Rosuvastatin

(Crestor®)

Rosuvastatin

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Drug updated on 4/17/2024

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.

Summary
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  • Rosuvastatin (Crestor) is notably effective in lowering LDL-C levels, reducing them by approximately 50%, which aligns with current guidelines for high-intensity statin therapy. It also maintains its efficacy when used in combination with ezetimibe.
  • Eleven systematic reviews/meta-analyses were compared to assess the safety and effectiveness of Rosuvastatin against other drugs within the statin class and in combination therapies.
  • Rosuvastatin has been associated with similar rates of adverse events as other statins; however, it showed a higher risk of transaminase elevations compared to atorvastatin, indicating potential hepatic side effects.
  • Statins, including Rosuvastatin, were linked to increased risks of muscle-related symptoms, liver dysfunction, and minor increases in creatine kinase levels, but these did not significantly outweigh their cardiovascular benefits.
  • Genetic polymorphisms such as the ABCG2 421C>A variant have a notable impact on Rosuvastatin pharmacokinetics, suggesting nearly 1.5 times higher drug exposure among carriers of the A allele, emphasizing the potential for personalized medicine approaches based on genetic makeup.
  • In primary prevention cohorts, Rosuvastatin's risk of inducing diabetes or cognitive impairment appears low, while being counterbalanced by its efficacy in reducing cardiovascular events.
  • For patients suffering from hypertension alongside hyperlipidemia conditions like familial hypercholesterolemia or dysbetalipoproteinemia, this medication, along with antihypertensive agents, displayed a significant reduction in diastolic blood pressure, implying additional benefits outside lipid-lowering.
  • Rosuvastatin demonstrated superior efficacy over different types of statins concerning LDL-C reduction according to one study, although some studies suggest no significant differences between various types regarding the incidence of muscle symptoms and liver dysfunction, indicating that adverse effects may be more related to intensity rather than the type itself.

Product Monograph / Prescribing Information

Document TitleYearSource
Crestor (rosuvastatin) Prescribing Information.2023AstraZeneca Pharmaceuticals LP Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Moderate-intensity rosuvastatin/ezetimibe combination versus quadruple-dose rosuvastatin monotherapy: A meta-analysis and systemic review. 2024Yonsei Medical Journal
Comparative efficacy and safety among high-intensity statins. Systematic review and meta-analysis.2023Journal of Comparative Effectiveness Research
Is there benefit to adding ezetimibe to a statin for the secondary prevention of CVD? 2023The Journal of Family Practice
The association between ABCG2 421C>A (rs2231142) polymorphism and rosuvastatin pharmacokinetics: A systematic review and meta-analysis.2022Pharmaceutics
Associations between statins and adverse events in secondary prevention of cardiovascular disease: Pairwise, network, and dose-response meta-analyses of 47 randomized controlled trials. 2022Frontiers in Cardiovascular Medicine
Effect of statin therapy on muscle symptoms: An individual participant data meta-analysis of large-scale, randomised, double-blind trials. 2022The Lancet
Antihypertensive effects of rosuvastatin in patients with hypertension and dyslipidemia: A systemic review and meta-analysis of randomized studies.2021PLOS ONE
Associations between statins and adverse events in primary prevention of cardiovascular disease: Systematic review with pairwise, network, and dose-response meta-analyses.2021British Medical Journal
Fixed-dose combination of rosuvastatin and ezetimibe: Treating hypercholesteremia according to cardiovascular risk.2021Expert Review of Clinical Pharmacology
Impact of rosuvastatin versus atorvastatin on coronary atherosclerotic plaque volume – a systematic review and meta-analysis with trial sequential analysis of randomized control trials.2020Journal of Preventative Cardiology
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 trials.2020Cardiovascular Therapeutics
Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: A systematic review, meta-analysis, and network meta-analysis of randomized trials with 94,283 participants. 2019American Heart Journal

Clinical Practice Guidelines