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July 20, 2022
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Rosuvastatin shows higher risks of hematuria, proteinuria, kidney failure vs atorvastatin

Compared with atorvastatin, rosuvastatin is associated with increased risks of hematuria, proteinuria and kidney failure with replacement therapy, according to a study.

Further, investigators found many patients were prescribed a higher dose of rosuvastatin than the FDA recommends.

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“There have also been several case reports suggesting rosuvastatin causes hematuria and proteinuria through direct renal tubular toxicity since the FDA approval of rosuvastatin in 2003. Despite these safety signals, little post-marketing surveillance exists regarding rosuvastatin’s potential nephrotoxicity,” Jung-Im Shin, MD, PhD, from the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, and colleagues wrote. They added, “The FDA label suggests a starting dose for rosuvastatin of 5 mg and a maximum dose of 10 mg in patients with severe CKD. Adherence to this dosing recommendation in real-world practice is unknown.”

In a multicenter, observational cohort study, researchers examined 152,101 and 795,799 new users of rosuvastatin and atorvastatin, respectively, between 2011 and 2019. De-identified electronic health record data were derived from 40 health care organizations participating in Optum Labs Warehouse.

Researchers estimated inverse probability of treatment-weighted hazard ratios of hematuria, proteinuria and kidney failure with replacement therapy correlated with rosuvastatin. Similarly, researchers reported the initial rosuvastatin dose across eGFR categories and looked for an impact that dosage had on hematuria and proteinuria.

Analyses revealed rosuvastatin was associated with an 8% higher risk of hematuria, a 17% higher risk of proteinuria and a 15% higher risk of developing kidney failure requiring replacement therapy compared with atorvastatin. Researchers identified hematuria and proteinuria in 2.9% and 1% of patients, respectively, during a median of 3.1 years. Additionally, 44% of patients with an eGFR of less than 30 mL/min/1.73 m2 were prescribed a higher dose of rosuvastatin than the FDA recommends.

“We observed a higher risk of hematuria, proteinuria, as well as kidney failure with rosuvastatin use and similar cardiovascular benefits between the rosuvastatin and atorvastatin groups,” Shin said in a press release. “Because rosuvastatin may cause proteinuria and hematuria, especially with [a] high dose, high-dose rosuvastatin may not merit the risk — even if small — particularly for patients with advanced kidney disease.”

Reference:

Real-world data links rosuvastatin with signs of kidney damage. https://www.newswise.com/articles/real-world-data-links-rosuvastatin-with-signs-of-kidney-damage#:~:text=Compared%20with%20atorvastatin%2C%20rosuvastatin%20was%20associated%20with%20an,were%20higher%20with%20a%20higher%20dose%20of%20rosuvastatin.Published: July 19, 2022. Accessed: July 19, 2022.