• Lipid Disorders
• Hypertensive Disease
• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials Diabetes & Endocrinology Guidelines

• Lipid Disorders
• Hypertensive Disease
• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials
• Endocrinology
• Diabetes & Metabolic Syndrome
• Diabetes & Endocrinology Guidelines

Patients with type 2 diabetes mellitus (T2DM) who are treated with empagliflozin, a sodium glucose cotransporter 2 inhibitor, as monotherapy or add-on antihyperglycemic therapy experience clinically meaningful improvements in glycemic parameters and several cardiovascular risk factors, according to Thomas Hach, MD, Boehringer Ingelheim Pharma GmbH & Company KG, Ingelheim, Germany. Prof. Hach presented the results of a pooled analysis of four randomized, placebo-controlled Phase 3 trials in which the effects of 24 weeks of empagliflozin were evaluated in 2477 T2DM patients.

In the four trials, patients with HbA1C values ranging from 7% to 10% at screening were randomized to empagliflozin 10 mg (n=831) or 25 mg (n=821) QD or placebo (n=825) for 24 weeks as either monotherapy, add-on to metformin, add-on to metformin plus a sulfonylurea, or add-on to pioglitazone with or without metformin. The patient population had a mean age of 55.6 years and a mean body mass index of 28.7 kg/m²; 45.5% of the participants were female.

Relative to placebo, HbA1C levels significantly decreased by 0.62% and 0.68% in the empagliflozin 10- and 25-mg groups at Week 24 (p<0.001 for both vs placebo). Among patients with baseline HbA1C ≥7.0%, significantly more who were assigned to empagliflozin at either dose achieved an HbA1C levels <7.0% at Week 24 compared with placebo (empagliflozin 10 mg, 31.5%; empagliflozin 25 mg, 37.2%; placebo, 10.5%; p<0.001 for both vs placebo).

Over 24 weeks, fasting plasma glucose (FPG) declined by 20.5 mg/dL in the empagliflozin 10-mg group and by 23.2 mg/dL in the 25-mg group, while it increased by 7.4 mg/dL in the placebo group. The difference in FPG at Week 24 was significantly different between the two empagliflozin groups and placebo (p<0.001 for both vs placebo).

Confirmed hypoglycemic adverse events were more frequent with empagliflozin 10 mg (5.2%) and 25 mg (4.0%) versus placebo (2.9%); however, no hypoglycemic event required assistance.

Systolic blood pressure (BP) and diastolic BP decreased significantly more from baseline to Week 24 in patients randomized to empagliflozin 10 mg or 25 mg compared with placebo (p<0.001 for both vs placebo). The percentage of patients with uncontrolled hypertension (BP ≥130/80 mm Hg) at baseline whose BP was controlled at Week 24 was 18.6% with placebo, 33.3% with empagliflozin 10 mg, and 35.2% with empagliflozin 25 mg (p<0.001 for both doses vs placebo).

Empagliflozin 25 mg was associated with a significant increase from baseline in total cholesterol compared with placebo (p<0.001). Patients assigned to empagliflozin 10 mg had a significant decrease from baseline in triglyceride level when compared with placebo (p<0.05). Compared with placebo, low-density lipoprotein cholesterol levels increased substantially in both empagliflozin groups, but this change was only statistically significant in the 25-mg group (p<0.008). The level of high-density lipoprotein cholesterol increased significantly in both empagliflozin groups compared with placebo (p<0.001 for both vs placebo).

The changes from baseline to Week 24 in uric acid levels were +1.03 μmol/L in the placebo group, −28.95 μmol/L with empagliflozin 10 mg (p<0.001), and −29.55 μmol/L with empagliflozin 25 mg (p<0.001 for both vs placebo).

Relative to placebo, body weight declined by 1.81 kg in patients randomized to empagliflozin 10 mg and by 2.01 kg in those randomized to empagliflozin 25 mg (p<0.001 for both vs placebo).

In conclusion, the findings of this pooled analysis show that empagliflozin QD at 10 mg or 25 mg for 24 weeks is clinically superior to placebo in patients with T2DM.

• © 2013 MD Conference Express®