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Diabetology Xagena

Patients with type 2 diabetes and impaired kidney function: Empagliflozin significantly reduces blood glucose


The results of a 52-week phase III clinical trial of Empagliflozin, presented at the American Diabetes Association ( ADA ) 73rd Scientific Sessions, showed statistically significant reductions in HbA1c at week 24 with the addition of Empagliflozin to existing oral antihyperglycemic therapy in adults with type 2 diabetes ( T2D ) and mild to moderate kidney impairment ( eGFR greater than or equal to 60 to less than 90 ml/min/1.73 m2 and eGFR greater than or equal to 30 to less than 60 ml/min/1.73 m2 ).

Empagliflozin is a member of the sodium glucose co-transporter-2 ( SGLT2 ) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

Results from the study also demonstrated a significant reduction in body weight and blood pressure with Empagliflozin versus placebo in patients with mild to moderate kidney impairment.
Adverse events ( AEs ) were reported in 79.6%, 75.4% and 72.7% of patients at 24 weeks with Empagliflozin 10 mg, Empagliflozin 25 mg and placebo, respectively.

Results of the study with Empagliflozin in patients with renal impairment included:

Reductions in HbA1c for Empagliflozin of 0.52% and 0.68% ( p less than 0.001 ) for 10 mg and 25 mg, respectively, at week 24 versus placebo in patients with mild renal impairment; for Empagliflozin 25 mg, reduction in HbA1c was 0.42% ( p less than 0.001 ) in patients with moderate renal impairment versus placebo.

Additionally, results of the study with Empagliflozin in patients with renal impairment included the following exploratory endpoints

Decrease in fasting blood glucose ( FPG ) levels in patients with mild renal impairment of 13.88 mg/dL and 18.08 mg/dL ( p less than 0.001 ) for Empagliflozin 10 mg and 25 mg, respectively, and an increase of 5.67 mg/dL for placebo; in patients with moderate renal impairment, a decrease in FPG levels of 9.26 mg/dL ( p less than 0.001 ) for Empagliflozin 25 mg and an increase of 10.16 mg/dL for placebo.

Loss of 3.88 lbs and 5.14 lbs in body weight for Empagliflozin 10 mg and 25 mg, respectively ( p less than 0.001 ) compared with 0.73 lbs for placebo in patients with mild renal impairment; loss of 2.16 lbs in body weight for Empagliflozin 25 mg ( p less than 0.001 ) compared with 0.176 lbs for placebo in patients with moderate renal impairment.

Improvements in systolic blood pressure with Empagliflozin versus placebo

In patients with mild renal impairment, systolic blood pressure ( SBP ) decreased by 2.9 mmHg ( p=0.033 ) and 4.5 mmHg ( p=0.002 ) for Empagliflozin 10 mg and 25 mg, respectively, while it increased by 0.7 mmHg for placebo.

In patients with moderate renal impairment, systolic blood pressure decreased by 3.9 mmHg ( p=0.001 ) for Empagliflozin 25 mg and increased by 0.4 mmHg for placebo

Improvements in diastolic blood pressure with Empagliflozin versus placebo:

In patients with mild renal impairment, diastolic blood pressure ( DBP ) decreased by 1.4 mmHg ( p=0.006 ) and 2.2 mmHg ( p less than 0.001 ) for Empagliflozin 10 mg and 25 mg, respectively, while it increased by 1.1 mmHg for placebo.

In patients with moderate renal impairment, diastolic blood pressure decreased by 1.7 mmHg ( p=0.020 ) for Empagliflozin 25 mg and increased by 0.2 mmHg for placebo.

The percentage of people with mild renal impairment who reported drug-related adverse reactions at 52 weeks were 37.8%, Empagliflozin 10 mg; 41.2%, Empagliflozin 25 mg; and 32.6%, placebo. Drug-related adverse effects at 52 weeks in patients with moderate renal impairment were reported by 27.3%, Empagliflozin 25 mg; and 24.1%, placebo. Observed adverse effects included hypoglycemia, events consistent with urinary tract infection, events consistent with genital infection, events consistent with volume depletion, and events consistent with bone fracture.

The 52-week randomized, double-blind, placebo-controlled trial investigated the safety and efficacy of Empagliflozin as add-on to existing therapy in people with type 2 diabetes mellitus and renal impairment.
Patients with mild renal impairment received Empagliflozin 10 mg, Empagliflozin 25 mg, or placebo.
Patients with moderate or severe renal impairment received Empagliflozin 25 mg or placebo.
The primary endpoint was change from baseline in HbA1c at week 24. Exploratory endpoints included changes from baseline in fasting blood glucose, weight and blood pressure at week 24. ( Xagena )

Source: Lilly, 2013

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