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Findings presented at the European Society of Cardiology meeting could open the door to the use of the gout drug as a treatment targeting the underlying inflammation of cardiovascular disease.
A daily 0.5-mgdose of colchicine, the anti-inflammatory gout drug, reduced the relative risk of serious cardiovascular events by 31% among people with chronic coronary disease, according to results presented at the European Society of Cardiology today that were simultaneously published in the New England Journal of Medicine.
The results of the 5,522-patient study didn’t show any interaction between the low dose of colchicine and high doses of statins, according to the investigators, and could open the door to a treatment strategy directed at the inflammation that many now believe is the root cause of cardiovascular disease.
The results of the LoDoCo2 (low-dose colchicine) study may also stir up discussion about the cost of colchicine, which used to be priced at pennies a pill before an FDA program that required the re-testing of old drugs led to a market where only a brand-name version of colchicine, Colcrys, that costs dollars a pill, was available. Colcrys now has competition from a generic, Mitigare, and an authorized generic. But this morning on GoodRx, an order of 30, 0.6-mg tablets of Mitigare at Walmart, with a coupon, was more expensive than the same amount of Colcrys ($78.21, or $2.60 per pill vs. $56.59, or$1.87 a pill), and both were still priced far higher than colchicine used to be.
The results reported at ESC are not a huge surprise because they are consistent with those from an earlier, much-discussed study conducted by the same investigators, an Australian group led by Stefan M. Nidorf, M.D. But that earlier study was an open-label trial with just over 500 patients whereas these results have added credibility because they are from a randomized, double-blind study with ten times as many patients.
Nidorf and his colleague designed their study so the primary endpoint was a composite of cardiovascular death, spontaneous (i.e., nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. During a median follow-up period of just over 28 months, 187 patients (6.8%) randomized to take the low-dose colchicine tablet every day experienced one of those primary endpoint events compared with 264 (9.6%) of those in the placebo group. That works out to a hazard ratio of 0.69 and thus the relative risk difference of 31%. The patients randomized to colchicine also fared better when came to some secondary endpoints.
However, Nidorf and his co-investigator noted that their results showed the incidence of death from noncardiovascular causes was higher in the colchicine group than those who took the placebo pill. Statistically, though, it was not significant finding and could be due to chance, they said in the NEJM article, while acknowledging that the hazard ratio of 1.51 “is of potential concern.”