Influence of Renal Function on the Efficacy and Safety of the Luseogliflozin in Japanese Patients

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Influence of Renal Function on the 52-Week Efficacy and Safety of Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus

Purpose

To evaluate the influence of renal function on the efficacy and safety of the sodium glucose cotransporter 2 inhibitor luseogliflozin (TS-071) in Japanese patients with type 2 diabetes mellitus (T2DM).

Methods

Study 1 was a 52-week, Phase III study to evaluate the efficacy and safety of 2.5 mg/d luseogliflozin (or increased to 5 mg/d) in patients with T2DM with moderate renal impairment. During the initial 24 weeks, efficacy and safety of luseogliflozin were compared with placebo.

Study 2 was a pooled analysis of four 52-week, Phase III studies of luseogliflozin, including Study 1, to evaluate the efficacy and safety of luseogliflozin in patients with various degrees of renal function. Patients were stratified into 3 groups by baseline estimated glomerular filtration rate (eGFR): normal renal function (≥90 mL/min/1.73 m2), mild impairment (≥60 to <90 mL/min/1.73 m2), and moderate impairment (≥30 to <60 mL/min/1.73 m2).

Patients with moderate impairment were further divided into those with mild-moderate (≥45 to <60 mL/min/1.73 m2) and moderate-severe (≥30 to <45 mL/min/1.73 m2). In both studies, efficacy end points included changes in glycated hemoglobin (HbA1c) level, fasting plasma glucose (FPG) level, and body weight. The safety end points included adverse events (AEs) and laboratory parameters.

Findings

In Study 1, HbA1c, FPG, and body weight significantly decreased at Week 24 in patients treated with luseogliflozin compared with patients treated with placebo, with the decrease in these parameters also observed with luseogliflozin at Week 52. The incidence of AEs was similar between groups.

In Study 2, 1030 patients were included (normal, 275; mildly impaired, 598; and moderately impaired, 157). At Week 52, HbA1c, FPG, and body weight were significantly decreased from baseline in all groups. In between-group comparisons, the decreases in HbA1c and body weight were significantly smaller in patients with moderate impairment than in those with normal function; however, the HbA1c-lowering efficacy was reduced by nearly half, whereas the efficacy of body weight lowering was not so much diminished in the moderate impairment group.

Furthermore, a scatter plot showed that changes in HbA1c were more influenced by baseline HbA1c than by baseline eGFR. The incidence of AEs during 52 weeks was similar among all groups, with the majority being mild.

Please take a look at this essay, and share the safety outcomes and efficacy outcomes in both studies.

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This article is from the free online course:

Evidence-Based Medicine in Clinical Pharmacy Practice

Taipei Medical University