Australian cardiologists are closer to confirming that a drug used for decades to treat gout could be used long-term to prevent MI in people with heart disease.
Interest in using colchicine for secondary prevention first came to light in 2012 when Australian cardiologists reported findings from their small pilot study among 500 Western Australian patients, some of whom were given 0.5mg of the medication daily in addition to their usual care.
Perth cardiologist Dr Mark Nidorf who is now overseeing a much larger international trial to test the drug’s use in this setting said colchicine could dramatically reduce heart attacks in patients already treated for their heart disease.
“When we gave the drug to patients the risk of heart attack was reduced by half and the side effects were minimal compared to those who did not receive the drug,” Dr Nidorf told the limbic.
“It’s the first time we’ve been able to show that a drug with primarily inflammatory effects can alter the natural history of patients with coronary disease,” he said.
Dr Nidorf explained that many people who are optimally treated with high dose statins and lipid-lowering drugs will still experience ischaemic events because until now, no one has been able to treat the inflammation that occurs in some cholesterol plaques in the coronary artery.
“Even patients who have been involved in the more sophisticated recent trials of [PCSK9 inhibitors] that can lower cholesterol even more than current targets may still have strokes or heart attack or unstable angina because, as much as lowering LDL-cholesterol is important, it’s not the whole problem,” he said.
“It’s really the inflammatory process that causes the atherosclerotic process to proceed and that’s a process which is potentially modifiable,” he added.
Dr Nidorf said thousands more patients in Western Australia will participate in a double blind placebo controlled study to confirm these initial findings.
Some 1,900 patients have already been recruited into the trial called the LoDoCo2 Trial.
The study has also garnered international interest – researchers in the Netherlands have signed on to participate in the trial with plans to recruit another 2,000 patients into the study.
According to Dr Nidorf it may not be long before the drug becomes more routinely used in patients with heart disease.
“I don’t think the regulatory authorities will hold it up on safety, we already have long term safety data on this drug which the FDA have had a careful look at in the past. What they’ll be looking for is efficacy so this second trial is really important.”
According to Dr Nidorf the drug has a broad range of effects. It targets neutrophils, which are active in the development and instability of atherosclerotic plaque, and it also inhibits the actions of a number of other cells involved in the inflammatory process including macrophages fibrocytes and other cell lines in the vessel wall.
Commenting on recent findings presented at the ACC conference this week, Dr Nidorf said that while drugs like the PCSK9 inhibitors are being trialled and developed they are expensive and relatively inaccessible – the good thing about colchicine is that it’s widely available and relatively inexpensive.
“Data from Fourier presented at the ACC last week showed that we can modify about 50% of the risk associated with coronary disease just by lowering LDL-cholesterol in whichever way you can … but there’s a big concern about price with the PCSK9 inhibitors. It costs about US$14,000 a year to give these drugs to people which means these drugs will not be affordable by the average person.
“I think it will be quite a while before these drugs transfer into routine clinical practice.”