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Dr Jim McDermott Discusses Objectives and Outcomes of CVD-REAL Trial

The CVD-REAL study presented at the American College of Cardiology 66th Scientific Session asked whether cardiovascular outcomes seen in the EMPA-REG OUTCOME trial could be seen in a real-world environment, and for the entire class of SGLT2 inhibitors, according to AstraZeneca’s Jim McDermott, PhD, vice president for Medical Affairs, Diabetes.


The CVD-REAL study presented at the American College of Cardiology 66th Scientific Session asked whether the cardiovascular effects of SGLT2 inhibitors in a real-world environment (RWE) setting with a broad patient population, according to AstraZeneca’s Jim McDermott, vice president for Medical Affairs, Diabetes. For more on the CVD-REAL trial, see The American Journal of Managed Care®’s coverage of the research findings.

What were the goals and outcomes of the CVD-REAL trial?

CVD-REAL, as you know, is the first large RWE study looking at patients with type 2 diabetes, looking at the all-cause mortality, hospitalization for heart failure, comparing SGLT2s to other glucose-lowering drugs. The purpose of the study was 3 objectives.

The first was, following the results of EMPA-REG, we wanted to see if hospitalization for heart failure was actually a class effect for the agents. Secondly, we wanted to see if the patient population, if these effects were seen in a broader patient population. And then third, we wanted to see if this applied to the real-world setting.

So with these results, we did see that overall the reduction in hospitalization for heart failure, a 39% reduction in hospitalization for heart failure, and a 51% reduction in all-cause mortality, was associated with a class effect. Secondly, we did see that these results were in a broader patient population, and what I’m saying is that 87% of the patients that were in CVD-REAL, which included 300,000 patients, 87% of those patients did not have cardiovascular disease, so these findings obviously are across a broader patient population than what has been studied in the past. Third is that this does demonstrate a real-world evidence effect, that this is what’s going on when patients are being given SGLT2s, treated with SGLT2s by their physicians.

 
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