AstraZeneca on Sunday said that data from a broad population of patients with type-2 diabetes indicate that treatment with SGLT-2 inhibitors, including the company's Farxiga (dapagliflozin), Johnson & Johnson's Invokana (canagliflozin), and Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin), reduced the rate of hospitalisation for heart failure by 39 percent and death from any cause by 51 percent, compared with other medications for diabetes. For the composite endpoint of hospitalisation for heart failure and death from any cause, results showed SGLT-2 inhibitors reduced the risk by 46 percent.
According to AstraZeneca, the CVD-REAL study assessed data from more than 300 000 patients across six countries, 87 percent of whom did not have a history of cardiovascular disease. The comparator drugs included metformin, DPP-4 inhibitors and insulin, among others. Bruce Cooper, head of global medical affairs at AstraZeneca, noted that "CVD-REAL is the first study to observe these effects of SGLT-2 inhibitor treatment in a much broader and lower risk group of type-2 diabetes patients than previously evaluated in clinical trials."
Last December, the FDA expanded Jardiance's label to include reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. The decision was based on data from the post-marketing EMPA-REG OUTCOME trial, which had shown that Jardiance, in combination with standard of care, significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke versus placebo.
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However, the CVD-REAL data presented by Mikhail Kosiborod at the American College of Cardiology (ACC) scientific meeting appear to suggest that cardiovascular protection is not limited to Jardiance. "The fact that the results are remarkably consistent from country to country regardless of which compound predominates, that certainly seems to suggest that it's a class effect," Kosiborod said. He noted that most US patients in the study were taking Invokana, while Farxiga was dominant in Europe. Meanwhile, according to study data, less than 10 percent of patients overall were taking Jardiance.
The CVD-REAL study was conducted using anonymised patient data from Denmark, Germany, Norway, Sweden, the UK and the US, with various real-world sources, including medical records, claims databases and national registers, AstraZeneca said. "This is the first of several comparative analyses" of the ongoing study, the company noted, adding that "future analyses will be conducted using this dataset, as well as data from additional countries." However, AstraZeneca cautioned that given the observational nature of the CVD-REAL study, "the possibility of residual, unmeasured confounding factors cannot be definitively excluded." The company is currently assessing the cardiovascular benefits of Farxiga in the DECLARE trial, with data expected in 2019.
AstraZeneca CEO Pascal Soriot last month indicated that he was "very confident that, in 2017, Farxiga will…exceed $1 billion in sales." Meanwhile, analysts at Berenberg are forecasting mid-single-digit growth at AstraZeneca's US diabetes unit, with the help of products such as Farxiga, but the investment bank predicted Eli Lilly would become "the fastest growing diabetes player for the next five years at least," in part due to Jardiance, as well as its GLP-1 receptor agonist Trulicity (dulaglutide).
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