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"With this drug, we are avoiding not only the first heart attack, but potentially the second and possibly the third fatal accident," said Bhatt, executive director of cardiovascular intervention programs at Brigham and Women's Hospital & # 39; s and professor of medicine at Harvard Medical School.
According to these latest data on cardiovascular episodes, Vascepa has reduced first quarter events, second and third events by more than 30% and subsequent events by almost half. The researchers estimated that by treating 1,000 patients for five years, they could prevent 76 coronary revascularizations, 42 heart attacks, 14 strokes, 16 hospitalizations due to unstable angina and 12 cardiovascular-related deaths.
Vascepa is a prescription drug derived from a single omega-3 fatty acid isolated from fish. Patients received four grams a day, which Bhatt described as the approximate equivalent of eating more than 20 servings of fish a week, according to Monday's release. However, eating so much fish would also add saturated fats and other ingredients to her diet, the statement said.
"Studies on fish oil have given ambiguous results, but this component (…) has a significant effect," said cardiologist Russell Luepker, a professor of public health at the University of Minnesota to Mayo, who did not participate in the test. He said the latest results show "definitely clearer results than just taking fish oil capsules".
In September, Luepker initially reserved his judgment on the drug but now has a more positive vision.
"The number of events averted is not trivial," he said shortly after attending a presentation of the drug at a meeting of the American College of Cardiology on Monday. . "This gives more meaning to something that many of us have suspected for years: triglycerides are important and treating people with high triglyceride levels is a useful thing."
However, Dr. Rita Redberg, a cardiologist, shared her concerns, saying in an email that many questions remained unanswered. For example, the most common events in the study were coronary revascularizations – procedures such as stents that bring blood flow back to the heart. However, she said that it could be "quite subjective and at the discretion of the investigator without objective criteria".
She also expressed concern about Amarin's degree of involvement in "all aspects of the study", which could cast "a wide shadow of bias," said Redberg, a professor of medicine at the University of California at San Francisco, who was also not involved. in the trial.
"It is premature to recommend Vascepa," she said. "We should stick to our strong science-based recommendation to eat a Mediterranean-style diet, including several servings of fish a week, to reduce cardiovascular risk."
The 8,179 patients in the study had normal LDL levels, controlled by statins, as well as elevated triglycerides. In addition, they had either an "established cardiovascular disease" or type 2 diabetes and at least one other cardiovascular risk factor. Patients were followed for 4.9 years on average.
The new study describes the drug as "well tolerated, with no significant difference in rates of serious adverse events when compared to placebo". The researchers found an increased risk of irregular heartbeat and bleeding, unrelated to other serious events such as stroke.
Additional questions remain about the actual functioning of the drug. Experts say it's not clear whether the drug prevents cardiovascular events by acting directly on triglycerides or whether they mark another ongoing process in our body. Or maybe a combination of both.
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