Influence of Adding Empagliflozin to Conventional Anti-diabetic Therapy on Quality of Life Scale for Type 2 Diabetic Patients

Authors

DOI:

https://doi.org/10.31351/vol33iss3pp142-149

Keywords:

type 2 DM, empagliflozin, hemoglobin A1c, quality of life

Abstract

To evaluate the efficacy of empagliflozin on the quality of life (QoL) and glycemic index in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with conventional oral anti-diabetic agents (OADs).

A pre-post study involved forty T2DM patients who were on a combination of three OADs (glimepiride + metformin + vildagliptin) with glycated hemoglobin A1c (HbA1c) 7.0% - 12.0%. All patients received empagliflozin (10 mg/day) as add-on therapy for 16 weeks.

Adding empagliflozin showed significant reduction in postprandial plasma glucose (PPG), (HbA1c), body mass index (BMI) and index of central obesity (ICO) (p<0.001). Significant improvements have been shown in the Quality of Life in Iraqi type 2 diabetic patients (QOLSID) scores post-intervention (p<0.001). Besides, good QoL was reported in patients with lower BMI and among those who had DM for duration less than 10 years.

The outcome of this study showed that empagliflozin as add-on to oral antidiabetic triple therapy in poorly controlled T2DM has achieved a better weight management, well glycaemic control and enhanced QoL through the therapy, and was well tolerated among the study sample.

Keywords: Empagliflozin, Glycemic index, Quality of life, SGLT2 inhibitors, Type 2 DM.

How to Cite

1.
Hadeel Delman Najim, Mohammed Mahmood Mohammed, Abbas Mahdi Rahmah. Influence of Adding Empagliflozin to Conventional Anti-diabetic Therapy on Quality of Life Scale for Type 2 Diabetic Patients. Iraqi Journal of Pharmaceutical Sciences [Internet]. 2024 Sep. 15 [cited 2024 Nov. 21];33(3):142-9. Available from: https://bijps.uobaghdad.edu.iq/index.php/bijps/article/view/2742

Publication Dates

References

IDF. International Diabetes Federation. IDF Diabetes Atlas . http:// www. idf. org /diabetesatlas. Vol. 6th editio, Brussels, Belgium: International Diabetes Federation. 2013.

Associaton AD. Diagnosis and classification of diabetes mellitus. Vol. 37, Diabetes care. Am Diabetes Assoc; 2014.

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. 2012;55(6):1577–96.

Association AD. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S98–110.

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. 2022 Sep 28;45(11):2753–86.

Hadi RA, Mohammed MM, Salman IN. Studying the Effect of Adding Alpha Lipoic Acid to Gabapentin to Improve Nerve Conduction Velocity and Glycemic Control of Patients with Diabetic Neuropathy (Sample of Iraqi population). Al-Mustansiriyah J Pharm Sci. 2020;20(1).

Li Y-Y, Yang Y-M, Zhu S, Cheng H, Hernandez J, Huang W, et al. Changes in body weight and cardiovascular risk factors in a Chinese population with type 2 diabetes mellitus: a longitudinal study. Front Endocrinol (Lausanne). 2023;14:1112855.

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.

Yerevanian A, Soukas AA. Metformin: Mechanisms in Human Obesity and Weight Loss. Curr Obes Rep. 2019;8(2):156–64.

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.

Rowlands J, Heng J, Newsholme P, Carlessi R. Pleiotropic Effects of GLP-1 and Analogs on Cell Signaling, Metabolism, and Function. Front Endocrinol (Lausanne). 2018;9:672.

Thrasher J. Pharmacologic Management of Type 2 Diabetes Mellitus: Available Therapies. Am J Med. 2017 Jun;130(6S):S4–17.

Galindo RJ, Dhatariya K, Gomez-Peralta F, Umpierrez GE. Safety and Efficacy of Inpatient Diabetes Management with Non-insulin Agents: an Overview of International Practices. Curr Diab Rep. 2022 Jun;22(6):237–46.

Nesti L, Tricò D, Mengozzi A, Natali A. Rethinking pioglitazone as a cardioprotective agent: a new perspective on an overlooked drug. Cardiovasc Diabetol. 2021;20(1):109.

Association AD. Economic costs of diabetes in the US in 2012. Diabetes Care. 2013;36(4):1033–46.

Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, et al. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan;388(2):117–27.

Moher D, Hopewell S, Schulz KF. Empagliflozin and progression of kidney disease in type 2 diabetes. New Engl J Med. 2008;358:2560–72.

Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413–24.

