EMPA-REG OUTCOME
Trial question
What is the role of empagliflozin in patients with T2DM at high cardiovascular risk?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 7020
7020 patients (2004 female, 5016 male).
Inclusion criteria: patients with T2DM at high cardiovascular risk who are on standard care.
Key exclusion criteria: uncontrolled hyperglycemia with glucose > 240 mg/dL, indication of liver disease, planned cardiac surgery or angioplasty within 3 months, bariatric surgery within the past 2 years, blood dyscrasias, medical history of cancer and/or treatment of cancer within the last 5 years, uncontrolled endocrine disorder, or pregnant or lactating women.
Interventions
N=4687 empagliflozin (10 mg or 25 mg once daily).
N=2333 placebo (matching placebo once daily).
Primary outcome
CV death, nonfatal MI, or nonfatal stroke
10.5%
12.1%
12.1 %
9.1 %
6.0 %
3.0 %
0.0 %
Empagliflozin
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in CV death, nonfatal MI, or nonfatal stroke (10.5% vs. 12.1%; HR 0.86, 95% CI 0.74 to 0.99).
Secondary outcomes
Significant decrease in CV death (3.7% vs. 5.9%; HR 0.62, 95% CI 0.49 to 0.77).
Safety outcomes
No significant differences in adverse events, serious adverse events and adverse events leading to discontinuation of study drug.
Significant difference in genital infection (6.4% vs. 1.8%).
Conclusion
In patients with T2DM at high cardiovascular risk who are on standard care, empagliflozin was superior to placebo with respect to CV death, nonfatal MI, or nonfatal stroke.
Reference
Zinman B, Wanner C, Lachin JM et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28.
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