Debunk the FUD
Some thoughts on mineral oil and LDL-C to totally debunk the FUD:
When one looks at the graphs of the Odyssey data one is struck by the fact that Alirocumab (Pyrrhonian’s favorite drug!) was virtually ineffective in the two sub-groups LDL-C less than 80 and 80 to 100. The incidence rates were A 8.3 Placebo 9.5 for less than 80 and then (read carefully) A 9.2 and Placebo 9.5 for 80-100 mg /dL. That’s right – contrary to what the LDL-C lowering hypothesis would tell you, the drug was less effective at preventing events in the 80-100 range than in the sub 80.
A very similar phenomenon is to be noted on slide 51 of the REDUCE-IT final brief. There is no difference in event percentages in the placebo arm, regardless of whether the LDL-C was raised slightly on not, i.e. in the 70-80s mg/dL range.
What this tells me is common sense – the law of dimishing returns. Big gains are made in reducing LDL-C in the well over 100 range, but once below that, continuing reductions are minimal or non-existent for event outcome percentages. I submit that even if mineral oil raised median placebo mg/dL to the mid-80s – IT MADE NO DIFFERENCE IN OUTCOMES. REDUCE-IT placebo data shows this and the Odyssey trial shows it as well – LDL-C under 100 mg/dL does not follow a linear pattern of consistent reductions in LDL-C with similar reductions in MACE events. (Actually both trials would indicate one is better off being in the 80-100 range than below 80.)
As others have shown, Odyssey saw median placebo LDL-C rise from 87 to 103.1 by the 48 month mark. Yep, that’s way higher than the “mineral oil” effect in REDUCE-IT. So where are the FUDsters crying to throw out the Odyssey trial? Oh, yeah, that’s right – they are telling you that Alirocumab is the one to use – it is going to get all the over 100 mg/dL business! (Let’s not forget that it was statistically insignificant in lowering CV death, but it will get all of Vascepa’s business!)
I am left with several conclusions from looking at the data:
A. If your LDL-C is below 100, try something other than a drug that lowers your LDL-C – you are very, very likely already optimal. (Too low – like 50 mg/dL might even start interfering with natural processes in the body.)
B. Mineral oil as a placebo made no difference for outcome percentages. There really is no difference in having LDL-C from 70-90 – “it is all good.”
C. People writing articles trying to undercut Vascepa are hypocrites when looking at 1. LDL-C placebo rate increases in other trials and 2. the horrible, terrible things that happen when your LDL-C is 85 instead of 79. Sorry folks, the stats say there really is no difference at this level. Oh and a 10% increase at this level is not comparable to say 150 and 165. The constant use of 10% is FUD in and of itself. This range is pretty much perfect so 10% is meaningless!
Enough said. (Other than – Pyrrhonian – I dare you to reply to this with facts. You conveniently have ignored my other posts, when showing you the statistics surrounding mineral oil, etc.)
AI
