Safety of rosuvastatin
Section snippets
Ethical considerations
The trials in the rosuvastatin clinical development program were designed and conducted in accordance with the Declaration of Helsinki (versions amended October 1996 and October 2000) and in compliance with the ethical principles of good clinical practice. Appropriate ethics committees or institutional review boards approved the research protocols; all patients (or their parents or guardians) gave their written, informed consent before initiation of any trial procedure.
Patient population
The patients studied had
Demographic and baseline characteristics
Demographic and baseline characteristics of the 12,400 patients who received 5 to 40 mg of rosuvastatin in the phase II/III program are listed in Table 1. This population included large numbers of patients ≥65 years old, women, and patients who had cardiovascular disease, diabetes mellitus, hypertension, and renal impairment. The 8 patients who were <18 years of age were included in a trial in patients with homozygous familial hypercholesterolemia. No major differences in demographic or
Discussion
The rosuvastatin phase II/III program was designed to study a patient population that had dyslipidemia and was representative of the patients who should receive statin therapy in clinical practice, particularly those patients characterized as “high risk” according to international cholesterol guidelines.12, 13 Altogether, 12,400 patients received 5 to 40 mg of rosuvastatin, representing >12,000 patient-years of continuous exposure in clinical trials. In this program, rosuvastatin was well
Acknowledgment
We gratefully acknowledge the investigators, their co-investigators and study coordinators, and the patients who participated in the rosuvastatin clinical development program. In addition, we thank Eric Justice, MA, and Gregg Truitt, BS, for assistance in the preparation of this report.
References (27)
- et al.
ACC/AHA/NHLBI clinical advisory on the use and safety of statins
J Am Coll Cardiol
(2002) - et al.
Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia
Am Heart J
(2002) - et al.
Safety of atorvastatin derived from analysis of 44 completed trials in 9,416 patients
Am J Cardiol
(2003) - et al.
Safety profile of atorvastatin-treated patients with low LDL-cholesterol levels
Atherosclerosis
(2000) - et al.
Comparison of efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR trial)
Am J Cardiol
(2003) - et al.
Cerivastatin and reports of fatal rhabdomyolysisCorrespondence
N Engl J Med
(2002) - et al.
Classification of hyperlipidaemia and hyperlipoproteinaemias
Bull World Health Organ
(1970) - et al.
A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial
Curr Med Res Opin
(2001) - et al.
Efficacy and safety of cerivastatin 0.8 mg in patients with hypercholesterolaemia: the pivotal placebo-controlled clinical trial
J Int Med Res
(2000) Coding Symbols for Thesaurus of Adverse Reaction Terms
(1993)
The Centers for Disease Control–National Heart, Lung, and Blood Institute Lipid Standardization Program: an approach to accurate and precise lipid measurements
Clin Lab Med
Prediction of creatinine clearance from serum creatinine
Nephron
Severe rhabdomyolysis and acute renal failure following recent coxsackie B virus infection
Neth J Med
Cited by (117)
Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy
2021, Journal of the American College of CardiologyDrug-Induced Liver Injury
2017, Zakim and Boyer's Hepatology: A Textbook of Liver DiseaseRosuvastatin: Beyond the cholesterol-lowering effect
2016, Pharmacological ResearchRenal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): A randomised clinical trial
2015, The Lancet Diabetes and EndocrinologyCaveolin-1-eNOS/Hsp70 interactions mediate rosuvastatin antifibrotic effects in neonatal obstructive nephropathy
2012, Nitric Oxide - Biology and Chemistry
This research was supported by AstraZeneca LP, Wilmington, Delaware, and AstraZeneca, Alderley Park, United Kingdom.