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Association of Rosuvastatin Use with Risk of Hematuria and Proteinuria
Jung-Im Shin1, Derek M Fine2, Yingying Sang1
1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Insights
Rosuvastatin use increases risks of hematuria, proteinuria, and kidney failure compared to atorvastatin. High doses and severe chronic kidney disease (CKD) further elevate these risks, necessitating careful monitoring.
Area of Science:
- Nephrology
- Pharmacology
- Real-world evidence studies
Background:
- Postmarketing surveillance for rosuvastatin's renal risks is limited despite initial FDA reports.
- Current guidelines recommend a 10 mg daily dose for patients with severe chronic kidney disease (CKD).
Purpose of the Study:
- To assess the real-world risk of hematuria, proteinuria, and kidney failure with replacement therapy (KFRT) associated with rosuvastatin compared to atorvastatin.
- To evaluate initial rosuvastatin dosing and its effect on renal outcomes in different estimated glomerular filtration rate (eGFR) categories.
Main Methods:
- Analysis of deidentified electronic health record data from new users of rosuvastatin (n=152,101) and atorvastatin (n=795,799) between 2011 and 2019.
- Estimation of inverse probability of treatment-weighted hazard ratios (HRs) for adverse renal events.
- Assessment of rosuvastatin dosage across eGFR categories and dose-response evaluation.
Main Results:
- Rosuvastatin was associated with increased risks of hematuria (HR, 1.08), proteinuria (HR, 1.17), and KFRT (HR, 1.15) compared to atorvastatin.
- 44% of patients with eGFR <30 ml/min/1.73 m² received high-dose rosuvastatin (20 or 40 mg daily).
- Higher rosuvastatin doses correlated with increased risk of hematuria and proteinuria.
Conclusions:
- Rosuvastatin use is linked to a higher risk of adverse renal events than atorvastatin.
- A significant proportion of patients with severe CKD received rosuvastatin doses exceeding FDA recommendations.
- Prescribing and monitoring of rosuvastatin require increased caution, especially in patients with severe CKD or those on high doses.
Background:
Despite reports of hematuria and proteinuria with rosuvastatin use at the time of its approval by the US Food and Drug Association (FDA), little postmarketing surveillance exists to assess real-world risk. Current labeling suggests dose reduction (maximum daily dose of 10 mg) for patients with severe CKD.
Methods:
Using deidentified electronic health record data, we analyzed 152,101 and 795,799 new users of rosuvastatin and atorvastatin, respectively, from 2011 to 2019. We estimated inverse probability of treatment-weighted hazard ratios (HRs) of hematuria, proteinuria, and kidney failure with replacement therapy (KFRT) associated with rosuvastatin. We reported the initial rosuvastatin dose across eGFR categories and evaluated for a dose effect on hematuria and proteinuria.
Results:
Overall, we identified 2.9% of patients with hematuria and 1.0% with proteinuria during a median follow-up of 3.1 years. Compared with atorvastatin, rosuvastatin was associated with increased risk of hematuria (HR, 1.08; 95% confidence interval [95% CI], 1.04 to 1.11), proteinuria (HR, 1.17; 95% CI, 1.10 to 1.25), and KFRT (HR, 1.15; 95% CI, 1.02 to 1.30). A substantial share (44%) of patients with eGFR <30 ml/min per 1.73 m2 was prescribed high-dose rosuvastatin (20 or 40 mg daily). Risk was higher with higher rosuvastatin dose.
Conclusions:
Compared with atorvastatin, rosuvastatin was associated with increased risk of hematuria, proteinuria, and KFRT. Among patients with eGFR <30 ml/min per 1.73 m2, 44% were prescribed a rosuvastatin daily dose exceeding the FDA's recommended 10 mg daily dose. Our findings suggest the need for greater care in prescribing and monitoring rosuvastatin, particularly in patients who receive high doses or who have severe CKD.
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