"Novo Nordisk's anti-obesity drug Wegovy not only helped people lose weight but also reduced their risk of heart attacks, strokes and cardiovascular deaths by 20% in a large study.
The results provide evidence that the weight loss that Wegovy delivers can have important secondary benefits, such as improved cardiovascular health, in people who don't have diabetes. Novo and other companies are studying whether these types of drugs can treat sleep apnea, liver disease and chronic kidney disease.
Analysts say a proven heart-health benefit beyond weight loss could increase pressure on more U.S. employers and insurers to pay for Wegovy and similar weight-loss drugs.
Many insurers don't cover them, including the federal Medicare program for older people, partly because of the high cost -- Wegovy has a list price of about $1,350 a month.
Novo Nordisk said Tuesday it plans to seek U.S. and European regulatory approvals to add the evidence of a heart benefit to Wegovy's prescribing label. Such approval would allow the company to promote a heart benefit in addition to weight loss for Wegovy.
"This is a pivotal trial," said Dr. Ania Jastreboff, an obesity-treatment specialist and professor at Yale University School of Medicine. "Here you're demonstrating clear improvement in health outcomes." Jastreboff enrolled patients in the study and consults for Novo Nordisk.
Novo Nordisk issued limited results of the company-funded study in a press release, and they haven't been published yet in a peer-reviewed journal. Novo said it plans to present full results at a scientific conference later in 2023.
Obesity-treatment specialists say Wegovy and similar drugs have the potential to help people reduce cholesterol and blood pressure, and to avoid heart attacks and strokes, among other benefits for complications of obesity.
Obesity can increase a person's risk of cardiovascular disease. Previously, researchers found that weight loss from bariatric surgery can reduce a person's risk of heart attacks and strokes.
Wegovy belongs to a class of drugs that work by mimicking a gut hormone known as GLP-1, which has various effects including promoting insulin production and suppressing appetite.
Wegovy contains semaglutide, the same main ingredient in the drug Ozempic, which is approved to treat Type 2 diabetes and has gained popularity for weight loss.
GLP-1 drugs have been used to treat diabetes for years, and have been shown to reduce the risk of cardiovascular disease in people with diabetes. But until now, it wasn't known whether any of the drugs could deliver a cardiovascular benefit in people without diabetes, when used as a weight-loss aid.
"To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death," said Martin Holst Lange, executive vice president for development at Novo Nordisk.
Novo Nordisk started the heart-disease study in 2018 and enrolled more than 17,600 adults 45 and older who had a history of cardiovascular disease such as a heart attack, and a body-mass index of at least 27. A BMI of 27 is equivalent to a weight of 177 pounds for a 5-foot-8 person.
Some were given injections of Wegovy and others a placebo, once weekly. Researchers tracked heart attacks and strokes, including fatal ones, in addition to weight loss and other measures in study subjects.
Researchers found that the people who took Wegovy had 20% fewer heart attacks, strokes, and cardiovascular deaths, combined, than those who received a placebo in the study. The reduction surpassed the study's goal of demonstrating at least a 17% reduction in risk.
Novo Nordisk said Wegovy appeared to be safe and well-tolerated in the study, but it didn't release details on Tuesday. The most common side effects of Wegovy include gut problems such as nausea and diarrhea. The drug's prescribing label in the U.S. also cautions that patients should be monitored for depression and suicidal thoughts, a potential risk that European health regulators recently started to probe.
Novo Nordisk didn't disclose the magnitude of weight loss of patients in the study.
"The positive result should be meaningful for payers to drive improved coverage," including Medicare, Jefferies analyst Peter Welford said in a research note.
Supplies of Wegovy, however, remain constrained. Novo Nordisk earlier this year reduced supplies of the lower doses of the drug temporarily to deter new patients from starting treatment, while the company builds inventory to catch up to the strong demand.
Eli Lilly is conducting a separate study of whether its drug Mounjaro prevents heart attacks, strokes and other cardiovascular problems in adults with obesity, but results aren't expected for a couple more years." [1]
1. U.S. News: Weight Drug Shown to Cut Heart Risks. Loftus, Peter.
Wall Street Journal, Eastern edition; New York, N.Y.. 09 Aug 2023: A.3.
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