Drug updated on 11/1/2024
| 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.
Latest News
Summary
- 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% CI (confidence interval) 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 (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 LDL (low-density lipoprotein) 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 chronic kidney disease (CKD), acute coronary syndrome (ACS), hypertension, percutaneous coronary intervention (PCI), and diabetes, statins such as rosuvastatin, atorvastatin, and simvastatin demonstrated effectiveness in reducing major adverse cardiovascular events (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-HDL-C levels, respectively.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Crestor (rosuvastatin) Prescribing Information. | 2024 | AstraZeneca, Wilmington, DE |