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AstraZeneca’s releases positive results in CVD-REAL study

Monday, March 20, 2017

AstraZeneca has announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalization for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).

The CVD-REAL study assessed data from more than 300,000 patients across six countries, 87% of whom did not have a history of cardiovascular disease. The data showed that across this broad population of patients with T2D compared to other T2D medicines, treatment with SGLT-2i medicines—Farxiga (dapagliflozin), canagliflozin, empagliflozin—reduced the rate of hospitalization for heart failure by 39% (HR 0.61; 95% CI 0.51-0.73; p<0.001) and death from any cause by 51% (HR 0.49; 95% CI 0.41-0.57; p<0.001). For the composite endpoint of hospitalization for heart failure and death from any cause, the reduction was 46% (HR 0.54; 95% CI 0.48-0.60; p<0.001).

Worldwide, diabetes affects around 415 million adults, a number estimated to rise to 642 million by 2040 (one in 10 adults). People with T2D have a two to three times greater risk of heart failure and are at an increased risk of having a heart attack or stroke, and some 50% of deaths in people with T2D are caused by cardiovascular disease.

Bruce Cooper, M.D., vice president and head of Global Medical Affairs at AstraZeneca, said: “Diabetes is a growing epidemic worldwide, which is associated with significant comorbidities that contribute to an increased risk of costly hospitalizations and even death. 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.”

The hospitalizations for heart failure analysis was conducted using anonymized patient data from Denmark, Germany, Norway, Sweden, the U.K. and the U.S. Of the data reviewed, 41.8% of patients were on Farxiga (dapagliflozin), 52.7% on canagliflozin and 5.5% on empagliflozin. The analysis of death from any cause was conducted using anonymized patient data from Denmark, Norway, Sweden, the U.K. and the U.S. Of the data reviewed, 51.0% of patients were on Farxiga (dapagliflozin), 42.3% on canagliflozin and 6.7% on empagliflozin.

This is the first of several comparative analyses of CVD-REAL. The study is ongoing and future analyses will be conducted using this dataset as well as data from additional countries. The data for this study were obtained from real-world sources including medical records, claims databases and national registers, and were not independently adjudicated or verified against source documents. The analysis was validated by the independent academic statistical group at St. Luke’s Mid America Heart Institute, Kansas City, U.S. While CVD-REAL was a large study with a robust propensity-matching technique, given its observational nature the possibility of residual, unmeasured confounding factors cannot be definitively excluded.

Farxiga (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. Farxiga is not indicated to reduce the risk of CV events, death or hospitalization for heart failure. There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Farxiga. The dapagliflozin cardiovascular outcomes trial, DECLARE, is ongoing and expected to provide data in 2019 at the latest.

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