Oslo, November 10, 2018 – The VITAL study1, published on November 10 in the New England Journal of Medicine, showed that supplementation with one gram of Omacor®, omega-3 acid ethyl esters 90%, reduces the occurrence of myocardial infarction in low risk patients with no history of cardiovascular disease. The results of the VITAL study were presented in Chicago during the Late Breaking Clinical Trial Session on Cardiovascular Prevention at the American Heart Association (AHA) Scientific Sessions. The VITAL study was conducted by the Brigham and Women’s Hospital, an affiliate of Harvard Medical School, as a randomized, prospective double-blind study, enrolling 25,874 patients from all over the United States.
During the over five-year follow-up, the study evaluated whether one gram of prescription omega-3s (Omacor, omega-3 acid ethyl esters from BASF), could prevent cardiovascular diseases and cancer in apparently healthy patients.
Of the 12,933 patients who received Omacor, major cardiovascular events occurred in 386 patients, failing to demonstrate a difference when compared to placebo (419 patients; 95% CI 0.80-1.06). The composite of major cardiovascular events included myocardial infarction, stroke, and cardiovascular mortality.
Despite the primary outcomes, statistically significant reduction was seen in a number of secondary endpoints such as myocardial infarction by 28% (HR=0.72 [0.59-0.90], percutaneous coronary intervention by 22% (PCI) (HR=0.78 [0.63-0.95]); fatal myocardial infarction by 50% (HR=0.50 [0.26-0.97]) and total coronary heart disease by 17% (HR=0.83 [0.71-0.97]) after supplementation with Omacor.
Among those patients with low fish consumption (less than the cohort average of 1 ½ servings per week), the VITAL study showed a statistically significant reduction in the primary cardiovascular endpoint was observed (HR=0.81; 95% CI 0.67-0.98) and a 40% reduction in myocardial infarction (HR= 0.60; 95% CI 0.45-0.81) with Omacor vs placebo, but no reduction was observed in either endpoint among those with higher fish intake (p-value for interaction <0.05 for both endpoints).
The currently approved indications for Omacor are hypertriglyceridemia and post-myocardial infarction (after heart attacks). Highly concentrated prescription omega-3s (omega-3 acid ethyl esters 90%) are approved in more than 80 countries as a drug for the secondary prevention of myocardial infarction and for the treatment of hypertriglyceridemia.
1 Manson, J. (2018). The VITamin D and OmegA-3 TriaL (VITAL)
About BASF’s Nutrition & Health division
BASF Nutrition & Health provides a comprehensive product and service portfolio for the human and animal nutrition, pharmaceutical, ethanol and flavor & fragrance industries. With innovative solutions and modern technologies, we help our customers improve their business efficiency and the sustainability of their products. Our human nutrition solutions include vitamins and carotenoids, plant sterols, emulsifiers and omega-3 fatty acids. Vitamins and carotenoids also form an important part of our animal nutrition portfolio, as do other feed additives such as trace elements, enzymes and organic acids. We provide the pharmaceutical industry with a broad range of excipients and selected large-volume active pharmaceutical ingredients such as ibuprofen and omega-3 fatty acids. Leveraging our advanced technology, we create high performance industrial enzymes for different markets, such as ethanol production. Furthermore, we offer aroma ingredients such as citral, geraniol and L-menthol. BASF Nutrition & Health operates sites in Europe, North America, South America and in Asia-Pacific. For more information, go to www.basf.com.
At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. The more than 115,000 employees in the BASF Group work on contributing to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into four segments: Chemicals, Performance Products, Functional Materials & Solutions and Agricultural Solutions. BASF generated sales of more than €60 billion in 2017. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (BAS). Further information at www.basf.com.