Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients
Keywords:
Type 2 DM, Dapagliflozin, Haemoglobin A1c, Quality of life
Abstract
Evaluate the efficacy of dapagliflozin on glycaemic and non-glycaemic indices and assess quality of life in type 2 diabetes patients (T2DM) with inadequate glycaemic control on three oral antidiabetic agents (OADs). Patients with uncontrolled type 2 diabetes [Haemoglobin A1c 7.0%-12.0%] on sulfonylurea, metformin and gliptin were selected to receive dapagliflozin 5mg/day for 16 weeks (n=40). Fasting and postprandial plasma glucose, glycated haemoglobin A1c, body weight, and waist circumference were measured. Assessment of patients’ quality of life was performed using Quality of Life Scale for Iraqi Diabetic patients (QOLSID) at baseline and after administration of dapagliflozin. Dapagliflozin showed high significant reduction in fasting and postprandial plasma glucose, glycated haemoglobin A1c (HbA1c), body mass index (BMI) and index of central obesity (ICO) (p<0.001). High significant changes in the QOLSID score after treatment (p<0.001). High BMI is negative predictor for patients’ quality of life. Dapagliflozin improved both glycaemic and non-glycaemic parameters in T2DM patients who already on three OADs. This is promising results in short period makes the treatment a suitable alternative to insulin specially in patients not prefer to use injected medication. Dapagliflozin showed an improvement in the patients’ physical and psychological condition and consequently overall QOL.
References
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25. Aso Y, Suzuki K, Chiba Y, Sato M, Fujita N, Takada Y, et al. Effect of insulin degludec versus insulin glargine on glycemic control and daily fasting blood glucose variability in insulin-naïve Japanese patients with type 2 diabetes: I’D GOT trial. Diabetes Res Clin Pract. 2017 Aug;130:237–43.
26. Mostafa NM, Ahmed GH, Anwar W. Effect of educational nursing program on quality of life for patients with type II diabetes mellitus at Assiut University Hospital. J Nurs Educ Pr. 2018;8(11).
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28. Matthaei S, Bowering K, Rohwedder K, Sugg J, Parikh S, Johnsson E. Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. Diabetes Obes Metab. 2015 Nov;17(11):1075–84.
29. 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 [Internet]. 2014;16(2):159–69. Available from: https://doi.org/10.1111/dom.12189
30. Jabbour SA, Hardy E, Sugg J, Parikh Shamik, Group for the S 10. 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 [Internet]. 2014 Feb 11;37(3):740–50. Available from: https://doi.org/10.2337/dc13-0467
31. Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S, Group for the S 05. 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 [Internet]. 2015 Jan 15;38(3):365–72. Available from: https://doi.org/10.2337/dc14-0666
32. Heine RJ, Balkau B, Ceriello A, Del Prato S, Horton ES, Taskinen M-R. What does postprandial hyperglycaemia mean? Diabet Med. 2004 Mar;21(3):208–13.
33. Monnier L, Colette C, Dunseath GJ, Owens DR. The loss of postprandial glycemic control precedes stepwise deterioration of fasting with worsening diabetes. Diabetes Care. 2007 Feb;30(2):263–9.
34. Faruqui A. Post Prandial Hyperglycemia: A Real Threat for Patients with Type 2 Diabetes Mellitus. 2017;
35. Bolinder J, Ljunggren Ö, Kullberg J, Johansson L, Wilding J, Langkilde AM, et al. Effects of Dapagliflozin on Body Weight, Total Fat Mass, and Regional Adipose Tissue Distribution in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin. J Clin Endocrinol Metab [Internet]. 2012 Mar 1;97(3):1020–31. Available from: https://doi.org/10.1210/jc.2011-2260
36. Kalra S, Jena BN, Yeravdekar R. Emotional and psychological needs of people with diabetes. Indian J Endocrinol Metab. 2018;22(5):696.
37. Diabetes NHS. Emotional and psychological support and care in diabetes. Rep from Emot Psychol Support Work Gr NHS Diabetes Diabetes UK. 2010;
38. Egede LE, Ellis C. Diabetes and depression: global perspectives. Diabetes Res Clin Pract. 2010;87(3):302–12.
39. Huang C-J, Chiu H-C, Lee M-H, Wang S-Y. Prevalence and incidence of anxiety disorders in diabetic patients: a national population-based cohort study. Gen Hosp Psychiatry. 2011;33(1):8–15.
