Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg, 10 mg, 20 mg, 40 mg) |
Drug Class | HMG 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.
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Summary
- 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 Title | Year | Source |
---|---|---|
Crestor (rosuvastatin) Prescribing Information. | 2023 | AstraZeneca Pharmaceuticals LP Wilmington, DE |