Background Colchicine (COL) is widely used in rheumatology for treatment and prophylaxis of acute gout flares, other crystal diseases, and autoinflammatory diseases. In recent years evidence on the efficacy of COL for the prevention and treatment of cardiovascular diseases (CVD) has accrued. Since patients with gout and other inflammatory RMDs have a higher CV risk, COL may be a useful resource for CV prevention in rheumatology.

Objectives To review the randomised controlled trials (RCT) investigating the use of COL for CV prevention from a rheumatology perspective.

Methods A systematic literature review (SLR) of 7 databases was conducted following the PICO framework. Three researchers independently screened abstracts and titles and then full texts were reviewed to determine eligibility (RCTs enrolling adult subjects with or w/o history of CVD treated with COL for CV prevention). Data from eligible articles were extracted and risk of bias (RoB) was assessed with validated tools.

Results A total of 3867 articles were retrieved and screened, 174 articles were read in full and 20 of them were eligible for inclusion. Of 19440 enrolled patients, 9655 were randomised to receive COL at a dose varying between 0.5mg/day and 2mg/day and for a period ranging between 10 days and several months (covering in part or in full the study follow-up period). Main inclusion criteria were recent acute coronary syndrome or planned cardiac surgery. In two studies, patients with stable chronic heart failure or stable coronary disease were recruited. The primary outcome varied across studies, being for example new-onset CV events, need of hospital admission, CV death, a composite index including all of these, or serum concentrations of high-sensitivity C-reactive protein. Median follow up time was largely different across studies allowing to stratify them in short term (<1 month, 2 studies), medium term (1-3 months, 7 studies), long term (4-6 months, 4 studies), very long term (>6 months, 4 studies) studies. The remaining studies assessed in-hospital events. In 7 out of 20 RCTs previous or ongoing COL use for any indication was as exclusion criterion. However, no further details about the reason for taking COL was provided. Male gender was predominant in all studies (between 65 and 96%) whereas mean age ranged between 59 and 69 years. A thorough CV history was collected at recruitment, however there was no mention to uric acid levels or a previous diagnosis of gout. Furthermore, 3 RCTs excluded patients with known autoimmune/inflammatory disease (in 2 of them ongoing immunosuppressive or steroid therapy was an additional exclusion criterion) however the other RCTs did not mention coexisting autoimmune/inflammatory diseases. The primary endpoint was met by 0/2 (0%) short term studies, 4/7 (57%) medium term studies, 2/4 (50%) long term studies and 2/4 (50%) very long-term studies. Neither of the studies assessing in-hospital events met the primary endpoint.

Conclusion Our SLR of RCTs showed that COL may be useful in preventing new CV events/CV death in the general population when administrated for at least on month. However, the overall lack of information about coexisting gout/other inflammatory RMDs does not allow to derive meaningful data to be applied in rheumatology practice. Future RCTs should consider this aspect when defining the eligibility criteria and describing the patient cohorts since COL may be even more effective in patients that display a higher CV risk due to an underlying inflammatory disease. This may ultimately increase the likelihood to achieve the study primary endpoints.

REFERENCES: NIL.

Acknowledgements: NIL.

Disclosure of Interests None Declared.