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Kidney Week

Abstract: TH-PO1145

The ALL STAR CKD Trial: Pleiotropic Effect of Atorvastatin Focused on Renoprotection in Patients with CKD

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

  • 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Yamamoto, Eriko, Nagoya Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Nagoya, Aichi, Japan
  • Kato, Sawako, Nagoya Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Nagoya, Aichi, Japan
  • Ando, Masahiko, Nagoya Daigaku Igakubu Fuzoku Byoin, Nagoya, Aichi, Japan
  • Maruyama, Shoichi, Nagoya Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Nagoya, Aichi, Japan
  • Yasuda, Yoshinari, Nagoya Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Nagoya, Aichi, Japan
Background

Statins have been recognized for their pleiotropic effects which include anti-inflammation, antioxidant, improved endothelial function, stabilization of atherosclerotic plaques, and also reducing proteinuria. In this trial, we evaluated renoprotective effect of atorvastatin beyond lipid lowering in patients with chronic kidney disease (CKD) and hyperlipidemia.

Methods

The ALL STAR CKD (UMIN000006662) study was a 6-month multicenter, open-label, randomized (1:1= atorvastatin : ezetimibe), parallel-group trial of CKD patients with serum low-density lipoprotein cholesterol (LDL) ≧ 140 mg/dL (if patients with diabetes mellitus, LDL ≧ 120). The patients were allocated to receive once-daily atorvastatin 10 mg or ezetimibe 10mg: intestinal absorption of cholesterol inhibitor. We directly measured Glomerular Filtration Rate (mGFR) by the clearance of inulin at baseline and 6 months after start of the trial. We also assessed estimated GFR based by creatinine (eGFRcr) and cystatin C (eGFRcyst), and protein/albuminuria. The primary endpoint was the change in mGFR after 6 months of treatment in the atorvastatin group (Group A) and ezetimibe groups (Group E).

Results

A total 117 patients (men 53%, 56.7 years) were randomized. Mean eGFRcr, albuminuria and LDL were 54.3 ml/min, 178 mg/gCr and 150 mg/dL at the baseline, respectively. Serum LDL levels in Group A were significantly lower than those in Group E at six months after start of the trial (Group A vs Group E; 83.7 ± 25.1 vs 114.5 ± 19.0 mg/dL). When we compared the mean change from baseline to six months between the two groups by Wilcoxon rank-sum test, there were no significant differences in any parameters including mGFR (Group A vs Group E; 1.4 ± 11.2 vs -1.1 ± 18.9 ml/min: P = 0.09), eGFRcr (-6.7 ± 9.5 vs -6.1 ± 9.5 ml/min: P = 0.87), eGFRcyst (3.7 ± 8.1 vs 2.1 ± 6.4 ml/min: P = 0.37), proteinuria (-0.02 ± 0.36 vs 0.14 ± 0.65 g/gCr: P = 0.23) and albuminuria (124 ± 617 vs 244 ± 698 mg/gCr: P = 0.40).

Conclusion

The present trial did not demonstrate renoprotective effects of atorvastatin after 6-month treatment, as either reservation of GFR or anti- proteinuria. A longer-term observation might be needed to detect a renoprotective power of statins as a pleiotropic effect of atorvastatin in CKD patients.