Rosuvastatin

An independent analysis of risks and benefits

Douglas P. Zipes, Nathan J. Zvaifler, Richard J. Glassock, Sid Gilman, Alvaro Muñoz, Victor Gogolak, Leon Gordis, Peter C. Dedon, Frederick P. Guengerich, Stephen I. Wasserman, Joseph L. Witztum, Gerald N. Wogan

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number73
JournalMedGenMed Medscape General Medicine
Volume8
Issue number2
StatePublished - 2006

Fingerprint

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rhabdomyolysis
Proteinuria
Literature
Muscular Diseases
Drug-Related Side Effects and Adverse Reactions
Renal Insufficiency
Publications
Rosuvastatin Calcium
Skeletal Muscle
Kidney
Lipids
Safety
Food
Liver

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Zipes, D. P., Zvaifler, N. J., Glassock, R. J., Gilman, S., Muñoz, A., Gogolak, V., ... Wogan, G. N. (2006). Rosuvastatin: An independent analysis of risks and benefits. MedGenMed Medscape General Medicine, 8(2), [73].

Rosuvastatin : An independent analysis of risks and benefits. / Zipes, Douglas P.; Zvaifler, Nathan J.; Glassock, Richard J.; Gilman, Sid; Muñoz, Alvaro; Gogolak, Victor; Gordis, Leon; Dedon, Peter C.; Guengerich, Frederick P.; Wasserman, Stephen I.; Witztum, Joseph L.; Wogan, Gerald N.

In: MedGenMed Medscape General Medicine, Vol. 8, No. 2, 73, 2006.

Research output: Contribution to journalArticle

Zipes, DP, Zvaifler, NJ, Glassock, RJ, Gilman, S, Muñoz, A, Gogolak, V, Gordis, L, Dedon, PC, Guengerich, FP, Wasserman, SI, Witztum, JL & Wogan, GN 2006, 'Rosuvastatin: An independent analysis of risks and benefits', MedGenMed Medscape General Medicine, vol. 8, no. 2, 73.
Zipes DP, Zvaifler NJ, Glassock RJ, Gilman S, Muñoz A, Gogolak V et al. Rosuvastatin: An independent analysis of risks and benefits. MedGenMed Medscape General Medicine. 2006;8(2). 73.
Zipes, Douglas P. ; Zvaifler, Nathan J. ; Glassock, Richard J. ; Gilman, Sid ; Muñoz, Alvaro ; Gogolak, Victor ; Gordis, Leon ; Dedon, Peter C. ; Guengerich, Frederick P. ; Wasserman, Stephen I. ; Witztum, Joseph L. ; Wogan, Gerald N. / Rosuvastatin : An independent analysis of risks and benefits. In: MedGenMed Medscape General Medicine. 2006 ; Vol. 8, No. 2.
@article{7e18fefe473541b5bcb52c456c23dd76,
title = "Rosuvastatin: An independent analysis of risks and benefits",
abstract = "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.",
author = "Zipes, {Douglas P.} and Zvaifler, {Nathan J.} and Glassock, {Richard J.} and Sid Gilman and Alvaro Mu{\~n}oz and Victor Gogolak and Leon Gordis and Dedon, {Peter C.} and Guengerich, {Frederick P.} and Wasserman, {Stephen I.} and Witztum, {Joseph L.} and Wogan, {Gerald N.}",
year = "2006",
language = "English",
volume = "8",
journal = "MedGenMed Medscape General Medicine",
issn = "1531-0132",
publisher = "Medscape Health Network",
number = "2",

}

TY - JOUR

T1 - Rosuvastatin

T2 - An independent analysis of risks and benefits

AU - Zipes, Douglas P.

AU - Zvaifler, Nathan J.

AU - Glassock, Richard J.

AU - Gilman, Sid

AU - Muñoz, Alvaro

AU - Gogolak, Victor

AU - Gordis, Leon

AU - Dedon, Peter C.

AU - Guengerich, Frederick P.

AU - Wasserman, Stephen I.

AU - Witztum, Joseph L.

AU - Wogan, Gerald N.

PY - 2006

Y1 - 2006

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=33745216692&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745216692&partnerID=8YFLogxK

M3 - Article

VL - 8

JO - MedGenMed Medscape General Medicine

JF - MedGenMed Medscape General Medicine

SN - 1531-0132

IS - 2

M1 - 73

ER -