Table 1. Literature summary of colchicine in cardiovascular disease.
Trial (year) | N | Patient population | Intervention | Primary endpoint(s) | Primary result(s) (colchicine vs placebo) | Adverse effects (colchicine vs placebo) |
PPS and POAF | ||||||
COPPS (2010)8 | 360 | Adults undergoing cardiac surgery without baseline liver, renal, or GI disease | Colchicine 1 mg bid on POD 3, followed by 0.5 mg bida x 1 month vs placebo | Incidence of PPS at 12 months | 8.9% vs 21.1%; P = .002 (NNT = 9) | 8.9% vs 5%; P = .212 |
COPPS AF Substudy (2011)4 | 336 | COPPS patients in sinus rhythm at randomization (POD 3) | Colchicine 1 mg bid on POD 3, followed by 0.5 mg bida x 1 month vs placebo | Incidence of POAF at 1 month | 12.0% vs 22.0%; P = .021 (NNT = 11) | 9.5% vs 4.8%; P = .137 |
COPPS-2 (2014)12 | 360 | Adults undergoing cardiac surgery in sinus rhythm at enrollment | Colchicine 0.5 mg bida x 1 month starting 48–72 h before surgery vs placebo | PPS within 3 months | 19.4% vs 29.4%; 95% CI, 1.1–18.7 (NNT = 10) | 20.0% vs 11.7%; 95% CI, 0.76–15.9 (NNH = 12) |
POAFb | 33.9% vs 41.7%; 95% CI, -2.2 to 17.6 (NS) | |||||
POAF on-treatment analysisb | 27.0% vs 41.2%; 95% CI, 3.3–24.7 (NNT = 7) | |||||
Acute pericarditis | ||||||
COPE (2005)14 | 120 | Adults with first episode of acute pericarditis and no C/I to colchicine therapy | Conventional therapyc plus colchicine 2 mg on day 1, then 1 mg daily x 3 monthsa vs placebo | Incidence of recurrent pericarditis | 11.7% vs 33.3%; P = .009 (NNT = 5) | 8.3% vs 6.7%; P = NS |
ICAP (2013)15 | 240 | Adults with first episode of acute pericarditis and no C/I to colchicine therapy | Conventional therapyd plus colchicine 2 mg on day 1, then 1 mg daily x 3 monthsa vs placebo | Incidence of incessant or recurrent pericarditis | 16.7% vs 37.5%; P < .001 (NNT = 4) | 11.7% vs 10.0%; P = .84 |
Recurrent pericarditis | ||||||
CORE (2005)21 | 84 | Adults with first episode of recurrent pericarditis | Conventional therapyc plus colchicine 2 mg on day 1, then 1 mg daily x 6 monthsa vs placebo | Incidence of recurrent pericarditis at 18 months | 24.0% vs 50.6%; 95% CI, 2.5–7.1; P = .02 (NNT = 4) | 7.1% vs 14.3%; P = .48 |
CORP (2011)22 | 120 | Adults with first episode of recurrent pericarditis | Conventional therapyd plus colchicine 2 mg on day 1, then 1 mg daily x 6 monthsa vs placebo | Incidence of recurrent pericarditis at 18 months | 24.0% vs 55.0%; 95 CI, 0.13–0.46; P < .001 (NNT=4) | 6.7% vs 6.7%; P > .99 |
CORP-2 (2014)23 | 240 | Adults with ≥2 prior pericarditis recurrences | Conventional therapye plus colchicine 0.5 mg bida x 6 months vs placebo | Incidence of recurrent pericarditis at 18 months | 21.6% vs 42.5%; 95% CI, 0.24–0.65; P = .0009 (NNT = 5) | 11.7% vs 8.3%; P = .519 |
Note: BID = twice daily; C/I = contraindication; COPE = COlchicine for Acute PEricarditis; COPPS = Colchicine for the Prevention of the Postpericardiotomy Syndrome; COPPS-2 = Colchicine for the Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation; CORE = COlchicine for REcurrent pericarditis; CORP = COlchicine for Recurrent Pericarditis; CORP-2 = Colchicine for Recurrent Pericarditis 2; GI = gastrointestinal; ICAP = Investigation on Colchicine for Acute Pericarditis; NNH = number needed to harm; NNT = number needed to treat; NS = not significant; POAF = postoperative atrial fibrillation; POD = postoperative day; PPS = postpericardiotomy syndrome.
Doses halved (ie, 0.5 mg daily) in patients weighing <70 kg or intolerant to the highest dose.
Secondary endpoint.
Aspirin 800 mg every 6–8 hours for 7–10 days, followed by 3–4 week taper. Alternative: prednisone 1.0 to 1.5 mg/kg/day x 4 weeks with subsequent taper if contraindication.
Aspirin 800–1000 mg or ibuprofen 600 mg every 8 hours x 7–10 days, followed by 3–4 week taper. Alternative: prednisone 0.2–0.5 mg/kg/day x 4 weeks with subsequent taper if contraindication or intolerance.
Aspirin, ibuprofen, or indomethacin dosed by provider. Alternative: prednisone 0.2–0.5 mg/kg/day x 4 weeks with subsequent taper if contraindication or intolerance.