Effect of statin on life prognosis in Japanese patients undergoing hemodialysis

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Abstract

The effect of statin on hemodialysis patients is controversial. Although previous large-scale studies did not clarify its effect in this population, recent studies suggest that statins could be useful in reducing the risk of cardiovascular events and all-cause mortality in specific groups of patients undergoing hemodialysis. The aforementioned large-scale studies included a small percentage of Asians, and few studies have investigated the effects of statins in Asians undergoing hemodialysis. Thus, we investigated the benefits of statins in patients undergoing maintenance hemodialysis at a single center in Japan. We obtained demographic, clinical, and hemodialysis data of all patients who underwent maintenance hemodialysis at the Nagasaki Renal Center between July 2011 and June 2012. Patients were followed-up until June 2018. We studied 339 patients, of which 51 (15.0%) were prescribed pitavastatin. The mean observation period was 4.1±2.3 years, 43% were women, and the median hemodialysis vintage at baseline was 4.7 years. During the follow-up, 198 patients (58%) died, of which 22 (43%) were prescribed pitavastatin and 176 (61%) were not prescribed any statins. After propensity score matching based on age, sex, dialysis vintage, dialysis time, diabetes mellitus, ischemic heart disease, dry weight, left ventricular ejection fraction, and serum albumin, an intergroup comparison between those who received statins and those who did not (44 patients in each group) showed significant differences in survival rate based on the log-rank test (P<0.05). Although the causes of death did not differ significantly between groups, deaths due to cardiovascular events, infections, and cancer were fewer in the group prescribed statins. Our results suggest that statins may reduce mortality in Japanese patients undergoing maintenance hemodialysis. Although potential residual confounders exist, statins may have an influence on the reduction in the incidence of cardiovascular events, infections, and cancer. Nevertheless, further studies are required to prove this hypothesis.

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Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

Bengt C Fellström, Alan Jardine, Roland E Schmieder … (2009)

Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51). In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.) 2009 Massachusetts Medical Society

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Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.

J Downs, M Clearfield, S. Weis … (1998)

Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low-density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL-C) levels. A randomized, double-blind, placebo-controlled trial. Outpatient clinics in Texas. A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51 st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/L (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (1 83 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [CI], 0.50-0.79; P<.001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% CI, 0.43-0.83; P=.002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% CI, 0.49-0.95; P=.02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% CI, 0.52-0.85; P=.001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% CI, 0.61-0.92; P =.006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% CI, 0.62-0.91; P = .003). Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.

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KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient.

Christoph Wanner, Marcello Tonelli (2014)

The Kidney Disease: Improving Global Outcomes (KDIGO) organization developed clinical practice guidelines on lipid management for all adults and children with chronic kidney disease (CKD). Thirteen recommendations were obtained from the available evidence outlining a three-step management including assessment in all, treatment in many, and follow-up measurements in few. A key element is the recommendation of statin or statin/ezetimibe treatment in adults aged ⩾50 years with estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m(2) but not treated with chronic dialysis or kidney transplantation. In dialysis patients, the magnitude of any relative reduction in risk appears to be substantially smaller than in earlier stages of CKD and initiation of statin treatment is not recommended for most prevalent hemodialysis patients. In the past, clinical practice guidelines suggested the use of targets for LDL cholesterol, which require repeated measurements. Treatment escalation with higher doses of statin would be a consequence when LDL cholesterol targets are not met. The KDIGO Work Group did not recommend this strategy because higher doses of statins have not been proven to be safe in the setting of CKD. Since LDL cholesterol levels do not necessarily suggest the need to increase statin doses, follow-up measurement of lipid levels is not recommended.

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Author and article information

Contributors

Yuki Ota: Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: Project administrationRole: SoftwareRole: Writing – original draft

Mineaki Kitamura:

ORCID: http://orcid.org/0000-0002-0003-8645

Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing

Kumiko Muta: Role: Data curation

Hiroshi Yamashita: Role: Data curation

Tadashi Uramatsu: Role: Data curationRole: Supervision

Yoko Obata: Role: Supervision

Takashi Harada: Role: Data curationRole: Supervision

Satoshi Funakoshi: Role: Data curationRole: SupervisionRole: ValidationRole: Visualization

Hiroshi Mukae: Role: Supervision

Tomoya Nishino: Role: ConceptualizationRole: SupervisionRole: Writing – review & editing

Tatsuo Shimosawa: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 22 October 2019

Publication date Collection: 2019

Volume: 14

Issue: 10

Electronic Location Identifier: e0224111

Affiliations

[1 ] Department of Nephrology, Nagasaki University Hospital, Nagasaki, Japan

[2 ] Division of Blood Purification, Nagasaki University Hospital, Nagasaki, Japan

[3 ] Department of Nephrology, Nagasaki Renal Center, Nagasaki, Japan

[4 ] Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

International University of Health and Welfare, School of Medicine, JAPAN

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: minekitamura@ 123456nagasaki-u.ac.jp

Author information

Mineaki Kitamura http://orcid.org/0000-0002-0003-8645

Article

Publisher ID: PONE-D-19-22009

DOI: 10.1371/journal.pone.0224111

PMC ID: 6804988

PubMed ID: 31639169

SO-VID: c4708261-cada-4407-8a95-94da1ce7ab2e

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 5 August 2019

Date accepted : 4 October 2019

Page count

Figures: 2, Tables: 4, Pages: 11

Funding

Funded by: Grant-in-Aid for Scientific Research

Award ID: 19K17747

Award Recipient :

ORCID: http://orcid.org/0000-0002-0003-8645

Mineaki Kitamura

This study was supported by a Grant-in-Aid for Scientific Research (KAKENHI; grant number 19K17747) (recipient: Mineaki Kitamura). This funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Effect of statin on life prognosis in Japanese patients undergoing hemodialysis

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Most cited references 30

Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.

KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient.

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