Replies to post #75768 on Amarin Corp Plc (AMRN)

[AVII77]

I think I answered my own question. In this trial the event rate/year is 3.8% approximately even when 73% of the patients had CVD. Study can be found online

Yes, the event rate was only 3.8%/year in that trial but you can't draw any direct comparisons with REDUCE-IT.

For that SAVOR trial, the 3.8% was composed of:

* cardiovascular death,
* nonfatal myocardial infarction,
* non-fatal ischemic stroke

REDUCE-IT has more MACE components.

* CV death,
* Nonfatal MI (including silent MI; ECGs will be performed annually for the detection of silent Mis),
* Nonfatal stroke,
* Coronary revascularization
* Hospitalization for unstable angina determined to be caused by myocardial ischemia by invasive/non-invasive testing.

The first 3 are similar to SAVOR but REDUCE-IT will also be hunting for "silent MI's" and include both ischemic and hemorrhagic strokes (why hemorrhagic strokes weren't included in the SAVOR trial I haven't a clue). The latter 2 REDUCE-IT MACE components are arguably "soft" components and not included in the SAVOR trial primary events but may make up the majority of REDUCE-ITs primary events.

That SAVOR trials secondary endpoint was very similar to REDUCE-ITs Primary endpoint, and for that their event rate was 6.4%.

I guess my point is, you have to be careful comparing event rates from one trial with another (and the above just looks at MACE components and doesn't even take into account the differences in patient populations.)

I think a more interesting observation is that the SAVOR trial anticipated (powered using) a 2.1%/year event rate. And you note above the actual event rate was 3.8%/year, almost double what they thought.