Raising the bar for primary prevention

摘要

There have been several high-profile examples recently of drugs that seemed exciting based on clinical trials with surrogate outcomes yet proved to be of no benefit (or harm) after clinical trials with real clinical outcomes. For example, torcetrapib was touted to be "one of the most important compounds of our generation" based on trials showing it raised high-density lipoprotein cholesterol and lowered how-density lipoprotein cholesterol, just a few months before it was withdrawn because of a 60% increase in all-cause mortality. Learning from these experiences, and remembering that all drugs have adverse effects, Prasad and Vandross advocate raising the bar for primary prevention campaigns, so that they are undertaken only if there is clear evidence of clinical benefit on hard outcomes.