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Re: The million (no, billion) dollar question for HPS2-Thrive baseline trigs were 125,mg/dl for the entire population. Trigs in the treatment arm were further reduced by 33mg/dl However, as you know, this reduction did not correlate with a SS reduction in CV events. Even in the subgroup of high baseline trig patients, CV event reduction was not SS But remember, failing to hit SS is absence of evidence. It is not evidence of absence. HPS2-THRIVE observed 3400 events and did not meet its primary endpoint. Had IMPROVE-IT only observed 3400 events, it also would not have met its primary endpoint (it observed over 5000 events). This whole ANCHOR thing relies on Trigs being a valid surrogate for reduced cardiac risk (in high B/L trig patients). That was the rational for granting the SPA. The MOA of Vascepa was presumed to be trig lowering. Perhaps it is something else, ie reducing inflammation. Problem is, ANCHOR measured trig reduction as the primary, not inflammation reduction. For REDUCE-IT, the MOA will not matter. Either it reduces cardiac events or it does not. I'm just scratching my head over how the FDA might view positive subgroup data from a trial that met its primary (still likely only just "hypothesis generating") |
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Msg # | Subject | Author | Recs | Date Posted |
1672 | Re: The million (no, billion) dollar question | ex_hacker202 | 0 | 11/24/2014 4:54:34 PM |