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ORIGINAL ARTICLE

To Compare the Efficacy of Dapagliflozin & Vs & Metformin in Newly Diagnosed Type 2 Diabetic patients

FAIQ ABDULLAH1, ABDUL SATTAR2, KAMRAN SHAUKAT3, SARFRAZ AHMAD4, SHAHID NAWAZ5, BUSHRA MARYAM6 1PGR, Department of medicine, Sahiwal Medical College, Sahiwal 2Associate Prof. Medicine, Sahiwal Medical College, Sahiwal 3Assistant Prof. Medicine, Sahiwal Medical College, Sahiwal 4Assistant Prof. Medicine, Sahiwal Medical College, Sahiwal 5Senior Registrar Medicine, NMU, Multan 6WMO, THQ Hospital, Kabirwala Correspondence to Dr. Abdul Sattar

ABSTRACT

Aim: To compare the efficacy of Dapagliflozin in combination with Metformin versus Sitagliptin in type 2 diabetic patients. Design of study: Controlled randomized study in department of Medicine, DHQ Hospital, Sahiwal for six months i.e. 05-05-2019 to 05-11-2019 Methodology: 220 subjects were selected via OPD of DHQ Hospital, Sahiwal. Patients were randomly divided into two groups. In Group-A, patients were given 100mg q.d sitagliptin plus 850 mg metformin twice a day. In Group-B, patients were given 10mg qd dapagliflozin plus 850mg metformin twice a day. Patients were followed up in OPD for 24 weeks. After 24 weeks, blood sample was obtained for assessment of HbA1c. Reports were assessed and if HbA1c is < 7.0 then efficacy achieved. All this information was recorded on Performa. Results: Efficacy of dapagliflozin and metformin versus sitagliptin and metformin in mellitus patients shows that 39(35.5% in Group A and 28(25.5%) in Group-B had efficacy and p value was 0.10. Conclusion: Efficacy of Metformin and Dapagliflozin is not significantly different when compared with Metformin and Sitagliptin in Diabetes Mellitus Type 2 patients Keywords: Type 2 diabetes mellitus, Dapagliflozin, Metformin, Sitagliptin

INTRODUCTION Data Collection Procedure: A total of 220 patients were selected from OPD of DHQ Hospital, Sahiwal. Consent was Among these, depagliflozin with metformin is generally well taken and patients were divided into A and B groups. In tolerated and is an effective tool in helping patients with Group-A, patients were given 100mg q.d sitagliptin plus 1 diabetes to improve glycemic control . Sitagliptin has higher 850mg metformin twice daily. In Group-B, 10mg qd cost than dapagliflozin for management of Diabetes dapagliflozin plus 850mg metformin twice daily was given. 2 Mellitus Type 2 . In one study, dapagliflozin is more If HbA1c is <7 then efficacy achieved. The information were effective than sitagliptin for Diabetes Mellitus Type 2 analyzed by SPSS version 21.0. 3 patients . The efficacy was achieved in 18% patients with sitagalptin and 22% patients with dapagliflozin having 4 RESULTS Diabetes Mellitus Type 2.(p>0.05) . In anotherstudy, efficacy was achieved in 43% patients with sitagaliptin and The detail of results is given in tables 1, 2, 3, 4. 27% patients with dapagliflozin for management of Diabetes Mellitus Type2 (p<0.05) and sitagalptin treatment Table 1: Age distribution Group-A (n=110) Group-B (n=110) over 24 weeks resulted in greater %age of patients Age (yrs) achieving HbA1c goal than dapagliflozin5. n= %age n= %age 40-55 70 63.64 68 61.82 METHODOLOGY 56-75 40 36.36 42 38.18 Total 110 100 110 100 This controlled random study in department of Medicine, Mean±SD 51.58±6.06 51.59±6.16 DHQ Hospital, Sahiwal for six months i.e. 05-05-2019 to 05-11-2019. Sample size of 220 patients; 110 subjects in Table 2: Gender distribution Group-A (n=110) Group-B (n=110) two groups A and B calculated with 80% study power and Gender n= %age n= %age level of significance was 5%. Expected %age of efficacy Male 60 54.6 58 52.7 was 43% with sitagliptin and 27% with dapagliflozin. Non- Female 50 45.4 52 47.3 probability type of sampling technique was used. Patients Total 110 100 110 100 of age 40-75 years of either gender presenting with diagnosed DM2 were included and patients having HbA1c Table 3: Mean BMI at baseline >10 and with renal failure i.e. creatinine >1.2mg/dl and on Group-A (n=110) Group-B (n=110) hemodialysis and patients of liver disease were excluded. BMI Mean SD Mean SD ------30.58 3.08 30.62 2.85 Received on 05-12-2019 Accepted on 05-01-2021

