After a median follow-up of 1.8 years, a major cardiovascular event such as a heart attack or stroke occurred in 7.0% of those getting weekly subcutaneous injections of the drug versus 9.2% of volunteers getting placebo injections (P=0.007 for superiority).
When the research team, led by Dr. Hertzel Gerstein of McMaster University and Hamilton Health Services in Ontario, Canada, looked at renal problems, such as macroalbuminuria or a decrease in kidney function, the rates were 13.0% in the efpeglenatide group versus 18.4% with placebo (P<0.001).
Sanofi paid for the study, known as AMPLITUDE-O. Its results were published online by The New England Journal of Medicine and were released virtually at the 81st Scientific Sessions of the American Diabetes Association.
In all, 4,076 volunteers from 28 countries were involved in the test.
The Gerstein team found that the drug produced more nausea, vomiting, bloating, diarrhea and constipation than placebo.
The overall odds of a severe gastrointestinal event were 3.3% with efpeglenatide versus 1.8% with placebo (P=0.009).
The rates of discontinuation because adverse events were 5.4% with the drug and 3.6% with placebo.
The efpeglenatide recipients had the same type of gastrointestinal problems seen in earlier trials of other drugs in the same class, known as GLP-1 receptor agonists, "but there was no evidence of retinal, pancreatic or thyroid-related events," the Gerstein team wrote.
Nearly all people with type 2 diabetes are at risk for heart or kidney problems. Overall, 24% have kidney disease, 22% have cardiovascular disease and 82% have hypertension.
SOURCE: https://bit.ly/2SuhIAX The New England Journal of Medicine, online June 28, 2021.
By Reuters Staff
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