An evidence review of 39 clinical trials found that patients who received continuous long-term treatment with colchicine had no reduction in all-cause mortality or cardiovascular mortality.
The researchers added that there was moderate quality evidence showing that colchicine was associated with reductions in MI, although most of the evidence came from one study.
Lead researcher Lars G. Hemken, MD, MOH, of University Hospital Basel in Switzerland, and colleagues published their results online in JAMA on Sept. 13.
They noted that colchicine, an anti-inflammatory drug, is used to treat familial Mediterranean fever or pericarditis or prevent gout. They said no current clinical practice guidelines recommend colchicine to prevent cardiovascular events.
This review included 4,992 participants who enrolled in studies conducted from 1973 through July 31, 2013, including 1,230 participants with high cardiovascular risk. The mean age of participants was 55 years old, and 56 percent were men.
Of the 39 trials, four were in patients with high risk for cardiovascular disease. In addition, 13 trials were conducted in the European Union, eight were conducted in the U.S. and six were conducted in other countries. The country was not reported in 12 trials.
The researchers found that colchicine was not associated with reduced all-cause mortality or cardiovascular mortality but was associated with a lower risk for MI. Colchicine was also associated with an increased risk for gastrointestinal adverse effects.
They added that treating 1,000 persons with colchicine during three years may have been associated with 46 fewer MIs and 110 more people experiencing adverse gastrointestinal events.
They also mentioned the review had a few limitations, including that many of the trials were conducted more than 20 years ago and that adverse events and cardiovascular outcomes were not typically monitored. They said that most of the evidence on cardiovascular events came from three randomized trials published within the last three years. In addition, the total number of events was low for cardiovascular mortality, MI, stroke and heart failure.
“More high-quality randomized clinical trials are needed to confirm or refute the associations described herein,” the researchers wrote. “Based on the available evidence, it appears reasonable to defer using colchicine for prevention of cardiovascular events until further trials are completed that establish whether colchicine improves outcomes in patients with established cardiovascular disease or at high risk for cardiovascular disease.”