The effect of rosuvastatin on renal function was once controversial, with calls from a public advocacy group for the drug's withdrawal in the United States based on its supposed potential for renal injury. However, a number of studies have demonstrated that rosuvastatin either did not harm, or actually slightly improved, renal function over the short- and long-term, and in March 2005 the US Food and Drug Administration (FDA) rejected the contention that rosuvastatin posed a risk of serious renal injury, ruling that "no consistent pattern of clinical presentation or of renal injury (ie, pathology) [was] evident among the cases of renal failure reported to date that clearly indicated causation by rosuvastatin or other statins." Data from almost 17,000 patients in clinical trials of rosuvastatin up to and including September 2005 showed no development of proteinuria predictive of acute or progressive renal disease, and both short- and long-term rosuvastatin treatment was associated with small increases in glomerular filtration rate (GFR), according to a recent report.
Data from high-risk patients who received ≥ 144 weeks of treatment with rosuvastatin in clinical trials were reported at this year's American College of Cardiology (ACC) meeting in a poster presented by Jonathan Sorof, MD (AstraZeneca, Wilmington, Delaware). Dr. Sorof and his colleagues identified 620 patients with 144 or more weeks of rosuvatatin treatment from among 4259 patients estimated to be at high risk by National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III criteria. To avoid bias in this retrospective, uncontrolled study, 12 patients with less than 144 weeks of treatment due to discontinuation from a renal adverse event were also included using the last available serum creatinine value to calculate glomerular filtration rate (GFR). The mean age of the total 632 patients was 62 years, 64% of the patients were hypertensive, 21% diabetic, and 74% had coronary artery disease. Mean baseline low-density lipoprotein (LDL) cholesterol was 188 mg/dL and high-density lipoprotein (HDL) cholesterol 47 mg/dL. Estimated GFR (eGFR) was 63.3 mL/min/1.73 m2; 40% of patients had moderate renal dysfunction (< 60 mL/min/1.73 m2).
Overall, GFR increased 4.5% between baseline and final serum creatinine measurements ( Table 1 ). This increase was consistent across clinical and demographic subgroups, including age (65 years or older), gender (male), hypertensive and/or diabetic, and across all rosuvastatin doses. The greatest increase in eGFR (7.4%) was seen in patients with moderate renal dysfunction at baseline.
Dr. Sorof suggests that these results are consistent with previous studies and show that long-term rosuvastatin treatment may slow the progression of renal dysfunction in high-risk patients with expected progressive renal dysfunction. "This evidence of statin renoprotection is consistent with previous studies and hypothesis-generating for future statin trials with primary renal endpoints," he said. These results are consistent with those of previous studies and show that long-term rosuvastatin treatment may slow the progression of renal dysfunction in high-risk patients with expected progressive renal dysfunction, Dr Sorof suggested. "This evidence of statin renoprotection is consistent with previous studies and hypothesis-generating for future statin trials with primary renal endpoints," he said.
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Cite this: Long-term Beneficial Effect of Rosuvastatin on Renal Function - Medscape - Jun 12, 2007.