Amarin’s ‘breakthrough’ fish oil drug for heart patients comes with big caveats

By PharmaCompass

2018-11-15

Impressions: 128 Article

In late September, we had carried news on Amarin’s fish oil drug, which made history in the field of heart medicines with its proprietary, prescription formulation of fish oil known as Vascepa (ethyl eicosapentaenoic acid). The clinical trial results had revealed that Vascepa, which contains omega-3 fatty acids, reduced the risk of deaths, heart attacks, strokes and other serious cardiovascular outcomes quite significantly. The claim was astounding — a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions.

Though the drug did cut heart risks significantly, the choice of placebo and the effect it had on the results has now stirred up a debate. After reviewing the results of the REDUCE-IT study, some analysts had a problem with the study’s design. They say the placebo might have caused harm and in turn inflated Vascepa’s effectiveness profile.

Patients on the dummy pill saw their bad cholesterol levels up by 10 percent in the first year versus less than 3 percent changes in the Vascepa group. Level of high-sensitivity C-reactive protein (hsCRP) — an indication of inflammation — also increased 30 percent in the placebo group.

Commenting on the 8,179-subject trial, Jefferies analyst Michael Yee said patients in the control arm received a mineral oil-filled pill, which looked like Amarin’s purified fish-oil drug. And that these patients saw some key cardiovascular biomarkers trending in a bad way. That should not have been the case with normal placebos.

Vascepa isn’t a new drug — it was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at the risk for pancreatic problems. As of December 2017, Vascepa retailed in the US for about US$ 280 for a month’s supply.

Meanwhile, late last month, Amarin sued two dietary supplement firms after releasing results of the REDUCE-IT study. In the lawsuits, Amarin claimed that the two dietary supplement firms have used results from the REDUCE-IT study to deceptively and falsely claim their omega-3 products are effective in reducing the risk of cardiovascular disease.

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