Efficacy

In patients with mixed dyslipidemia, TriCor provided significant results in all key lipid parameters vs placebo.

To view details about an additional clinical study, click here.

TriCor provided significant results in all key lipid parameters vs placebo (1)

Baseline LDL-C > 160 mg/dL and TG >150 mg/dL (type llb)

HDL-C		Triglycerides
LDL-C		The effects of fenofibrate were assessed in multicenter clinical trials of 3 to 6 months' duration, at a dose equivalent to 145 mg TriCor per day, from four randomized, placebo-controlled, double-blind, parallel-group studies in type IIa and type IIb patients with a mean baseline LDL-C of 213.8 mg/dL. (1) The independent effect of raising HDL-C or lowering TG on the risk of cardiovascular morbidity and mortality has not been determined. (1)

TriCor Type IIa/IIb Indications (1)

TriCor is indicated as adjunctive therapy to diet in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb) to: increase high-density lipoprotein cholesterol (HDL-C), reduce triglycerides (TG), reduce low-density lipoprotein cholesterol (LDL-C), reduce total cholesterol (Total-C), reduce apolipoprotein B (Apo B).

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Additional Clinical Study

In a subgroup analysis of patients with mixed dyslipidemia

Demonstrated results of TriCor vs a statin (2)

HDL-C *Fenofibrate 200-mg capsule/day; simvastatin 20 mg/day

Triglycerides *Fenofibrate 200-mg capsule/day; simvastatin 20 mg/day

LDL-C	Total-C	Apo B
*Fenofibrate 200-mg capsule/day; simvastatin 20 mg/day

In a multicenter, double-blind, randomized, parallel-group clinical trial of patients with types IIa or IIb hyperlipidemia, the LDL-C lowering efficacy of fenofibrate vs simvastatin was assessed. After 8 weeks of diet-only therapy, patients were randomized to either a fenofibrate 200-mg capsule/day (a dose equivalent to a 145-mg TriCor tablet) or simvastatin 20 mg/day for 12 weeks. Subgroup analyses were performed in patients with type IIa (fenofibrate 44/66 and simvastatin 41/64) and patients with type IIb (fenofibrate 22/66 and simvastatin 23/64). Inclusion criteria were Total-C levels >250 mg/dL and LDL-C between 180 mg/dL and 300 mg/dL. (2)

In combined type IIa and type IIb patients, TriCor vs simvastatin: LDL-C, -21% vs -35% (P < 0.001); HDL-C, +18% vs +15% (P=0.015); TG, -41% vs -17% (P < 0.001); Total-C, -19% vs -25% (P=0.045); and Apo B, -21% vs -26% (P=NS). (2)

The adverse events reported by patients were similar in both groups: 14 (20.9%) fenofibrate patients and 16 (24.2%) simvastatin patients reported adverse events. Seven fenofibrate patients and 6 simvastatin patients discontinued the study prematurely. (2)

TriCor showed similar trends in lipid parameter effects in a separate study with a statin (atorvastatin). (3)

The independent effect of raising HDL-C or lowering TG on the risk of cardiovascular morbidity and mortality has not been determined. (1)

References

1. TriCor tablets package insert, Abbott Laboratories.
2. Steinmetz A, Schwartz T, Hehnke U, Kaffarnik H. Multicenter comparison of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipoproteinemia. J Cardiovasc Pharmacol. 1996;27:563-570.
3. Després JP, Lemieux I, Salomon H, Delaval D. Effects of micronized fenofibrate versus atorvastatin in the treatment of dyslipidaemic patients with low plasma HDL-cholesterol levels: a 12-week randomized trial. J Intern Med. 2002;251:490-499.