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CVD-REAL: SGLT2 inhibitors benefit patients with diabetes, irrespective of CV history
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SAN DIEGO — Treatment with an SGLT2 inhibitor was associated with lower rates of death and heart failure compared with other glucose-lowering drugs, regardless of the presence or absence of cardiovascular disease and the specific SGLT2 inhibitor used, according to new data from the CVD-REAL study.
The current analysis evaluated rates of heart failure, death, and a composite of heart failure and death in more than 300,000 patients with type 2 diabetes in Denmark, Norway, Sweden, the United Kingdom and the United States. Patients from Germany were enrolled in the overall CVD-REAL study, but left out of this analysis due to a lack of data on death and hospitalization for heart failure, Matthew A. Cavender, MD, MPH, assistant professor of medicine at the University of North Carolina School of Medicine, said during a press conference.
The main results of the CVD-REAL study, presented at the American College of Cardiology Scientific Session in March and published recently in Circulation, demonstrated that SGLT2 inhibition was associated with significant reductions in death and heart failure compared with initiation of other glucose-lowering drugs.
“However, it remains unknown whether the effect of SGLT2 inhibition is different based on the presence or absence of established CVD,” Cavender said.
Thus, the primary focus of the new analysis presented at the American Diabetes Association Scientific Sessions was to examine the association between SGLT2 inhibition and heart failure, death and heart failure/death combined in patients with and without established CVD.
Absolute rates of CV events were lower among patients with established CVD who were treated with an SGLT2 inhibitor vs. other glucose-lowering drugs. In the group with CVD, the rate of heart failure was 3.4 per 100 patient-years with other glucose-lowering drugs vs. 2.2 per 100-patient years with SGLT2 inhibitors; death was 3.5 per 100 patient-years vs. 1.4 per 100 patient-years; and heart failure/death was 6.8 per 100 patient-years vs. 3.6 per 100 patient-years. Absolute rates were lower and event reductions with SGLT2 inhibition persisted in the group without established CVD: the rate of heart failure was 0.2 per 100 patient-years with other glucose-lowering drugs vs. 0.1 per 100 patient-years with SGLT2 inhibitors; death was 0.8 per 100 patient-years vs. 0.4 per 100 patient-years; and heart failure/death was 1 per 100 patient-years vs. 0.5 per 100 patient-years, according to data presented here.
Both patients with and without established CVD had a lower risk for death and heart failure after initiation of SGLT2 inhibitors:
death: HR = 0.47 (95% CI, 0.36-0.61) with CVD vs. HR = 0.54 (95% CI, 0.44-0.66) without CVD;
Heart failure: HR = 0.69 (95% CI, 0.59-0.8) with CVD vs. HR = 0.45 (95% CI, 0.32-0.63) without CVD; and
Heart failure/death: HR = 0.59 (95% CI, 0.52-0.67) with CVD vs. HR = 0.52 (95% CI, 0.44-0.61) without CVD.
“These data suggest that SGLT2 inhibition may benefit a broad population, including both patients with and without CVD,” Cavender said. “The fact that we saw no geographic heterogeneity suggests that SGLT2 inhibitors in general can be effective, rather than the effect of a specific SGLT2 inhibitor.” He noted, however, that there were differences in the particular SGLT2 inhibitor used in each country.
Another important point from this analysis, he said, is that “the majority of patients treated with SGLT2 inhibitors in clinical practice do not have established CVD.” Prior CVD at the time of treatment initiation was only 13%, he noted.
“Data from ongoing randomized clinical trials will provide further evidence regarding the CV benefits of different SGLT2 inhibitors, including in patients without established CVD,” he said. – by Katie Kalvaitis
Reference:
Cavender MA, et al. 377-OR. Presented at: American Diabetes Association 77th Scientific Sessions; June 9-13, 2017; San Diego.
Disclosures: The study was funded by AstraZeneca. Cavender reports serving as a board member for Merck; consulting for AstraZeneca, Chiesi, Merck and Sanofi Aventis; and receiving research support from Abbott Laboratories, AstraZeneca, GlaxoSmithKline, Merck, Takeda and The Medicines Company.
Perspective
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Eliot A. Brinton, MD, FAHA, FNLA
This international observational study found decreased chronic heart failure and total mortality with use of SGLT2 inhibitors, as presented and published earlier, but now showing that these benefits occurred both with and without prior CVD. Further, there was no heterogeneity in these results by country or by individual agent.
This suggests that these benefits may truly be a class effect, despite the suggestion of minor differences in the two completed trials (EMPA-REG Outcome with empagliflozin and CANVAS with canagliflozin).
Perspective
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Yehuda Handelsman, MD, FACP, FNLA, MACE
We’ve recently seen results of trials that show that SGLT2 inhibitors reduce morbidity and mortality in people with established cardiovascular disease. CVD-REAL, an observational “big data” study, is the first study to show an effect of the class on primary prevention of CV events and mortality. The magnitude of the reduction in CV events and mortality was smaller in the primary prevention than in the secondary prevention populations; however, it is encouraging.
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