The event of cerivastatin is the starting point for several methodological issues that, in the era of evidence-based medicine, should be the scientific basis of clinical practice. The article goes into three main issues: the production of evidence about efficacy of drugs, their safety profile through the collection of data about adverse drug reactions and the appropriateness of drug prescription.
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Statin safety: lessons from new drug applications for marketed statins.
Am J Cardiol
April 2006
Office of Health Promotion and Disease Prevention, Emory University, Atlanta, Georgia 30303, USA.
Safety has become a central issue in the management of dyslipidemia with statins. A review of New Drug Applications (NDAs) and the US Food and Drug Administration (FDA) Web site was conducted for all 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins, with a major focus on cerivastatin and rosuvastatin. The findings provide insight into the incidence of adverse events for this class of drugs and support the significant benefits of statins relative to associated risks.
View Article and Find Full Text PDFRosuvastatin safety: lessons from the FDA review and post-approval surveillance.
Expert Opin Drug Saf
November 2004
Rush Medical College, Rush University Medical Center, Chicago, Illinois, USA.
Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use.
View Article and Find Full Text PDFThe noted myotoxicity and subsequent withdrawal of cerivastatin from the worldwide market in August 2001 has demonstrated that the safety of statins is not a class effect. The total rhabdomyolysis rate for cerivastatin was 16 - 80 times more frequent than with other statins without providing additional efficacy. Cerivastatin has a pharmacokinetic profile (high potency, bioavailability, lipophilicity and renal excretion) that is different from other statins, which may explain the high myotoxicity rate.
View Article and Find Full Text PDFThe event of cerivastatin is the starting point for several methodological issues that, in the era of evidence-based medicine, should be the scientific basis of clinical practice. The article goes into three main issues: the production of evidence about efficacy of drugs, their safety profile through the collection of data about adverse drug reactions and the appropriateness of drug prescription.
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