Hypothesis
Adding fenofibrate to statin therapy would lower cardiovascular events in high-risk patients with type 2 diabetes, compared with a statin alone.
What failed
Across 5,518 patients followed for a mean 4.7 years, the primary outcome (nonfatal MI, nonfatal stroke or cardiovascular death) ran at 2.2% a year with fenofibrate vs 2.4% with placebo (HR 0.92, P=0.32), with no difference on any secondary outcome.
Broken assumption
Lowering triglycerides with a fibrate adds cardiovascular protection on top of a statin in type 2 diabetes.
Why
The combination did not reduce events in the trial population as a whole. Prespecified subgroups hinted at benefit in men and in patients with both high triglycerides and low HDL, and possible harm in women — the authors treat these as hypotheses, not findings.
From the published paper: ACCORD Study Group. N Engl J Med, 2010. NCT00000620 ↗