6/28/23, 11:31 PM ICAP Pathway Feedback Search Clinical Topics Home Studies ICAP ICAP Disease Acute pericarditis Trial question What is the effect of colchicine in patients with acute pericarditis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 40.0% female N = 240 60.0% male 240 patients (95 female, 145 male) Inclusion criteria: adults with acute pericarditis who were receiving conventional treatment Key exclusion criteria: tuberculous, neoplastic, or purulent pericarditis; severe liver disease, skeletal myopathy; blood dyscrasia; IBD; hypersensitivity to colchicine or other contraindication to its use; current treatment with colchicine; and life expectancy < 18 months; pregnant or lactating women Interventions N=120 colchicine (at a dose of 0.5 mg BID for 3 months for patients weighing > 70 kg or 0.5 mg once daily for patients weighting 70 kg) N=120 placebo (identical placebo for 3 months) Primary outcome Incessant or recurrent pericarditis 37.5 % 37.5 https://web.pathway.md/studies/rech5UryaqePukKjw 1/2 6/28/23, 11:31 PM ICAP Pathway 28.1 % 18.8 % 16.7 Significant decrease 9.4 % NNT = 5 0.0 % Colchicine Placebo Significant decrease in incessant or recurrent pericarditis (16.7% vs. 37.5%; RR 0.44, 95% CI 0.28 to 0.7) Secondary outcomes Significant decrease in symptom persistence at 72 hours (19.2% vs. 40%; RR 0.48, 95% CI 0.2 to 0.76) Significant decrease in hospitalization (5% vs. 14.2%; RR 0.35, 95% CI 0.05 to 0.65) Significant increase in remission at 1 week (85% vs. 58.3%; RR 1.46, 95% CI 0.59 to 2.33) Safety outcomes No significant difference in overall adverse effects and rates of study-drug discontinuation. Conclusion In adults with acute pericarditis who were receiving conventional treatment, colchicine was superior to placebo with respect to incessant or recurrent pericarditis. Reference Imazio M, Brucato A, Cemin R et al. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. Open reference URL https://web.pathway.md/studies/rech5UryaqePukKjw 2/2