Pitavastatin Compared with Differential Intervention Trial by Standard Therapy on Cardiovascular Events in Patients with Dyslipidemia on Chronic Hemodialysis (DIALYSIS): A Randomized Controlled Trial

Chieko Hamada; Masumi Okuda; Yasuhiko Tomino

doi:10.1159/000528763

Pitavastatin Compared with Differential Intervention Trial by Standard Therapy on Cardiovascular Events in Patients with Dyslipidemia on Chronic Hemodialysis (DIALYSIS): A Randomized Controlled Trial

Blood Purif. 2023;52(5):483-492. doi: 10.1159/000528763. Epub 2023 Jan 30.

Authors

Chieko Hamada¹, Masumi Okuda², Yasuhiko Tomino³

Affiliations

¹ Juntendo University Faculty of Health Sciences and Nursing, Mishima, Japan.
² Department of Nephrology, Medical Corporation SHOWAKAI, Shinsen-ikebukuro clinic, Tokyo, Japan.
³ Asian Pacific Renal Research Promotion Office, Medical Corporation SHOWAKAI, Shinjuku, Tokyo, Japan.

Abstract

Introduction: Statin has been reported to reduce cardiovascular events. However, the comparative efficacy of statin with standard therapy on cardiovascular events has not been sufficiently reported in patients on chronic hemodialysis. Thus, this study aimed to compare the effects of pitavastatin and standard therapy on mortality and cardiovascular events in chronic hemodialysis patients with dyslipidemia in Japan.

Methods: Patients on chronic hemodialysis with dyslipidemia were randomized into pitavastatin-administered (pitavastatin group) or dietary therapy as standard therapy (control) group. Primary outcomes are all-cause mortality and myocardial infarction; secondary outcomes are cardiac arrest and fatal myocardial infarction. The composite outcomes included the incidence of coronary intervention, stroke, fracture, and hospitalization due to heart failure and unstable angina. The clinical outcome analyses used a logistic regression model to categorize the variables. A p value of <0.05 was considered statistically significant.

Results: This study included 848 patients (422 in the control group and 426 in the pitavastatin group) from 79 health facilities. The mean age of the patients was 60.1±10.3 years, and the dialysis period was 7.2±7.6 years. The mean observation period was 36.5 months. The low-density lipoprotein cholesterol level was significantly lower than the baseline value in the pitavastatin group after 12 months of trial (79.8±26.1 vs. 107.8±25.5 mg/dL, p < 0.001). Moreover, the total number of deaths was 85, of which 50 occurred in the control group and 35 in the pitavastatin group. In an analysis adjusted for confounding factors due to participant attributes, there was a significant difference between the control group and the pitavastatin group in the primary and composite endpoints (p = 0.007 and p = 0.022, respectively).

Conclusion: Our study has demonstrated that aggressive intervention with pitavastatin is more effective than the standard (dietary) therapy for improving the clinical outcomes in patients with dyslipidemia on chronic hemodialysis.

Keywords: Cardiovascular diseases; Dyslipidemia; Hemodialysis; Mortality; Statins.

Publication types

Randomized Controlled Trial

MeSH terms

Aged
Cholesterol, LDL
Dyslipidemias* / drug therapy
Dyslipidemias* / etiology
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects
Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use
Middle Aged
Myocardial Infarction* / chemically induced
Myocardial Infarction* / drug therapy
Renal Dialysis / adverse effects
Treatment Outcome

Substances

Hydroxymethylglutaryl-CoA Reductase Inhibitors
pitavastatin
Cholesterol, LDL

Grants and funding

This study was carried out by a research grant from the Japan Kidney Foundation (Chiyoda-Ku, Tokyo, Japan), which manages funds donated by various related companies (no grant number). The Japan Kidney Foundation provided the fund, properly managed expenditures, and monitored research progress.