Novo Nordisk’s diabetes pill Rybelsus slashes cardiovascular risk

Novo Nordisk on Saturday said its diabetes pill Rybelsus showed cardiovascular advantages in a late-stage trial, paving the way in which for it to turn out to be a brand new treatment option for people living with diabetes and heart disease. 

The pill lowered the chance of cardiovascular-related death, heart attack and stroke by 14% in comparison with a placebo after 4 years on average in patients with diabetes and established heart disease, with or without chronic kidney disease. The Danish drugmaker presented the outcomes on Rybelsus, which is already approved for Type 2 diabetes, on the American College of Cardiology’s Annual Scientific Session in Chicago.  

Novo Nordisk has already applied within the U.S. and EU to expand the pill’s approval to incorporate lowering the chance of significant cardiovascular complications, Stephen Gough, the corporate’s global chief medical officer, said in an interview.

Rybelsus is the once-daily oral formulation of Novo Nordisk’s blockbuster diabetes injection Ozempic, which is taken once every week. Each treatments, in addition to the corporate’s weekly weight reduction injection Wegovy, contain the lively ingredient semaglutide.

Wegovy in March 2024 won U.S. approval for slashing the chance of major cardiovascular events in adults with heart problems and who’re obese or obese. However the pill data presented on Saturday suggests that patients who’re hesitant to take injections, akin to those that are afraid of needles, could soon access treatment in a more convenient way. 

“We all know not everybody wants an injection, whether it’s painful or not, they need the choice of an oral medication,” Gough told CNBC. “We offer that option, that you may have one or the opposite, depending on what the patients and the healthcare skilled think is true in that joint discussion.”

The information comes as a slate of other drugmakers, including Eli Lilly, work to develop oral GLP-1s for diabetes, weight reduction and other conditions, akin to sleep apnea.

The phase three trial examined just over 9,600 patients 50 years and older who received either Rybelsus or placebo, each on top of their standard treatment regimen, for a mean of just below 4 years. Nearly half of all patients received medications called SGLT2 inhibitors, that are primarily used to lower blood sugar in adults with Type 2 diabetes, sooner or later in the course of the trial. 

By the tip of the trial, 12% of individuals taking Rybelsus and 13.8% of those taking placebo experienced cardiovascular-related death, heart attack or stroke. That represents a 14% overall lower risk amongst those that took Rybelsus. 

Researchers said that the reduced risk is in keeping with the cardiovascular advantages observed in eight previous trials involving injectable GLP-1s, which include semaglutide and other popular medications, in line with a release from the American College of Cardiology. GLP-1s mimic certain gut hormones to tamp down appetite and regulate blood sugar, but additionally produce other effects akin to reducing inflammation. 

Rybelsus helped lower the chance of non-fatal heart attacks by 26% in comparison with the placebo, which was “the first driver” of the general reduction of risk for cardiovascular complications within the trial, the discharge said. The pill also slashed the chance of non-fatal strokes by 12% and cardiovascular-related death by 7% in comparison with placebo. 

There was no significant difference between the Rybelsus and placebo groups in outcomes related to kidney function, the discharge added. However the trial was “clearly” designed to look at the cardiovascular relatively than kidney advantages of the pill, Gough said. 

Ozempic is already approved to treat chronic kidney disease in diabetes patients. 

Essentially the most common negative effects reported within the study were gastrointestinal issues, akin to nausea, diarrhea and constipation, which rarely led patients to stop taking Rybelsus, in line with the discharge. Those symptoms are consistent with the negative effects of injectable semaglutide. 

Similar results were seen across all subgroups of patients – by age, sex and amongst individuals with different health conditions in the beginning of the trial, the discharge said. 

Unlike its injectable counterparts, Rybelsus have to be taken on an empty stomach a minimum of half-hour before breakfast with a small amount of water. Despite those requirements, the study offers “reassurance that patients were in a position to take the drug as directed and reap cardiovascular health advantages from it,” said Dr. Darren McGuire, professor of medication at UT Southwestern Medical Center and the study’s first writer.