A fish oil derivative may cut risks of major cardiovascular problems like heart attack and stroke by as much as 25 percent, preliminary results announced by its manufacturer suggest.
Vascepa is a Food and Drug Administration (FDA) approved prescription fish oil.
Its maker, Amarin, has been conducting a large global study on the drug since 2011.
The results are due to be presented at the American Heart Association meeting in November, but Amarin did not wait to announce REDUCE-IT’s surprising top-line results.
Capsules of fish oil derivative are low-risk, and even a pricey $311 bottle of 120 capsules is cheap compared to a heart attack, so the findings could be game-changing, but cardiologists remain skeptical of the rushed announcement.
A drug company is claiming that Vaspeca, its fish oil derivative drug, can reduce the risk of heart attack and stroke by a quarter – but cardiologists are dubious of its early study report
Heart disease and the disastrous cardiovascular events it causes are the leading cause of death in the US, and have been for 90 years.
So-called ‘bad’ cholesterol – low-density lipoprotein (LDL) – and another form of fat called triglycerides are among the major culprits in the development of heart disease.
These stubborn fat cells build up in the arteries, making passageways for blood more narrow.
The heart has to work much harder to muscle blood through the clogged-up arteries, which can eventually even become completely blocked.
Heart attack, stroke and heart failure risks are much higher among patients who have high LDL cholesterol.
Cholesterol is also a risk factor that we can exert some control over, however – unlike genetics.
LDL comes from foods that are high in saturated fats, including dairy, red meat and fried foods or trans fats, found in many sweets and baked goods.
Exercise helps to burn these off, and diets high in fiber and healthy fats, like the omega-3 fatty acids found in oily fish, may help to keep cholesterol and triglycerides from being absorbed into your blood stream.
And some studies – and many supplement companies – suggest that you can skip the fish dinner and just take capsules of fish oil to get these benefits.
The American Heart Association (AHA) does not endorse an either-or approach, but rather suggests that medications like statins and fish oil prescriptions or supplements may be useful in addition to diet and lifestyle changes for those whose cholesterol remains high.
Most studies have shown that fish oil is useful for lowering triglycerides, but not so much LDL.
Amarin claims that its fish oil ester, Vascepa does so well enough to drastically reduce the risks of heart attack or stroke.
Vascepa is one of two FDA-approved, prescription omega-3 acid drugs. Both it and Lovaza are ethyl esters, meaning they are derived from fish oil but are not themselves pure fish oil.
The value of Amarin stock more than quadrupled overnight after announcing the top-line result of the REDUCE-IT trial, spiking from where its hovered around $3.00 to more than $12
For some people, fish oil can actually raise LDL levels though it may reduce triglycerides.
Amarin boasts that its drug drug can reduce by triglycerides by a third, without touching LDL levels.
In a test of Vascepa’s power, Amarin began conducting the REDUCE-IT study in 2011.
The study, overseen by steering committee chair and Harvard University cardiology professor Dr Deepak Bhatt at Brigham and Women’s Hospital, involved more than 8,100 high risk heart patients from around the world, according to Amarin’s announcement.
All of the the study participants were already taking statins, the most commonly prescribed drug to help control cholesterol levels.
But only half of them were also given Vascepa.
According to Amarin, the study has at last concluded, and those that got both medications were 25 percent less likely to have a heart attack, stroke or other major cardiovascluar problems, be hospitalized or die from these problems.
However, that’s about as much information as the company is offering at this time, ahead of the study’s official presentation at the AHA meeting in November.
And that raises more questions that hopes for Dr David Brown, a cardiologist with Washington University, St Louis.
‘I’m not sure why this was released early, there’s no scientific reason to do so,’ he told Daily Mail Online.
‘Frequently, in these studies, the composite endpoint’ – the top-line result Amarin is announcing – ‘is driven by components that are less meaningful, but more common,’ he explained.
In other words, if (for example) measures like deaths were only reduced by a small percentage, but hospitalizations were significantly less common among those taking the capsules, that drive the overall result to 25 percent – and Amarin can say that all of those measures were driven down in their advertising.
‘It happens all the time,’ Dr Brown said.
The study itself, of course, will have to disclose those specific numbers, but that won’t come out for more than a month.
‘So I’m assuming this was done to manipulate the stock, which I think leaves a bad taste in everybody’s mouth,’ said Dr Brown.
Whatever Amarin’s intentions were, that is exactly what happened: Its stock value more than quadrupled overnight, from $3.03 to $12.47 a share, on the heals of its Vascepa announcement.
‘Until we really know what differences were driving [the result of the study] … there’s not a lot that can be deduced from the small amount of information from the company,’ Dr Brown added.