Despite reports of hematuria and proteinuria with Rosuvastatin ( Crestor ) 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 chronic kidney disease ( CKD ).
Using deidentified electronic health record data, researchers have analyzed 152,101 and 795,799 new users of Rosuvastatin and Atorvastatin, respectively, from 2011 to 2019.
The initial Rosuvastatin dose across eGFR categories and the assessment for a dose effect on hematuria and proteinuria were reported.
Overall, 2.9% of patients with hematuria and 1.0% with proteinuria during a median follow-up of 3.1 years were identified.
Compared with Atorvastatin, Rosuvastatin was associated with increased risk of hematuria ( hazard ratio, HR=1.08; 95% confidence interval [ 95% CI ], 1.04-1.11 ), proteinuria ( HR=1.17; 95% CI, 1.10-1.25 ), and kidney failure with replacement therapy ( KFRT ) ( HR=1.15; 1.02-1.30 ).
A substantial share ( 44% ) of patients with eGFR less than 30 mL/min per 1.73 m2 was prescribed high-dose Rosuvastatin ( 20 or 40 mg daily ).
Risk was higher with higher Rosuvastatin dose.
In conclusion, compared with Atorvastatin, Rosuvastatin was associated with increased risk of hematuria, proteinuria, and kidney failure with replacement therapy.
Among patients with eGFR less than 30 mL/min per 1.73 m2, 44% were prescribed a Rosuvastatin daily dose exceeding the FDA's recommended 10 mg daily dose.
The findings suggest the need for greater care in prescribing and monitoring Rosuvastatin, particularly in patients who receive high doses, or who have severe chronic kidney disease. ( Xagena )
Shin JI et al, J Am Soc Nephrol 2022; Online ahead of print