medwireNews: Twenty-four weeks of treatment with dapagliflozin significantly improves glycemic control, body weight and systolic blood pressure in patients with type 2 diabetes and moderate kidney impairment, phase III study data show.
And although use of the selective sodium glucose cotransporter (SGLT)2 inhibitor was associated with an initial decrease in estimated glomerular filtration rate (eGFR) compared with placebo, there was a trend toward recovery by week 24 of treatment and a return to baseline values at 3 weeks post-treatment (week 27).
Paola Fioretto (University of Padova, Italy) and co-investigators say that this trend is “similar to what is seen in patients with normal renal function” and that their study findings “support the positive benefit/risk profile of dapagliflozin” for the treatment of patients with type 2 diabetes and moderate kidney impairment.
The researchers report in Diabetes, Obesity and Metabolism that the 160 patients with inadequately controlled type 2 diabetes (glycated hemoglobin [HbA1c] 7.0–11.0%) and chronic kidney disease (CKD) stage 3A (eGFR 45–59 mL/min per 1.73 m2) who were randomly assigned to receive 24 weeks of treatment with dapagliflozin 10 mg had a significantly greater decrease in HbA1c at week 24 than the 161 randomly assigned to receive placebo (0.37 vs 0.03%).
Patients in the dapagliflozin group also experienced significantly greater decreases in body weight (3.17 vs 1.92 kg), fasting plasma glucose (1.2 vs 0.3 mmol/L), and systolic blood pressure (4.8 vs 1.7 mmHg) than those in the placebo group.
In addition, dapagliflozin was well tolerated and resulted in numerically fewer adverse events (41.9 vs 47.8%) and serious adverse events (5.6 vs 8.7%) than placebo, with 1.9% of patients in each group discontinuing treatment due to adverse events.
Fioretto et al say that even though the glycemic efficacy of dapagliflozin in their cohort of patients with moderate renal impairment was lower than that that seen in patients with normal renal function, the findings were consistent with previous studies with SGLT2 inhibitors and showed that dapagliflozin has “clinical value within this population.”
They add: “The long-term renal benefits of dapagliflozin in CKD are currently being explored in an ongoing renal outcomes study.”
By Laura Cowen
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