P J M H S Vol. 15, NO. 1, JANUARY 2021 85 Efficacy of Dapagliflozin & Metformin Vs Sitagliptin & Metformin

Table 4: Efficacy of Dapagliflozin and Metformin vs Sitagliptin and SU added on to metformin as well as a component Metformin of dual add-on therapy with to metformin. Group-A (n=110) Group-B (n=110) Efficacy n= %age n= %age CONCLUSION Yes 39 35.5 28 25.5 No 71 64.5 82 74.5 Efficacy of Metformin and Dapagliflozin is not significantly Total 110 100 110 100 different when compared with Metformin and Sitagliptin in P value=0.10 Diabetes Mellitus Type 2 patients

DISCUSSION REFERENCES

In our study, comparison of efficacy of dapagliflozin and 1. Yu H, Woo VC. Emerging use of combination therapies for metformin versus sitagliptin and metformin in newly the management of type 2 diabetes—focus on saxagliptin and diagnosed type 2 diabetes mellitus patients was dapagliflozin. Diab Metab Syndrome Obes 2017;10:317. 35.5%(n=39) in Group A and 25.5%(n=28) in Group B and 2. Parker ED, Wittbrodt ET, McPheeters JT et al. Comparison of p value was 0.10. Other study reveals that dapagliflozin is healthcare resource utilization and costs in patients with type 2 diabetes initiating dapagliflozin versus sitagliptin. Diabetes more effective than sitagliptin for Diabetes Mellitus Type 2 8 Obes Metab 2018;1-7. patients. The efficacy was in 18% patients with sitagalptin 3. Kang BK, An SH, Kim JY et al. Comparisons of efficacy and 22% patients with dapagliflozin having DM Type between dapagliflozin and sitagliptin in combination with 2.(p>0.05).4 In another study, efficacy was 43% with metformin in type 2 diabetes mellitus patients. Korean J Clin sitagaliptin and 27% with dapagliflozin for management of Pharm 2017;27:99-104. Diabetes Mellitus Type 2 (p<0.05) and sitagalptin treatment 4. Rosenstock J, Hansen L, Zee P et al. Dual add on therapy in over 24 weeks resulted in greater %age of patients type 2 diabetes poorly controlled with metformin achieving HbA1c goal than dapagliflozin.5 Our findings are monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of in agreement with this study however, the difference in our saxagliptin or dapagliflozin to metformin. Diab Care study was statistically not significant. 2015;38:376-83. In another study, efficacy of dapagliflozin as monotherapy 5. Scott RS, Morgan JD, Zimmer Z et al. Safety and efficacy of in patients with T2DM.7 The review6 focuses on Sitagliptin (SITA) Compared with Dapagliflozin (DAPA) in dapagliflozin as add-on and initial combination therapy to subjects with T2D, Mild Renal Impairment, and inadequate other antidiabetes agents in patients with T2DM. glycemic control on metformin (MET)+a (SU). Dapagliflozin has been studied as initial combination Am Diab Assoc 2018;67:1142-P. therapy with metformin and as add-on therapy to 6. Yacoub T. Dapagliflozin combination therapy in type 2 diabetes mellitus. Postgrad Med. 2016 Jan;128(1):124-36. metformin, , , sitagliptin (with or 7. Kaku K, Kiyosue A, Inoue S. Efficacy and safety of without metformin), metformin plus SU and (with or dapagliflozin monotherapy in Japanese patients with type 2 without up to two oral antidiabetes medications). The diabetes inadequately controlled by diet and exercise. efficacy of dapagliflozin has also been compared with the Diabetes Obes Metab 2014;16:1102–10.

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