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Pitavastatin Compared with Differential Intervention Trial by Standard Therapy on Cardiovascular Events in Patients with Dyslipidemia on Chronic Hemodialysis (DIALYSIS): A Randomized Controlled Trial.
- Source :
-
Blood purification [Blood Purif] 2023; Vol. 52 (5), pp. 483-492. Date of Electronic Publication: 2023 Jan 30. - Publication Year :
- 2023
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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.<br />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.<br />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).<br />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.<br /> (© 2023 The Author(s). Published by S. Karger AG, Basel.)
- Subjects :
- Humans
Middle Aged
Aged
Cholesterol, LDL
Renal Dialysis adverse effects
Treatment Outcome
Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects
Dyslipidemias drug therapy
Dyslipidemias etiology
Myocardial Infarction chemically induced
Myocardial Infarction drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1421-9735
- Volume :
- 52
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Blood purification
- Publication Type :
- Academic Journal
- Accession number :
- 36716708
- Full Text :
- https://doi.org/10.1159/000528763