Omega-3 has a positive impact as a preventative treatment
The US Medicines Agency recently approved omega-3 as a risk reducer for cardiovascular disease. At the end of last week, the Agency approved the drug Vascepa as adjunctive therapy for patients with high levels of blood triglycerides.
Reducing saturated fat and eating unsaturated fats instead is essential for changing cholesterol balance. This means less of fat meat, fatty meat products and fat dairy products, and more of fatty fish, such as salmon, mackerel and herring, and vegetable oils and fats, except coconut fat.
How to use fat also plays a significant role. It is useful if you can find alternatives to frying, but if you want to fry the food, dietitians recommend using rapeseed oil or liquid margarine.
The US Medicines Agency recently approved omega-3 as a risk reducer for cardiovascular disease. At the end of last week, the US Medicines Agency approved the drug Vascepa as adjunctive therapy for patients with high levels of blood triglycerides.
Vascepa, as previously reported by the World of Medicines, consists of high-dose omega-3 fatty acid eicosapentaenoic acid (EPA). According to the approval, the drug may reduce the risk of cardiovascular events in patients with elevated triglyceride levels (1.5 mmol per litre or more) who have either an established cardiovascular disease or diabetes plus two or more additional cardiovascular risk factors. They must also be treated with the highest tolerable dose of statins.
Discussed value of omega-3
There has been a lot of discussion about the importance of fish liver oil products, such as protecting and promoting cardiovascular health. As the World of Medicines previously reported, several different review studies have not been able to show that omega-3 products have any positive effects on cardiovascular health. A year ago, the European Medicines Agency’s Expert Committee recommended the CHMP to withdraw the drug status for omega-3s.
The fact that the FDA now approves omega-3 as a preventive treatment for cardiovascular disease can, therefore, seem contradictory.
The difference between Vascepa and other omega-3 products is that it contains only the fish liver oil EPA. Most other omega-3 supplements consist of a combination of EPA and docosahexaenoic acid (DHA). The dose of EPA, when treated with Vascepa, is also significantly higher than in other omega-3 products, two grams per capsule twice a day – a total of four grams per day.
Reduced risk in the treatment group
The clinical trial that underlies Vascepa approval included just over 8,000 patients with elevated triglyceride levels who received either EPA or placebo and were followed for five years, as reported by the World of Medicines. All also had an established cardiovascular disease or diabetes with additional risk factors for cardiovascular disease.
The study’s primary efficacy measure t was a combination of events such as cardiovascular-related death, non-fatal heart attack, stroke, coronary revascularization, and unstable angina.
The results after the follow-up period showed that an event as described above occurred in 17 per cent of patients who received omega-3 and in 22 per cent of those who received a placebo. This means a 25 per cent risk reduction in the treatment group.
Side effects occur
The clinical studies also showed that Vascepa was associated with an increased risk of atrial fibrillation and flutter. Patients treated with Vascepa also had an increased risk of bleeding, which was increased if the patient also took drugs with acetylsalicylic acid or warfarin.
The most common side effects in the treatment group were muscle pain, peripheral edema (swollen hands and legs), atrial fibrillation and joint pain.
Vacepa has been approved in the United States since 2012 for the treatment of adults with very high levels of triglycerides in the blood, but not with the indication to reduce the risk of cardiovascular disease.
According to a press release from Amarin, which markets Vascepa, it is planned to continue seeking regulatory approval in several markets – including Euro