In a clinical trial, the diabetes and weight-loss drug semaglutide significantly reduced symptoms and enhanced quality of life in patients with obesity and the most typical form of heart failure, potentially broadening the drug’s already wildly popular use and providing a new treatment option where few are currently available.
A 2 point 4 milligram dose of semaglutide, marketed as Wegovy for weight loss, was found to improve symptoms of heart failure with preserved ejection fraction by 17 points on a 100-point scale, according to a study of 529 patients funded by the pharmaceutical company Novo Nordisk. Participants who received a placebo experienced a 9-point improvement, in contrast. The research was released in the New England Journal of Medicine on Friday.
According to Dr. Mikhail Kosiborod, cardiologist and vice president for research at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, who oversaw the trial, this difference translates to Wegovy helping people with heart failure have less shortness of breath, fatigue, difficulty exerting themselves, and swelling, as well as better exercise function and quality of life.
Kosiborod told CNN before the findings were presented at the European Society of Cardiology meeting in Amsterdam: “This is the largest treatment benefit we’ve ever seen for that endpoint in this patient population with any drug.”.
According to a statement Novo Nordisk released about the trial’s findings, 64 million people worldwide suffer from heart failure. It is a condition where the heart struggles to pump enough blood to meet the demands of the body.
The heart can pump normally but cannot fill fully if the ejection fraction is preserved. Kosiborod and his co-authors claim that this kind of heart failure is becoming more common and is responsible for more than half of all cases in the US.
He stated that in the US, 80 percent of patients with this type of heart failure are obese or considered to be overweight. Weight loss was a secondary objective of the study, and semaglutide was effective in achieving it as well. Over the course of the year-long trial, participants on semaglutide lost about 13% of their body weight, compared to 26% of those on placebo.
Diuretics, also known as water pills, were previously the primary treatments for patients with this type of heart failure, according to Kosiborod. Although they can temporarily relieve symptoms and increase urination to reduce the body’s fluid retention, he said they are “woefully insufficient.”.
The risk of heart failure hospitalisation has been shown to be decreased by a different class of medications known as SGLT2 inhibitors, which are also used to treat Type 2 diabetes, but, in Kosiborod’s words, “it’s not enough for most people.”. The symptom improvement has been “relatively modest”.
Utilising a test known as the six-minute walk test, the semaglutide trial evaluated exercise function. It was discovered that by the end of the trial, the medication had enabled participants to walk 20 metres farther than those who received a placebo.
More patients discontinued semaglutide use, primarily due to gastrointestinal problems, which are frequent side effects of this class of drugs, known as GLP-1 receptor agonists, compared to the placebo group, but there were fewer serious safety events in the drug group.
The trial’s lack of diversity—96% of the participants were White—was one of its drawbacks.
As a community, Kosiborod said, “clinical trials know that we need to do better in terms of patients who are Black, Hispanic, and from other backgrounds that are underrepresented in clinical trials.”.
He pointed out that results from another semaglutide heart failure trial involving diabetic patients should be available soon, and combining the data could provide a clearer picture of how the medication performs for people of various racial and ethnic backgrounds.
Wegoby may be prescribed for purposes other than weight loss, according to new data that support other recent findings. Early in August, Novo Nordisk revealed that Wegovy cuts the risk of heart attack, stroke, or heart-related death in people with cardiovascular disease and obesity by 20%; this news is anticipated to increase use of the drug even more. Already, the manufacturer is unable to keep up with demand and has been forced to restrict access to some lower starter doses of the drug in order to supply established patients.
After decades of medications with poor efficacy and risky safety issues, Wegovy, its sister drug for Type 2 diabetes, Ozempic, as well as a related drug from Eli Lilly called Manjaro, have revolutionised the way doctors approach weight loss with medications.
Additionally, they are altering the way scientists view obesity, and Kosiborod claimed that this paradigm shift is a result of the findings regarding heart failure.
He said, “It is obvious that we cannot continue to treat obesity in these patients as if it were an accident” . “It should be handled as if it were the primary cause of the complications”.
But he also noted that the medication might be beneficial in ways other than those that are directly related to weight loss, such as by reducing inflammation and congestion.
Kosiborod stated that as a doctor caring for patients, he found the results “extremely gratifying, because what I now can tell them is that we have pretty definitive evidence that if we prescribe this medication, you will feel better and be able to do more, and it’s going to have a significant impact on your quality of life. “.
For Novo to successfully move Wegoby beyond its reputation as a recreational drug, it is imperative to demonstrate specific medical benefits. Such information might persuade American insurers to cover the cost for a wider range of patients, as well as cost-conscious European health authorities.
In the U.S., prices reach $1,300 per month.
in Germany, for about 300 euros ($324) per month, without any discounts or coupons.
However, given that new heart failure treatments are being developed, it is unclear what conclusions regulators and medical professionals will make from the STEP HFpEF results.
Novartis’s Entresto (NOVN.S)won the U.S. AstraZeneca’s (AZN) approval for specific cases of HFpEF in 2021. L) Trial results from late last year showed that Farxiga was beneficial for HFpEF patients.
As it will take years before it can meet global demand, Novo Nordisk CEO Lars Fruergaard Jorgensen stated at a Reuters Newsmaker event on Friday that the company planned to launch Wegovy in more nations, albeit in a “constrained” way.
($1 = 0.9266 euros)