Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial

Dunbar, Richard L.; Nicholls, Stephen J.; Maki, Kevin C.; Roth, Eli M.; Orloff, David G.; Curcio, Danielle; Johnson, Judith; Kling, Douglas; Davidson, Michael H.

doi:10.1186/s12944-015-0100-8

Lipids in Health and Disease

Table 1 Baseline, end-of-treatment, and percent change values for lipoprotein particle sizes and concentrations^a,b

From: Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial

	Statin + OO	Statin + OM3-CA	Statin + OM3-CA
	4 g/d	2 g/d^c	4 g/d
Variable	(n = 211)	(n = 209)	(n = 207)
Lipoprotein particle sizes
VLDL (nm)
Baseline	55.0 (5.7)	55.4 (5.6)	55.2 (5.9)
End-of-treatment	54.7 (5.9)	52.2 (5.4)	50.8 (5.8)
%Δ LSM-BT (95 % CI)	−0.6 (−1.7, 0.4)	−5.6 (−6.6, −4.6)^***	−8.0 (−9.0, −7.0)^***
LDL (nm)
Baseline	19.9 (0.4)	19.9 (0.3)	19.9 (0.4)
End-of-treatment^d	19.9 (0.4)	20.0 (0.4)	20.1 (0.4)
%Δ LSM-BT (95 % CI)	−0.1 (−0.2, 0.1)	0.3 (0.1, 0.5)^**	0.6 (0.4, 0.8)^***
HDL (nm)
Baseline	8.5 (0.3)	8.5 (0.3)	8.5 (0.3)
End-of-treatment	8.5 (0.3)	8.4 (0.3)	8.4 (0.4)
%Δ LSM-BT (95 % CI)	−0.2 (−0.5, 0.1)	−0.6 (−0.9, −0.2)^*	−0.5 (−0.9, −0.2)^*
Lipoprotein particle concentrations
Total VLDL/chylomicron remnant (nmol/L)
Baseline	129 (47.0)	128 (43.0)	130 (48.2)
End-of-treatment	123 (53.4)	119 (47.0)	114 (54.4)
%Δ LSM-BT (95 % CI)	−6.9 (−11.1, −2.5)	−8.5 (−12.6, −4.1)	−16.0 (−19.8, −12.0)^**
Large VLDL/chylomicron remnant (nmol/L)
Baseline	13.2 (7.2)	14.0 (7.4)	13.9 (8.3)
End-of-treatment	12.7 (7.9)	9.6 (7.3)	7.5 (6.8)
%Δ LSM-BT (95 % CI)	−10.1 (−17.5, −2.0)	−36.8 (−42.0, −31.1)^***	−55.8 (−59.5, −51.8)^***
Medium VLDL (nmol/L)
Baseline	72.1 (30.9)	69.7 (32.2)	72.0 (37.4)
End-of-treatment	68.4 (35.5)	62.9 (33.2)	60.0 (36.3)
%Δ LSM-BT (95 % CI)	−9.7 (−15.5, −3.5)	−12.6 (−18.2, −6.5)	−22.8 (−27.8, −17.4)^*
Small VLDL (nmol/L)
Baseline	43.5 (31.1)	44.3 (25.5)	44.2 (29.5)
End-of-treatment	42.4 (30.4)	46.8 (28.3)	46.8 (30.4)
%Δ LSM-BT (95 % CI)	−1.1 (−10.1, 8.7)	4.7 (−4.8, 15.3)	8.6 (−1.4, 19.6)
Total LDL (nmol/L)
Baseline	1286 (360)	1309 (357)	1323 (342)
End-of-treatment	1317 (374)	1359 (391)	1359 (378)
%Δ LSM-BT (95 % CI)	2.0 (−0.6, 4.5)	3.3 (0.8, 6.0)	2.4 (−0.2, 5.0)
IDL (nmol/L)
Baseline	74.9 (77.2)	79.0 (78.5)	75.5 (76.6)
End-of-treatment	75.6 (92.0)	72.9 (73.8)	70.7 (78.9)
%Δ LSM-BT (95 % CI)	−13.5 (−25.2, 0.2)	−6.9 (−19.7, 7.8)	−15.7 (−27.3, −2.3)
Large LDL (nmol/L)
Baseline	661 (576)	660 (569)	656 (592)
End-of-treatment	389 (408)	439 (440)	445 (407)
%Δ LSM-BT (95 % CI)	−49.8 (−58.5, −39.3)	−40.1 (−50.6, −27.4)^***	−21.6 (−35.4, −4.7)^***
Small LDL (nmol/L)
Baseline	1004 (310)	1014 (313)	1033 (296)
End-of-treatment	1024 (325)	1023 (331)	1008 (334)
%Δ LSM-BT (95 % CI)	1.0 (−2.7, 4.7)	0.3 (−3.3, 4.1)	−4.2 (−7.7, −0.7)^*
Total HDL (mmol/L)
Baseline	32.8 (5.8)	32.7 (6.2)	32.6 (6.8)
End-of-treatment	33.0 (6.1)	32.3 (6.1)	31.6 (6.7)
%Δ LSM-BT (95 % CI)	0.6 (−0.7, 1.9)	−1.5 (−2.8, −0.2)^*	−3.2 (−4.5, −1.9)^***
Large HDL (mmol/L)
Baseline	2.6 (1.9)	2.4 (1.8)	2.4 (1.9)
End-of-treatment	2.6 (1.8)	2.2 (2.0)	2.2 (2.3)
%Δ LSM-BT (95 % CI)	−6.9 (−20.9, 9.5)	−39.0 (−48.2, −28.1)^***	−29.0 (−39.8, −16.3)^***
Medium HDL (mmol/L)
Baseline	6.0 (3.2)	6.1 (3.4)	6.5 (5.1)
End-of-treatment	5.9 (3.4)	6.3 (3.3)	6.7 (3.5)
%Δ LSM-BT (95 % CI)	−6.6 (−12.2, −0.7)	3.9 (−2.4, 10.5)^*	11.3 (4.6, 18.4)^***
Small HDL (mmol/L)
Baseline	24.1 (4.7)	24.2 (4.5)	23.7 (4.9)
End-of-treatment	24.5 (5.0)	23.7 (4.8)	22.7 (4.6)
%Δ LSM-BT (95 % CI)	1.7 (−1.0, 4.4)	−1.9 (−4.5, 0.7)^**	−3.6 (−6.1, −1.0)^***

Abbreviations: %∆ percent change, CI confidence interval, HDL high-density lipoprotein, IDL = intermediate-density lipoprotein, LDL low-density lipoprotein, LSM-BT least-squares means–back transformed, OM3-CA omega-3 carboxylic acids, OO Olive oil, VLDL very low-density lipoprotein
^aMeans (standard deviation) are presented for baseline and end-of-treatment values
^bSuperscript letters represent p-values for each OM3-CA dosage vs. OO: ^* p < 0.05, ^** p < 0.01, and ^*** p < 0.001
^cPatients in the OM3-CA 2 g/d treatment arm also received OO capsules at a dosage of 2 g/d
^dNumber of patients with data in the OM3-CA 2 g/d treatment group = 208

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