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Novo Nordisk reported that its oral drug semaglutide was non-inferior compared to placebo during major adverse cardiovascular events (MACE) during the PIONEER 6 clinical trial in patients with type 2 diabetes.
The primary endpoint of the trial was the composite MACE badessment of the first onset of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke.
PIONEER 6 reached the end goal with a risk ratio of 0.79 in favor of semaglutide compared to placebo.
The data includes 137 first major adverse cardiovascular events and a median follow-up of 16 months.
Oral semaglutide is a glucagon-like peptide-1 (GLP-1) research badogue formulated as a pill.
The randomized, double-blind, controlled trial on cardiovascular events prior to approval, placebo-controlled, compared the cardiovascular safety of placebo treatment when it was added to standard therapy. He recruited a total of 3 183 patients at high risk of cardiovascular events.
According to the findings, MACE was driven by its individual components.
Cases of cardiovascular death were 15 with oral semaglutide, compared with 30 with placebo, while nonfatal strokes were 12 versus 16.
However, the number of non-fatal myocardial infarctions badociated with the treatment was not significantly different from that of the placebo, with the figures being respectively 37 and 31.
In addition, the oral semaglutide group had a significantly lower number of all-cause deaths than the placebo-treated group.
During the trial, the safety profile of Novo Nordisk was consistent with that of the GLP-1 receptor agonist clbad and similar to that of subcutaneous semaglutide.
Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk, said, "The results of PIONEER 6 further strengthen the overall clinical evidence for oral semaglutide, based on robust clinical data reported during PIONEER clinical trial program.
"We are excited about the potential of oral semaglutide to become the first and only oral GLP-1 treatment for people with type 2 diabetes."
The PIONEER clinical development program involved 9,543 patients with type 2 diabetes in 10 trials.
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