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By Shefali Luthra, Kaiser Health News
When the Amarin biopharmaceutical company released its latest clinical trial results this fall, it caused buzz and controversy in the medical community by suggesting that his drug, Vascepa, could transform the prevention of heart disease. The stock of the company exploded.
But this month, at the scientific sessions of the American Heart Association, an annual meeting of cardiology, the company unveiled the full results of the study, also published in the publication New England Journal of Medicine. In summary: vascepa, a prescription fish oil derivative, has reduced the risk of cardiovascular death, stroke and heart attack by approximately 26%, affecting tens of millions of Americans.
"The result is spectacular," said Dr. Ethan Weiss, a cardiologist at the University of California at San Francisco, who did not participate in the trial. But, like many other doctors, he still had scruples.
Even though Amarin and some cardiologists use superlatives to praise the results of the Vascepa trial, there are plenty of questions – about the design of the study and whether the benefits of Vascepa justify its price, given comparing its ingredients with non-prescription fish oil supplements. According to Red Book, a pharmaceutical publication specializing in the pharmaceutical trade, a one-month stock of Vascepa costs about $ 280.
ConsumerLab.com, a private company that tests dietary supplements, recently completed its biennial review of fish oil products. He analyzed 28, including those marketed for cardiovascular health, for pregnant women, for children and even for pets. Four of these posed serious problems, including inaccurate labeling and an inability to accurately identify ingredients, namely enteric coating of pills.
And ConsumerLab has found one, the CNC Triple Strength EPA 1000, which has a chemical breakdown similar to that of Vascepa, but sells at a fraction of the price. A bottle of 45 tablets costs about $ 30 and users take four a day.
Vascepa is already approved as a preventative for people with extremely high triglyceride levels – 500 milligrams per deciliter or higher. The purpose of the study was to demonstrate that it could be healthy for the much larger group of people at increased risk for heart disease. People in this extended population included in the trial were already taking a cholesterol-lowering statin.
After five years, patients taking Vascepa in addition to a statin had a reduced likelihood of major cardiovascular problems, including death, compared with those taking a placebo.
But how it applies to the doctor or at home remains controversial. "We have this test, [but] what does this mean for our patients? "Asked Dr. Sanket Dhruva, another UCSF cardiologist, who, like Weiss, was not affiliated with the study. "It's tricky."
For starters, the trial included patients with high triglyceride levels, a history of heart disease or other high risk and already taking statins. This means that the benefits are focused on a specific population, said Dr. Steven Woloshin, who co-directs the Center for Medicine and Media at the Dartmouth Institute and is studying effective science communication.
And the underlying method of the study – specifically comparing patients under Vascepa to those taking a mineral oil pill – fueled the questions. Placebos are supposed to act in a neutral way so that researchers can compare the drug to an unchanged environment. The substitution of mineral oil can establish an imperfect baseline. Some evidence suggests that it increases the risk of heart problems. This would mean that Vascepa's results seemed more optimistic because they had been measured against a particularly favorable benchmark.
Dr. Steven Nissen, head of the cardiac department at Cleveland Clinic, acknowledged that the mineral oil effect questioned the extent to which Vascepa prevented heart attacks.
"I would never recommend a dietary supplement to a patient and I would never take one myself."
– Steven Nissen, Chief of Cardiology at Cleveland Clinic
Amarin and his researchers claim that such an effect is sufficiently weak not to compromise the overall results. Others were less safe. "This makes the interpretation of it all more complicated than anyone would like it to be," Weiss said.
To make medical decision-making even more complicated, a separate study presented at the same November meeting found that healthy seniors who take over-the-counter fish oil supplements – especially fatty acids omega-3 – do not reduce the risk of heart disease. Conventional wisdom has long suggested that fish oil, ingested in food or by pills, could improve heart health. Many doctors recommend it as part of a healthy diet.
All of this creates a problem for heart-healthy consumers, especially those who are trying to spend limited funds wisely, "said Dr. Tod Cooperman, president of ConsumerLab.
There is no evidence that fish oil is harmful, and the heart association Supplements may reduce the risk of death if a person has recently had a heart attack. (However, he is less enthusiastic about thinking about the pill as a global preventive prevention of cardiovascular disease.)
So, is it worth it to spend money on Vascepa instead of buying a convenience store supplement?
"If their doctor thinks that they might benefit from Vascepa – but that affordability is a problem – definitely consider a [fish oil] product that has been tested, "suggested Erin Fox, a pharmacist and drug expert at the University of Utah.
"I would never recommend a dietary supplement to a patient and I would never take it myself," said Nissen, noting that the over-the-counter variant was not subject to the Food and Drug Regulations. Drug Administration, which means less guarantee of purity and security. precise dosage. "There have been many problems with products like these. Even if I would like to believe that some over the counter products would work and save tons of money to the public, this is just not a recommended approach. "
Nissen, who is launching his own study on drugs derived from fish oil, said that when it comes to Vascepa, doctors and patients need to "take a deep breath" and see what the FDA makes Amarin's results, even before thinking about what kind of value it offers.
"Our conversations with our patients, at the clinic or at the bedside, focus on what is realistic given the very high cost of drugs," said Dhruva.
Principal Correspondent Liz Szabo contributed to this report.
Kaiser Health News is a non-profit news service covering health issues. This is an independent editorial program of the Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
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