Replies to post #26350 on Amarin Corp Plc (AMRN)

[ggwpq]

Interesting video about TG, HDL and LDL starting at 36 minute mark :

[ziploc_1]

Thank you for the link to the SA article. I wish the author had gone further to a 35% reduction in events or even greater reduction as in the subgroup of 1000 patients in the Jelis study who had a trig level of over 200(and who had over 50% event reduction) and discussed what the timing for adequate power would be in those cases.

[BioChica]

I would not expect the trial results to be ready until 2017...

REDUCE-IT and other Vascepa-related clinical development

Enrollment for the REDUCE-IT outcomes trial of Vascepa continues at over 400 sites spanning 11 countries. Earlier this year enrollment for the REDUCE-IT trial surpassed 6,500 patients. As previously reported, the mean and median baseline triglyceride levels for patients participating to date in the REDUCE-IT cardiovascular outcomes study is > 200 mg/dL. Results of the REDUCE-IT study will not be available until a specified number of cardiovascular events have been observed. Based on current expectations, unless feedback from pending discussion with the FDA regarding the ANCHOR sNDA results in modification or termination of the REDUCE-IT study, completion of this blinded study is anticipated in or about 2017. Amarin estimates that over $100 million is required to complete this study. While Amarin remains scientifically committed to continuing the REDUCE-IT study, Amarin anticipates that the trial may be difficult to complete in its current form without the expected revenues from the previously anticipated ANCHOR indication, as communicated to the FDA.

[BioChica]

The Interim Analysis.
interim analysis link to article

Amarin has mentioned that there will be an interim analysis when 60% of the events are achieved. When will this happen? What is the probability that the outcome would be positive enough to stop the trial earlier?

We need 967 events (60% of 1,612 events). With only 967 events instead of 1,612, the power of the study is no longer 90%. According to my calculation, the power would then be 71%. This means that if Vascepa works to reduce the cardiovascular (CV) events by 15% (relative risk reduction = RRR of 15%), then 967 events would be enough to show this with a probability of 71%. This would happen in January 2016.

The following is also interesting to consider. Imagine that Vascepa is more effective at reducing the CV events by 15% and instead it reduces them by 20% or more. At that point, what would be the power of the test with 967 events? The table below shows what the power of the study at the interim results would be depending on the efficacy of Vascepa. It also gives the expected timings.

We can see that if the efficacy is 19%, then the power with 967 events is 90%, which is the same power of the study with 1,612 events and 15% efficacy. If the efficacy is 25%, the power would be 99%, and the probability of stopping the study at the interim analysis would then be very high.