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FOURIER was an event-driven study and was to conclude when least 1,630 hard major adverse cardiovascular event (MACE) events were accumulated. Amgen expected the study to run for 43 months with a 2 percent annual event rate in the placebo arm. However, the annual event rate in the placebo arm exceeded 3 percent and led to a faster accumulation of hard MACE events. Since the relative risk reduction in the hard MACE composite endpoint grew from 16 percent in the first year to 25 percent beyond 12 months, Amgen anticipates that a longer duration trial would have led to further relative risk reduction.
Would you please consider correcting this sentence of your post?
“The study was stopped early, presumably to stop the hard end points of dead patients from becoming too obvious.”
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You can see how Amgen made their decision. Am I incorrect in my presumption about why the study was terminated early?
Well, technically yes. The protocol is laid out. That's unarguable. So they have a point and have designed the study well, from their point of view.
The fact that 444 people died in the treatment arm vs 426 in the placebo arm was not statistically significant, despite representing a 4.2% increased relative risk of death over the study duration.
What seems to concern Amgen is the implication that all cause mortality had any influence on the decision to terminate the study early. Obviously I cannot know whether this is the case and Amgen are certain that my presumption is incorrect. So maybe some compromise:
If we go with this I can reword the sentence to:
“The study was stopped early due to an unexpected excess of combined cardiac adverse end points in the placebo arm. At this time point the 4.2% increase in relative risk of all cause mortality in the treatment arm was not statistically significant”.
I don't think these facts are arguable with.
Well, that's been interesting. I feel somewhat honoured to have been contacted by a company representing Amgen to correct my presumptions!
Peter
