Without Shefali Luthra, Kaiser Health News
When an Amarin biopharma company puts pressure on its latest clinical trial results, this falls, it's excited buzz and controversial in the medical community by suggesting that his drug, Vascepa, could transform the prevention of heart disease. The company's stock has been cut back.
But this month, in the American Heart Society's scientific sessions, whoever is of cardiology, the company has revealed the findings of a full study, also published in the Journal Journal of Medicine New England. The bottom line: Vascepa, derived from prescription fish oil, has reduced the likelihood of cardiovascular death, stroke and heart attack, harassments that affect tens of millions of Americans, about 26 percent.
"The result is spectacular," said Dr. Ethan Weiss, a cardiologist at the University of California-San Francisco, who was not part of the test. But he was like many other doctors – still comparatively.
Even as Amarin and some cardiologists use superlatives to get the results of the Vascepa experiment, there are a lot of questions about the design of the study and whether Vascepa's benefits justify her price, considering how its ingredients comparing over-the-counter fish supplements. According to Red Book, a pharmaceutical trade announcement, Vascepa's month supply sells for about $ 280.
ConsumerLab.com, a private company that has been testing dietary supplements recently, conducted its bi-annual review of fish oil products. I've been analyzed 28, including those who have been marketing for heart health, for pregnant women, for children and even for pets. Severe issues have been found with four of them, including incorrect labeling and failure to correctly identify ingredients – the pill binding coating.
And of those 28, ConsumerLab One-GNC Triple Strength EPA 1000 found that it says that a chemical analysis similar to Vascepa only retail at a fraction of the price. A bottle of 45 pills costs around $ 30, and the users would take four pills a day.
Vascepa has already been approved as preventative for people with extremely high triglyceride-500 milligrams per deciliter or higher. The aim of the study was to show that the group could be healthy for many more people with a greater risk of heart disease. People in this wider population included in the trial were already taking a statine to lower cholesterol.
After five years, patients who took Vascepa as well as statin saw lower reductions of large cardiovascular problems, including death, over those who took place into placebo.
But this applies to the doctor's or home office remains controversial. "We have this trial, [but] what does this mean for patients? "Dr. Sanket Dhruva, another UCSF cardiologist, asked," We're tough. "did not, like Weiss, be involved in the study.
For beginners, the test focused on patients with high triglyceride levels, a history of heart disease or other high risk, and they were already taking statins. That means that the benefits focus on a specific population, Dr Steven Woloshin, who co-ordinates the Center of Medicine and the Dartmouth Institute Media and is studying effective scientific communication.
And the basics of the study-in particular, comparing patients on Vascepa for those who take a mineral oil pill-have raised questions. Placebos must operate neutrally, so that researchers can compare the drug to an environment unchanged. Replacement of mineral oil could establish a defective baseline. Some evidence suggests that it increases the risk of heart problems. That would mean that Vascepa results look softer because they are measured against a favorable benchmark.
Dr. agreed Steven Nissen, chief pharmacology at the Cleveland Clinic, said that the mineral oil effect was being questioned to the extent to which Vascepa suffered a heart attack.
"I would never recommend a dietary supplement to a patient, and I will never take one myself."
– – Steven Nissen, chief gardi at Cleveland Clinic
Amarin and researchers say that any impact of this type is small enough that should not undermine the general results. Others were less certain. "He's doing the interpretation of everything older than anyone would want," said Weiss.
In order to make even more complex medical decisions, a separate study presented at the same meeting in November found that healthy older people who take over-the-counter fish supplements-specifically omega-3 fatty acids – reduces the risk of heart disease. Conventional wisdom has long suggested that fish oil, which is being overcome by food or pill, can strengthen heart health. Many doctors recommend it as part of a healthy diet.
All this is a great deal for consumers who are worried about heart disease, especially those who try to spend a limited dollar wisely, suggested by Dr Tod Cooperman, president of ConsumerLab.
There is no evidence that fish oil is harmful, and that the heart society says supplements could reduce the risk of death if someone has recently had a heart attack. (It's less enthusiastic, however, about the pill as a preventative across the board for cardiovascular disease.)
So, is it worth selling money for Vascepa against buying an attachment in the corner store?
"If their doctor thinks they could benefit from Vascepa – but affordability is a problem – definitely consider and [fish oil] product that has proven, "said Erin Fox, a pharmacist and drug specialist at the University of Utah.
"We will never recommend a dietary supplement to a patient, and we will never take one," said Nissen, stating that the over-the-counter variation is not subject to regulation of Food and Drug Administration, Reduces purity guarantee and precise partitioning. "There have been a number of issues with products like these. As much as I would like to believe that some over-the-counter product would work, and save the tons of public money, it's just a recommended approach."
Nissen, who launches his own study of drugs that comes from fish oil, when he comes to Vascepa, says that both doctors and patients need to "take a deep breath" and see what they are FDA makes Amarin results, even thinking about what kind of value it offers.
"I'm coming down to conversations with patients, in the clinic or on the bed side, about what is realistic considering the very high costs of these drugs," says Dhruva.
Senior correspondent Liz Szabo contributed to this report.
Kaiser Health News is a not-for-profit news service that covers health issues. It is an independent editorial program of the Kaiser Family Foundation that is not related to Kaiser Permanente.