Colchicine increases rate of diarrhea, gastrointestinal events
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Colchicine treatment increases the rate of diarrhea and adverse gastrointestinal events, but not liver, sensory, muscle, infectious or hematological events, or death, according to the results of a meta-analysis published in Arthritis Research & Therapy.
“There is a lot of concern regarding the safety of colchicine, and this study was an attempt to demonstrate that colchicine is a safe drug,” Philip C. Robinson, MB, ChB, PhD, FRACP, of the University of Queensland, in Brisbane, Australia, told Healio Rheumatology. “We were aiming to also show the safety in patients with impaired kidney function but there simply was not the data published to be able to do that.”
To analyze the side effects of colchicine across published controlled clinical trials, Robinson and colleagues conducted a systematic literature review of the Cochrane Library, MEDLINE and EMBASE. The researchers focused on double-blind controlled trials of oral colchicine in adult patients who reported adverse event data, published from inception to November 2019.
Researchers identified 4,915 unique studies, of which 35 were included in the final analysis. Among the included randomized controlled trials, 30 featured a placebo while five used active comparators. The studies included a total of 8,659 pooled participants, among whom 4,225 received colchicine, 3,956 received a placebo and 411 received an active comparator. Robinson and colleagues used meta-analyses to determine the relative risk for adverse events among patients treated with colchicine compared with other groups.
According to the researchers, diarrhea was reported in 17.9% participants treated with colchicine, compared with 13.1% among those in comparator groups (RR = 2.4; 95% CI, 1.6-3.7). Gastrointestinal events were reported in 17.6% of those who received colchicine, compared with 13.1% in the comparator groups (RR = 1.7; 95% CI, 1.3-2.3).
Additionally, adverse liver events were reported in 1.9% of colchicine users, compared with 1.1% in the comparator groups (RR = 1.6; 95% CI, 0.9-3), with muscle events were reported in 4.2% of those treated with colchicine, compared with 3.3% in the comparator groups (RR = 1.3; 95% CI, 0.8-1.9). Hematology events had a rate of 0.6% in colchicine groups, compared with 0.4% in the comparator groups (RR = 1.34; 95% CI, 0.64-2.82).
There were no data on neuropathy events. Other sensory events were reported in 1.1% of colchicine users, compared with 1.5% in the comparator groups (RR = 1.4; 95% CI, 0.3-6.7), and infectious events were reported in 0.4% of colchicine users, compared with 2.1% in comparator groups (RR = 1; 95% CI, 0.7-1.5). There were no reported deaths.
“The key takeaways are that compared to placebo there are more GI side effects, but no other side effect is increased in randomized trials,” Robinson said. “The clinical significance is that this drug is effective — we know that — and now we have a robust systematic review and meta-analysis showing it is also safe. It should be reassuring to doctors who harbor concerns about the safety of this medicine.” – by Jason Laday
Disclosures: Robinson reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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