14 CLINICAL STUDIES

14.1 Severe Hypertriglyceridemia

The effects of VASCEPA 4 grams per day were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients (76 on VASCEPA, 75 on placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C levels in these patients were 684 mg/dL and 86 mg/dL, respectively. Median baseline HDL-C level was 27 mg/dL. The randomized population in this study was mostly Caucasian (88%) and male (76%). The mean age was 53 years and the mean body mass index was 31 kg/m2. Twenty-five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750 mg/dL.

The changes in the major lipoprotein lipid parameters for the groups receiving VASCEPA or placebo are shown in Table 2.

Table 2. Median Baseline and Percent Change from Baseline in Lipid Parameters in Patients with Severe Hypertriglyceridemia (≥500 mg/dL) 

Parameter

VASCEPA 4 g/day

N=76

Placebo

N=75

Difference (95% Confidence Interval)

Baseline

% Change

Baseline

% Change

% Change= Median Percent Change from Baseline 

Difference= Median of [VASCEPA % Change – Placebo % Change] (Hodges-Lehmann Estimate) 

p-values from Wilcoxon rank-sum test 

* p-value < 0.001 (primary efficacy endpoint) † p-value < 0.05 (key secondary efficacy endpoints determined to be statistically significant according to the pre-specified multiple comparison procedure)  

TG (mg/dL) 680 -27 703 +10 -33* (-47, -22) 

LDL-C (mg/dL) 91 -5 86 -3 -2 (-13, +8) 

Non-HDL-C (mg/dL) 225 -8 229 +8 -18 (-25, -11) 

TC (mg/dL) 254 -7 256 +8 -16 (-22, -11) 

HDL-C (mg/dL) 27 -4 27 0 -4 (-9, +2) 

VLDL-C (mg/dL) 123 -20 124 +14 -29† (-43, -14) 

Apo B (mg/dL) 121 -4 118 +4 -9†(-14, -3) 

VASCEPA 4 grams per day reduced median TG, VLDL-C, and Apo B levels from baseline relative to placebo. The reduction in TG observed with VASCEPA was not associated with elevations in LDL-C levels relative to placebo.

The effect of VASCEPA on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined.

The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

16 HOW SUPPLIED/STORAGE AND HANDLING

VASCEPA (icsapent ethyl) capsules are supplied as 0.5-gram amber-colored soft-gelatin capsules imprinted with V500 or as 1-gram amber-colored soft-gelatin capsules imprinted with VASCEPA.

Bottles of 240 (0.5-gram): NDC 52937-003-40

Bottles of 120 (1-gram): NDC 52937-001-20.

Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

VASCEPA should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.2)].