6/27/23, 11:46 PM ACCORD Lipid Pathway Feedback Search Clinical Topics Home Studies ACCORD Lipid ACCORD Lipid Disease Disease Disease Acute ischemic stroke Coronary artery disease Diabetes m 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 N = 5518 69.0% male 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) https://web.pathway.md/studies/recAh2yFvKCMSHCqk 1/2 6/27/23, 11:46 PM ACCORD Lipid Pathway N=2753 placebo (identical placebo per day) Primary outcome Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke 2.4 % 2.4 2.2 1.8 % 1.2 % 0.6 % No significant difference 0.0 % Fenofibrate Placebo 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. Open reference URL https://web.pathway.md/studies/recAh2yFvKCMSHCqk 2/2