Diabetes mellitus is a leading cause of chronic kidney disease ( CKD ) worldwide. Optimum glycaemic control in patients with type 2 diabetes is important to minimise the risk of microvascular and macrovascular complications and to slow the progression of CKD.
Researchers have assessed the efficacy and safety of Empagliflozin ( Jardiance ) as an add-on treatment in patients with type 2 diabetes and chronic kidney disease.
EMPA-REG RENAL was a phase 3, randomised, double-blind, parallel-group, placebo-controlled trial at 127 centres in 15 countries. Patients with HbA1c of 7% or greater to 10% or less were eligible for inclusion. Patients with stage 2 chronic kidney disease ( estimated glomerular filtration rate [ eGFR ] greater than or equal o 60 to less than 90 mL/min per 1.73 m2; n=290 ) were randomly assigned ( 1:1:1 ) to receive Empagliflozin 10 mg or 25 mg or placebo once daily for 52 weeks.
Patients with stage 3 chronic kidney disease ( eGFR greater than or equal to 30 to less than 60 mL/min per 1.73 m2; n=374 ) were randomly assigned ( 1:1 ) to receive Empagliflozin 25 mg or placebo for 52 weeks.
Randomisation was done with a computer-generated random sequence and stratified by renal impairment, HbA1c, and background antidiabetes medication. Treatment assignment was masked from patients and investigators.
The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in the full analysis set.
In patients with stage 2 chronic kidney disease, adjusted mean treatment differences versus placebo in changes from baseline in HbA1c at week 24 were -0.52% for Empagliflozin 10 mg and -0.68% for Empagliflozin 25 mg ( both p less than 0.0001 ).
In patients with stage 3 chronic kidney disease, adjusted mean treatment difference versus placebo in change from baseline in HbA1c at week 24 was -0.42% for Empagliflozin 25 mg ( p less than 0.0001 ).
In patients with stage 2 chronic kidney disease, adverse events were reported over 52 weeks by 83 patients ( 87% ) on placebo ( 15 severe [ 16% ] and 11 serious [ 12% ] ), 86 ( 88% ) on Empagliflozin 10 mg ( six severe [ 6% ] and six serious [ 6% ] ) and 78 ( 80% ) on Empagliflozin 25 mg ( eight severe [ 8% ] and seven serious [ 7% ] ).
In patients with stage 3 chronic kidney disease, adverse events were reported over 52 weeks by 156 patients ( 83% ) on placebo ( 15 severe [ 8% ] and 23 serious [ 12% ] ) and 156 ( 83% ) on Empagliflozin 25 mg ( 18 severe [ 10% ] and 22 serious [ 12% ] ).
In patients with type 2 diabetes and stage 2 or 3 chronic kidney disease, Empagliflozin has reduced HbA1c and was well tolerated.
However, the findings might not be applicable to the general population of patients with type 2 diabetes and renal impairment. ( Xagena )
Barnett AH et al, The Lancet Diabetes & Endocrinology 2014; 2: 369-384