Effectiveness & Safety of Dapagliflozin & Vildagliptin FDC in T2DM Patients: Real-World Data
Introduction
Fixed-dose combinations (FDCs) represent a rational therapeutic strategy in the treatment of chronic disorders such as type-2 diabetes mellitus (T2DM). FDCs address multiple pathways simultaneously, improve metabolic outcomes, reducing pill burden, and enhance patient adherence. The FDC of dapagliflozin [a sodium-glucose cotransporter-2 inhibitor (SGLT-2i)] 5 mg and vildagliptin [a dipeptidyl peptidase-4 inhibitor (DPP-4i)] 50 mg has been approved for use in patients with T2DM. Nevertheless, the real-world data on its effectiveness and safety are currently limited.
Aim
To ascertain the real-world effectiveness and safety of the FDC of dapagliflozin 5 mg and vildagliptin 50 mg in patients with T2DM over a period of three months.
Patient Profile
- Patients with T2DM (either newly diagnosed or with uncontrolled diabetes while on existing therapies; age ≥ 18 years, N=49) and having baseline glycosylated hemoglobin (HbA1c) ≥6.0%.
Methods
Study Design
- An open-label single-center, retrospective study.
Treatment Strategy
- The study participants were treated with the FDC of dapagliflozin 5 mg and vildagliptin 50 mg for a period of 3 months.
Outcomes
Primary Outcome
- The mean change in HbA1c from baseline to 3 months.
Secondary Outcomes
- The changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG).
- Changes in lipid profile [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG)], and liver enzymes [aspartate amino transferase (AST) and alanine amino transferase (ALT)].
Safety Outcomes
- The frequency and nature of adverse events (AEs), such as hypoglycemia, genitourinary infections, gastrointestinal symptoms, and abnormalities in hepatic or renal function.
Results
- The mean age of the study population was 55.31 ± 12.04 years, 65.31% of the study population was under 60 years. The mean baseline HbA1c was 8.87 ± 1.65%, most of the patients (61.22%) had HbA1c levels above 8%.
- Majority of the participants were obese as per the Asia-Pacific/Indian body mass index (BMI) criteria (mean BMI: 27.25 ± 4.38 kg/m²).
- Treatment with the FDC of dapagliflozin 5 mg and vildagliptin 50 mg resulted in a significant improvement in all the glycemic parameters after three months (Table 1).
Table 1: Changes in the glycemic parameters from baseline to 3 months
|
Parameter |
Baseline (SD) |
3 Months (SD) |
Difference |
P value |
|
FPG (mg/dL) |
190.57 (± 60.56) |
122.43 (± 26.34) |
-68.14 (± 54.31) |
<0.001 |
|
PPG (mg/dL) |
271.53 (± 93.78) |
149.08 (± 39.05) |
-122.45 (± 83.08) |
<0.001 |
|
HbA1c (%) |
8.87 (± 1.65) |
7.22 (± 0.78) |
-1.65 (± 1.23) |
<0.001 |
- Treatment with the FDC of dapagliflozin 5 mg and vildagliptin 50 mg was associated with a significant improvement in lipid profile (Table 2). The treatment was also associated with improvement in liver enzyme profile, indicating a favorable hepatic tolerance to the therapy (Table 2).
Table 2: Changes in lipid and liver enzyme profile from baseline to 3 months
|
Parameter |
Baseline (SD) |
3 Months (SD) |
Difference |
P value |
|
HDL-C (mg/dL) |
44.71 (±11.49) |
41.76 (±9.47) |
-2.96 (±6.33) |
0.002 |
|
LDL-C (mg/dL) |
101.61 (±32.06) |
80.22 (±29.64) |
-21.39 (±23.65) |
<0.001 |
|
VLDL-C (mg/dL) |
30.91 (±16.89) |
25.35 (±10.01) |
-5.56 (±12.39) |
0.003 |
|
TC (mg/dL) |
170.98 (± 36.53) |
141.96 (± 27.00) |
-29.02 (± 29.07) |
<0.001 |
|
TG (mg/dl) |
154.55 (± 84.43) |
126.76 (± 50.04) |
-27.80 (± 61.96) |
0.003 |
|
ALT (U/L) |
23.65( ± 11.66) |
19.61 (± 10.05) |
-4.04 (± 5.57) |
<0.001 |
|
AST (U/L) |
25.24 (± 14.32) |
20.00 (± 9.43) |
-5.24 (± 7.91) |
<0.001 |
- Subgroup analyses showed consistent glycemic benefits across age, BMI, diabetes duration, and comorbidity categories.
- The FDC was well tolerated, with a favorable safety profile observed among the 49 treated patients. Mild AEs occurred infrequently and included gastrointestinal discomfort (2%), genitourinary infections (1.5%), and mild hypoglycemia (1.5%). No serious AEs, clinically significant elevations in liver enzymes, or renal complications were reported during therapy or within the two-week follow-up period.
Conclusions
- An FDC of dapagliflozin 5 mg and vildagliptin 50 mg may improve glycemic control in patients with T2DM over a period of three months.
- Larger, long-term studies are warranted to confirm durability and safety of the FDC in patients with T2DM.
Cureus 17(11): e97192. DOI 10.7759/cureus.97192.
