Breakthrough Drug Beats Heart Disease By Reducing Inflammation

About every 40 seconds, an American has a heart attack, and almost 15% of those heart attacks are fatal. As the leading cause of death in the US, heart disease has been the subject of thousands of studies in the last several decades, and breakthroughs in the last 50 years have been significant. First, diet, exercise, and smoking cessation were all proven to play an enormous role in heart health, helping physicians guide patients to less risky lifestyle choices. Then, in the 1980s, the first commercial statin was approved by the FDA, ushering in an era in which medication could be used alongside lifestyle changes to lower cholesterol levels, potentially reducing heart attack risk by over a third for some high risk patients.

Despite these gains and the fact that statins are one of the most frequently prescribed drugs, heart disease is still the number one killer of Americans, but researchers are excited about the results of a study published last month in the New England Journal of Medicine that investigates the impact of a new drug on cardiovascular risk. The trial is the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS), and the drug, called Canakinumab, may be able to bring heart attack risk to an all-time low by targeting inflammation. This study is the first in which a systemic anti-inflammatory, a drug that reduces inflammation throughout the body, has been shown to lower heart attack risk independent of cholesterol-lowering medications.

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The purpose of the trial was to see whether reducing inflammation could reduce the risk of recurring cardiovascular events among people who had already had a heart attack and who had elevated levels of high sensitivity C-reactive protein (hsCRP), an indication of systemic inflammation. The study was the culmination of more than 25 years of research. By treating all patients in the trial with standard care (high doses of statins) and then dividing them into groups that would receive either 50, 150, or 300 mg of Canakinumab (or a placebo), the researchers were able to accurately assess the impact of the new drug. More than 10,000 patients took part in the trial, some of whom were monitored for up to four years.

The results showed a 15% reduction in heart attacks and strokes for patients taking either 150 or 300 mg of the of Canakinumab, proving for the first time that inflammation plays a role in heart disease risk independent of cholesterol levels. This discovery may change therapeutic practice for patients at high risk of heart attack or stroke. More studies are underway to establish the best strategies for using Canakinumab – which patients benefit most and how the drug can be used in combination with other therapies.

According to the Paul M. Ridker, M.D., the study’s lead author, “These findings represent the end game of more than two decades of research, stemming from a critical observation: Half of heart attacks occur in people who do not have high cholesterol. For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk. This has far-reaching implications. It tells us that 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.”

The need for invasive and expensive interventions, like bypass surgery and angioplasty, were reduced by more than 30% in patients taking Canakinumab, a far greater reduction than is usually found with the use of statins alone.

The study also discovered that Canakinumab halved participants’ risk of dying from cancer. This was an incidental finding, but it may inspire cancer researchers may begin investigating the role anti-inflammatories may play in preventing cancer for high-risk patients. (In this study, the reduction in cancer deaths was balanced out by an increase in fatal infections among those taking Canakinumab, but further research may discover a way to minimize infection-related risks.)

“In my lifetime, I’ve gotten to see three broad eras of preventative cardiology. In the first, we recognized the importance of diet, exercise, and smoking cessation. In the second, we saw the tremendous value of lipid-lowering drugs such as statins. Now, we’re cracking the door open on the third era,” said Ridker. “This is very exciting.”