Novo Nordisk On Saturday he said that his diabetes rybelsus pill showed cardiovascular benefits in a late phase test, paving the way for 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 cardiovascular 14% compared to a placebo after four years on average in patients with established diabetes and heart disease, with or without chronic kidney disease. The Danish drug maker presented the results to Rybelsus, which is already approved for type 2 diabetes, in the annual scientific session of the Chicago School of Cardiology.
Novo Nordisk has already been requested in the United States and the EU to expand the approval of the pill to include the reduction in the risk of severe cardiovascular complications, said Stephen Gough, the company’s global medical director, in an interview.
Rybelsus is the oral formulation once a day of blocking diabetes for injection of Novo Nordisk diabetes, which is taken once a week. Both treatments, as well as the weekly company loss injection of the company, contain the semaglutide of active ingredients.
Wegovy, in March 2024, obtained the United States approval to reduce the risk of important cardiovascular events in adults with cardiovascular disease and are obese or overweight. But the data of the pills presented on Saturday suggests that patients who are hesitant to take injections, such as those who are afraid of needles, could soon access treatment in a more convenient way.
« We know that not everyone wants an injection, whether it is painful or not, they want the option of an oral drug, » Gough said to CNBC. « We provide this option, which you can have one or the other, depending on what patients and the healthcare professional think that it is correct in this joint discussion. »
The data is produced as a board of other drug manufacturers, including Eli Lilly, Work to develop GLP-1 oral for diabetes, weight loss and other conditions, such as sleep apnea.
The trial of phase three examined just over 9,600 patients of 50 years and more received by Rybelsus or Placebo, both at the top of their standard treatment regime, for an average of less than four years. Almost half of all patients received medicines called SGLT2 inhibitors, which are mainly used to reduce blood sugar in adults with type 2 diabetes, at some point in trial.
At the end of the test, 12% of people who took Rybelsus and 13.8% of those who had placebo experienced cardiovascular death, heart attack or stroke. This represents a global risk of 14% among those who took Rybelsus.
Researchers said that the reduced risk is in line with the cardiovascular benefits observed in eight previous trials involving injectable GLP-1, which include semaglutids and other popular medicines, according to a statement by the American College of Cardiology. GLP-1s imitates some 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 attack by 26% compared to placebo, which was « the main engine » of the overall reduction in the risk of cardiovascular complications in the trial, according to the statement. The pill also reduced the risk of non -fatal deaths by 12% and cardiovascular death by 7% compared to placebo.
There was no significant difference between the Rybelsus and Placebo groups in renal function results, he added the launch. But the trial was « clearly » designed to examine cardiovascular benefits instead of the pill renals, said Gough.
Ozempic is already approved to treat chronic kidney disease in patients with diabetes.
The most common side effects reported 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 semaglutide.
Similar results were observed in all patients subgroups: by age, sex and between people with different health conditions at the beginning of the test, the statement said.
Unlike his injectable counterparts, Rybelsus should be taken in the empty stomach at least 30 minutes before breakfast with a small amount of water. Despite these requirements, the study offers « patients’ peace of mind was able to take the drug as they were addressed and to gain benefits on cardiovascular health, » said Dr. Darren McGuire, a medical professor at the South Medical Center -the UT’s west and the first author of the study.
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