Abstract: PO2373
Association of Rosuvastatin Use with Risk of Hematuria and Proteinuria
Session Information
- CKD: Insights from Recent Clinical Trials and Large Real-World Effectiveness Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Shin, Jung-Im, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States
- Fine, Derek M., Johns Hopkins Medicine, Baltimore, Maryland, United States
- Sang, Yingying, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States
- Surapaneni, Aditya L., Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States
- Dunning, Stephan C., OptumLabs, Minnetonka, Minnesota, United States
- Inker, Lesley Ann, Tufts Medical Center, Boston, Massachusetts, United States
- Nolin, Thomas D., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
- Chang, Alex R., Geisinger Health, Danville, Pennsylvania, United States
- Grams, Morgan, Johns Hopkins Medicine, Baltimore, Maryland, United States
Background
Early safety signals suggested potential nephrotoxicity with rosuvastatin, and the US FDA recommends a maximum dose of 10 mg for patients with severe CKD. Whether these recommendations are followed and whether rosuvastatin use is associated with nephrotoxicity in real-world practice is uncertain.
Methods
Using data from OptumLabs® Data Warehouse, a database that contains de-identified claims and electronic health record data, we identified adult patients who initiated rosuvastatin (N=155416) or atorvastatin (N=793513) in 44 health systems (“cohorts”) between 2011-2019, were free of ESKD, and did not have history of hematuria or proteinuria at the time of prescription. The outcomes were hematuria (dipstick hematuria≥+ or presence of ≥3 red blood cells in urine microscopy) and proteinuria (dipstick proteinuria≥++ or urine albumin-to-creatinine ratio≥300 mg/g). We fit Cox models with inverse-probability of treatment weights within cohorts and then meta-analyzed using random-effects models.
Results
Overall, 2.6% and 0.8% of patients developed hematuria and proteinuria during a median follow-up of 2.6 years. Compared with atorvastatin, rosuvastatin was associated with an increased risk of hematuria (HR, 1.07 [95% CI, 1.03-1.11]) and proteinuria (1.18 [1.11-1.26]). Among those with eGFR<30 ml/min/1.73 m2, rosuvastatin use was associated with greater risk of hematuria (1.78 [1.25-2.54]) and proteinuria (1.80 [1.15-2.83]) (Figure). Patients with eGFR<30 ml/min/1.73 m2 frequently were prescribed a higher rosuvastatin dose than the maximum recommended dose of 10 mg; 30.5% received 20 mg while 14.4% received 40 mg.
Conclusion
Among patients with eGFR<30 ml/min/1.73 m2, the use of higher-than-recommended dose rosuvastatin was common, and rosuvastatin was associated with an almost 2-fold increased risk of hematuria and proteinuria.
Figure. Risks of outcomes associated with rosuvastatin vs. atorvastatin, overall and across eGFR levels
Funding
- NIDDK Support