Albuminuria Reduction with Low- vs. High-Dosage Empagliflozin: Is More Always Better?

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Background: Sodium-glucose co-transporter 2 inhibitors (SGLT2is) reduce albuminuria and improve cardiovascular (CV) and renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes. The EMPA-REG OUTCOME trial showed similar CV benefit with both 10 mg and 25 mg doses of empagliflozin, but the dose-response relationship for albuminuria reduction is unclear. We evaluated the real-world impact of empagliflozin dose on albuminuria in patients with severe albuminuria (urine albumin-to-creatinine ratio [UACR] > 300 mg/g). Methods: We conducted a retrospective analysis of 10,138 adult patients with UACR > 300 mg/g who were prescribed empagliflozin 10 mg or 25 mg daily. Baseline characteristics and comorbidities were compared by dose. An intention-to-treat analysis using a linear mixed-effects model assessed changes in UACR, adjusting for key covariates including baseline use of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), estimated glomerular filtration rate (eGFR), and presence of CKD, CV disease (CVD), and heart failure. Results: Of 10,138 patients, 75% received 10 mg and 25% received 25 mg of empagliflozin. ACEi use was 29% and ARB use 23% across both groups (Table 1). CKD was more common in the 10 mg group (47% vs. 33%), as were heart failure (23% vs. 16%) and CVD (52% vs. 42%).The adjusted model showed a mean decline in UACR of 15% per year, with no significant differences between doses (p = 0.57). Conclusion: In this large real-world cohort, the 25 mg dose of empagliflozin did not offer greater albuminuria reduction than the 10 mg dose, even after adjusting for key clinical factors. Prospective, randomized trials are needed to determine whether dose escalation provides additional benefit in high-risk populations.

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