What is the indication for Rosuvastatin (HMG-CoA reductase inhibitor)?

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From the Guidelines

Rosuvastatin is indicated for patients with high cardiovascular risk, familial hypercholesterolemia, or those who haven't responded adequately to other statins, and is typically prescribed at doses ranging from 5-40 mg once daily, with most patients starting at 10 or 20 mg. The medication works by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production in the liver, resulting in decreased LDL ("bad") cholesterol and triglycerides while slightly increasing HDL ("good") cholesterol 1. According to the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol, rosuvastatin is classified as a high-intensity statin, with an LDL-C lowering of ≥50% at a dose of 20 mg (40 mg) 1. Some key points to consider when prescribing rosuvastatin include:

  • Starting dose: 10 or 20 mg once daily
  • Dose range: 5-40 mg once daily
  • LDL-C lowering: ≥50% at a dose of 20 mg (40 mg)
  • Common side effects: muscle pain, weakness, and rarely, liver enzyme elevations
  • Monitoring: regular monitoring of lipid levels and liver function is recommended, especially when starting therapy
  • Patient education: patients should report any unexplained muscle pain, tenderness, or weakness, as these could indicate rare but serious side effects requiring immediate medical attention. It's also important to note that rosuvastatin has been evaluated in several clinical trials, including the CORONA and GISSI HF trials, which demonstrated its efficacy and safety in patients with heart failure 1. Overall, rosuvastatin is a valuable treatment option for patients with high cardiovascular risk or those who require intensive lipid-lowering therapy.

From the FDA Drug Label

Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: reduce LDL-C in adults with primary hyperlipidemia. reduce LDL-C and slow the progression of atherosclerosis in adults. reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 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). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

The indication for Rosuvastatin (HMG-CoA reductase inhibitor) is to:

  • Reduce the risk of major adverse cardiovascular (CV) events in adults without established coronary heart disease who are at increased risk of CV disease.
  • Reduce LDL-C in adults with:
    • Primary hyperlipidemia.
    • Heterozygous familial hypercholesterolemia (HeFH) aged 8 years and older.
    • Homozygous familial hypercholesterolemia (HoFH) aged 7 years and older.
  • Slow the progression of atherosclerosis in adults.
  • Treat adults with:
    • Primary dysbetalipoproteinemia.
    • Hypertriglyceridemia. 2

From the Research

Indications for Rosuvastatin

  • Rosuvastatin is indicated to reduce elevated levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides and to increase levels of high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia, mixed dyslipidemia, and homozygous familial hypercholesterolemia 3.
  • It is also used to slow the progression of atherosclerosis and reduce cardiovascular events in patients with elevated high-sensitivity C-reactive protein and normal LDL-C 4.
  • Rosuvastatin is appropriate therapy in addition to antihypertensive treatment to reduce cardiovascular risk in hypertensive patients 4.

Patient Populations

  • Rosuvastatin is effective in patients with severe hypercholesterolemia, including those with heterozygous familial hypercholesterolemia 5.
  • It is also used in patients with a broad spectrum of dyslipidemias, including high-risk patients 6.
  • Rosuvastatin can be used in combination with ezetimibe for the management of primary hypercholesterolemia in adults 7.

Dosage and Efficacy

  • Rosuvastatin is effective at doses of 5-40 mg/day, with significant reductions in LDL-C and increases in HDL-C observed at doses of 10-40 mg/day 3, 6, 5.
  • The combination of rosuvastatin and ezetimibe is more effective than rosuvastatin monotherapy in reducing LDL-C and total cholesterol in adults with hypercholesterolemia 7.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Rosuvastatin in the management of hyperlipidemia.

Clinical therapeutics, 2004

Research

Current Perspectives on rosuvastatin.

Integrated blood pressure control, 2013

Research

Rosuvastatin: a review of its use in the management of dyslipidemia.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2004

Research

Rosuvastatin/Ezetimibe: A Review in Hypercholesterolemia.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2020

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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