw W, Nijpels G, et al. NHG-Standaard Diabetes mellitus type 2 (derde herziening). Huisarts Wet. 2013;56(10):512–25.
Colagiuri S, Matthews D, Leiter LA, Chan SP, Sesti G, Marre M. The place of gliclazide MR in the evolving type 2 diabetes landscape: a comparison with other sulfonylureas and newer oral antihyperglycemic agents. Diabetes Res Clin Pract. 2018;143:1–14.
Jarvis JD, Woods H, Bali A, Oronsaye E, Persaud N. Selection of WHO-recommended essential medicines for non-communicable diseases on National Essential Medicines Lists. PLoS One. 2019;14(8):e0220781.
Rauch W. The decision Delphi. Technol Forecast Soc Chang. 1979;15(3):159–69.
American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(Supplement 1):S90–102.
Aschner P. New IDF clinical practice recommendations for managing type 2 diabetes in primary care. Diabetes Res Clin Pract. 2017;132:169–70.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364–79.
Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naïve patients with type 2 diabetes. Horm Metab Res. 2009;41(12):905–9.
Landman GW, de Bock GH, van Hateren KJ, et al. Safety and efficacy of gliclazide as treatment for type 2 diabetes: a systematic review and meta-analysis of randomized trials. PLoS One. 2014;9(2):e82880.
Leiter LA, Shestakova MV, Satman I. Effectiveness of gliclazide MR 60 mg in the management of type 2 diabetes: analyses from the EASYDia trial. Diabetol Metab Syndr. 2018;10:30.
Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract. 2009;15(6):540–59.
Kalra S, Bahendeka S, Sahay R, et al. Consensus recommendations on sulfonylurea and sulfonylurea combinations in the management of type 2 diabetes mellitus—International Task Force. Indian J Endocrinol Metab. 2018;22(1):132–57.
Bolen S, Tseng E, Hutfless S, et al. Diabetes medications for adults with type 2 diabetes: an update. 2016. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Apr. Report No.: 16-EHC013-EF.
Schernthaner G, Grimaldi A, Di Mario U, et al. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest. 2004;34(8):535–42.
Royal Australian College of General Practitioners. General practice management of type 2 diabetes: 2016–18. RACGP. 2016. https://www.racgp.org.au/FSDEDEV/media/documents/Clinical%20Resources/Guidelines/Diabetes/General-practice-management-of-type-2-diabetes_1.pdf. Accessed 21 Jan 2020.
Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018;61(12):2461–98.
World Health Organization. Guidelines on second-and third-line medicines and type of insulin for the control of blood glucose levels in non-pregnant adults with diabetes mellitus. Guidelines on second-and third-line medicines and type of insulin for the control of blood glucose levels in non-pregnant adults with diabetes mellitus. 2018. Geneva: WHO.
Ahrén B, Mathieu C, Bader G, Schweizer A, Foley JE. Efficacy of vildagliptin versus sulfonylureas as add-on therapy to metformin: comparison of results from randomised controlled and observational studies. Diabetologia. 2014;57(7):1304–7.
Yang W, Chen L, Ji Q, et al. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial. Diabetes Obes Metab. 2011;13(1):81–8.
Derosa G, Putignano P, Bossi AC, et al. Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients. Eur J Pharmacol. 2011;666(1–3):251–6.
Derosa G, Maffioli P, Salvadeo SA, et al. Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients. Metabolism. 2010;59(6):887–95.
Li Z, Zhang Y, Quan X, et al. Efficacy and acceptability of glycemic control of glucagon-like peptide-1 receptor agonists among type 2 diabetes: a systematic review and network meta-analysis. PLoS One. 2016;11(5):e0154206.
Ahrén B, Johnson SL, Stewart M, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care. 2014;37(8):2141–8.
Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–72.
Satoh J, Takahashi K, Takizawa Y, et al. Secondary sulfonylurea failure: comparison of period until insulin treatment between diabetic patients treated with gliclazide and glibenclamide. Diabetes Res Clin Pract. 2005;70(3):291–7.
Zhou J, Zheng F, Guo X, et al. Glargine insulin/gliclazide MR combination therapy is more effective than premixed insulin monotherapy in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. Diabetes Metab Res Rev. 2015;31(7):725–33.
McIntosh B, Cameron C, Singh SR, Yu C, Dolovich L, Houlden R. Choice of therapy in patients with type 2 diabetes inadequately controlled with metformin and a sulphonylurea: a systematic review and mixed-treatment comparison meta-analysis. Open Med. 2012;6(2):e62-74.
Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010;303(14):1410–8.
