Omega-3 carboxylic acids monotherapy and combination with statins in the management of dyslipidemia

Figures & data

Figure 1 OM3-CA bioavailability compared to OM3-EE as measured by steady-state levels of EPA and DHA in the ECLIPSE II trial.

Notes: Baseline adjusted – after 7 days following a TLC diet, subjects in both cohorts exhibited relatively similar baseline concentrations of total EPA+DHA (for OM3-CA: arithmetic mean concentration ranging from 175 to 197 nmol/mL and for OM3-EE from 172 to 193 nmol/mL).
Abbreviations: AUC, area under the plasma concentration versus time curve; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; Max, maximum; OM3-CA, omega-3 carboxylic acid; OM3-EE, omega-3 ethyl ester; TLC, therapeutic lifestyle changes.

Figure 2 Changes in lipoprotein levels from baseline with omega-3 carboxylic acid use in those on statin therapy in the EVOLVE trial.⁴⁴

Note: *Significant at p<0.05.
Abbreviations: EVOLVE, EpanoVa fOr Lowering Very high triglyceridEs; HDL-C, high-density lipoprotein-cholesterol; LS, least square; OO, olive oil; TG, triglyceride.

Table 1 Summary of EVOLVE and ESPRIT trials

	ESPRIT^Citation54			EVOLVE^Citation43
Subjects	N=647			N=399
	TG ≥200 and <500 mg/dL on maximally tolerated statin			TG ≥500 and <2000 mg/dL with or without a statin
Duration	6 weeks			12 weeks
Results	Percent change from baseline (p-value of treatment vs OO control)			Percent change from baseline (p-value of treatment vs OO control)
	4 g/d OO control	2 g/d OM3-CA	4 g/d OM3-CA	4 g/d OO control	2 g/d OM3-CA	4 g/d OM3-CA
TG	−5.9	−14.6***	−20.6***	−4.3	−25.9**	−30.9***
Total-C	0.5	−1.7*	−3.8***	3.2	−5.4*	−7.5**
Non-HDL-C	−0.9	−3.9*	−6.9***	2.5	−7.6*	−9.6**
HDL-C	2.2	2.6	3.3	1.9	7.4	5.8
LDL-C	1.1	4.6*	1.3	3.0	19.2**	19.4***
VLDL-C	−5.9	−14.3**	−21.5***	−8.5	−26.6**	−33.0***
ApoB	0.6	0.7	−2.1*	0.9	3.8	3.8
ApoA1	0.3	−0.8	−1.2*	5.9	0.0**	–0.9**

Notes: Those randomized to the 2 g/d dose of OM3-CA also received a 2 g/d dose of OO. A 3 g/d dose was also used in EVOLVE, however the values are not shown here.

* p<0.05,

** p<0.01,

*** p<0.001.

Abbreviations: OM3-CA, omega-3 carboxylic acid; OO, olive oil.

Figure 3 Change in lipoprotein levels with omega-3 carboxylic acid compared to olive oil placebo.

Notes: *Significant at p<0.05. ***Significant at p<0.001.
Abbreviations: ESPRIT, Epanova Combined with a Statin in Patients with Hypertriglyceridemia to Reduce non-HDL Cholesterol; HDL-C, high-density lipoprotein-cholesterol; LDL-C, low-density lipoprotein-cholesterol; LS, least square; OM3-CA, omega-3 carboxylic acid, TG, triglyceride; VLDL-C, very low-density lipoprotein cholesterol.

Epanova® (omega-3 carboxylic acids) [prescribing information]New JerseyOmthera Pharmaceuticals, Inc2015

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