Efficacy and tolerability of adding prescription Omega-3 fatty acids 4 g/d to Simvastatin 40 mg/d in hypertriglyceridemic patients: An 8-week, randomized, double-blind, placebo-controlled study

Davidson, Michael; Stein, Evan A.; Bays, Harold; Maki, Kevin C.; Doyle, Ralph T.; Shalwitz, Robert A.; Ballantyne, Christie M.; Ginsberg, Henry N.

doi:10.1016/j.clinthera.2007.07.018

Cited by 357 publications

(250 citation statements)

References 26 publications

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“…After 6 weeks of treatment, the triglyceride levels decreased by 41.0% in the combination treatment group and 13.9% in the simvastatin monotherapy group. These findings were consistent with previous studies in Western countries (Durrington et al, 2001;Davidson et al, 2007; Maki et al, Figure 2 Mean percent change in triglycerides (TG), total cholesterol (TC), HDL-cholesterol (HDL-C), and LDL-C from the baseline to the end of treatment in the intention-to-treat population.…”

Section: Discussionsupporting

confidence: 82%

Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability

Kim

Lee

et al. 2010

Eur J Clin Nutr

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Background: This study was designed to evaluate the effects of omega-3 fatty acids supplements and simvastatin on lipoproteins and heart rate variability (HRV), a surrogate parameter of cardiac autonomic function, in patients with mixed dyslipidemia. Methods: This study was a prospective, randomized, open-label study. Among the 171 patients screened, 62 who met the inclusion criteria after 6 weeks on a strict diet therapy were randomized into two treatment groups. The inclusion criteria were mixed dyslipidemia with a high triglyceride level (200-499 mg per 100 ml) and a total cholesterol level 4200 mg per 100 ml. After a run-in period of 6 weeks, the patients were randomized into two groups and given a combination treatment with 4 g of omega-3 fatty acids (four 1 g Omacor (eicosapentaenoic acid, 465 mg; docosahexaenoic acid, 375 mg; other omega-3 fatty acids, 60 mg; others 100 mg, Gun-il Pharmacy, Seoul, Korea)) and 20 mg of simvastatin daily or a monotherapy of 20 mg simvastatin for 6 weeks. In the combination therapy group, seven patients dropped out, and in the simvastatin alone therapy group, five patients dropped out during the study period. Results: After 6 weeks of drug treatment, triglyceride levels decreased by 41.0% in the combination treatment group and 13.9% in the simvastatin monotherapy group (from 309.2 ± 95 mg per 100 ml to 177.7 ± 66 versus 294.6 ± 78 mg per 100 ml to 238.3 ± 84 mg per 100 ml, respectively, P ¼ 0.0007). No significant changes in the HRV parameters were observed in either group. Conclusion: The combination of omega-3 fatty acids plus simvastatin, which achieved a significantly greater reduction of triglycerides without adverse reactions, should be considered as an optimal treatment option for patients with mixed dyslipidemia.

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Section: Discussionsupporting

confidence: 82%

Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability

Kim

Lee

et al. 2010

Eur J Clin Nutr

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“…Davidson et al (96) found that after treating HC patients with n-3 PUFA and/or simvastatin for 12 weeks, the TAG responses were similar in the EPA/DHA-group (2 25·3 %) and the combined group (2 28·8 %), and borderline significantly lower in the simvastatin group (2 18·5 %), whereas decreases in non-HDL-cholesterol and increases in HDL-cholesterol were statistically significant only for the combined (non-HDL: 2 24·8 %, HDL: þ10·4 %) and simvastatin group (non-HDL: 2 25·8 %, HDL: þ7·2 %). All other studies found significant improvements of TAG with a combination therapy compared with the statin therapy alone (94,95,97,99,104) . Study populations included, besides HC patients, renal transplant patients with persistent hypercholesterolaemia (99) and insulin-resistant obese men with dyslipidaemia (95) .…”

Section: Effects Of Combination Therapy With N-3 Pufa and Statinsmentioning

confidence: 94%

“…Most studies performed in patients on statin therapy did not find any significant changes in total, LDL-or HDL-cholesterol, although in some studies VLDLcholesterol was decreased (93,98,101) . In the COMBOS (COMBination of prescription Omega-3 with Simvastatin) study (97) , administration of n-3-acid ethyl esters plus simvastatin improved, besides TAG levels, also total, HDL-and VLDL-cholesterol to a greater extent than simvastatin alone. On the unfavourable side, a trend was observed towards a greater reduction in LDL-cholesterol in the simvastatin-only group (0·7 v. 22·8 %; P¼0·052).…”

