From the PROactive study:
Lancet 2005 Oct 8;366(9493):1279-89
There is no significant reduction in the primary endpoint, but a reported reduction in the secondary endpoint which is a composite of all-cause mortality, non-fatal myocardial infarction and stroke.
But look at table 4: there is in fact no difference in each individual endpoint of death, non-fatal myocardial infarction (including silent MI), and stroke. Why is this?
A careful review of the article shows why. For the secondary endpoint they chose non-fatal myocardial infarction excluding silent MI. When this is thrown in you get figure 3 with an HR of 0.84 and CI of 0.72-0.98.
Does this really indicate anything significant about a reduction in macrovascular disease events when the data is manipulated in this way?
It is funny how for the TZD, there are clear studies that show intimal regression of atherosclerosis, but yet this doesn't translate slow easily to mortality.
ReplyDeleteI am more convinced that are current surrogates for atherosclerosis is insufficient.