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high-density lipoprotein cholesterol and lowered how-density lipoprotein cholesterol, just a few months before it was withdrawn because of a 60% increase in all-cause mortality.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. Primary prevention, by definition, means healthy people, and while we can recommend healthy lifestyle without qualms (or more clinical trials) to all of our patients, the same cannot be said for drugs or devices in healthy people. This article cautions us not to let enthusiasm and good intentions and the urge to “do something” overpower evidence in considering what is best for our patients.
Redberg RF. Raising the Bar for Primary PreventionComment on “Cardiovascular Primary Prevention”. Arch Intern Med. 2012;172(8):659. doi:10.1001/archinternmed.2012.842