Colchicine Gout Therapy Appears Safe Despite Patient Comorbidities: Presented at ACR/ARHP
By Ed Susman
ATLANTA -- November 11, 2010 -- Treatment with colchicine appears safe in patients who experience gout flares even if those individuals have other comorbid conditions, researchers said here at the 2010 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
In an analysis of the Acute Gout Flare Receiving Colchicine Evaluation (AGREE) trial, researchers could find no statistically significant differences in adverse event profile of 185 patients in the study on the basis of their age, how long they had been diagnosed with gout, their renal function, the presence of cardiovascular disease, obesity, or liver function.
“Although additional studies would be needed to corroborate these results, these data offer reassurance regarding the safety of colchicine in patients with several comorbid conditions,” reported Matthew W. Davis, MD, URL Pharma, Philadelphia, Pennsylvania.
“Many patients with gout have other serious health conditions to consider, including cardiovascular and metabolic disorders, hypertension, and kidney disease, which can make gout treatment complex,” said Dr. Davis on November 8. “This analysis demonstrates that patients with these comorbidities did not have an increased likelihood of adverse events from the use of colchicines.”
In the phase 3 AGREE study, 185 patients meeting ACR criteria for acute gout flares were randomised to receive, within 12 hours of symptom onset, either high-dose colchicine (1.2 mg as a loading dose followed by 0.6 mg hourly for 6 hours or a total of 4.8 mg); colchicine 1.2 mg (then 0.6 mg in 1 hour for a total of 1.8 mg total, followed by 5 placebo doses hourly); or 2 placebo capsules, followed by 1 capsule hourly for 6 hours.
Dr. Davis said the incidence of adverse events among comorbid patients with acute gout flares treated with colchicine was not affected by any of the independent variables analysed.
During the study, 83 patients experienced an adverse event; about three-fourths of these events were mild to moderate gastrointestinal complaints. The researchers observed that 40 of the 52 patients who received high-dose colchicines experienced an adverse event (76.9%); 27 of the 74 patients who received the low-dose colchicines experienced an adverse event (36.5%), and 16 of 59 patients who were on the placebo arm of the study experienced adverse events (27.1%). No patient discontinued the study due to adverse events, Dr. Davis said.
[Presentation title: Chronologic Age, Renal Function, and Comorbid Conditions (Physiologic Age) of Patients With Gout Did Not Increase Likelihood of Adverse Events (AEs): AGREE Study Post Hoc Analyses. Abstract 147]