Original Research

Efficacy and Safety of Dapagliflozin in Treatment Naive or Treatment Experienced Type 2 Diabetes Mellitus Patients from South Punjab, Pakistan

DOI https://doi.org/10.70302/jpsim.v2i2.2133
Received: 26 Feb 2021 Accepted: 15 Apr 2021 Published Online: 17 Jun 2021

Abstract

Objective

To gather clinical data regarding weight reduction, glycemic control and safety of dapagliflozin oral tablets in
Type 2 Diabetes Mellitus patients from South Punjab, Pakistan.

Methods

This prospective clinical trial was conducted at Department of Medicine, Bahawal Victoria Hospital,
Bahawalpur from July 2019 to June 2020. A total of 400 patients of genders aged above 18 years, BMI > 25 and having
type-2 diabetes mellitus were enrolled. Patients losing planned follow ups were excluded from the final analysis.
Dapagliflozin as 5mg or 10mg was prescribed. Patients were asked to follow up after every 2 weeks up till 24 weeks.
Change in weight, HbA1c, FBS, RBS and blood pressure was recorded during the follow ups.

Results

Out of a total of 400 patients enrolled, 238 (59.5%) were female. Overall, mean age was 48.06+10.38 years.
Mean baseline body weight was noted to 78.81±15.67 kg. Mean HbA1c (%) was recorded to be 9.14+2.12. Statistically
significantly reduction in body weight was noted at 4 weeks, 12 weeks and 24 weeks when compared to baseline values
(p<0.05). Statistically significant reduction in HbA1c levels were recorded among study participants at 12th week (change
in HbA1c=0.42+0.75, p=0.0022) and 24th weeks (change in HbA1c=0.85+0.67, p<0.0001). In terms of side effects,
hypoglycemia was reported in 12 (3.0%) patients, polyuria 10 (2.5%), urinary tract infection 5 (1.3%) and genital infection
4 (1.0%) patients.

Conclusion

Dapagliflozin was found to have good efficacy in terms of body weight reduction and improvement in
glycemic control among patients with T2DM. Overall, safety profile of dapagliflozin was good.

Keywords
Efficacy safety dapagliflozin HbA1c body weight.

How to Cite This Article

Ali QM, Imran A, Khan R, Masroor M, Tariq S, Chaudhary GMUD. Efficacy and Safety of Dapagliflozin in Treatment Naive or Treatment Experienced Type 2 Diabetes Mellitus Patients from South Punjab, Pakistan. J Pak Soc Intern Med. 2021;2(2):135–139. doi:10.70302/jpsim.v2i2.2133

⭳ Download PDF

Conflict of Interest

All authors declare no competing interests.

Disclosed in accordance with ICMJE and COPE guidelines.

Funding

No specific funding was received for this research.

Funder information follows the Crossref Funder Registry standard.

References

  1. Basit A, Fawwad A, Qureshi H, Shera AS. Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open. 2018;8(8):e020961.
  2. Papatheodorou K, Banach M, Bekiari E, Rizzo M, Edmonds M. Complications of Diabetes 2017. J Diabetes Res. 2018; https://doi.org/10.1155/2018/3086167. doi:10.1155/2018/3086167
  3. Oral EA. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPAREG outcome trial and beyond. Drugs Context. 2016;5: doi: 10.7573/dic.212299. doi:10.7573/dic.212299
  4. Singh JSS, Fathi A, Vickneson K, Mordi I, Mohan M, Houston JG, et al. Research into the effect of SGLT2 inhibition on left ventricular remodelling in patients with heart failure and diabetes mellitus (REFORM) trial rationale and design. Cardiovasc Diabetol. 2016;15(1):97.
  5. United States Food and Drug Administration: Highlights of prescribing information for Farxiga (dapagliflozin) tablets. [Updated 2019, cited April 2021]. Available from website. [https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf]
  6. Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, doubleblind, placebo-controlled 102-week trial. BMC Med. 2013;11(1):43.
  7. Baker WL, Smyth LR, Riche DM, Bourret EM, Chamberlin KW, White WB. Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis. J Am Soc Hypertens. 2014;8(4):262–75.e9.
  8. Jayawardene D, Ward GM, O'Neal DN, Theverkalam G, MacIsaac AI, MacIsaac RJ. New treatments for type 2 diabetes: cardiovascular protection beyond glucose lowering? Heart Lung Circ. 2014;23(11):997–1008.
  9. Faerch K, Amadid H, Nielsen LB, Ried-Larsen M, Karstoft K, Persson F, et al. Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial). BMJ Open. 2017;7(5):e013802.
  10. Ferreira-Hermosillo A, Molina-Ayala MA, Molina-Guerrero D, Garrido-Mendoza AP, Ramírez-Rentería C, Mendoza-Zubieta V, et al. Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial. Trials. 2020;21(1):186.
  11. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33(10):2217-24.
  12. Kamin M, Ishtiaq O, Raashid K, Wahab MU, Khan SA, Raja U. The outcomes of dapagliflozin use in real-life clinical settings in endocrinology clinics of Islamabad, Pakistan. Cureus. 2020;12(6):e8565.
  13. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009;32:650–7.
  14. Leiter LA, Cefalu WT, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin added to usual care in individuals with type 2 diabetes mellitus with preexisting cardiovascular disease: a 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. J Am Geriatr Soc. 2014;62:1252–1262.
  15. Kosiborod M, Gause-Nilsson I, Xu J, Sonesson C, Johnsson E. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and concomitant heart failure. J Diabetes Complications. 2017;31(7):1215–21.
  16. Sanz-Serra P, Pedro-Botet J, Flores-Le Roux JA, Benaiges D, Chillaron JJ, et al. Dapagliflozin: beyond glycemic control in the treatment of type 2 diabetes mellitus. Clínica E Investigación En Arteriosclerosis. 2015;27(4):205–11.
  17. Weber MA, Mansfield TA, Alessi F, Iqbal N, Parikh S, Ptaszynska A. Effects of dapagliflozin on blood pressure in hypertensive diabetic patients on renin–angiotensin system blockade. Blood Press. 2016;25(2):93-103.
  18. Sonesson C, Johansson PA, Johnsson E, Gause-Nilsson I. Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories: a meta-analysis. Cardiovasc Diabetol. 2016;15(1):37.
  19. Toulis KA, Willis BH, Marshall T, Kumarendran B, Gokhale K, Ghosh S, et al. All-cause mortality in patients with diabetes under treatment with dapagliflozin: a population-based, open-cohort study in the health improvement network database. J Clin Endocrinol Metab. 2017;102(5):1719–25.
  20. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35(7):1473-8.

Reference list indexed for Google Scholar and ResearchGate. DOI links resolve via doi.org.

CC BY CC BY 4.0 This article is published under the Creative Commons Attribution 4.0 International License. May be shared and adapted with attribution. © 2021 Journal of Pakistan Society of Internal Medicine.