ACCORD Lipid
Trial question
What is the effect of combination lipid therapy in patients with T2DM mellitus who are at high risk for CVD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 5518
5518 patients (1694 female, 3824 male)
Inclusion criteria: patients with T2DM mellitus who are at high risk for CVD and being treated with simvastatin
Key exclusion criteria: history of hypoglycemic coma/seizure within past 12 months, history consistent with T1DM, known hypersensitivity to statins or fibrates, history of pancreatitis, untreated or inadequately treated thyroid disease, breastfeeding, preexisting gallbladder disease, or previous occurrence of myositis/myopathy
Interventions
N=2765 fenofibrate (160 mg/day at the start of the trial, but adjusted according to eGFR using Modification of Diet in Renal Disease equation)
N=2753 placebo (identical placebo per day)
Primary outcome
Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
2.2
2.4
2.4 %
1.8 %
1.2 %
0.6 %
0.0 %
Fenofibrate
Placebo
No significant difference ↔
No significant difference in cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (2.2% vs. 2.4%; HR 0.92, 95% CI 0.79 to 1.08)
Secondary outcomes
No significant difference in death at 1 year (1.47% vs. 1.61%; HR 0.91, 95% CI 0.75 to 1.1)
No significant difference in major coronary event (2.58% vs. 2.79%; HR 0.92, 95% CI 0.79 to 1.07)
No significant difference in stroke (0.38% vs. 0.36%; HR 1.05, 95% CI 0.71 to 1.56)
Conclusion
In patients with T2DM mellitus who are at high risk for CVD and being treated with simvastatin, fenofibrate was not superior to placebo with respect to cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Reference
ACCORD Study Group, Ginsberg HN, Elam MB et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74.
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