LACK OF HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTRED OUTCOME MEASURES IN RANDOMIZED CONTROLLED TRIALS CONDUCTED FOR DIABETES PHARMACOTHERAPY: SGLT-2 RECEPTOR INHIBITORS AS AN EXAMPLE

Main Article Content

Pendar Farahani

Keywords

diabetes, sulfonylurea, hypoglycemia, obesity, quality of life, SGLT-2

Abstract

Background
Use of SGLT-2 receptor inhibitors has been associated with weight loss and a low rate of hypoglycemia in comparison to sulfonylureas. These factors may improve health-related quality of life for patients with diabetes.


Objective
To systematically explore randomized controlled trials (RCTs) involving SGLT-2 receptor inhibitors that reported health-related quality of life changes.


Methods
A systematic review of SGLT-2 receptor inhibitors clinical trials, limited to RCTs and English language, was conducted utilizing PubMed databases.


Results
One-hundred and eighteen RCTs were reviewed and 62 RCTs meeting the inclusion criteria were assessed. All 62 RCTs reported body mass index (BMI) changes and HgbA1c reduction. Measures of health-related quality-of-life (HRQoL) were reported in only 2 RCTs. Both studies illustrate improvement in HRQoL domains for SGLT-2 receptor inhibitors in comparison to the other arms in the RCTs.


Conclusion
Only a small portion of RCTs involving SGLT-2 receptor inhibitors reported on HRQoL. Because of the potential for weight loss and hypoglycemia avoidance to improve HRQoL, future studies of SGLT-2 receptor inhibitors should measure and report on patient-centred outcomes such as HRQoL.

Abstract 97 | PDF Downloads 38

References

1. Cannella L, Caocci G, Jacobs M, et al. Health-related quality of life and symptom assessment in randomized controlled trials of patients with leukemia and myelodysplastic syndromes: What have we learned? Crit Rev Oncol Hematol 2015;96:542–54.
2. Bridoux V, Moutel G, Lefebure B, et al. Reporting on quality of life in randomised controlled trials in gastrointestinal surgery. J Gastrointest Surg 2010;14:156–65.
3. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev 1999;15:205–18.
4. Wycherley TP, Clifton PM, Noakes M, Brinkworth GD. Weight loss on a structured hypocaloric diet with or without exercise improves emotional distress and quality of life in overweight and obese patients with type 2 diabetes. J Diabetes Investig 2014;5:94–98.
5. Sheu WH, Ji LN, Nitiyanant W et al. Hypoglycemia is associated with increased worry and lower quality of life among patients with type 2 diabetes treated with oral antihyperglycemic agents in the Asia-Pacific region. Diabetes Res Clin Pract 2012;96:141–48.
6. Williams SA, Pollack MF, Dibonaventura M. Effects of hypoglycemia on health-related quality of life, treatment satisfaction and healthcare resource utilization in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract 2011;91:363–70.
7. Grandy S, Hashemi M, Langkilde AM, Parikh S, Sjos - trom CD. Changes in weight loss-related quality of life among type 2 diabetes mellitus patients treated with dapagliflozin. Diabetes Obes Metab 2014;16:645–50.
8. Traina S, Guthrie R, Slee A. The impact of weight loss on weight-related quality of life and health satisfaction: results from a trial comparing canagliflozin with sitagliptin in triple therapy among people with type 2 diabetes. Postgrad Med 2014;126:7–15.
9. Richard Sicree, Jonathan Shaw, Paul Zimmet. Diabetes and impaired glucose tolerance The Global Burden. IDF diabetes atlas, 4 th ed; 2013 Available at: http:// www idf org/sites/default/files/The_Global_Burden pdf [serial online].
10. Canadian Diabetes Association. Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes 2013;37:S1–S212.
11. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2015;58:429–42.
12. Shingler S, Fordham B, Evans M, et al. Utilities for treatment-related adverse events in type 2 diabetes. J Med Econ 2015;18:45–55.
13. Williams SA, Shi L, Brenneman SK, et al. The burden of hypoglycemia on healthcare utilization, costs, and quality of life among type 2 diabetes mellitus patients. J Diabetes Complicat 2012;26:399–406.
14. Green AJ, Fox KM, Grandy S. Self-reported hypoglycemia and impact on quality of life and depression among adults with type 2 diabetes mellitus. Diabetes Res Clin Pract 2012;96:313–18.
15. Marrett E, Radican L, Davies MJ, Zhang Q. Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: A survey study. BMC Res Notes 2011;4:251.
16. Gilet H, Gruenberger JB, Bader G, Viala-Danten M. Demonstrating the burden of hypoglycemia on patients’ quality of life in diabetes clinical trials: measurement considerations for hypoglycemia. Value Health 2012;15:1036–41.
17. Daniel H. Stemming the escalating cost of prescription drugs: a position paper of the American College of Physicians. Ann Intern Med 2016. Available at: http:// annals.org/aim/article/2506848/stemming-escalating- cost-prescription-drugs-position-paper-american- college-physicians.