40. Grandy S, Langkilde AM, Sugg JE, Parikh S, Sjöström CD. Health-related quality of life (EQ-5D) among type 2 diabetes mellitus patients treated with dapagliflozin over 2 years. Int J Clin Pract [Internet]. 2014;68(4):486–94. Available from: https://doi.org/10.1111/ijcp.12341
41. Grandy S, Hashemi M, Langkilde A-M, Parikh S, Sjöström CD. Changes in weight loss-related quality of life among type 2 diabetes mellitus patients treated with dapagliflozin. Diabetes, Obes Metab [Internet]. 2014;16(7):645–50. Available from: https://doi.org/10.1111/dom.12263
42. Ishii H, Nakajima H, Kamei N, Niiya T, Hiyoshi T, Hiramori Y, et al. Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study). Diabetes Ther Res Treat Educ diabetes Relat Disord. 2020 Dec;11(12):2959–77.
2. Vanstone M, Rewegan A, Brundisini F, Dejean D, Giacomini M. Patient perspectives on quality of life with uncontrolled type 1 diabetes mellitus: a systematic review and qualitative meta-synthesis. Ont Health Technol Assess Ser. 2015;15(17):1.
3. Gebremedhin T, Workicho A, Angaw DA. Health-related quality of life and its associated factors among adult patients with type II diabetes attending Mizan Tepi University Teaching Hospital, Southwest Ethiopia. BMJ Open Diabetes Res Care. 2019;7(1):e000577.
4. Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care [Internet]. 2022 Sep 28;45(11):2753–86. Available from: https://doi.org/10.2337/dci22-0034
5. Vijan S, Sussman JB, Yudkin JS, Hayward RA. Effect of Patients’ Risks and Preferences on Health Gains With Plasma Glucose Level Lowering in Type 2 Diabetes Mellitus. JAMA Intern Med [Internet]. 2014 Aug 1;174(8):1227–34. Available from: https://doi.org/10.1001/jamainternmed.2014.2894
6. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia 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). Diabetologia [Internet]. 2012;55(6):1577–96. Available from: https://doi.org/10.1007/s00125-012-2534-0
7. Association AD. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S98–110.
8. Hermansen K, Mortensen LS. Bodyweight changes associated with antihyperglycaemic agents in type 2 diabetes mellitus. Drug Saf. 2007;30:1127–42.
9. Sazan DS, Kassim JS, Ansam NH. Comparative study between Metformin, Glibenclamide and their combination in newly diagnosed diabetic (type II) patients in Hawler City. Al Mustansiriyah J Pharm Sci. 2012;12(2):61–74.
10. Derosa G, Maffioli P. Effects of thiazolidinediones and sulfonylureas in patients with diabetes. Diabetes Technol Ther. 2010;12(6):491–501.
11. Najim HD, Majeed IA, Rahmah AM. Effects of Metformin &/or Glimepiride on Resistin Level and Related Biochemical Markers in Type 2 Diabetes Mellitus. Al Mustansiriyah J Pharm Sci. 2014;14(2):78–88.
12. Fonseca V. Effect of thiazolidinediones on body weight in patients with diabetes mellitus. Am J Med [Internet]. 2003;115(8, Supplement 1):42–8. Available from: https://www.sciencedirect.com/science/article/pii/S0002934303005631
13. Tamez-Pérez HE, Proskauer-Peña SL, Hernández-Coria MI, Garber AJ. AACE COMPREHENSIVE DIABETES MANAGEMENT ALGORITHM 2013 ENDOCRINE PRACTICE/IN RESPONSE. Endocr Pract. 2013;19(4):736.
14. Heerspink HJL, Stefánsson B V., Correa-Rotter R, Chertow GM, Greene T, Hou F-F, et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020;383(15):1436–46.
15. Solomon SD, McMurray JJ V, Claggett B, de Boer RA, DeMets D, Hernandez AF, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2022;387(12):1089–98.
16. 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.
17. McMurray JJ V, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995–2008.
18. Addington-Hall J, Kalra L. Who should measure quality of life? BMJ. 2001 Jun;322(7299):1417–20.
19. Gholami A, Jahromi LM, Zarei E, Dehghan A. Application of WHOQOL-BREF in measuring quality of life in health-care staff. Int J Prev Med. 2013;4(7):809.
20. Devlin NJ, Brooks R. EQ-5D and the EuroQol group: past, present and future. Appl Health Econ Health Policy. 2017;15:127–37.
21. Abedini MR, Bijari B, Miri Z, Shakhs Emampour F, Abbasi A. The quality of life of the patients with diabetes type 2 using EQ-5D-5 L in Birjand. Health Qual Life Outcomes. 2020;18(1):1–9.
22. Prajapati VB, Blake R, Acharya LD, Seshadri S. Assessment of quality of life in type II diabetic patients using the modified diabetes quality of life (MDQoL)-17 questionnaire. Brazilian J Pharm Sci. 2018;53.
23. Mikhael EM, Hassali MA, Hussain SA, Shawky N. The Development and Validation of Quality of Life Scale for Iraqi Patients with Type 2 Diabetes Mellitus. J Pharm Bioallied Sci. 2020;12(3):262–8.
