Rosuvastatin

(Crestor®)

Rosuvastatin

Drug updated on 12/11/2024

Dosage FormTablet (oral; 5 mg, 10 mg, 20 mg, 40 mg)
Drug ClassHMG Co-A reductase inhibitors (statins)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP 2 mg/L, and at least one additional CV risk factor
  • Indicated as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia
  • Indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults
  • Indicated as an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)
  • Indicated as an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)
  • Indicated as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia, hypertriglyceridemia.

Latest News

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Summary
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  • This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-27]
  • Major Adverse Cardiovascular Events (MACEs): In chronic kidney disease (CKD) patients, rosuvastatin reduced MACEs with a pooled risk ratio of 0.55 (95% confidence interval (CI) 0.33-0.91), while atorvastatin had a pooled risk ratio of 0.67 (95% CI 0.49-0.90). In patients undergoing percutaneous coronary intervention (PCI), single high-dose statin preloading significantly reduced MACEs (odds ratio (OR) 0.50, 95% CI 0.35-0.71), with 80 mg atorvastatin and 40 mg rosuvastatin each showing efficacy in MACE reduction.
  • All-Cause Mortality: For PCI patients, preloading with a single high-dose statin significantly lowered all-cause mortality (OR 0.56, 95% CI 0.39-0.81), and in the post-PCI population, rosuvastatin (OR 0.30, 95% CI 0.11-0.84) and ezetimibe combined with statins (OR 0.55, 95% CI 0.43-0.89) demonstrated mortality reductions.
  • Blood Pressure Control: Statins, particularly rosuvastatin, contributed to blood pressure reductions in hypertensive patients, with a decrease in diastolic blood pressure of -2.12 mmHg (95% CI -3.72 to -0.52) and systolic blood pressure by -2.27 mmHg (95% CI -4.75 to 0.25).
  • Lipid Profile Changes: Rosuvastatin was more effective than atorvastatin in reducing low-density lipoprotein (LDL) cholesterol, with pitavastatin being 1.7 times more potent than rosuvastatin. Cerivastatin showed greater potency than rosuvastatin in reducing total cholesterol and triglyceride levels.
  • General Safety Outcomes: Statin therapy, particularly atorvastatin, showed a higher risk of transaminase elevations when compared to non-statin controls and other statins. Rosuvastatin was associated with a higher risk of mild muscle pain or weakness compared to simvastatin, while statins overall presented a slightly increased risk of renal insufficiency (OR 1.14, 95% CI 1.01 to 1.28). Statins were not significantly linked to an increase in diabetes or cognitive impairment.
  • Specific Adverse Effects in Subpopulations: In patients with cirrhosis, simvastatin 40 mg was associated with a higher incidence of rhabdomyolysis relative to lower doses and other statins. Among hyperuricemia patients, atorvastatin was found to be the most effective statin for lowering serum uric acid (SUA) levels.
  • In patients with CKD, acute coronary syndrome (ACS), hypertension, PCI, and diabetes, statins such as rosuvastatin, atorvastatin, and simvastatin demonstrated effectiveness in reducing MACEs, improving lipid profiles, and, in some cases, reducing blood pressure. Specifically, studies in 77,826 participants with non-dialysis CKD showed significant reductions in MACEs with rosuvastatin and atorvastatin, while in 6,207 PCI patients, high-dose statin preloading significantly reduced MACEs and all-cause mortality. Among hypertensive and diabetic populations, statins were associated with reductions in blood pressure and non-high-density lipoprotein cholesterol (non-HDL-C) levels, respectively.

Product Monograph / Prescribing Information

Document TitleYearSource
Crestor (rosuvastatin) Prescribing Information.2024AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy and choice of lipid-lowering drugs for cardiovascular and kidney outcomes in patients with chronic kidney disease: A systematic review and network meta-analysis2024Journal of the Formosan Medical Association = Taiwan Yi Zhi
Comparison of Efficacy of Atorvastatin and Rosuvastatin in Patients With Acute Coronary Syndrome: A Systematic Review and Meta-Analysis2024Cureus
Statins As Anti-Hypertensive Therapy: A Systematic Review and Meta-Analysis2024Cureus
Efficacy of single high-dose statin prior to percutaneous coronary intervention in acute coronary syndrome: a systematic review and meta-analysis2024The Egyptian Heart Journal : (ehj) : Official Bulletin of the Egyptian Society of
The Effect of Statin Therapy on Serum Uric Acid Levels: A Systematic Review and Meta-analysis2024Current Medicinal Chemistry
Effectiveness of lipid-lowering therapy on mortality and major adverse cardiovascular event outcomes in patients undergoing percutaneous coronary intervention: a network meta-analysis of randomised controlled trials2023Bmj Open
Pravastatin for lowering lipids2023The Cochrane Database of Systematic Reviews
Pharmacological interventions for asymptomatic carotid stenosis2023The Cochrane Database of Systematic Reviews
Is there benefit to adding ezetimibe to a statin for the secondary prevention of CVD?2023The Journal of Family Practice
Comparative efficacy and safety among high-intensity statins. Systematic Review and Meta-Analysis2023Journal of Comparative Effectiveness Research
A Systematic Review of Randomized Clinical Trials on the Efficacy and Safety of Pitavastatin2023Current Reviews in Clinical and Experimental Pharmacology
Associations between statins and adverse events in secondary prevention of cardiovascular disease: Pairwise, network, and dose-response meta-analyses of 47 randomized controlled trials2022Frontiers in Cardiovascular Medicine
Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials2022Lancet (london, England)
Comparative effectiveness of statins on non-high density lipoprotein cholesterol in people with diabetes and at risk of cardiovascular disease: systematic review and network meta-analysis2022Bmj (clinical Research Ed.)
Rosuvastatin for the prevention of venous thromboembolism: a pooled analysis of the HOPE-3 and JUPITER randomized controlled trials2022Cardiovascular Research
Antihypertensive effects of rosuvastatin in patients with hypertension and dyslipidemia: A systemic review and meta-analysis of randomized studies2021Plos One
Associations between statins and adverse events in primary prevention of cardiovascular disease: systematic review with pairwise, network, and dose-response meta-analyses2021Bmj (clinical Research Ed.)
The Cost-Effectiveness and Cost-Utility of Statin Drug for the Treatment of Patients with Cardiovascular Disease, A Systematic Review2021International Journal of Preventive Medicine
Fixed-dose combination of rosuvastatin and ezetimibe: treating hypercholesteremia according to cardiovascular risk2021Expert Review of Clinical Pharmacology
A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis2021Bmc Gastroenterology
Pitavastatin for lowering lipids2020The Cochrane Database of Systematic Reviews
Effect of statins on cardiovascular complications in chronic kidney disease patients: A network meta-analysis2020Medicine
Comparative Lipid-Lowering/Increasing Efficacy of 7 Statins in Patients with Dyslipidemia, Cardiovascular Diseases, or Diabetes Mellitus: Systematic Review and Network Meta-Analyses of 50 Randomized Controlled Trials2020Cardiovascular Therapeutics
Statin treatment and accrual of covert cerebral ischaemia on neuroimaging: a systematic review and meta-analysis of randomized trials2020European Journal of Neurology
Cerivastatin for lowering lipids2020The Cochrane Database of Systematic Reviews
Statin therapy increases lipoprotein(a) levels2020European Heart Journal
Efficacy and safety of statin therapy in pulmonary hypertension: a systematic review and meta-analysis2019Annals of Translational Medicine

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