Given their preventive efficacy in patients with heart diseases (a decrease in overall mortality), can we consider the use of statins in primary prevention (that is to say in patients with CV risk but not affected by heart diseases yet)? Some European researchers have extracted from 11 randomized trials the results referred only to high-CV-risk patients but with no CV diseases. The sample has been represented by 65,000 subjects between 51 and 75 years of age and the primary outcome has been established in mortality for any cause. During the follow-up of about 4 years, the average level of LDL cholesterol has been of 134 mg/dl in the subjects treated with placebo and of 94 mg/dl in the ones treated with statins. There have been about 2800 deaths, with 100 deaths less in the statin group (RR 0.91: about 7 deaths less every 10,000 people/year): the difference is not statistically significant (CI 95%; P=0.83-1.01). Always concerning statins in primary prevention, some authors have mentioned the JUPITER trial, which has shown a significant benefit obtainable with rosuvastatin in primary prevention in subjects with no heart diseases but with high high-sensitiveness PCR levels. The main criticisms addressed to this trial are: 1. the trial has been interrupted when some secondary outcomes have been reached, so just few cardiovascular events have been considered in this trial 2. the apparent convergence of mortality curves when the trial has been interrupted suggests that a longer follow-up would have cancelled the differences between the treatment groups 3. a strangely low CV mortality and a strangely all the same low infarction-related mortality suggest the presence of non-identified biases 4. the involvement of pharmaceutical industry in the trial is very strong 5. a good 9 researchers out of 14 in the JUPITER trial had potential clashes of interests.
Criticisms to the JUPITER trial, which arose and still arises wide discussions, are not only the above mentioned ones. For example, the examined subjects all presented high PCR levels, so we do not know the results that we would have obtained in patients with normal values of this CV marker. Besides, it is well known that the early interruption of a trial obtains, as a result, the exaggeration of the apparent benefits, not considering damages in the long term. As we have already affirmed, it is necessary to focus the attention on the real active primary prevention (changes in lifestyle) without being attracted by pharmacological illusions.
