The inflammation-fighting drug colchicine, already a treatment for gout, dramatically reduces the odds of future cardiovascular problems in people who have just survived a heart attack, a large new study has concluded.
While 7.1 per cent of patients who took placebo pills died, had a second heart attack, a stroke or needed a stent or heart surgery over the next two years, the rate was reduced to 5.5 per cent among those who took a half-milligram colchicine pill every day.
The reduction in risk with colchicine was seen even though patients were receiving standard care with aspirin and cholesterol-lowering drugs.
“Not only did we reduce first events and recurrent events, the drug was well tolerated, the drug is well known, the safety profile is well known, it is inexpensive, and it’s widely available. So it’s only good news for patients,” said chief author Dr. Jean-Claude Tardif, director of the Montreal Heart Institute.
The results of the study were reported Saturday at the American Heart Association’s annual Scientific Sessions in Philadelphia and online in The New England Journal of Medicine.
The work also affirms earlier research showing that inflammation plays an important role in cardiovascular problems.
“Twenty-five years ago, people would look at atherosclerosis as rust in the pipe,” said Tardif. “We’ve learned this is not rust in a pipe. This is a very dynamic disease.”
“This is exciting because it’s really telling us we have a major new direction to go in the treatment of heart disease that goes beyond cholesterol alone,” said Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at the Boston-based Brigham and Women’s Hospital, who has been studying inflammation for years but was not involved in the study. “This will open up this whole field.
“We’re going to be giving patients very aggressive, cholesterol-lowering and inflammation-lowering treatment in the future,” he said.
Less clear is the value of giving colchicine to patients who haven’t had a first heart attack, even when they face a higher risk because of high blood pressure, diabetes, high cholesterol or a family history of heart disease. Tardif said a study would be done to examine that question.
Ridker cautioned against giving the drug as a way to prevent a first heart attack, noting that the treatment “does come with some risk.”
“It does have an increased risk of pneumonia,” said Ridker, noting that pneumonia appeared in 0.9 per cent of colchicine patients, versus 0.4 per cent in the placebo group.
Colchicine is also not prescribed for long-term use.
“We have overwhelming proof colchicine is safe and effective,” Ridker said, in part because it is widely used. “But right now, we’re talking about secondary prevention, where the patients are at such high risk, we would accept the downsides. Colchicine’s use has to be limited unless we come up with a much safer drug.”
“Whether [doctors] will decide immediately to not even wait for another study and use it in primary prevention remains to be seen,” said Tardif, who is also a professor of medicine at the University of Montreal.
Drug is largely affordable
The study’s 4,745 volunteers — recruited at 167 medical centres in 12 countries — had experienced a heart attack within the previous 30 days. Patients with severe heart failure, a recent stroke, or several other medical conditions were excluded. Only 19 per cent were women.
The once-a-day, half-milligram pill trimmed the odds of death from any cardiovascular cause by 16 per cent, reduced the likelihood of being resuscitated from a cardiac arrest by 17 per cent, shaved the chance of subsequent heart attack by 9 per cent, slashed the risk of being hospitalized for coronary bypass or a stent procedure in half, and cut the odds of a stroke by 74 per cent, the study found.
But only the last two outcomes were statistically significant. Thus, the lower rate of strokes, and the reduced need to go to the emergency room to receive a stent or heart bypass surgery for chest pain, accounted for most of the benefit from colchicine.
Colchicine, derived from the autumn crocus, has been around for centuries and is cheap, at least outside the U.S.
Both the drug and placebo groups had similar rates of side effects during the study, and side effects attributed to colchicine were few.
Besides the risk of pneumonia, nausea was a problem for 1.8 per cent of patients taking colchicine versus one per cent taking the placebo. Flatulence was reported in 0.6 per cent of the drug recipients, compared with 0.2 per cent among those on placebo.