Findings from the REAL-CVD outcomes study reported at ACC.17 suggest class effect for cardioprotection.
In late 2015, authors of the multicenter Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes trial (EMPA-REG OUTCOME) reported that at 3.1 years of follow-up, empagliflozin (vs placebo) was associated with a reduction in CV mortality, nonfatal MI, or nonfatal stroke as well as reductions in all-cause and CV mortality.
The Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors (CVD-REAL) study was designed to assess the potential for a class effect on CV outcomes for the currently approved SGLT-2 inhibitors empagliflozin, canagliflozin, and dapagliflozin.
Primary outcome measures: incidence of hospitalizations for heart failure (from index date to one year)
Secondary outcome measures: Incidence of all-cause mortality
Results were presented at the American College of Cardiology 2017 Scientific Sesssions on March 19, 2017 in Washington, DC.
Click through this brief slide show for highlights of the results.
CVD-REAL enrolled <350,000 subjects from 6 countries diagnosed with T2D, naive to antihyperglycemic therapy, the majority of which (87%) had no history of cardiovascular disease.
CVD-REAL results: Primary endpoint--risk of hospitalization for heart failure--was reduced by more than one-third (39%); death from any cause was reduced by 51%; composite endpoint reduced by 46%.
CVD-REAL limitations: Residual confounding cannot be ruled out as this was an observational study; data from a variety of sources could not be adjudicated against the original source materials.
CVD-REAL Conclusions: Cardioprotective effects of SGLT2 inhibitors were seen across currently approved agents in the class in a real-world clinical population.
CVD-REAL take-home points: Hospitalization for HF and death were about 50% lower in new users of all currently approved SGLT2 inhibitors vs new users of oGLD; SGLT2 inhibitors may help prevent new heart failure in patients with T2D.
Kosiborod M, Cavender M, Norhammar A, et al. Lower rates of hospitalization for heart failure and all-cause death in new users of SGLT-2 inhibitors: The CVD-REAL study. Presented March 19, 2017 at the American College of Cardiology 66th Annual Scientific Session, Washington DC. Abstract 415-14. Accessed March 22, 2017 at http://www.abstractsonline.com/pp8/#!/4223/presentation/38125
Clinical Trials.gov. Comparative effectiveness of cardiovascular outcomes in new users of SGLT-2 inhibitors (CVD-REAL). Accessed March 22, 2017 at https://clinicaltrials.gov/ct2/show/NCT02993614
Astrazeneca Press Release. AstraZeneca’s CVD-REAL study shows SGLT-2 inhibitors significantly reduced hospitalizations for heart failure and death versus other type-2 diabetes medicines. Marched 19, 2017. Accessed March 22 2017 at https://www.astrazeneca-us.com/media/press-releases/2017/astrazenecas-cvd-real-study-shows-sglt-2-inhibitors-significantly-reduced-hospitalizations-for-heart-failure-and-death-versus-other-type-2-diabetes-medicines-03192017.html