Heart disease may have met a new foil in the form of a powerful anti-inflammatory drug that, believe it or not, has already been approved by the FDA.
In a pioneering new study, researchers tested canakinumab, also known as Ilaris which currently is used to treat arthritis, on patients who had previously experienced a heart attack.
After about four years of taking the drug, some study participants showed a reduced risk of heart attack, stroke or other cardiovascular event by up to 15 percent.
“For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk,” said lead author Dr. Paul Ridker of Brigham and Women’s Hospital and Harvard Medical School.
The researchers tested several different doses of canakinumab on a group of about 10,000 study participants, with the doses ranging from low to medium to high. All study participants had elevated levels of high-sensitivity C-reactive protein, a marker of widespread inflammation in the body.
The researchers administered an injection once every three months and found that the most positive benefits came from the group that received the highest doses of the anti-inflammatory drug.
After four years, those who received the highest dose, or 300 mg, had a 41 percent improvement in their levels of C-reactive protein, which the researchers believe indicates the effectiveness of the injections. Ultimately, the injections “led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering,” report the study authors in the New England Journal of Medicine.
“I think it’s a game changer,” said Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, who was not involved in the study. “The only good therapies we’ve had so far were statins. But now it seems like we have something new in the future.”
The drug’s manufacturer, Novartis, plans to fund additional tests to further study the drug’s impact on cardiovascular health.
A Big Step From Previous Research
That inflammation is tied to poor heart health has long been a vein of thought coursing the medical community.
“Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved,” write the study authors.
The current findings brought excitement to some in the medical community.
“This is fantastic,” Dr. David J. Maron, the director of preventive cardiology at Stanford University School of Medicine, told the New York Times. “The green light just went on for full-fledged investigation and development of effective and cost-effective new therapies.”
Others, however, weren’t as optimistic – at least not without further tests and a closer look at the price of the drug, which currently costs about $200,000 per year in the treatment of arthritis.
While the canakinumab treatment marks a significant first as the only anti-inflammatory to directly treat heart disease, the author of an accompanying editorial expressed several reservations.
“Despite the scientific and clinical excitement associated with having a new mechanism of action to attack in the treatment of coronary artery disease, a better understanding of the risks and benefits of this form of therapy is needed,” Dr. Robert Harrington wrote in the editorial.
Harrington also balked at the price tag. “Such pricing may be suitable for rare diseases, but not for a common indication such as coronary artery disease, even if given every three months,” he wrote.
Ultimately, according to Harrington at least, the outlook appears uncertain.
“The modest absolute clinical benefit of canakinumab cannot justify its routine use in patients with previous myocardial infarction until we understand more about the efficacy and safety trade-offs and unless a price restructuring and formal cost-effectiveness evaluation supports it,” he concluded.
Richard Scott is a health care reporter focusing on health policy and public health. Richard keeps tabs on national health trends from his Philadelphia location and is an active member of the Association of Health Care Journalists.