Fenofibrate (Page 2 of 6)

Clinical Trials

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The effects of fenofibrate at a dose equivalent to 200 mg fenofibrate per day were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, total-C, and the LDL-C/HDL-C ratio. Fenofibrate therapy also lowered triglycerides and raised HDL-C (see Table 1).

Table 1: Mean Percent Change in lipid Parameters at End of Treatment *
*
Duration of study treatment was 3 to 6 months
p = <0.05 vs. Placebo

TreatmentGroup

Total-C

LDL-C

HDL-C

TG

Pooled Cohort

Mean baseline lipid values (n=646)

306.9 mg/dL

213.8 mg/dL

52.3 mg/dL

191.0mg/dL

All FEN (n=361)

-18.7%

-20.6%

+11.0%

-28.9%

Placebo (n=285)

-0.4%

-2.2%

+0.7%

+7.7%

Baseline LDL-C > 160 mg/dL and TG < 150 mg/dL (Type IIa)

Mean baseline lipid values (n=334)

307.7 mg/dL

227.7 mg/dL

58.1 mg/dL

101.7 mg/dL

All FEN (n=193)

-22.4%

-31.4%

+9.8%

-23.5%

Placebo (n=141)

+0.2%

-2.2%

+2.6%

+11.7%

Baseline LDL-C > 160 mg/dL and TG < 150 mg/dL (Type IIb)

Mean baseline lipid values (n=242)

312.8 mg/dL

219.8 mg/dL

46.7 mg/dL

231.9 mg/dL

All FEN (n=126)

-16.8%

-20.1%

+14.6%

-35.9%

Placebo (n=116)

-3.0%

-6.6%

+2.3%

+0.9%

In a subset of the subjects, measurements of apo B were conducted. Fenofibrate treatment significantly reduced apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p<0.0001, n=213 and 143 respectively).

Hypertriglyceridemia (Fredrickson Type IV and V)

The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemia patients (Fredrickson Type IV and V). Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline triglyceride (TG) levels of 500 to 1,500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia (Type IV/V hyperlipidemia), treatment with fenofibrate at dosages equivalent to 200 mg fenofibrate per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol. Treatment of patients with type IV hyperlipoproteinemia and elevated triglycerides often results in an increase of low density lipoprotein (LDL) cholesterol (see Table 2).

Table 2: Effects of Fenofibrate Capsules in Patients With Fredrickson Type IV/V Hyperlipidemia
*
= p<0.05 vs. Placebo

Study 1

Placebo

Fenofibrate Capsules

Baseline TG levels 350 to 499 mg/dL

N

Baseline (Mean)

Endpoint (Mean)

% Change (Mean)

N

Baseline (Mean)

Endpoint (Mean)

% Change (Mean)

Triglycerides

28

449

450

-0.5

27

432

223

-46.2*

VLDL Triglycerides

19

367

350

2.7

19

350

178

-44.1*

Total Cholesterol

28

255

261

2.8

27

252

227

-9.1 *

HDL Cholesterol

28

35

36

4

27

34

40

19.6 *

LDL Cholesterol

28

120

129

12

27

128

137

14.5

VLDL Cholesterol

27

99

99

5.8

27

92

46

-44.7 *

Study 2

Placebo

Fenofibrate Capsules

Baseline TG levels 350 to 499 mg/dL

N

Baseline (Mean)

Endpoint (Mean)

% Change (Mean)

N

Baseline (Mean)

Endpoint (Mean)

% Change (Mean)

Triglycerides

44

710

750

7.2

48

726

308

-54.5 *

VLDL Triglycerides

29

537

571

18.7

33

543

205

-50.6 *

Total Cholesterol

44

272

271

0.4

48

261

223

-13.8 *

HDL Cholesterol

44

27

28

5.0

48

30

36

22.9 *

LDL Cholesterol

42

100

90

-4.2

45

103

131

45.0 *

VLDL Cholesterol

42

137

142

11.0

45

126

54

-49.4 *

The effect of fenofibrate on cardiovascular morbidity and mortality has not been determined.

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