Rybelsus, a diabetic medication made by Novo Nordisk, shown cardiovascular advantages in a late-stage trial on Saturday, opening the door for it to be a new treatment option for individuals with both diabetes and heart disease.
After four years on average, the pill reduced the risk of heart attack, stroke, and cardiovascular-related death by 14% when compared to a placebo in patients with diabetes and established heart disease, whether or not they also had chronic kidney disease. At the American College of Cardiology's Annual Scientific Session in Chicago, the Danish pharmaceutical company gave a presentation on the findings of Rybelsus, which is currently approved for Type 2 diabetes.
According to Stephen Gough, the company's global chief medical officer, Novo Nordisk has already appealed to the US and EU to broaden the pill's clearance to include reducing the risk of major cardiovascular problems.
The once-daily oral version of Novo Nordisk's popular weekly diabetes injectable, Ozempic, is called Rybelsus. Semaglutide is the active ingredient in both therapies and the company's weekly weight loss injectable, Wegovy.
Wegovy was approved in the United States in March 2024 for reducing the risk of major cardiovascular events in persons with cardiovascular disease who are overweight or obese. However, based on the pill data that was provided on Saturday, patients who are reluctant to receive injections—for example, those who are terrified of needles—may soon have easier access to medication.
"We are aware that some people prefer the option of oral medication over injections, regardless of how painful they may be," Gough told CNBC. "We give you the choice, so you can choose either one based on what the patient and the healthcare provider agree upon during that collaborative discussion."
The information comes as a number of other pharmaceutical companies, including Eli Lilly, are working on developing oral GLP-1s to treat illnesses like sleep apnea, diabetes, and weight loss.
Just over 9,600 individuals aged 50 and over who got Rybelsus or a placebo in addition to their usual course of treatment for an average of less than four years were studied in the phase three trial. During the experiment, nearly half of all patients were given drugs known as SGLT2 inhibitors, which are mainly used to decrease blood sugar in adults with Type 2 diabetes.
12% of Rybelsus users and 13.8% of placebo users died from cardiovascular causes, had a heart attack, or had a stroke by the end of the trial. Those who took Rybelsus had an overall risk reduction of 14%.
According to a press statement from the American College of Cardiology, researchers noted the lower risk is consistent with the cardiovascular advantages seen in eight prior trials utilizing injectable GLP-1s, which include semaglutide and other well-known drugs. GLP-1s suppress hunger and control blood sugar by imitating specific gut hormones, but they also have other benefits like lowering inflammation.
According to the release, Rybelsus was "the primary driver" of the trial's overall decrease in risk for cardiovascular complications, helping to reduce the risk of non-fatal heart attacks by 26% when compared to the placebo. In comparison to a placebo, the pill also reduced the incidence of cardiovascular-related death by 7% and non-fatal strokes by 12%.
According to the announcement, there was no discernible difference in kidney function outcomes between the Rybelsus and placebo groups. However, according to Gough, the experiment was "clearly" intended to look at the pill's cardiovascular rather than kidney benefits.
Ozempic is already authorized to treat diabetic patients with chronic renal disease.
According to the announcement, gastrointestinal problems like nausea, diarrhea, and constipation were the most often reported side effects in the trial and infrequently caused people to discontinue taking Rybelsus. The side effects of injectable semaglutide are consistent with those symptoms.
According to the announcement, comparable outcomes were observed for all patient subgroups, including those by age, sex, and health status at the beginning of the experiment.
In contrast to its injectable equivalents, Rybelsus needs to be taken with a little amount of water and on an empty stomach at least half an hour before breakfast. Dr. Darren McGuire, a professor of medicine at UT Southwestern Medical Center and the study's first author, stated that despite those restrictions, the study provides "reassurance that patients were able to take the drug as directed and reap cardiovascular health benefits from it."