Novo Nordisk On Saturday, his Diabetes pill Rybelsus showed cardiovascular advantages in an advanced stage test, opening the way to become a new treatment option for people with diabetes and heart disease.
The pill lowered the risk of death in cardiovascular, heart attack and stroke of 14% compared to a placebo after four years on average in patients with diabetes and established heart disease, with or without chronic kidney disease. The Danish drug manufacturer presented the results on Rybelsus, which is already approved for type 2 diabetes, during the annual scientific session of the American College of Cardiology in Chicago.
Novo Nordisk has already applied to the United States and the EU to extend the pill approval to include the risk of serious cardiovascular complications, said Stephen Gough, a global home doctor in an interview.
Rybelsus is the oral formulation once a day of the successful diabetes injecting diabetes of Novo Nordisk, which is taken once a week. The two treatments, as well as the weekly weight loss injection of the Wegovy company, contain the semaglutide of active ingredients.
Wegovy in March 2024, won us the approval of the United States to reduce the risk of major cardiovascular events in adults with cardiovascular disease that are obese or overweight. But the data on the pills presented on Saturday suggest that patients who hesitate to take injections, like those who are afraid of needles, could soon access the treatment in a more practical way.
“We know that everyone does not want an injection, whether painful or not, they want the option of an oral drug,” Gough told CNBC. “We provide this option, which you can have one or the other, depending on what patients and the health professional think they are just in this joint discussion.”
Data is a list of other drug manufacturers, in particular Eli Lilly, Work to develop GLP-1 oral for diabetes, weight loss and other conditions, such as sleep apnea.
The phase three test examined just over 9,600 patients 50 years and over who received either Rybelsus or placebo, both in addition to their standard treatment regime, for an average of just under four years. Almost half of all patients have received drugs called SGLT2 inhibitors, which are mainly used to lower blood sugar in adults with type 2 diabetes, at a given time during the trial.
At the end of the test, 12% of people taking Rybelsus and 13.8% of those who took a place of death linked to cardiovascular, heart attack or stroke have experienced a placebo. This represents an overall risk of 14% among those who took Rybelsus.
Researchers said risk reduction complies with the cardiovascular advantages observed in eight previous trials involving injectable GLP-1s, which include semaglutide and other popular drugs, according to a statement from the American College of Cardiology. GLP-1s imitate certain intestinal hormones to prevent appetite and regulate blood sugar, but also have other effects such as reduction in inflammation.
Rybelsus has helped reduce the risk of 26% non -fatal heart attacks compared to placebo, which was “the main engine” of the overall reduction in the risk of cardiovascular complications in the trial, the press release said. The pill has also reduced the risk of non -fatal blows by 12% and death -related deaths by 7% compared to placebo.
There was no significant difference between the Rybelsus and placebo groups in the results related to the renal function, added the version. But the test was “clearly” designed to examine the cardiovascular rather than renal pills, Gough said.
Ozempic is already approved to treat chronic kidney disease in diabetes patients.
The most common side effects in the study were gastrointestinal problems, such as nausea, diarrhea and constipation, which has rarely led patients to stop taking Rybelsus, the press release. These symptoms are consistent with the side effects of the injectable semaglutide.
Similar results have been observed in all patient subgroups – by age, sex and in people with various health problems at the start of the trial, the statement said.
Unlike his injectable counterparts, Rybelsus must be taken fast at least 30 minutes before breakfast with a small amount of water. Despite these requirements, the study offers “assurance that patients were able to take the drug as indicated and take advantage of the benefits for cardiovascular health,” said Dr. Darren McGuire, professor of medicine at the UT Southwestern Medical Center and the first author of the study.