Rosuvastatin

(Crestor®)

Crestor®

Drug updated on 9/4/2024

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

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Crestor (rosuvastatin) is 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. It is also used as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia, to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults, and to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Additionally, Crestor is used 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). Lastly, it is indicated as an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia and hypertriglyceridemia.
  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-12]
  • The combination of 5 mg rosuvastatin with 10 mg ezetimibe achieved similar LDL-C reduction to 20 mg rosuvastatin monotherapy (SMD 0.08; 95% CI -0.09 to 0.26; p = 0.35).
  • Rosuvastatin 40 mg was more effective in lowering LDL levels than atorvastatin 80 mg.
  • Rosuvastatin had the highest efficacy in lowering LDL-C and ApoB among seven statins, with a SUCRA value of 93.1%.
  • Ezetimibe combined with moderate-intensity rosuvastatin (10 mg) was noninferior to high-intensity rosuvastatin (20 mg) in reducing cardiovascular events, while being more tolerable.
  • The combination of 5 mg rosuvastatin with 10 mg ezetimibe had similar rates of composite adverse events, including muscle-related symptoms, compared to 20 mg rosuvastatin monotherapy (OR 0.50; 95% CI 0.15 to 1.72; p = 0.27).
  • High-intensity statins, such as 40-80 mg atorvastatin or 20-40 mg rosuvastatin, were associated with a small excess of muscle pain, with higher dosages linked to more adverse drug reactions (ADRs).
  • Statins, including rosuvastatin, were associated with an increased risk of transaminase elevations and self-reported muscle symptoms, liver dysfunction, renal insufficiency, and eye conditions, though no significant association was found with clinically confirmed muscle disorders or diabetes.
  • Rosuvastatin therapy showed a modest significant reduction in diastolic blood pressure (DBP) among patients with hypertension, and carriers of the A allele of the ABCG2 421C>A polymorphism had significantly higher AUC0-∞ and Cmax values, indicating a potential need for genetic testing for personalized therapy.

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