Section: Effects Of Combination Therapy With N-3 Pufa and Statinsmentioning

confidence: 99%

Support of drug therapy using functional foods and dietary supplements: focus on statin therapy

et al. 2010

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Functional foods and dietary supplements might have a role in supporting drug therapy. These products may (1) have an additive effect to the effect that a drug has in reducing risk factors associated with certain conditions, (2) contribute to improve risk factors associated with the condition, other than the risk factor that the drug is dealing with, or (3) reduce drug-associated side effects, for example, by restoring depleted compounds or by reducing the necessary dose of the drug. Possible advantages compared with a multidrug therapy are lower drug costs, fewer side effects and increased adherence. In the present review we have focused on the support of statin therapy using functional foods or dietary supplements containing plant sterols and/or stanols, soluble dietary fibre, n-3 PUFA or coenzyme Q 10 . We conclude that there is substantial evidence that adding plant sterols and/or stanols to statin therapy further reduces total and LDL-cholesterol by roughly 6 and 10 %, respectively. Adding n-3 PUFA to statin therapy leads to a significant reduction in plasma TAG of at least 15 %. Data are insufficient and not conclusive to recommend the use of soluble fibre or coenzyme Q 10 in patients on statin therapy and more randomised controlled trials towards these combinations are warranted. Aside from the possible beneficial effects from functional foods or dietary supplements on drug therapy, it is important to examine possible (negative) effects from the combination in the long term, for example, in post-marketing surveillance studies. Moreover, it is important to monitor whether the functional foods and dietary supplements are taken in the recommended amounts to induce significant effects. Combination therapy: Dyslipidaemia: Statins: Functional foodsThe world market for functional foods (FF) and dietary supplements (DS) is expanding rapidly. In 2010 FF are expected to represent 5 % of the total global food market (1) and the market for DS is estimated at more than $60 billion worldwide (2) . In general, the target population of FF or DS is healthy individuals with slightly elevated risk factors or some physical discomfort. However, due to the fast growing market of FF or DS and the accompanying strong advertising and marketing, also patients on medication may be stimulated to use FF or DS. This may have several consequences for the quality of drug treatment as stated by de Jong et al. with the example of the combined intake of plant sterols and/or stanols and statins (3) . Whereas they addressed the additive effect of plant sterols and/or stanols on reducing LDL-cholesterol values in patients on statin treatment, their main focus was the possible negative aspects of the combination, such as unfavourable effects on patient adherence with drug treatment and increasing the potential for food-drug interactions.In the present review we will focus on the possible beneficial effects that FF or DS may have on drug therapy. Because of the large number of subjects treated suboptimally with statins (hydroxymethylglutaryl Co...

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“…The physician's must rely on their own experience and knowledge to make diagnoses, to determine dosages and the best treatment for each individual patient and to take all appropriate safety precautions. 24 Sadovsky et al, 25 Maki et al, 26 Davidson et al, 27 Durrington et al 28 Fig . 2 e Risk ratio seen in various cardiovascular outcomes following supplementation with u-3 PUFA versus placebo.…”

Section: Disclaimermentioning

confidence: 99%

“…Various researchers (Harris et al, 24 Sadovsky et al, 25 Maki et al, 26 Davidson et al, 27 Durrington et al 28 etc) have studied the effects of n-3 acid ethyl esters (90%) of EPA (460 mg) & DHA (380 mg) with or without statins in patients with hypertriglyceridemia. All have shown that n-3 acid ethyl esters (90%) of EPA (460 mg) & DHA (380 mg) was well tolerated and had a beneficial effect in terms of significant reduction in triglyceride levels (Fig.…”

mentioning

confidence: 99%

Role of omega-3 ethyl ester concentrate in reducing sudden cardiac death following myocardial infarction and in management of hypertriglyceridemia: An Indian consensus statement

Dalal

Kasliwal

Dutta

et al. 2012

Indian Heart Journal

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Efficacy and tolerability of adding prescription Omega-3 fatty acids 4 g/d to Simvastatin 40 mg/d in hypertriglyceridemic patients: An 8-week, randomized, double-blind, placebo-controlled study

Cited by 357 publications

References 26 publications

Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability

Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability

Support of drug therapy using functional foods and dietary supplements: focus on statin therapy

Role of omega-3 ethyl ester concentrate in reducing sudden cardiac death following myocardial infarction and in management of hypertriglyceridemia: An Indian consensus statement

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