Research: SAMUEL and COLLEAGUES,

Listed in Issue 192

Abstract

SAMUEL and COLLEAGUES, Archimedes, Inc., San Francisco, California, USA. stuart.samuel@archimedesmodel.com  conducted a simulated 20-year clinical trial to study whether prescription omega-3 fatty acids decreased risk of cardiac events in patients with increased triglyceride levels.

Background

Patients with increased triglyceride levels compared to those with normal levels are at higher risk for coronary heart disease. In patients with severe (>=500 mg/dl) hypertriglyceridemia (SHTG), clinical trials have demonstrated that prescription omega-3 fatty acids (P-OM3s) 4 g/day can decrease triglyceride levels by 45%. However, the precise health and economic benefits of decreasing SHTG with P-OM3 are unknown.

Methodology

The authors used the previously validated Archimedes model to simulate a 20-year trial involving subjects 45 to 75 years old with SHTG. The trial consisted of an intervention arm (P-OM3 4 g/day) and a control arm.

Results

Simulation results for the control arm indicated that subjects with SHTG are at about 2 times higher risk for myocardial infarction than those with normal triglyceride levels. Using estimates from previous epidemiologic studies and meta-analyses with OM3s, the model predicted 29% to 36% decreases in various measurements of adverse cardiac events for the intervention arm. The model also predicted a decrease in ischaemic stroke of 24% (95% confidence interval 15 to 33). For the 20-year simulated trial, the cost per quality-adjusted life-year gained for the currently available P-OM3 approved by the Food and Drug Administration was $47,000. Results remained robust under different clinical assumptions. In the authors' model P-OM3 was effective in decreasing triglyceride levels and cardiovascular disease risk in patients with SHTG.

Conclusion

In conclusion, P-OM3 medication is cost effective in this simulated trial and comparable to other cost-effective cardiovascular interventions.

References

Samuel S, Peskin B, Arondekar B, Alperin P, Johnson S, Blumenfeld I, Stone G and Jacobson TA. Estimating health and economic benefits from using prescription omega-3 fatty acids in patients with severe hypertriglyceridemia. Source American Journal of Cardiology. 108(5): 691-7. Sep 1 2011. Copyright 2011 Elsevier Inc.

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