Eighteen RCTs (n=45,058) were included in the review. Totals of 2,870 major cardiovascular events, 4,552 coronary events and 3,880 deaths were reported. Sample sizes ranged from 81 to 10,627. Trial quality was variable and poor reporting of criteria was widespread; this was particularly the case for randomisation, allocation concealment and use of intention-to-treat analysis. Completion rates ranged from 19% to 100%. Eight trials had a Jadad score of 4, five scored 2 points, four scored 1 and one trial scored 0.
There was a statistically significant reduction in risk of cardiovascular events (RR 0.90, 95% CI 0.82 to 1.00; five RCTs), coronary events (RR 0.87, 95% CI 0.81 to 0.93; 16 RCTs), non-fatal coronary events (RR 0.81, 95% CI 0.75 to 0.89; 10 RCTs) and coronary revascularisation (RR 0.88, 95% CI 0.78 to 0.98; four RCTs) in groups treated with fibrates with no significant statistical heterogeneity. There were also benefits in reduced progression of albuminuria (RR 0.86, 95% CI 0.75 to 0.98; three RCTs) and retinopathy (RR 0.63, 95% CI 0.49 to 0.81; two RCTs).
No statistically significant differences between groups were found for the following outcomes: stroke; all-cause mortality; cardiovascular death; sudden death; non-vascular death; and serious drug-related adverse events. There were statistically significant increases in serum creatinine concentrations in fibrate groups (RR 1.99, 95% CI 1.46 to 2.70), but no other statistically significant differences in adverse events were found.
Results of subgroup and sensitivity analyses were reported. These included the finding that there was a stronger effect of therapy (p=0.03) in trials with a higher mean baseline triglyceride concentration. There was some evidence of publication bias for the outcome of coronary events, but not for major cardiovascular outcomes.