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Ertugliflozin passes post-approval cardiovascular safety test

New England Journal of Medicine
Reuters Health - 23/09/2020 - Oral ertugliflozin, approved in December 2017 as a therapy for type 2 diabetes, shows no signs of producing major cardiovascular problems and appears to reduce hospitalization for heart failure by 30%, according to the results of a new industry-sponsored test that followed 8,238 patients for a mean of 3.5 years.

An identical percentage of patients in the drug and placebo groups -- 11.9% -- hit the primary endpoint, a composite of heart attack, stroke, or death from a cardiovascular cause.

The combined rate of death from a cardiovascular cause or hospitalization for heart failure was 8.1% with the drug versus 9.1% with placebo.

There was also no significant difference when the research team, led by Dr. Christopher Cannon at Brigham and Women's Hospital in Boston, looked at individual markers such as death from cardiac causes and amputations.

Similarly, the combined endpoint of death from renal causes, the need for renal replacement therapy or a doubling of the serum creatinine level was similar for ertugliflozin and volunteers who received a placebo.

But while 3.6% of placebo recipients were hospitalized for heart failure, the rate was only 2.5% with ertugliflozin, one of a class of drugs that inhibits sodium-glucose co-transporter 2.

That 30% reduction is significant and comparable to what has been seen in seven other trials of this class of drugs, Dr. Cannon said. "My takeaway is this is yet another trial showing the benefits of this class. Now it's up to doctors to get with the guidelines and try using them."

"They certainly control the glucose, but if patients have kidney or heart disease, these are really cardio and kidney-protective drugs independent of their effects on glucose," he told Reuters Health in a telephone interview. "We need to offer this to all the appropriate patients."

All the volunteers in the new study had established atherosclerotic cardiovascular disease.

The study, known as VERTIS CV, pooled data from patients who received both the 5 mg and 15 mg dose.

The research was conducted as part of a mandate by the U.S. Food and Drug Administration to assess cardiovascular safety for new glucose-lowering drugs. The results are published online in The New England Journal of Medicine.

The test was financed by Pfizer and Merck, who co-developed the drug for glycemic control in adults. It is sold under the brand name Steglatro.

By Gene Emery

SOURCE: https://bit.ly/3hNG1QZ The New England Journal of Medicine, online September 23, 2020.

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