<p>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</p>

Abstract

PurposeThe 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 methodsIn 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.ResultsAlthough 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.ConclusionAlthough renoprotective effects might be limited, empagliflozin can safely and effectively improve metabolic parameters, even in elderly subjects.

Different renoprotective effects of luseogliflozin depend on the renal function at the baseline in patients with type 2 diabetes: A retrospective study during 12 months before and after initiation

“…The uPE, uACR and urinary L-FABP were all inversely correlated with the corresponding values at baseline, and as a result, the eGFR improved in the low eGFR group. These results do not contradict our findings report in non-elderly and elderly patients with type 2 diabetes treated with empagliflozin, whose eGFR values at the baseline were 84.5 mL/min/1.73 m 2 and 67.2 mL/min/1.73 m 2 , respectively [ 24 ]. The reductions in the body weight, blood pressure and HbA1c caused by SGLT2 inhibitors seem to be associated with urinary glucose excretion.…”

“…Although total AEs were significantly more common in the low eGFR group in the present study than in the other groups, there were no significant differences in the frequency of AEs that were specific for SGLT2 inhibitors. This result is likely due to the phenomenon wherein non-specific AEs are generally observed more frequently in the elderly and/or patients with renal impairment than in others [ 15 , 24 ]. Samukawa et al .…”

“…The urinary protein excretion (uPE) was evaluated by the pyrogallol red method using urine test-strips (Uriflet S; ARKRAY, Inc., Kyoto, Japan) and an automatic analyzer (Austin MAX AX 4280; ARKRAY, Inc.). Proteinuria was graded as (±), (1+), (2+) and (3+) corresponding to 15 mg/dL, 50 mg/dL, 150 mg/dL and 325 mg/dL, respectively, according to the median value of the measurement range in the semi-quantitative results [ 24 , 35 , 36 ]. Urinary liver-type fatty-acid binding protein (L-FABP), a biomarker of tubulointerstitial injury of the kidneys that predicts renal dysfunction associated with diabetic nephropathy [ 37 – 39 ], was measured using a chemiluminescent enzyme immunoassay at an external laboratory (SRL Co., Tokyo, Japan).…”

“…Recently, it was reported that ipragliflozin therapy was well tolerated and reduced surrogate endpoints of diabetic vascular complications, such as HbA1c, body weight and blood pressure, in elderly Japanese patients with type 2 diabetes based on a post-marketing surveillance study [ 22 , 23 ]. Furthermore, we reported the safety and efficacy of empagliflozin through the improvement of the blood glucose level, body weight, liver function, hemoglobin value and serum high-density lipoprotein (HDL)-cholesterol concentration in elderly Japanese patients with type 2 diabetes whose renal function was lower than that in non-elderly patients [ 24 ].…”

Use of Sodium Glucose Co-Transporter 2 Inhibitor (SGLT2i) in Geriatric Population

“…The decrease in the HbA1c value was observed as 0.58%, 0.46%, and 0.51% in age groups, respectively (9). In a comparative study of empagliflozin with placebo in a total of 110 patients, HbA1c values decreased by 1.1% and 1.2% in the groups <65 and >65, respectively (10). As a result, SGLT2 inhibitors seem to be effective in lowering HbA1c values in the geriatric group as with the 18-65 age group.…”