Comparison of the changes in the factors associated with the renal prognosis of non-elderly and elderly subjects treated with empagliflozin- a retrospective observation study in Japanese patients with type 2 diabetes

Abstract

Purpose: The factors associated with the renal prognosis over six months after the initiation of empagliflozin were compared between the non-elderly and elderly Japanese patients with type 2 diabetes.

Patients and methods: In total, 132 patients treated with empagliflozin (10 mg, once daily) were studied as the safety analysis set. One hundred ten subjects whose medications were not changed during the observation period were investigated as the full analysis set to assess the effectiveness. The subjects were divided into two groups: non-elderly subjects (n=72) of<65 years of age and elderly subjects (n=38) of≥65 years of age.

Results: Although the body weight and HbA1c, AST, ALT and γ-GTP levels were significantly reduced in both the non-elderly and elderly subjects, blood pressure, eGFR and urinary protein excretion were only significantly decreased in the non-elderly subjects. The hemoglobin, hematocrit and serum HDL-cholesterol levels were significantly elevated in both groups. The change in eGFR showed a significant positive association with the change in blood pressure. The change in urinary protein excretion tended to be correlated with the change in blood pressure.

Conclusion: Although renoprotective effects might be limited, empagliflozin can safely and effectively improve metabolic parameters, even in elderly subjects.

Keywords: elderly; empagliflozin; renal impairment; renoprotection; sodium-glucose cotransporter 2 inhibitor; type 2 diabetes mellitus.

Figure 1

Flowchart of patient selection. The safety of empagliflozin was analyzed in the safety analysis set (n=132) and the effectiveness was investigated in the full analysis set (n=110).

Figure 2

Changes in the eGFR (A) and urinary protein excretion (B) in non-elderly and elderly subjects. The open (n=72) and closed (n=38) circles indicate non-elderly and elderly subjects, respectively. The open (n=68) and shaded (n=31) bars indicate non-elderly and elderly subjects, respectively. *P<0.01 vs baseline (0 month) value.

Figure 3

Changes in the eGFR in subgroups according to the eGFR at baseline in non-elderly (A) and elderly (B) subjects. The closed and open circles indicate subjects with a normal eGFR (eGFR≥60 mL/min/1.73 m²) and those with a reduced eGFR (eGFR <60 mL/min/1.73 m²), respectively. *P<0.05 and **P<0.01 vs baseline (0 month) value.

Figure 4

The relationships between the changes in the eGFR and the changes in body weight (A), HbA1c (B), systolic blood pressure (C) and diastolic blood pressure (D) in the full analysis set.