COMPARISON OF EFFICACY AND SAFETY PROFILE OF EMPAGLIFLOZIN VERSUS DAPAGLIFLOZIN AS ADD ON THERAPY IN TYPE 2 DIABETIC PATIENTS
Abstract
Background: SGLT-2 (sodium-glucose cotransporter-2) inhibitors are a novel class of oral hypoglycemic agents for the management of type 2 diabetes mellitus (T2DM). Herein, we aimed to assess the efficacy and safety profile of empagliflozin versus dapagliflozin in type 2 diabetic patients Methods: In this randomized controlled trial, type 2 diabetic patients with inadequate glycaemic control HbA1c 7.5-11% with different first line anti diabetic medications were randomly divided in to two groups. Group A were given tablet Empagliflozin 25mg while Group B were given tablet Dapagliflozin 10mg over a period of 12 weeks. The primary end point was to measures efficacy profile in terms of changes in body weight, BMI, fasting blood sugar and HbA1c. The secondary end point was to determine safety and tolerability profile. Results: After 12 weeks of treatment body weight was reduced significantly in both groups empagliflozin -2.9±6.4kg (p‚Œ0.002) versus dapagliflozin -1.7±2.4 (p‚Œ0.007). However, comparison between two groups was non-significant (p‚Œ0.032). FBS was reduced in both study groups empagliflozin -75.6±43.5 mg/dl versus dapagliflozin -63.5±60.5 mg/dl with p< 0.01. However, empagliflozin caused a significant reduction in fasting blood sugar as compared to dapagliflozin (p‚Œ0.001). HbA1c was also significantly reduced in both groups empagliflozin -1.7±0.9% versus dapagliflozin -1.2±1.4% with p<0.01. However, empagliflozin caused a more significant reduction in HbA1c as compared to dapagliflozin (p‚Œ0.002). The tolerability profile of both drugs was quite good and no major adverse effects were reported in both study groups. However minor adverse effects were observed in both study groups. There was low risk of urinary and genital infection with empagliflozin (2.34% & 3.1%) as compared to dapagliflozin (7.08% and 8.66%) with p-value 0.003 and 0.005 respectively. Conclusion: Both empagliflozin and dapagliflozin has excellent efficacy and safety profile. They can be used as add on therapy in type 2 diabetic patients.
References
Zheng Y, Ley SH, Hu FB. Global etiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol 2018;14(2):88-98.
Hussain A, Ali I. Diabetes mellitus in Pakistan: A major public health concern. Arch Pharm Pract 2016;7(1):30-3.
Chikara G, Sharma PK, Dwivedi P, Charan J, Ambwani S, Singh S. A narrative review of potential future antidiabetic drugs: should we expect more? Indian J Clin Biochem 2018;33(2):121-31.
Misra M. SGLT2 inhibitors: a promising new therapeutic option for treatment of type 2 diabetes mellitus. J Pharm Pharmacol 2013;65(3):317-27.
Miller BR, Nguyen H, Hu CJ, Lin C, Nguyen QT. New and emerging drugs and targets for type 2 diabetes: reviewing the evidence. Am Health Drugs Benefits 2014;7(8):452-63.
Kalra S. Sodium glucose co-transporter-2 (SGLT2) inhibitors: a review of their basic and clinical pharmacology. Diabetes Ther 2014;5(2):355-66.
Satoh H. Pleiotropic effects of SGLT2 inhibitors beyond the effect on glycemic control. Diabetol Int 2018;9(4):212-4.
Garofalo C, Borrelli S, Liberti ME, Andreucci M, Conte G, Minutolo R, et al. SGLT2 Inhibitors: Nephroprotective Efficacy and Side Effects. Medicina (Kaunas) 2019;55(6):268.
American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. Diabetes care 2019;42(Suppl 1):S90-102.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, 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 Spectr 2012;25(3):154-71.
Neeland IJ, McGuire DK, Chilton R, Crowe S, Lund SS, Woerle HJ, et al. Empagliflozin reduces body weight and indices of adipose distribution in patients with type 2 diabetes mellitus. Diabetes Vasc Dis Res 2016;13(2):119-26.
Bolinder J, Ljunggren Ö, Johansson L, Wilding J, Langkilde AM, Sjöström CD, et al. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab 2014;16(2):159-69.
Ku EJ, Lee DH, Jeon HJ, Oh TK. Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study. Diabetes Res Clini Pract 2019;151:65-73.
Hussain Syed S, Gosavi S, Shami W, Bustamante, M, Farah Z, Teleb M, et al. A review of sodium glucose co-transporter 2 inhibitors canagliflozin, dapagliflozin and empagliflozin. Cardiovasc Hematol Agents Med Chem 2105;13(2):105-112.
Schubert A, Buchholt AT, El Khoury AC, Kamal A, Taieb V. Evaluating the costs of glycemic response with canagliflozin versus dapagliflozin and empagliflozin as add-on to metformin in patients with type 2 diabetes mellitus in the United Arab Emirates. Curr Med Res Opin 2017;33(6):1155-63.
Lee PC, Gu Y, Yeung MY, Fong CH, Woo YC, Chow WS, et al. Dapagliflozin and empagliflozin ameliorate hepatic dysfunction among chinese subjects with diabetes in part through glycemic improvement: a single-center, retrospective, observational study. Diabetes Ther 2018;9(1):285-95.
Rosenstock J, Seman LJ, Jelaska A, Hantel S, Pinnetti S, Hach T, et al. Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes Obes Metab 2013;15(12):1154-60.
Kovacs CS, Seshiah V, Swallow R, Jones R, Rattunde H, Woerle HJ, et al. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab 2014;16(2):147-58.
Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial combination of empagliflozin and metformin in patients with type 2 diabetes. Diabetes Care 2016;39(10):1718-28.
Romera I, Gomis R, Crowe S, de Pablos-Velasco P, Aranda U, GarcÃa A, et al. Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: A pooled analysis of three randomized trials. J Diabetes Complications 2016;30(8):1571-6.
Fioretto P, Giaccari A, Sesti G. Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus. Cardiovasc Diabetol 2015;14(1):142.
Jabbour SA, Hardy E, Sugg J, Parikh S. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care 2014;37(3):740-50.
Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care 2015;38(3):365-72.
Müller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, et al. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metabo 2018;20(11):2598-607.
Frias JP, Gonzalez-Galvez G, Johnsson EK, Maaske J, Peters A. Dapagliflozin plus Saxagliptin Add-On vs. Glimepiride Add-On to Metformin in Patients with Poorly Controlled Type 2 Diabetes. Diabetes 2018;67(Suppl 1):18-261.
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380(4):347-57.
Minze MG, Will KJ, Terrell BT, Black RL, Irons BK. Benefits of SGLT2 Inhibitors Beyond Glycemic Control-A Focus on Metabolic, Cardiovascular and Renal Outcomes. Curr Diabetes Rev 2018;14(6):509-17.
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