) -- A large study has once again demonstrated the failure of fish oil supplements to reduce heart disease or death in patients at higher risk for heart disease. The negative results of the Italian Risk and Prevention Study, published yesterday in the
New England Journal of Medicine
, could not come at a worse time for
and its prescription fish oil pill Vascepa.
Amarin is already struggling to convince doctors and patients to try Vascepa, so the last thing the company needs is more definitive clinical evidence ripping apart the theory that daily fish oil intake leads to improved heart health.
Vascepa was not used in the Italian study published Wednesday, but still, the odds of Amarin convincing a large pharmaceutical company to partner up on Vascepa's marketing or acquire the entire company went from low to nearly impossible.
Amarin will release first-quarter financial results and hold an investor conference call after the close of regular trading today. Street consensus for Vascepa first-quarter sales is $3.65 million, according to
Italian Risk and Prevention Study
enrolled 12,513 patients with multiple cardiovascular risk factors or evidence of heart disease but no prior history of heart attacks. Half the patients were randomized to receive 1 gram per day of n-3 fatty acids (fish oil) or an olive oil placebo.
After five years of follow up, 11.7% of the patients taking daily fish oil died or were hospitalized due to cardiovascular disease compared to 11.9% of patients treated with a placebo. There was also no difference in any of the prospective secondary endpoints.
"On the basis of the results, we conclude that there was no significant benefit of n-3 fatty acids in reducing the risk of death from cardiovascular causes or hospital admission for cardiovascular causes," the researchers conclude.
Eric Topol, a well-known cardiologist at the Scripps Clinic who was not involved in the study, was even more blunt in
comments made to TheHeart.org
"Fish oil does nothing," said Topol. "We can't continue to argue that we didn't give the right dose or the right preparation. It is a nada effect."