MD Conference Express ADA 2013 - (Page 17)
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.
MDCE 2013
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MD Conference Express ADA 2013
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