A retrospective chart analysis of patients treated with a unique 4:1 EPA
to DHA ratio omega-3 formulation in addition to a dietary program.
This open-label examination reflected a "real-world" representation of patients with multiple comorbidities and concomitant medications. Notably, published trials with Lovaza ®(1) incorporated a
dietary phase and National Cholesterol Education Program Step 1 Dietary Instructions (Harris WS,
et al. 1997).
The unique 4:1 EPA to DHA ratio omega-3 formulation was dosed at 1.5 grams/day in patients
with a stable medication regimen during their treatment period. Patients in this cohort were
treated for a mean of 3.6 months (N=100).
Results:
Patients demonstrated statistically significant reductions in serum triglycerides (p<0.05), LDL
(p<0.05), and total cholesterol (p<0.05). Results included a 31% reduction in mean baseline serum
triglycerides in the cohort, while 73% of patients experienced a reduction from baseline
triglycerides. Additionally, a 13% reduction from mean baseline of Total Cholesterol in the cohort
was identified. 78% of patients experienced a reduction from baseline of Total Cholesterol.
Further, there was an 11 % reduction in mean baseline Low Density Lipoprotein (LDL), and 71 %
of patients experienced a reduction from baseline LDL.
Several specific clinical cases are also particularly instructive.
In Clinical Case 1, a 50% decrease in triglycerides, 36% decrease in total cholesterol, and 36%
decrease in LDL were obtained after addition of Unique 4:1 EPA to DHA ratio ultra-pure omega-3
at 1.5 g per day.
Clinical Case 2 showed a 60% decrease in triglycerides, 45% decrease in total cholesterol, and
26% decrease in LDL obtained after addition of Unique 4:1 EPA to DHA ratio ultra-pure omega-3
at 1.5 g per day.
Open-label Omax 1.5g/day + Dietary Program
Effect on Mean Total Cholesterol, n=100
Open-label Omax 1.5g/day + Dietary Program
Effect on Mean Triglycerides, n=100
160
220
210
120
*
100
80
200
Triglycerides
143.5
60
99.5
Mean Total Chol.
Mean Triglyceride Levels
140
190
207.71
*
180
40
180.05
170
20
0
160
Baseline
Post-Treatment
Baseline
Post-Treatment
Total Cholesterol
Open-label Omax 1.5g/day + Dietary Program
Effect on Mean LDL Levels, n=100
130
125
Mean LDL
120
*
115
LDL
123
110
105
109.4
100
Baseline
Post-Treatment
In summary, the open-label clinical study demonstrated that patients receiving Unique 4:1 EPA
to DHA ratio ultra-pure omega-3 (1.65 g omega-3-acid ethyl esters per day, 4:1 EPA / DHA ratio,
>90% omega-3 fatty acids) experienced a clinically significant lowering of triglyceride,
cholesterol and LDL levels. Unlike other previously available omega-3 formulations, this
improvement in lipid profile was obtained with just two 825 mg soft gels (1.65 grams total),
provided once daily.
Data also demonstrates potential added benefit of Unique 4:1 EPA to DHA ratio ultra-pure
omega-3 when administered in conjunction with statins.
(1) All brand names and trademarks are the property of their respective owners.
Research completed at Cardiology Associates of New Haven PC, New Haven, CT, USA