Addington-Hall J, Kalra L. Who should measure quality of life? BMJ. 2001 Jun;322(7299):1417–20.

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.

Devlin NJ, Brooks R. EQ-5D and the EuroQol group: past, present and future. Appl Health Econ Health Policy. 2017;15:127–37.

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.

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.

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.

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.

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.

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).

Administration USF and D, Commission FDADS. FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Accessed 21 July 2021.

Douros A, Lix LM, Fralick M, Dell’Aniello S, Shah BR, Ronksley PE, et al. Sodium–glucose cotransporter-2 inhibitors and the risk for diabetic ketoacidosis: a multicenter cohort study. Ann Intern Med. 2020;173(6):417–25.

White CA, Kennedy JF. Methods of enzymatic analysis, volume VI: Metabolites 1: Carbohydrates edited by HU Bergmeyer, J. Bergmeyer and M. GraRl, Verlag Chemie, Weinheim, 1984. pp. xxix+ 701, individual volume price 150.00,DM350.00;seriessubscriptionprice 130.00, DM 295.00. ISBN. Wiley Online Library; 1985.

Goldstein DE, Little RR, Wiedmeyer HM, England JD, McKenzie EM. Glycated hemoglobin: methodologies and clinical applications. Clin Chem. 1986 Oct;32(10 Suppl):B64-70.

Obesity: preventing and managing the global epidemic. Report of a WHO consultation. Vol. 894, World Health Organization technical report series. Switzerland; 2000.

Organization WH. Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008. 2011;

Parikh RM, Joshi SR, Menon PS, Shah NS. Index of central obesity - A novel parameter. Med Hypotheses. 2007;68(6):1272–5.

Kalra S, Jena BN, Yeravdekar R. Emotional and psychological needs of people with diabetes. Indian J Endocrinol Metab. 2018;22(5):696.

Diabetes NHS. Emotional and psychological support and care in diabetes. Rep from Emot Psychol Support Work Gr NHS Diabetes Diabetes UK. 2010;

Lai TC, McDaniel CC, Chou C. Diabetes management behaviors associated with depression in the U.S. Diabetol Metab Syndr. 2022 Nov;14(1):178.

Akhaury K, Chaware S. Relation Between Diabetes and Psychiatric Disorders. Cureus. 2022 Oct;14(10):e30733.

Najar IA, Masoodi SR, Mir SA, Bhat MH, Patyar RR, Patyar S. Impact of empagliflozin add-on therapy on quality of life in patients of type 2 diabetes mellitus with hypertension: A prospective study. Indian J Public Health. 2022 Nov;66(Supplement):S41–4.

Salman IN. β-Cell function in a sample of Iraqi Patients with type 2 diabetes mellitus Isam Noori Salman. Al Mustansiriyah J Pharm Sci. 2018;18(1):68–72.

Ku EJ, Lee D-H, Jeon HJ, Oh TK. Effectiveness and safety of empagliflozin-based quadruple therapy compared with insulin glargine-based therapy in patients with inadequately controlled type 2 diabetes: An observational study in clinical practice. Diabetes Obes Metab. 2019 Jan;21(1):173–7.

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.

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 Mar;13(2):119–26.

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.

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.

Faruqui A. Post Prandial Hyperglycemia: A Real Threat for Patients with Type 2 Diabetes Mellitus. 2017;

Ceriello A. Postprandial Hyperglycemia and Diabetes Complications: Is It Time to Treat? Diabetes. 2005 Jan 1;54(1):1–7.

Ferrannini E, Seman L, Seewaldt-Becker E, Hantel S, Pinnetti S, Woerle HJ. A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):721–8.

Devineni D, Morrow L, Hompesch M, Skee D, Vandebosch A, Murphy J, et al. Canagliflozin improves glycaemic control over 28 days in subjects with type 2 diabetes not optimally controlled on insulin. Diabetes Obes Metab. 2012 Jun;14(6):539–45.

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. 2012 Mar 1;97(3):1020–31.

Perry RJ, Shulman GI. Sodium-glucose cotransporter-2 inhibitors: Understanding the mechanisms for therapeutic promise and persisting risks. J Biol Chem. 2020 Oct;295(42):14379–90.

Fishman B, Shlomai G, Twig G, Derazne E, Tenenbaum A, Fisman EZ, et al. Renal glucosuria is associated with lower body weight and lower rates of elevated systolic blood pressure: results of a nationwide cross-sectional study of 2.5 million adolescents. Cardiovasc Diabetol. 2019;18(1):124.

Downloads

Published

2024-09-15