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.


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 containing particularly relevant data were identified, and from the US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) and Spontaneous Reporting System through June 30, 2004. For the AERS data and to control for overreporting in the first postmarketing year and the effect on reporting due to the withdrawal of cerivastatin in 2001, we used the rate of a given adverse event among all adverse events as a measure of risk. We found that adverse effects of rosuvastatin in skeletal muscle, liver, and kidney function did not substantially differ in 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 and rhabdomyolysis than rosuvastatin's, but there was no additional effect on renal failure beyond that mediated through rhabdomyolysis. From our literature review, we found that rosuvastatin reduces abnormal lipids on a milligram-per-milligram comparison more than atorvastatin.


CONCLUSIONS
We conclude that rosuvastatin at approved doses incurs no greater risk for adverse events than other marketed statins, except for a mild form of tubular proteinuria when doses at or above the maximum recommended levels (> or = 40 mg/day) were administered. Its risk-benefit ratio is acceptable when compared with other statins on the market in 2006.
Zipes
Douglas P
DP
Krannert Institute of Cardiology, Indiana University School of Medicine, Indianapolis, Indiana, USA. dzipes@iupui.edu
Zvaifler
Nathan J
NJ
Glassock
Richard J
RJ
Gilman
Sid
S
Muñoz
Alvaro
A
Gogolak
Victor
V
Gordis
Leon
L
Dedon
Peter C
PC
Guengerich
Frederick P
FP
Wasserman
Stephen I
SI
Witztum
Joseph L
JL
Wogan
Gerald N
GN
D005464:Fluorobenzenes / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D007674:Kidney Diseases / Q000139:chemically induced; D009135:Muscular Diseases / Q000139:chemically induced; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use; D018570:Risk Assessment; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium