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.

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.

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.

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.

尽管在美国食品和药物协会 (FDA) 批准瑞舒伐他汀时出现血尿和蛋白尿的报道，但几乎没有上市后监测来评估现实世界的风险。目前的标签建议对严重 CKD 患者减少剂量（每日最大剂量 10 mg）。

使用去识别化的电子健康记录数据，我们分别分析了 2011 年至 2019 年瑞舒伐他汀和阿托伐他汀的 152,101 名和 795,799 名新使用者。我们估计了替代疗法的血尿、蛋白尿和肾衰竭的治疗加权风险比 (HR) 的逆概率(KFRT) 与瑞舒伐他汀相关。我们报告了不同 eGFR 类别的瑞舒伐他汀初始剂量，并评估了对血尿和蛋白尿的剂量效应。

总体而言，在中位随访 3.1 年期间，我们发现 2.9% 的患者存在血尿，1.0% 的患者存在蛋白尿。与阿托伐他汀相比，瑞舒伐他汀与血尿（HR，1.08；95%置信区间[95% CI]，1.04至1.11）、蛋白尿（HR，1.17；95% CI，1.10至1.25）和KFRT风险增加相关。 HR，1.15；95% CI，1.02 至 1.30）。^{eGFR <30 ml/min / 1.73 m 2}的大部分患者 (44%)服用高剂量瑞舒伐他汀（每天 20 或 40 mg）。瑞舒伐他汀剂量越高，风险越高。

与阿托伐他汀相比，瑞舒伐他汀与血尿、蛋白尿和 KFRT 风险增加相关。在 eGFR <30 ml/min/1.73 m ²的患者中，44% 的瑞舒伐他汀日剂量超过 FDA 推荐的 10 mg 日剂量。我们的研究结果表明，在处方和监测瑞舒伐他汀时需要更加谨慎，特别是对于接受高剂量或患有严重 CKD 的患者。