Novo Nordisk On Saturday he said that his diabetes pill Rybelsus showed cardiovascular benefits in a late stage, racing the way to become a new treatment option for people living with diabetes and heart disease.
The pill reduced the risk of death, heart attack and stroke related to 14% cardiovascular compared to a placebo after four years on average in patients with diabetes and established heart disease, with or without chronic renal disease. The Danish drug manufacturer presented the results in Rybelsus, which is already approved for type 2 diabetes, in the annual scientific session of the American College of Cardiology in Chicago.
Novo Nordisk has already requested in the US. And the EU that expands the approval of the pill to include the risk of the risk of serious cardiovascular complications, said Stephen Gough, global medical director of the company, in an interview.
Rybelsus is the oral formulation once a day of the successful injection of Diabetes of Novo Nordisk Ozempic, which is taken once a week. Both treatments, as well as the weekly company loss injection of the company, contain the semagglutide of active ingredients.
Wegovy in March 2024 obtained the approval of the United States to reduce the risk of large cardiovascular events in adults with cardiovascular disease and that are obese or overweight. But the pill data presented on Saturday suggests that patients who hesitate to take injections, such as those who are afraid of needles, could soon access the treatment in a more convenient way.
“We know that not everyone wants an injection, whether painful or not, they want the option of an oral medicine,” Gough told CNBC. “We provide that option, which can have one or the other, depending on what patients and health professional think it is correct in that joint discussion.”
The data is produced as a list of other medications, including Eli Lilly, Work to develop oral LPG-1 for diabetes, weight loss and other conditions, such as sleep apnea.
Phase test three examined just over 9,600 patients of 50 years or more who received Rybelsus or placebo, both in addition to their standard treatment regime, during an average of just under four years. Almost half of all patients received medications called SGLT2 inhibitors, which are mainly used to reduce blood sugar in adults with type 2 diabetes, at some point during the test.
At the end of the trial, 12% of people who take Rybelsus and 13.8% of those who take placebo experienced death, heart attack or stroke with cardiovascular relationships. That represents a general general risk in general of 14% among those taken by Rybelsus.
The researchers said that the reduced risk is in line with the cardiovascular benefits observed in eight previous essays involving GLP-1 injectables, which include semaglutida and other popular medications, according to a statement from the American College of Cardiology. LPG-1 mimic certain intestinal hormones to reduce appetite and regulate blood sugar, but also have other effects, such as reducing inflammation.
Rybelsus helped reduce the risk of non -fatal heart attacks by 26% compared to placebo, which was “the main driver” of the general reduction of the risk of cardiovascular complications in the trial, according to the statement. The pill also cut the risk of non -fatal stroke in 12% and cardiovascular death by 7% compared to placebo.
There were no significant differences between Rybelsus and placebo groups in the results related to renal function, the launch added. But the trial was “clearly” designed to examine the cardiovascular benefits instead of renal of the pill, said Gough.
Ozempic is already approved to treat chronic kidney disease in patients with diabetes.
The most common side effects informed in the study were gastrointestinal problems, such as nausea, diarrhea and constipation, which rarely led patients to stop taking Rybelsus, according to the statement. These symptoms are consistent with the side effects of the injectable semaglutida.
Similar results were observed in all subgroups of patients: by age, sex and between people with different health conditions at the beginning of the trial, according to the statement.
Unlike its injectable counterparts, Rybelsus must be taken with an empty stomach at least 30 minutes before breakfast with a small amount of water. Despite these requirements, the study offers “the assurance that patients could take the medication as directed and reap cardiovascular health benefits,” said Dr. Darren McGuare, a professor of medicine at the Southwestern medical center of UT and the first author of the study.
