Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study

Table 2 Summary of statistical comparisons of baseline (day-0)-adjusted pharmacokinetic parameters between the treatment groups

PK parameter	Baseline-adjusted geometric LSMs at week-4 endpoint			Treatment comparison				Intra-subject CV (%)
	OM3-CA 2 g (n = 6)	OM3-CA 4 g (n = 6)	OM3-EE 4 g (n = 12)	OM3-CA 2 g vs OM3-EE 4 g		OM3-CA 4 g vs OM3-EE 4 g
	OM3-CA 2 g (n = 6)	OM3-CA 4 g (n = 6)	OM3-EE 4 g (n = 12)	%GLSMR (95% CI)	P value	%GLSMR (95% CI)	P value
Total EPA + total DHA
AUC_0–24 (hour*nmol/mL)	14,431.18	18,992.50	11,866.94	121.6 (49.2, 300.8)	0.637	160.1 (64.7, 395.8)	0.27	75.6
C_max (nmol/mL)	916.66	1333.25	687.56	133.3 (68.5, 259.5)	0.354	193.9 (99.6, 377.5)	0.05	52.7
T_max (hour)	7.19	7.51	6.37	112.9 (66.3, 192.3)	0.618	118.0 (70.8, 196.6)	0.48	38.9
Total EPA
AUC_0–24 (hour*μg/mL)	2916.91	4248.45	1639.14	178.0 (82.2, 385.2)	0.126	259.2 (119.8, 561.0)	0.021	62.4
C_max (μg/mL)	181.32	289.40	96.82	187.3 (103.0, 340.7)	0.042	298.9 (164.3, 543.7)	0.003	46.7
T_max (hour)	6.57	7.32	6.45	101.9 (56.8, 183.1)	0.943	113.5 (63.2, 203.8)	0.636	42.9
Total DHA
AUC_0–24 (hour*μg/mL)	1451.24	1659.71	2091.28	69.4 (20.1, 240.0)	0.522	79.4 (23.0, 274.5)	0.683	115.7
C_max (μg/mL)	100.59	130.80	124.83	80.6 (34.6, 188.0)	0.578	104.8 (44.9, 244.4)	0.903	69.7
T_max (hour)	7.33	7.66	6.24	117.5 (71.0, 194.4)	0.488	122.7 (75.6, 199.0)	0.362	36.7

Comparisons were made between treatments of exposure (pharmacokinetic) parameters for baseline-adjusted plasma total EPA + total DHA, total EPA and total DHA. Means are geometric least-squares means (LSMs). Analysis is for the pharmacokinetics population, defined as all participants who completed both treatment periods and who had sufficient quantifiable plasma concentration data to calculate C_max (n = 12). Percentage geometric least squares mean ratio (%GLSMR) = 100*(Test/Reference). CI confidence interval, CV coefficient of variation, DHA docosahexaenoic acid, EPA eicosapentaenoic acid, AUC_0–24 baseline-adjusted area under the plasma concentration versus time curve, from time 0 to 24 h after the start of the meal, C_max baseline-adjusted maximum measured plasma concentration over the time span specified, OM3-CA omega-3 carboxylic acids, OM3-EE omega-3 ethyl esters, PK pharmacokinetics, T_max time of the maximum measured plasma concentration

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