24. Ishii H, Niiya T, Ono Y, Inaba N, Jinnouchi H, Watada H. Improvement of quality of life through glycemic control by liraglutide, a GLP-1 analog, in insulin-naive patients with type 2 diabetes mellitus: the PAGE1 study. Diabetol Metab Syndr. 2017;9:3.
25. Aso Y, Suzuki K, Chiba Y, Sato M, Fujita N, Takada Y, et al. Effect of insulin degludec versus insulin glargine on glycemic control and daily fasting blood glucose variability in insulin-naïve Japanese patients with type 2 diabetes: I’D GOT trial. Diabetes Res Clin Pract. 2017 Aug;130:237–43.
26. Mostafa NM, Ahmed GH, Anwar W. Effect of educational nursing program on quality of life for patients with type II diabetes mellitus at Assiut University Hospital. J Nurs Educ Pr. 2018;8(11).
27. Jeon HJ, Ku EJ, Oh TK. Dapagliflozin improves blood glucose in diabetes on triple oral hypoglycemic agents having inadequate glucose control. Diabetes Res Clin Pract [Internet]. 2018;142:188–94. Available from: https://www.sciencedirect.com/science/article/pii/S0168822718302900
28. Matthaei S, Bowering K, Rohwedder K, Sugg J, Parikh S, Johnsson E. Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. Diabetes Obes Metab. 2015 Nov;17(11):1075–84.
29. 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 [Internet]. 2014;16(2):159–69. Available from: https://doi.org/10.1111/dom.12189
30. Jabbour SA, Hardy E, Sugg J, Parikh Shamik, Group for the S 10. 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 [Internet]. 2014 Feb 11;37(3):740–50. Available from: https://doi.org/10.2337/dc13-0467
31. Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S, Group for the S 05. 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 [Internet]. 2015 Jan 15;38(3):365–72. Available from: https://doi.org/10.2337/dc14-0666
32. Heine RJ, Balkau B, Ceriello A, Del Prato S, Horton ES, Taskinen M-R. What does postprandial hyperglycaemia mean? Diabet Med. 2004 Mar;21(3):208–13.
33. Monnier L, Colette C, Dunseath GJ, Owens DR. The loss of postprandial glycemic control precedes stepwise deterioration of fasting with worsening diabetes. Diabetes Care. 2007 Feb;30(2):263–9.
34. Faruqui A. Post Prandial Hyperglycemia: A Real Threat for Patients with Type 2 Diabetes Mellitus. 2017;
35. Bolinder J, Ljunggren Ö, Kullberg J, Johansson L, Wilding J, Langkilde AM, et al. Effects of Dapagliflozin on Body Weight, Total Fat Mass, and Regional Adipose Tissue Distribution in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin. J Clin Endocrinol Metab [Internet]. 2012 Mar 1;97(3):1020–31. Available from: https://doi.org/10.1210/jc.2011-2260
36. Kalra S, Jena BN, Yeravdekar R. Emotional and psychological needs of people with diabetes. Indian J Endocrinol Metab. 2018;22(5):696.
37. Diabetes NHS. Emotional and psychological support and care in diabetes. Rep from Emot Psychol Support Work Gr NHS Diabetes Diabetes UK. 2010;
38. Egede LE, Ellis C. Diabetes and depression: global perspectives. Diabetes Res Clin Pract. 2010;87(3):302–12.
39. Huang C-J, Chiu H-C, Lee M-H, Wang S-Y. Prevalence and incidence of anxiety disorders in diabetic patients: a national population-based cohort study. Gen Hosp Psychiatry. 2011;33(1):8–15.
40. Grandy S, Langkilde AM, Sugg JE, Parikh S, Sjöström CD. Health-related quality of life (EQ-5D) among type 2 diabetes mellitus patients treated with dapagliflozin over 2 years. Int J Clin Pract [Internet]. 2014;68(4):486–94. Available from: https://doi.org/10.1111/ijcp.12341
41. Grandy S, Hashemi M, Langkilde A-M, Parikh S, Sjöström CD. Changes in weight loss-related quality of life among type 2 diabetes mellitus patients treated with dapagliflozin. Diabetes, Obes Metab [Internet]. 2014;16(7):645–50. Available from: https://doi.org/10.1111/dom.12263
42. Ishii H, Nakajima H, Kamei N, Niiya T, Hiyoshi T, Hiramori Y, et al. Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study). Diabetes Ther Res Treat Educ diabetes Relat Disord. 2020 Dec;11(12):2959–77.
Published
2024-03-25
How to Cite
Najim, H. D., Mohammed Mahmood Mohammed, & Abbas Mahdi Rahmah. (2024). Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients. Indonesian Journal of Pharmacy, 35(1), 154–161. https://doi.org/10.22146/ijp.8501
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Research Article