Makrilakis K. The role of DPP-4 inhibitors in the treatment algorithm of type 2 diabetes mellitus: when to select, what to expect. Int J Environ Res Public Health. 2019;16(15):2720.
Polavarapu NK, Kale R, Sethi B, et al. Effect of gliclazide or gliclazide plus metformin combination on glycemic control in patients with T2DM in India: a real-world, retrospective, longitudinal, observational study from electronic medical records. Drugs Real World Outcomes. 2020;7(4):271–9.
Zhang Y, Hong J, Chi J, Gu W, Ning G, Wang W. Head-to-head comparison of dipeptidyl peptidase-IV inhibitors and sulfonylureas - a meta-analysis from randomized clinical trials. Diabetes Metab Res Rev. 2014;30(3):241–56.
Ridderstråle M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(9):691–700.
Del Prato S, Nauck M, Durán-Garcia S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17(6):581–90.
Simpson SH, Lee J, Choi S, Vandermeer B, Abdelmoneim AS, Featherstone TR. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. Lancet Diabetes Endocrinol. 2015;3(1):43–51.
Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669–701.
Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255–323.
Ekström N, Svensson AM, Miftaraj M, et al. Cardiovascular safety of glucose-lowering agents as add-on medication to metformin treatment in type 2 diabetes: report from the Swedish National Diabetes Register. Diabetes Obes Metab. 2016;18(10):990–8.
Mogensen UM, Andersson C, Fosbøl EL, et al. Metformin in combination with various insulin secretagogues in type 2 diabetes and associated risk of cardiovascular morbidity and mortality–a retrospective nationwide study. Diabetes Res Clin Pract. 2015;107(1):104–12.
Katakami N, Yamasaki Y, Hayaishi-Okano R, et al. Metformin or gliclazide, rather than glibenclamide, attenuate progression of carotid intima-media thickness in subjects with type 2 diabetes. Diabetologia. 2004;47(11):1906–13.
Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93.
Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–91.
Oellgaard J, Gæde P, Rossing P, et al. Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study. Diabetologia. 2018;61(8):1724–33.
Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2020;98(4s):S1-S115.
Neumiller JJ, Alicic RZ, Tuttle KR. Therapeutic considerations for antihyperglycemic agents in diabetic kidney disease. J Am Soc Nephrol. 2017;28(8):2263–74.
Pugliese G, Penno G, Natali A, et al. Diabetic kidney disease: new clinical and therapeutic issues. Joint position statement of the Italian Diabetes Society and the Italian Society of Nephrology on “The natural history of diabetic kidney disease and treatment of hyperglycemia in patients with type 2 diabetes and impaired renal function.” J Nephrol. 2020;33(1):9–35.
KDOQI Clinical Practice Guideline for Diabetes and CKD. 2012 Update. Am J Kidney Dis. 2012;60(5):850–86.
Perkovic V, Heerspink HL, Chalmers J, et al. Intensive glucose control improves kidney outcomes in patients with type 2 diabetes. Kidney Int. 2013;83(3):517–23.
Lee YH, Lee CJ, Lee HS, et al. Comparing kidney outcomes in type 2 diabetes treated with different sulphonylureas in real-life clinical practice. Diabetes Metab. 2015;41(3):208–15.
Srivastava K, Arora A, Kataria A, Cappelleri JC, Sadosky A, Peterson AM. Impact of reducing dosing frequency on adherence to oral therapies: a literature review and meta-analysis. Patient Prefer Adher. 2013;7:419–34.
Chan SP, Colagiuri S. Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents. Diabetes Res Clin Pract. 2015;110(1):75–81.
Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159(4):262–74.
Nichols GA, Gomez-Caminero A. Weight changes following the initiation of new anti-hyperglycaemic therapies. Diabetes Obes Metab. 2007;9(1):96–102.
Zoungas S, Chalmers J, Kengne AP, et al. The efficacy of lowering glycated haemoglobin with a gliclazide modified release-based intensive glucose lowering regimen in the ADVANCE trial. Diabetes Res Clin Pract. 2010;89(2):126–33.
Vaccaro O, Masulli M, Nicolucci A, et al. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial. Lancet Diabetes Endocrinol. 2017;5(11):887–97.
Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009;373(9681):2125–35.
Mohan V, Chopra V, Sanyal D, Jain S, Jayaprakashsai J. Treatment of type 2 diabetes with a breakable extended release gliclazide formulation in primary care: the Xrise Study. J Assoc Phys India. 2015;63(12):26–9.
Tessier D, Dawson K, Tétrault JP, Bravo G, Meneilly GS. Glibenclamide vs gliclazide in type 2 diabetes of the elderly. Diabet Med. 1994;11(10):974–80.