SGLT-2 inhibition reduces mortality and hospitalization for HF in patients with diabetes and PAD
Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients With Type 2 Diabetes and Peripheral Artery Disease: A Sub-Analysis of the EMPA-REG OUTCOME Trial
News - Nov. 15, 2017Background
Despite surgical and medical therapy, subjects with type 2 diabetes (T2DM) and peripheral artery disease (PAD) represent one of the highest risk groups for CV, renal and limb complications, and risk reduction strategies are urgently needed. In the EMPA-REG OUTCOME trial in patients with T2DM and established CV disease, empagliflozin (EMPA) reduced the risk of CV death by 38%, all-cause mortality by 32%, and hospitalization for heart failure (HHF) by 35% vs placebo. PAD was present at baseline in 21% (982/4687) of patients treated with empagliflozin and 21% (479/2333) of patients treated with placebo. This analysis investigated the effects of empagliflozin on CV outcomes, mortality and renal outcomes in patients with and without PAD at baseline.
Patients were randomized to receive EMPA 10 mg, EMPA 25 mg, or placebo once daily. Median observation time was 3.1 years. CV death, all-cause mortality, HHF and the composite of HHF or CV death were assessed in the pooled EMPA group vs placebo in subgroups of patients with and without PAD at baseline using Cox regression analyses. P-values for treatment by subgroup interaction were obtained from tests of homogeneity of treatment group differences among subgroups with no adjustment for multiple testing.
Main results
- At baseline, 21% (982/4687) of patients in the pooled EMPA group had PAD (mean [SD] age 64.1 [8.3] years; 68% male; 28% with a history of myocardial infarction [MI]; 10% with a history of HF), and 21% (479/2333) in the placebo group had PAD (mean [SD] age 63.8 [8.9] years; 71% male; 32% with a history of MI; 10% with a history of HF).
- In patients with PAD at baseline, EMPA reduced the risk of CV death by 43% (HR 0.57 [95% CI 0.37, 0.88]), all-cause mortality by 38% (HR 0.62 [95% CI 0.44, 0.88]), HHF by 44% (HR 0.56 [95% CI 0.35, 0.92]) and the composite of HHF or CV death by 35% (HR 0.65 [95% CI 0.45, 0.93]) vs placebo.
- These effects were consistent with those observed in the total trial population.
Conclusion
EMPA was associated with profound reductions in mortality and HHF in patients with T2DM and PAD.
The substantial risk reductions observed in the vulnerable subgroup of patients with T2D and PAD from the EMPA-REG OUTCOME trial, have important translational implications.
Discussion
Discussant Renato D. Lopes (Duke University Medical Center, Durham, NC, USA) said that with new drugs such as GLP-1 receptor agonists and SGLT-2 inhibitors, a new era has begun of better outcomes for patients with DM beyond glucose control. The benefits of empagliflozin are preserved in patients with and without PAD, with no signal of increase risk of amputation.
This is different from other SGLT-2 inhibitor programs (CANVAS) and deserves further investigation
An integrated management team of endocrinologists, cardiologists, vascular surgeons, primary care physicians, and other health care providers is the new paradigm of treatment of patients with DM.
Disclosures
- Our reporting is based on the information provided at the AHA 2017 congress -
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