LONDON--AstraZeneca kicked off the week with the release of data from the Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors (CVD-REAL) study. This is the first real-world evidence study of its kind and is assessing the risk of hospitalization for heart failure and death in type 2 diabetes patients treated with SGLT-2 inhibitors. The data were shared at the American College of Cardiology 66th Annual Scientific Session by Dr. Mikhail Kosiborod of St. Luke’s Mid America Heart Institute. An independent academic statistical group at St. Luke's was responsible for validating the analysis of the collected data.
The CVD-REAL study analyzed data from more than 300,000 individuals with type 2 diabetes across six countries, including the United States, United Kingdom, Germany, Denmark, Sweden and Norway. As noted in an ACC press release, the mean age of participants was 57 years, and 44 percent were women. Additionally, “At baseline, 3 percent had [heart failure], 13 percent established cardiovascular disease and 27 percent had microvascular disease.”
The analysis of hospitalizations for heart failure was based on anonymized patient data from the United Kingdom, United States, Denmark, Germany, Norway and Sweden. Within that data, AstraZeneca reported that 41.8 percent of patients were taking Farxiga (dapagliflozin), 52.7 percent were on canagliflozin and 5.5 percent were taking empagliflozin. The analysis of death from any cause utilized anonymized data from Denmark, Norway, the United Kingdom, Sweden and the United States. Within that data, 51 percent of patients were taking Farxiga (dapagliflozin), 42.3 percent were on canagliflozin and 6.7 were on empagliflozin. Eighty-seven percent of participants did not have a history of cardiovascular disease.
The results showed that compared to other drugs for type 2 diabetes, treatment with Farxiga (dapagliflozin), canagliflozin or empagliflozin reduced the rate of hospitalization due to heart failure by 39 percent, and reduced the rate of death from any cause by 51 percent. All told, there was a 46-percent reduction for the composite endpoint of hospitalization due to heart failure and death from any cause.
“Diabetes is a growing epidemic worldwide, which is associated with significant co-morbidities that contribute to an increased risk of costly hospitalizations and even death,” Dr. Bruce Cooper, vice president and head of Global Medical Affairs at AstraZeneca, said in a press release. “Real-world data from this study provide striking evidence that the newer SGLT-2i class of medicines cuts the rate of hospitalizations for heart failure and death by approximately half. CVD-REAL is the first study to observe these effects of SGLT-2i treatment in a much broader and lower risk group of type 2 diabetes patients than previously evaluated in clinical trials.”
As noted on the U.S. Food and Drug Administration website, “SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin and empagliflozin. They are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.”
Roughly 415 million adults worldwide have diabetes, according to the International Diabetes Federation, and that number is expected to jump to 642 million by 2040. Diabetic individuals are two to four times as likely to develop cardiovascular disease, as noted by the World Heart Foundation, which is the leading cause of death for the disease population.