Replies to post #210924 on Amarin Corp Plc (AMRN)

[Whalatane]

Chas ...re STRENGTH

Inclusion Criteria:
Men or women, ≥18 years of age.
Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
LDL-C <100 mg/dL
TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:
Any atherosclerotic CVD as defined in protocol.
History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.

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Do we know what % of this trial will be diabetics with previous events ?...which ( from memory ) is the highest risk cohort and was 60%-70% ? of the R-IT trial .
thx
Kiwi

[sts66]

IIRC one of the criticisms of STRENGTH was that they enrolled too many patients too fast, so my guess is they may have upped the # of events, not the median time in the trial. I forget exactly when they added the extra year, but some here believe it was because like what R-IT showed, major event curve separation didn't become apparent until patients had been in the trial for almost two years. That's one thing I think of every time someone says "FDA delaying R-IT approval by 3 months will kill thousands" - that's not the case, because V does not have anything close to rapid efficacy for 3 and 5 pt MACE. IMO V may be able to reduce risk of stroke relatively quickly, if Lp-PLA2 is as strong a risk indicator for stroke as it appears to be - my levels dropped -80% after 6 months, and I'd be willing to bet they came down a lot faster than that, we just didn't retest until my next appt.