Rosuvastatin: An independent analysis of risks and benefits

Background: Although the effectiveness of statins is well established, analyses of spontaneous adverse event reports have recently questioned the safety of rosuvastatin. Methods and results: We evaluated the risks and benefits of rosuvastatin and compared it with other statins presently on the market Information was obtained from a search of medical and scientific literature that produced 3001 entries, of which 591 publications conta particularly relevant data were identified, and from the US Food and Drug Administration (FDA) Adverse Events Reporting System (AE Spontaneous Reporting System through June 30, 2004. For the AERS data and to control for overreporting in the first postmarketing y the effect on reporting due to the withdrawal of cerivastatin in 2001, we used the rate of a given adverse event among all adverse ever measure of risk. We found that adverse effects of rosuvastatin in skeletal muscle, liver, and kidney function did not substantially differ i frequency from those reported for those of other statins in the market in 2004, except for the uncommon development of a mild form of presumably "tubular" proteinuria at doses of 40 mg/day or greater. In contrast, cerivastatin had significantly higher rates of myopathy a rhabdomyolysis than rosuvastatin's, but there was no additional effect on renal failure beyond that mediated through rhabdomyolysis. I literature review, we found that rosuvastatin reduces abnormal lipids on a milligram-per-milligram comparison more than atorvastatin. Conclusion: We conclude that rosuvastatin at approved doses incurs no greater risk for adverse events than other marketed statins, for a mild form of tubular proteinuria when doses at or above the maximum recommended levels (≥40 mg/day) were administered. Its benefit ratio is acceptable when compared with other statins on the market in 2006.