Novo Nordisk On Saturday said that his Diabetes Pille Rybelsus showed cardiovascular advantages in a study in the late stage and paved the way to become a new treatment option for people living with diabetes and heart disease.
The pill lowered the risk of cardiovascular death, heart attack and stroke by 14% compared to four years after four years in patients with diabetes and established heart disease with or without chronic kidney disease. The Danish drug maker presented the results on Rybelsus, which is already approved for type -2 diabetes, at the annual scientific session of the American College of Cardiology in Chicago.
Novo Nordisk has already expanded the approval of the pill in the United States and the EU to reduce the risk of serious cardiovascular complications, said Stephen Gough, Global Chief Medical Officer, in an interview.
Rybelsus is the once daily oral wording of the blockbuster diabetes injection by Novo Nordisk, which is taken once a week. Both treatments as well as the weekly weight loss injection Wegovy contain the active ingredient -semaglutid.
Wegovy in March 2024 received the US approval for the risk of a larger cardiovascular event in adults with cardiovascular diseases and obesity or overweight. However, the pill data presented on Saturday indicate that patients, hesitation, to take injections like those who are afraid of needles, could soon access more comfortable treatment.
“We know that not everyone wants an injection, whether it is painful or not, they want the option of an oral drug,” Gough told CNBC. “We offer this option that you can have one or the other, depending on what the patients and the health profession keep right in this joint discussion.”
The data are a number of other drug makers, including Eli Lilly, Work on developing oral GLP-1 for diabetes, weight loss and other diseases such as sleep apnea.
In phase three study, a little more than 9,600 patients aged 50 and over, who either received rybelsus or placebo, both in addition to their standard treatment scheme, received an average of almost four years. Almost half of all patients received medication that are called SGLT2 inhibitors, which are mainly used to reduce blood sugar in adults with type -2 diabetes, at some point during the study.
At the end of the experiment, 12% of the people who took Rybelsus experienced and 13.8% of the people who took placebo, cardiovascular death, heart attack or stroke. This is an overall 14% lower risk among those who take Rybelsus.
The researchers said that the reduced risk corresponds to the cardiovascular advantages, which were observed in eight earlier studies with injectable GLP-1, including Semaglutid and other popular medication, according to the publication of the American College of Cardiology. GLP-1S ahms according to certain intestinal hormones to fell the appetite and regulate blood sugar, but also have other effects such as reducing inflammation.
Rybelsus contributed to reducing the risk of non -fatal heart attacks by 26% compared to the placebo, which was “the main driver” for the overall reduction of the risk of cardiovascular complications in the study, according to the release. The pill also reduced the risk of non -fatal lines by 12% and cardiovascular death by 7% compared to placebo.
There was no significant difference between the rybelus and placebo groups in the results related to kidney function, added the publication. However, the attempt was “clear” to examine the cardiovascular as the kidney advantages of the pill, said Gough.
Ozempic is already approved for the treatment of chronic kidney diseases in diabetes patients.
The most commonly reported side effects in the study were gastrointestinal problems such as nausea, diarrhea and constipation, which, according to the release, rarely prompted patients to end Rybelsus. These symptoms agree with the side effects of injectable Semaglutid.
Similar results were observed in all subgroups of patients by age, gender and people with different health conditions at the beginning of the study.
In contrast to its injectable counterparts, Rybelus has to be absorbed on an empty stomach with a small amount of water at least 30 minutes before breakfast. Despite these requirements, the study offers “the certainty that the patient took the medication as stated and cardiovascular health benefits could benefit from it,” said Dr. Darren McGuire, Professor of Medicine at UT Southwestern Medical Center and the first author of the study.
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