Fresh data from REDUCE-IT study shows Amarin’s Vascepa cuts heart problems by 30%

By PharmaCompass

2019-03-21

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Fish oil contains omega-3 fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and both are known to lower serum triglycerides, or high cholesterol. Amarin’s Vascepa (an FDA-approved prescription EPA treatment) seeks to leverage that hypothesis and change the way cholesterol has been treated.

In September, Amarin released initial results from the study of 8,179 patients already taking other heart drugs. Known as REDUCE-IT, the study showed a 25 percent reduction in serious heart events for those receiving a 4 gram dose of Vascepa compared with a placebo.

However, in November the clinical trial design of the REDUCE-IT study was questioned. Though the drug did cut heart risks significantly, the choice of placebo and the effect it had on the results had stirred up a debate.

But this week, the drugmaker published fresh data from the REDUCE-IT study. This time, the results show a 30 percent decrease in serious heart problems.

The new data shows an average drop of “12 deaths, 42 heart attacks (myocardial infarctions), 14 strokes, 76 coronary revascularizations and 16 episodes of hospitalization for unstable angina”. There was also a 28 percent reduction of total events in the key secondary endpoint of 3-point MACE (short for major adverse cardiac events) in the intent-to-treat population consisting of a composite of cardiovascular death, non-fatal heart attack and non-fatal stroke.

Amgen taps Jay Leno for cholesterol awareness: Another company that focuses on cholesterol-lowering drugs is Amgen, whose drug Repatha has been on the market since 2015. Amgen is partnering with comedian and TV show host, Jay Leno, to sound the alarm on high cholesterol. The awareness campaign — Cholesterol 911 — aims to motivate patients and caregivers to get into the driver's seat insofar as cholesterol management is concerned.

Leno, himself a high-cholesterol patient, displays his love for cars, and deploys his sense of humor in the campaign to spread awareness about high cholesterol.

Through this campaign, Amgen is targeting high-risk patients with cardiovascular disease and people who have previously suffered a heart attack or stroke. These patients “need to know that there is more that can and should be done to further lower their LDL-C or ‘bad’ cholesterol in order to reduce their risk of another cardiovascular event,” Amgen’s spokeswoman said.

The headline and our report on Lupin was updated on March 23, 2019, following a clarification from the company that it had not received a warning letter for its US and India facilities, but an OAI, which is a 90-day facilities classification decisional letter. The error carried in our previous version is regretted.

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