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Randomized Controlled Trial
. 2017 Jun;21(3):417-424.
doi: 10.1007/s10157-016-1304-6. Epub 2016 Jul 8.

Effects of atorvastatin on renal function in patients with dyslipidemia and chronic kidney disease: assessment of clinical usefulness in CKD patients with atorvastatin (ASUCA) trial

Genjiro Kimura  1 , Masato Kasahara  2   3 , Kenji Ueshima  4 , Sachiko Tanaka  4 , Shinji Yasuno  4 , Akira Fujimoto  4 , Toshiya Sato  5 , Miyuki Imamoto  6 , Shinji Kosugi  7 , Kazuwa Nakao  8
Affiliations
Randomized Controlled Trial

Effects of atorvastatin on renal function in patients with dyslipidemia and chronic kidney disease: assessment of clinical usefulness in CKD patients with atorvastatin (ASUCA) trial

Genjiro Kimura et al. Clin Exp Nephrol. 2017 Jun.

Abstract

Background: Dyslipidemia is a risk factor for the progression of chronic kidney disease (CKD). While conventional lipid lowering therapy provides a benefit to CKD management, the effect of statins on eGFR remains unclear.

Methods: A prospective, multi-center, open-labeled, randomized trial. Total of 349 CKD patients with hyperlipidemia were randomized into 2 groups, and followed for 2 years. Group A included patients who were treated with atorvastatin. Group C were treated with conventional lipid lowering drugs other than statin. Primary endpoint was changes in eGFR. Secondary endpoints included changes in urinary albumin excretion, serum LDL-C, serum triglyceride, cardio-vascular events and all-cause mortality.

Results: As the primary endpoint, eGFR decreased by 2.3 ml/min/1.73 m2 in Group A and by 2.6 ml/min/1.73 m2 in Group C, indicating that there was no difference in change of eGFR between the two groups. As secondary endpoints, atorvastatin succeeded to reduce serum LDL-C level significantly and rapidly, but conventional therapy did not. In fact, mean LDL-C level did not reach the target level of 100 mg/dl in Group C. Serum triglyceride was lowered only by atorvastatin, but not conventional drugs. The number of cardiovascular events and all-cause mortality did not differ between in two groups.

Conclusion: The ASUCA (Assessment of Clinical Usefulness in CKD Patients with Atorvastatin) trial demonstrated that atorvastatin failed to exhibit reno-protections compared to conventional therapy in Japanese patients with dyslipidemia and CKD. It would be due in part to the ability of atorvastatin to more potently reduce serum LDL and triglycerides compared to conventional therapy.

Keywords: Chronic kidney disease (CKD); Hyperlipidemia; Low-density lipoprotein cholesterol (LDL-C); Reno-protective effect; Statins.

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Conflict of interest statement

Source funding

The ASUCA trial was funded by Department of EBM Research Institute of Advancement of Clinical and Translational Science Kyoto University Hospital with an unrestricted grant from Pfizer Japan.

Conflict of interest

Honoraria: Genjiro Kimura (Takeda, Daiichi-Sankyo, Novartis and Taisho-Toyama companies), Masato Ksahara (Pfizer, Daiichi-Sankyo, Fuji companies), Kenji Ueshima (Pfizer company).

Grants received: Genjiro Kimura (Japan Labour Health and Welfare Organization).

Figures

Fig. 1
Fig. 1
Patient’s flowchart in the ASUCA trial
Fig. 2
Fig. 2
Time course of LDL-C concentration. Solid line and dashed line represent Group A (atorvastatin) and B (control), respectively. Dotted line represents recommended value of Japanese society of nephrology. Error bars represent standard deviation. *p < 0.05: each point value vs. baseline value, # p < 0.05: group A vs group C
Fig. 3
Fig. 3
Time course of serum TG. Solid line and dashed line represent Group A (atorvastatin) and C (control), respectively. Error bars represent standard deviation. *p < 0.05: each points value vs. baseline value, # p < 0.05: Group A vs. Group C
Fig. 4
Fig. 4
Time course of eGFR changes. Solid line and dashed line represent Group A (atorvastatin) and C (control), respectively. *p < 0.05: each point value vs. baseline value
Fig. 5
Fig. 5
Time course of log-transformed urinary albumin excretion. Solid line and dashed line represent Group A (atorvastatin) and C (control), respectively. Error bars represent standard deviation. *p < 0.05: each point value vs. baseline value
See this image and copyright information in PMC

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