[Clinical trials with rosuvastatin: efficacy and safety of its use]

Cardiovascular diseases remain the leading cause of mortality and morbidity in the western countries. Statins have greatly improved the treatment of dyslipidemias in primary and secondary prevention. Rosuvastatin is a new statin with a high efficacy in reducing LDL cholesterol levels with a good safety profile. At present data about efficacy on mortality and morbidity of this statin are not available; but a very large program of clinical trials, named GALAXY, with over 20,000 subjects in 30 countries, is ongoing. The high capacity of rosuvastatin of lowering LDL cholesterol at usual starting dose of 10 mg is a very interesting characteristic of this molecule, as it helps in reducing the need for dose titration in many patients. Rosuvastatin 10 mg reduces LDL cholesterol levels by 46.7-48.1% vs a reduction of 36.4% with atorvastatin 10 mg, 35.7% with simvastatin 20 mg, and 27.1% with pravastatin 20 mg. Dose-ranging trials have documented that reductions of LDL cholesterol increase with higher doses of rosuvastatin. The STELLAR trial (with rosuvastatin in the range of 10-80 mg vs atorvastatin 10-80 mg, simvastatin 10-80 mg and pravastatin 10-40 mg in 2431 patients) demonstrated that the mean proportional reduction achieved with rosuvastatin at various doses was greater than the one obtained with comparators. Rosuvastatin is also better than other statins in achieving the target level of LDL cholesterol recommended by the recent guidelines. The proportion of patients reaching the goal is 82% with 10 mg and it raises to 89% with 40 mg of rosuvastatin. The proportion of subjects reaching LDL cholesterol levels < 100 mg with different doses of rosuvastatin is significantly higher (p < 0.002) than the one obtained with atorvastatin at the same doses and simvastatin or pravastatin at the same or higher doses. The safety data of rosuvastatin in the dose range of 10-40 mg are similar to the ones achieved by the other statins, therefore, considering the superior efficacy of rosuvastatin in reducing the LDL cholesterol levels, the risk-benefit profile of this new molecule seems very promising.