Findings from a randomized, double blind, placebo controlled trial named EMPA-REG Outcome trial, Jardiance (empagliflozin) an SGLT2 inhibitor combined with standard care was found to reduce CV risk by 38%. In addition, no significant difference was observed for non-fatal MI or stroke. The treatment group also experienced a 32% reduction in all-cause mortality and 35% decline in hospitalization risk for HF.
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One of the researchers claimed that this finding was very surprising, as it was not predicted and the results were predicted to be risk neutral. Researchers of the study analyzed data from 7,020 adults with T2DM, a BMI of 45 kg/m2 or less, HbA1c of 7-10%, and a known history of CVD. Demographics of the study were average age of 63 years, 72% men, average HbA1c of 8%, average BMI 30.6 kg/m2.
Subjects of the study were randomly allocated in treatment group with empagliflozin either 10 mg or 25 mg (n = 2342), or placebo (n = 2333). Parameters measured were incidence of CV death, non-fatal MI or non-fatal stroke. Researchers followed participants for roughly three years. In the treatment phase with empagliflozin 10 mg, patients exhibited a reduced risk for CV death (HR = 0.65; CI 95%, 0.5-0.85). For patients in the treatment group of 25 mg empagliflozin, a reduced CV death was also observed (HR = 0.59; CI 95%; 0.45-0.77). This combined HR was 0.62 with 95% CI, 0.49-0.77. The other endpoints of non-fatal MI included HR of 0.87, 95% CI, 0.7-1.09, whereas non-fatal stroke included HR of 1.24, 95% CI, 0.92-1.67.
Patient hospitalization for heart failure also declined with the use of empagliflozin (HR = 0.65; 95% CI, 0.5-0.85). An all-cause mortality reduction was also observed with a combined HR of 0.68; 95% CI, 0.57-0.82. It is important to note that genital infection rate increased for the treatment group, but no increase was observed in incidence of hypoglycemic events, DKA, or AKI. In addition, no increases in bone fractures were observed.
Authors conclude that T2DM patients receiving empagliflozin may have significantly lower risk of composite cardiovascular outcome. This also applies to the outcome of death from any cause. However, this benefit was seen only in T2DM patients with high risk of CV events, and when the drug was added to standard care.
- Jardiance (empagliflozin) added to standard care of therapy among type 2 diabetic patients with a history of CV events may reduce all-cause mortality and risk of CV events by 38%
- Most of the other SGLT-2 drugs will probably will show a similar result from their studies.
- The use of Jardiance correlated with low incidences of DKA, volume depletion, thromboembolic events, and bone fracture.
- These results of this study were unexpected; however, provides data to support long-term use of empagliflozin as well as strong evidence for reduction in CV risk. Nonetheless, further studies need to be performed to identify the exact mechanism behind the reduction in CV risk.
Zinman, B, et al. “Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.” N. Engl. J. Med (2015).