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Fresh clinical trial results released Saturday by high-flying biopharma Amarin have confirmed the heart-protecting benefits of Vascepa, its prescription drug derived from fish oil, suggesting it could become a blockbuster therapy, potentially prescribed to millions of Americans.

The company said in September that its treatment significantly reduced the risk of cardiovascular events compared with a placebo. Detailed results from the trial, known as REDUCE-IT, showed Vascepa cut the risk of death, heart attack, and stroke — the three most important cardiovascular events — by 26 percent.

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  • Chinese won just one Nobel prize, the scientist used a special way to extract the chemical from one special plant. Saved millions of life. Very similar, normal herbal way won’t work.

    • I would call it more what a widespread of bribery and lack of ethics.
      And the FDA, allowing these kind of trials (including the one from Sage), screams utter incompetence and/or widespread corruption.

  • mineral oil?
    I could say that’s the dumbest thing I ever heard, but unfortunately it is not! I wonder who was the MD/FDA genius that authorized such use.
    Couldn’t they have used any edible oil? Or commonly used Omega-3 fish oil?
    Too afraid not to see any significant beneficial effect, I guess.

  • There is excitement suddenly over Vascepa (and Reduce IT) – over today’s data. But the scientific community has forgotten that the results at 60 & 80% (cardiovascular outcomes) were not equally encouraging, and the stock faltered below $3 (from $15).
    The present data is statistically powered and suddenly seem to give outstanding results!
    Hope the success of Vascepa is due to use of pure EPA?!!
    Let us ignore the use of mineral oil in placebo.
    Let us ignore the unsuccessful other fish-oil clinical trials.
    Let us ignore that the reduction of triglycerides do not have linear relationship with cardiovascular outcomes.
    Let us assume that mechanism is not important; and under the best case scenario – Vascepa might benefit millions of patients (there may be other uses too).
    At least investigator Dr. D. Bhatt, and Ceo J. Thero think it will be true blockbuster?
    Will it work wonders?

    • Thiru, Vascepa’s mode of action is many fold, pleiotropic if you will.
      Pure EPA is a potent ant-inflammatory which helps to reduce systemic
      inflammation in the body safely. Pure EPA also helps to heal lesions
      in arteries and strengthens the fibrous lining over plaques keeping them
      from rupturing. Vascepa will save many lives and prevent some of the
      most horrific CV events for patients that take it. The mineral oil placebo
      is chemically inert and safe. It was chosen in part because its color being
      clear matched the Vascepa capsules which are also clear. Had the study
      used corn oil or olive oil there would be concerns over those as well.
      My expectation is that Big Pharma will acquire AMRN as it is too massive
      a market for a small company to handle. Someday, the number of patients
      taking Vascepa will be in the 10’s of milions…but it will be with Big Pharma
      at the helm. Having loved ones on Vascepa for years now I have proof that
      they made a wise choice.

  • Dr. Gulati is wrong that there is no benefit for women. The benefit is
    indeed equal. One other point is that Vascepa is anti-inflammatory,
    it reduces systemic inflammation which is why it works even when
    Triglyceride levels are not reduced. Vascepa also heals lesions and
    strengthens the lining over arterial plaques. Vascepa will change the
    landscape in how CVD is treated.

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