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Drug safety evaluation of rosuvastatin.
Expert Opin Drug Saf. 2011 Nov; 10(6):969-86.EO

Abstract

INTRODUCTION

Rosuvastatin is a highly efficacious statin approved for use throughout the world. Rosuvastatin has been exhaustively evaluated in the setting of a broad variety of dyslipidemias and cardiovascular disease states in clinical trials encompassed within the GALAXY program.

AREAS COVERED

The efficacy and adverse event profile of rosuvastatin are evaluated based on the results of randomized, controlled clinical trials and observational studies available in the Medline database.

EXPERT OPINION

Rosuvastatin is a safe and efficacious lipid modifying drug in a broad variety of patient populations (men and women, irrespective of race) for treating multiple forms of dyslipidemia. Rosuvastatin reduces atherogenic lipoproteins and triglycerides and increases high-density lipoprotein cholesterol better than other statins. Compared to other statins, it has no excess signal for liver, skeletal muscle or renal toxicity. This is supported by evidence from both an extensive clinical trial program as well as post-marketing surveillance. The incidence of myalgia with this drug is comparable to that observed with other statins. Rosuvastatin does not depend on cytochrome P450 3A4-dependent metabolism and has a favorable drug interaction profile. Care must be taken to reduce the dose of rosuvastatin in patients of Asian ancestry or with stage IV chronic kidney disease (severe renal insufficiency), as well as patients being treated with protease inhibitors or cyclosporine.

Authors+Show Affiliations

University of Illinois College of Medicine, CGH Medical Center, Sterling, Peoria, IL, USA. peter.toth@srfc.comNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

21999163

Citation

Toth, Peter P., and Thomas D. Dayspring. "Drug Safety Evaluation of Rosuvastatin." Expert Opinion On Drug Safety, vol. 10, no. 6, 2011, pp. 969-86.
Toth PP, Dayspring TD. Drug safety evaluation of rosuvastatin. Expert Opin Drug Saf. 2011;10(6):969-86.
Toth, P. P., & Dayspring, T. D. (2011). Drug safety evaluation of rosuvastatin. Expert Opinion On Drug Safety, 10(6), 969-86. https://doi.org/10.1517/14740338.2012.626764
Toth PP, Dayspring TD. Drug Safety Evaluation of Rosuvastatin. Expert Opin Drug Saf. 2011;10(6):969-86. PubMed PMID: 21999163.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug safety evaluation of rosuvastatin. AU - Toth,Peter P, AU - Dayspring,Thomas D, PY - 2011/10/18/entrez PY - 2011/10/18/pubmed PY - 2012/2/16/medline SP - 969 EP - 86 JF - Expert opinion on drug safety JO - Expert Opin Drug Saf VL - 10 IS - 6 N2 - INTRODUCTION: Rosuvastatin is a highly efficacious statin approved for use throughout the world. Rosuvastatin has been exhaustively evaluated in the setting of a broad variety of dyslipidemias and cardiovascular disease states in clinical trials encompassed within the GALAXY program. AREAS COVERED: The efficacy and adverse event profile of rosuvastatin are evaluated based on the results of randomized, controlled clinical trials and observational studies available in the Medline database. EXPERT OPINION: Rosuvastatin is a safe and efficacious lipid modifying drug in a broad variety of patient populations (men and women, irrespective of race) for treating multiple forms of dyslipidemia. Rosuvastatin reduces atherogenic lipoproteins and triglycerides and increases high-density lipoprotein cholesterol better than other statins. Compared to other statins, it has no excess signal for liver, skeletal muscle or renal toxicity. This is supported by evidence from both an extensive clinical trial program as well as post-marketing surveillance. The incidence of myalgia with this drug is comparable to that observed with other statins. Rosuvastatin does not depend on cytochrome P450 3A4-dependent metabolism and has a favorable drug interaction profile. Care must be taken to reduce the dose of rosuvastatin in patients of Asian ancestry or with stage IV chronic kidney disease (severe renal insufficiency), as well as patients being treated with protease inhibitors or cyclosporine. SN - 1744-764X UR - https://www.unboundmedicine.com/medline/citation/21999163/Drug_safety_evaluation_of_rosuvastatin_ L2 - http://www.tandfonline.com/doi/full/10.1517/14740338.2012.626764 DB - PRIME DP - Unbound Medicine ER -