(By Guest Blogger, Sceptical Rogue)
What a great morning to wake up to!
The Daily Mail is telling me all about the new statin drug that slashes the risk of heart attacks and strokes for EVERYONE by up to 44 per cent.
I can't believe it.
How happy I am.
Even BBC Breakfast is having a go, promising that 'rarely have we seen such clear and dramatic results'.
But before we all rush to the doctor demanding prescriptions of Crestor to crush up and put in our morning cereal, I thought I'd take a slightly closer look.
So, this story is about the The JUPITER Study which was published online in the New England Journal of Medicine on 9th Nov 2008. The study looks at patients with relatively low levels of total (HDL+LDL) and 'bad' (LDL-C) cholesterol but with elevated C-reactive protein (a marker of inflammation), and looks at the effect on several cardiovascular events (notably Heart Attack and Stroke) when treated with rosuvastatin 20mg or placebo.
Now let's start with the good stuff - this trial does tick the Thinking Is Dangerous box of acceptable trial design. The trial is Double-blind, Randomised, Placebo controlled, Multi-Centre and Peer review published. Disclosure of the randomisation is pretty good and thorough with very low differences in risk factors across the groups.
The headline grabbing stuff tells me that if I take rosuvastatin I can slash my risk of heart attack by 58% and stroke by 48% even if I have normal levels of cholesterol. Well what could be wrong with that? Surely, a miracle has occurred here today?
Well, no. Not really.
There were 31 Myocardial Infarctions (Heart Attacks) in the treatment group compared with 68 in the placebo group. Each group had 8901 patients in it. There were 33 strokes in the treatment group and 64 in the placebo group.
In real, proper, everyday terms, this means that if I have normal cholesterol levels, but higher c-reactive protein levels, over 2 years:-
- My risk of heart attack goes from a rather disappointingly low 0.76% to an indistinguishably lower 0.35%.
- My risk of stroke goes from a most decidedly non-headline-grabbing 0.72% to a yippee-I'm-gonna-live-forever 0.37%.
Putting this into context, it was the Scandinavian Simvastatin Survival Study (4S) in the 1990's which really propelled the statins into the biggest selling drug class of all time. This study, also Randomised, Multi-centre, double-blind, placebo controlled and peer review published, enrolled patients with high cholesterol levels, compared Simvastatin to placebo and looked again at cardiovascular outcomes.
In this study, the risk of having one or more major coronary event went from 30% in the placebo arm to 19% in the treatment arm! Now these numbers are impressive.
It is worth noting that the Relative Risk Reduction in both trials is roughly similar, but that the real world Absolute Risk Reduction of JUPITER pales in comparison to 4S. And yet, have a look at the media outlets with their impressive numbers and listen as they demand that NICE start funding high doses of expensive statin in primary prevention to make, well, little difference to most people really.
In the interests of fairness it should be pointed out that these studies looked at different patients with different risk factors. It should also be pointed out that 4S had a follow up of 5.4 years whereas JUPITER was stopped early after median follow up of 1.9.
However, my point still stands - The Media, and let's not forget Astra Zeneca themselves - (bless them) will go for the big numbers and the huge claims and to hell with context - but then 'New Study Reduced Risk of Heart Attack from 0.76% to 0.35% for only some people' won't set the media world on fire.