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Message: Forest plot

As a former clinical cardiovascular investigator, I've learnt that one needs to take time to look at trial results carefully before jumping to conclusions, but from what I've seen so far, these results are VERY encouraging indeed.

It's difficult for me to read the forest plot, but it looks as if all the end points but one (looks like stroke) were to the left of the line (i.e., in the direction of benefit), three of them were a whisker away from clinical significance (I can't read which ones), and one of them was statistically significant (again I can't see which one).

These results combined with the reported Primary MACE HR of 0.79 (21 per cent reduction), with a P of 0.06, are very good in my view. I think the AHA will be buzzing on these results. They are exciting.

I will say more at length, once I get to see more data, as soon as I can. But to put it in perspective, The Lipid Research Clinics Coronary Primary Prevention Trial of cholesterol-lowering with a drug called Questran in the 1980s (before the statins arrived), which was considered to be a great success and gave a massive boost to the cholesterol field at a time when it was struggling, achieved only a 19 per cent reduction in risk after 7.4 years of treatment (no reduction at 3 years). The P value was less than 0.05 (the critical cut-ff point), BUT this was by what's called a one-tailed test of statistical significance. One-tailed tests are no longer used, only two-tailed tests, which is what I am sure must have been used for BETonMACE. By a two-tailed test the result, the LRCCPPT result was NOT significant (P=0.05 by a one-tailed test is the equivalent of P=0.10 by a two-tailed test).  Nevertheless, in those days the result was considered good enough for the AHA and NIH to recommend that everyone with a high cholesterol level should reduce it...and until the statins Questran (a resin) was the drug of choice.

So by this yardstick, from what I have seen so far, the BETonMACE result actually looks better than the LRCCPT result that was considered such a milestone in cardiovascular disease prevention. It will be interesting to see how the FDA handles it!

So far, so good!

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