Abstract

Any new form of treatment, when based on solid experimental observations, initially generates a lot of enthusiasm among researchers as well as among patients (when media get involved). If the initial positive results in observational studies are then confirmed in small randomized trials with surrogate endpoints and finally in large randomized trials with clinical endpoints, the new treatment gains momentum and becomes common practice when incorporated in guidelines (for instance, the use of ACE inhibitors in patients with heart failure). At the other extreme, if the initial positive results are not confirmed in controlled randomized trials, the new treatment is quickly forgotten (for instance, the use of positive inotropic agents in patients with heart failure). As clinicians, we know, however, that we have to accept the grey area where things can remain uncertain for years or even decades. A good example is offered by lipid-lowering drugs: in spite of compelling evidence in the sixties that hypercholesterolaemia is a key atherogenic stimulus, statins have entered guidelines in the nineties only. The simple reason for this prolonged hovering in the grey area is that lipid-lowering drugs used prior to statins were able to significantly reduce cholesterol levels, but this reduction was not large enough to translate into a significant reduction of clinical endpoints. More recently, growing attention has been paid to the issue of safety. For instance, non-steroidal anti-inflammatory drugs are under close scrutiny because of an increased risk of thrombotic complications which went unnoticed during the last few decades. The interpretation of the growing number of trials of cell-based therapy following acute myocardial infarction (AMI) has to be considered in this broad context. After the seminal observation in 2001 by Anversa et al .1 that the human heart is not a post-mytotic organ, several studies in experimental models have confirmed that … *Corresponding author. Tel: +39 630154187; fax: +39 63055535. E-mail address : filippo.crea{at}rm.unicatt.it

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