Is rosuvastatin (Crestor) safe to use in patients with impaired renal (kidney) function?

Rosuvastatin Use in Renal Impairment

Rosuvastatin should be used with caution in renal impairment, with dose adjustment required for severe renal dysfunction (CrCl <30 mL/min/1.73 m²) where the recommended starting dose is 5 mg daily and should not exceed 10 mg daily.

Dosing Recommendations Based on Renal Function

• Normal to moderate renal impairment (CrCl ≥30 mL/min/1.73 m²):

  • Standard dosing can be used without adjustment 1
  • No significant accumulation occurs in mild to moderate renal impairment 2

• Severe renal impairment (CrCl <30 mL/min/1.73 m²):

  • Starting dose: 5 mg daily
  • Maximum dose: 10 mg daily 2
  • Exposure to rosuvastatin is increased to a clinically significant extent in these patients 2

• Hemodialysis patients:

  • Rosuvastatin 10 mg may be administered without need for dose reduction 3
  • Clearance of rosuvastatin via dialysis is minimal 3
  • However, the AURORA trial found no significant benefit in cardiovascular outcomes in hemodialysis patients 4

Special Considerations

Ethnicity

• Asian patients require lower doses due to approximately 2-fold increase in median exposure:
  • Starting dose: 5 mg daily (compared to 10 mg in non-Asian patients) 1, 2, 5

Monitoring

• Before initiating therapy:

  • Assess baseline renal function
  • Check for potential drug interactions 1

• During treatment:

  • Monitor for symptoms of myopathy (muscle pain, weakness)
  • Periodically reassess renal function
  • Monitor liver function tests 1

Efficacy and Safety in Renal Impairment

Non-dialysis CKD

• Statins provide significant cardiovascular benefits in non-dialysis CKD patients:
  • 34% reduction in all-cause mortality
  • 31% reduction in CV mortality
  • 45% reduction in CV events
  • 34% reduction in stroke 4

Dialysis Patients

• The AURORA trial showed that rosuvastatin lowered LDL-C as expected but had no significant effect on the composite cardiovascular endpoint in hemodialysis patients 4
• The expert consensus committee includes patients with CKD not on dialysis as a higher-risk subset who may merit consideration for more intensive LDL-C lowering 4

Drug Interactions of Concern in Renal Patients

• Avoid concomitant use with:

  • Cyclosporine (limit to 5 mg daily if combination necessary)
  • Gemfibrozil (initiate at 5 mg, do not exceed 10 mg daily)
  • Teriflunomide, enasidenib, or capmatinib (do not exceed 10 mg daily) 1

• Contraindicated with:

  • Dabigatran (due to P-gp inhibition) 4

Common Pitfalls to Avoid

• Inappropriate intensity selection: Avoid high-intensity statin regimens in patients with eGFR <60 mL/min/1.73m² despite high cardiovascular risk 1
• Overlooking drug interactions: Renal patients often have polypharmacy issues that increase risk of adverse effects 1
• Ignoring ethnicity: Asian patients require lower doses due to higher plasma concentrations 1, 2
• Discontinuing beneficial therapy: While not beneficial in dialysis patients, statins provide significant cardiovascular protection in non-dialysis CKD 4

Rosuvastatin has been shown to be well-tolerated in renal impairment when dosed appropriately, with transient proteinuria being noted but not associated with progressive deterioration in renal function at recommended dosages 6, 7.