A drug that fights inflammation can reduce the risk of heart attacks and strokes, and possibly lung cancer, in people who have already had one heart attack and are at high risk for another, a new study shows.
Dr. Ridker, the first author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, presented the study on Sunday in Barcelona at a meeting of the European Society of Cardiology. The cardiovascular results were published in The New England Journal of Medicine, and the cancer results in The Lancet.
The drug that was studied, canakinumab, is already marketed under the brand name Ilaris, but was approved to treat a type of juvenile rheumatoid arthritis and other rare disorders, not heart disease. It costs about $200,000 a year and is made by Novartis, which paid for the new study.
Researchers outside the study say the findings represent a major milestone, proof of a biologic concept that opens the door to new ways of treating and preventing cardiovascular disease in people who are still at risk despite standard therapies.
But experts also cautioned that potentially fatal side effects of the drug, as well as its high cost, mean it is unlikely to be widely used.
Cardiovascular disease is the leading cause of death worldwide and in the United States, where it killed nearly 634,000 people in 2015. Globally, it killed 15 million.
The Novartis drug is much stronger and works much faster, and by a different route, than more familiar anti-inflammatory medicines like aspirin and ibuprofen. It inhibits a substance called interleukin-1β, which causes systemic inflammation.
The new study included only people who had blood tests showing high levels of inflammation even though they were already taking statins and had lowered their “bad” LDL cholesterol to acceptable levels.
The researchers found that in the placebo group, for every 100 patients followed for a year, 4.5 had a heart attack or stroke, or died from cardiovascular disease. In those who received the optimal dose of the drug, the rate was lower, 3.86. When the length of time patients were treated was taken into account, the reduction in risk was 15 percent.
“This is the first evidence we have that if you inhibit this inflammatory process without changing cholesterol at all, you’re getting a risk reduction,” said Dr. Paul M. Ridker.
If the drug is used in practice, Dr. Ridker said it should be limited to patients like the ones in the study, who have already suffered heart attacks and have high levels of inflammation and therefore high risk of heart attacks and strokes. Even within that group, he said he would limit its use further, to patients whose blood tests showed that the medicine significantly lowered inflammation. And they would have to be monitored carefully and treated quickly for signs of infection.
The study also found that the drug could reduce cases of, and deaths from, lung cancer. No patients were known to have cancer when they entered the study. The highest dose appeared to cut lung cancer incidence by two-thirds, and deaths by three-quarters. But because heart disease was the main focus of the study, the authors called the cancer results “exploratory” and said more study is needed to see if they hold up.
Dr. Rudin, the chief of thoracic oncology at Memorial Sloan Kettering Cancer Center in New York, also added that although the study found the drug also lowered risk in people who still smoked, it does not mean they could just take the drug, keep smoking and figure they were safe.
Quitting is still the best way to lower the risks of both lung cancer and heart disease, he stated.