By E.J. Mundell
The findings were presented Sunday at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, and published in two major medical journals, The Lancet and the New England Journal of Medicine.
The trial focused on a new drug called canakinumab, which lowered by 15 percent the overall rate of heart events such as heart attack, stroke and cardiovascular death in people who'd already had a heart attack.
The people in the study also had high levels of a compound called C-reactive protein in their blood -- a marker that is indicative of a heightened inflammatory response.
Cardiologists had mixed opinions on the implications of the new findings.
"It's been shown that 50 percent of heart attacks occur in those people who do not have high cholesterol," said Dr. Suzanne Steinbaum, director of women's heart health at Lenox Hill Hospital, in New York City. "In many trials, inflammation has been implicated as being the driving force," she explained.
"This study is the window to the next generation of prevention, which is focusing on inflammation," Steinbaum added.
In an editorial accompanying the study in the New England Journal of Medicine, Dr. Robert Harrington of Stanford University, in California, agreed that the findings do "move the inflammatory hypothesis of coronary artery disease forward scientifically."
But Harrington called the drug's 15 percent reduction in the risk for heart events "modest," and added that it's just too soon to say whether this type of medication might be ready for routine use.
The new study was funded by Novartis, which is developing canakinumab. It was led by Dr. Paul Ridker, who directs the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital in Boston.
Ridker's team tracked outcomes for more than 10,000 patients who'd had a prior heart attack and had persistently high blood levels of C-reactive protein.
Every patient received standard care, including today's "gold standard" heart medicine, a cholesterol-lowering statin.
Patients were randomly assigned to one of four groups -- once-every-three-month injections of canakinumab at 50-, 150- or 300-millgram doses, or a "dummy" placebo shot. Outcomes were then tracked for up to four years.
The result: People who were on the 150-mg and 300-mg doses of canakinumab had a 15 percent and 14 percent, respectively, lowered risk of non-fatal heart attack, non-fatal stroke or cardiovascular death, compared to those given the placebo.
These two groups of patients also had a 17 percent lower odds for hospitalization due to angina (chest pains) that indicated they needed a stent or angioplasty, the findings showed.
There appeared to be no major safety concerns from canakinumab, the researchers added.
"These findings represent the end game of more than two decades of research, stemming from a critical observation that half of heart attacks occur in people who do not have high cholesterol," Ridker said in an ESC news release.
"For the first time, we've been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk," he added.
"This has far-reaching implications," Ridker said. "By leveraging an entirely new way to treat patients -- targeting inflammation -- we may be able to significantly improve outcomes for certain very high-risk populations."
Canakinumab is already approved for use in the United States as a drug to fight rare diseases, and is marketed under the brand name Ilaris. But, as reported in the Washington Post, Ilaris came with an increased risk for very rare but fatal infections.
In the new study, canakinumab also appeared linked to these rare infections in about one in every 1,000 cases, Ridker's team said.
Then there's the issue of price: The current list price for a year's supply of Ilaris is $64,000, the Post noted.
Still, Ridker -- who is co-inventor on a patent for a blood test to gauge inflammation -- said he is confident that the study shows an anti-inflammatory approach to heart disease does work.
"We found that, in high-risk patients, a drug that lowers inflammation but has no effect on cholesterol reduced the risk of major adverse cardiovascular events," Ridker said.
"In my lifetime, I've seen three broad eras of preventative cardiology. First we recognized the importance of diet, exercise and smoking cessation. Then we saw the tremendous value of lipid-lowering drugs such as statins. Now we're cracking the door open on the third era," he noted. "This is very exciting."
And there was even a hint in the study that canakinumab's anti-inflammatory effects might lower cancer risk, as well, although everyone agreed much more research is needed to confirm that.
"The data on cancer rates point to the possibility of slowing the progression of certain cancers, but these are exploratory findings that need replication," Ridker said.