Jung-Im Shin1, Derek M Fine2, Yingying Sang3, Aditya Surapaneni3,4, Stephan C Dunning5, Lesley A Inker6, Thomas D Nolin7, Alex R Chang8, Morgan E Grams3,4. 1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland jshin19@jhmi.edu. 2. Division of Nephrology, Johns Hopkins University, Baltimore, Maryland. 3. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. 4. Department of Medicine, New York University Grossman School of Medicine, New York, New York. 5. Optum Labs, Minnetonka, Minnesota. 6. Division of Nephrology, Tufts Medical Center, Boston, Massachusetts. 7. Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania. 8. Kidney Health Research Institute, Geisinger, Danville, Pennsylvania.
Abstract
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], 1.04-1.11), proteinuria (HR, 1.17; 95% CI, 1.10-1.25), and KFRT (HR, 1.15; 1.02-1.30). 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.
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], 1.04-1.11), proteinuria (HR, 1.17; 95% CI, 1.10-1.25), and KFRT (HR, 1.15; 1.02-1.30). 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.
Authors: Scott M Grundy; Neil J Stone; Alison L Bailey; Craig Beam; Kim K Birtcher; Roger S Blumenthal; Lynne T Braun; Sarah de Ferranti; Joseph Faiella-Tommasino; Daniel E Forman; Ronald Goldberg; Paul A Heidenreich; Mark A Hlatky; Daniel W Jones; Donald Lloyd-Jones; Nuria Lopez-Pajares; Chiadi E Ndumele; Carl E Orringer; Carmen A Peralta; Joseph J Saseen; Sidney C Smith; Laurence Sperling; Salim S Virani; Joseph Yeboah Journal: Circulation Date: 2018-11-10 Impact factor: 29.690
Authors: James Shepherd; John J P Kastelein; Vera Bittner; Prakash Deedwania; Andrei Breazna; Stephen Dobson; Daniel J Wilson; Andrea Zuckerman; Nanette K Wenger Journal: J Am Coll Cardiol Date: 2008-04-15 Impact factor: 24.094
Authors: Andrew S Levey; Lesley A Stevens; Christopher H Schmid; Yaping Lucy Zhang; Alejandro F Castro; Harold I Feldman; John W Kusek; Paul Eggers; Frederick Van Lente; Tom Greene; Josef Coresh Journal: Ann Intern Med Date: 2009-05-05 Impact factor: 25.391