For years cardiologists have been skeptical of omega-3 supplements' health benefits—but early results from a new clinical trial suggest Amarin's prescription formulation of fish oil substantially reduced the risk of deaths and serious cardiovascular events, Adam Feurstein reports for STAT News.
Amarin tests its own prescription formulation of fish oil and finds benefits
While other prescription formulations of fish oil have failed to show health benefits, Amarin for years has claimed its prescription formulation of fish oil, Vascepa, is different and more effective than others. FDA in 2012 approved Vascepa—which contains a highly purified form of EPA, an omega-3 fatty acid found in fish oil—to treat patients with high levels of triglycerides. Vascepa is delivered to patients at a higher daily dose when compared with other prescription fish oils. Most insurers broadly cover Vascepa, which costs about $2,400 annually.
To test whether Vascepa could reduce the risk of serious cardiovascular events, Amarin enrolled 8,179 patients in a clinical trial, called REDUCE-IT, and randomly assigned patients to receive the drug or a placebo. Patients in the clinical trial had their cholesterol levels controlled by a statin, but were experiencing other heart-related problems, such as diabetes or high triglyceride levels, that put them at higher risk of serious cardiovascular events. The researchers followed up with patients after a median period of about five years.
According to Amarin, the clinical trial showed Vascepa significantly reduced the risk of deaths and other cardiovascular events when compared with a placebo. In particular, Amarin found using Vascepa led to an approximately 25% relative risk reduction in:
- Coronary revascularization;
- Non-fatal heart attacks
- Non-fatal strokes;
- Cardiovascular death; and
- Unstable angina requiring hospitalization.
In terms of safety, Amarin found Vascepa was well-tolerated among patients, and the drug's side effects were consistent with those currently listed on the product's label.
Researchers have attributed Vascepa's success to the formulation's purity and dosage, which is not duplicated in formulations of fish oil created by other companies.
Amarin will release additional data from the clinical trial at the American Heart Association's annual meeting on Nov. 10.
Amarin CEO John Thero said, "We are delighted with these top-line study results. Given Vascepa is affordably priced, orally administered, and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT."
Matthew Budoff, a cardiologist at UCLA and investigator in the clinical trial, said, "This is absolutely the most significant study in the field of cardiovascular risk reduction since the statins were introduced."
Martha Gulati, chief of cardiology at the University of Arizona College of Medicine who was not involved in the study, said, "I need to see the [detailed] data, but if these are the results, then this may be a game changer."
Norman Lepor, a cardiologist at Cedars-Sinai Medical Center in Los Angeles who enrolled patients in the Vascepa trial, said, "I went into this study not convinced that Vascepa would make a difference, but these results will definitely change my practice and the way I treat patients" (Feuerstein, STAT News, 9/24).
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