Effects of Prescription Omega-3-Acid Ethyl Esters on Non-High-Density Lipoprotein Cholesterol When Coadministered With Escalating Doses of Atorvastatin

Louisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Ave, Louisville, KY 40213, USA.
Mayo Clinic Proceedings (Impact Factor: 6.26). 02/2010; 85(2):122-8. DOI: 10.4065/mcp.2009.0397
Source: PubMed


To evaluate the effects of prescription omega-3-acid ethyl esters on non-high-density lipoprotein cholesterol (HDL-C) levels in atorvastatin-treated patients with elevated non-HDL-C and triglyceride levels.
This study, conducted between February 15, 2007, and October 22, 2007, randomized patients with elevated non-HDL-C (>160 mg/dL) and triglyceride (>or=250 mg/dL and <or=599 mg/dL) levels to double-blind treatment with prescription omega-3-acid ethyl esters, 4 g/d, or placebo for 16 weeks. Patients also received escalating dosages of open-label atorvastatin (weeks 0-8, 10 mg/d; weeks 9-12, 20 mg/d; weeks 13-16, 40 mg/d).
Prescription omega-3-acid ethyl esters plus atorvastatin, 10, 20, and 40 mg/d, reduced median non-HDL-C levels by 40.2% vs 33.7% (P<.001), 46.9% vs 39.0% (P<.001), and 50.4% vs 46.3% (P<.001) compared with placebo plus the same doses of atorvastatin at the end of 8, 12, and 16 weeks, respectively. Prescription omega-3-acid ethyl esters plus atorvastatin also reduced median total cholesterol, triglyceride, and very low-density lipoprotein cholesterol levels and increased HDL-C levels to a significantly greater extent than placebo plus atorvastatin. Percent changes from baseline low-density lipoprotein-cholesterol, apolipoprotein A-I, and apolipoprotein B levels were not significantly different between groups at the end of the study.
Prescription omega-3-acid ethyl esters plus atorvastatin produced significant improvements in non-HDL-C and other lipid parameters in patients with elevated non-HDL-C and triglyceride levels.

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    • "OM3-FAs have been shown their well tolerability as an adjunct to statin therapy in numerous studies [15-17]. However, it was also reported that OM3-FAs can produce an increase in LDL in some patients [17-20]. So, there is ongoing research into new, safer and more effective agents to be used alone or in combination with existing cardiovascular drugs [21]. "
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    • "The Combination of Prescription Omega-3 with Simvastatin (COMBOS) trial evaluated the effects of P-OM3 ethyl ester addition to statin-treated patients with persistent HTG (≥200 and <500 mg/dL) [35]: TG and VLDL-C levels were significantly reduced by the combination therapy (−29.5% and −27.5%) as compared to simvastatin (−6.3% and −7.2%, respectively); no relevant changes were reported in LDL-C levels in both groups, but an increase in HDL-C was observed with the combination therapy compared to simvastatin (+3.4% vs −1.2%, p < 0.001) [35] (Table 3). These findings were confirmed by other studies [36] [37] (Table 3). When combined with fenofibrate, P-OM34 4 g/day induced a greater TG reduction compared to fenofibrate alone (60.8% vs 53.8%) in subjects with very high TG levels (≥500 mg/dL [5.65 mmol/l]) [38]. "
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