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The FIRST Trial: A Rationale Davidson M, Rosenson RS, Maki KC et al. Study design, rationale, and baseline characteristics: evaluation of fenofibric acid.

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Presentation on theme: "The FIRST Trial: A Rationale Davidson M, Rosenson RS, Maki KC et al. Study design, rationale, and baseline characteristics: evaluation of fenofibric acid."— Presentation transcript:

1 The FIRST Trial: A Rationale Davidson M, Rosenson RS, Maki KC et al. Study design, rationale, and baseline characteristics: evaluation of fenofibric acid on carotid intima-media thickness in patients with type IIb dyslipidemia with residual risk in addition to atorvastatin therapy (FIRST) trial. Cardiovasc Drugs Ther 2012;26:249-5

2 Residual Macrovascular Risk Remains High in Patients on Statins – CTT analysis Baigent C, Keech A, Kearney PM et al. Lancet 2005;366:1267–78. Relative reduction in major coronary events (95% CI) 23% (20% to 26%) But - lowering LDL-C by 1 mmol/L (  40 mg/dL) with statins leaves a relative residual risk of 77%

3 REALIST: Atherogenic Dyslipidemia is a Contributor to Residual Coronary Risk Elevated TG and low HDL-C act synergistically to increase coronary risk Carey VJ, Bishop L, Laranjo N et al. Am J Cardiol 2010;106:757-63

4 Targeting Atherogenic Dyslipidemia Reduces Residual Cardiovascular Risk Fibrate meta-analysis: The odds of a CV event were reduced by 35% in patients with atherogenic dyslipidemia* * TG > 204 mg/dL and HDL-C <34 mg/dL Sacks FM, Carey VJ, Fruchart JC. N Engl J Med 2010;363:692-4

5 Targeting Atherogenic Dyslipidemia in Hypertensive Patients Change from baseline Fenofibrate had significant benefits (p<0.05) on subclinical atherosclerosis and carotid plaque formation CC IMT Common carotid IMT IC IMT Internal carotid IMT D Diameter Zhu S, Su G, Meng QH. Clin Chem 2006;52:2036-42

6 The FIRST Trial Key Question: Does fenofibric acid reduce subclinical atherosclerosis in high-risk statin-treated patients with atherogenic dyslipidemia? Davidson M, Rosenson RS, Maki KC et al. Cardiovasc Drugs Ther 2012;26:249-5

7 The FIRST Trial: Design Multicentre, double-blind randomized trial Key inclusion criteria: Common CIMT  0.7 mm on at least one side TG  150 mg/dL [1.7 mmol/L] AND low HDL-C* Controlled LDL-C on atorvastatin Rate of change at 104 weeks in common CIMT (composite of both sides), a measure of subclinical atherosclerosis. Davidson M, Rosenson RS, Maki KC et al. Cardiovasc Drugs Ther 2012;26:249-5


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