Epidemiology

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Critical review
Dyslipidemias in chronic kidney disease:
Current guidelines and future perspectives

Introduction
Dyslipidemia is a major problem
in chronic kidney disease (CKD)
and haemodialysis patients. Although there has been much progress and reduction in the prevalence
of dyslipidemia after the Report of
the National Cholesterol Education
Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment
of High Blood Cholesterol in Adults
(Adult Treatment Panel), there were
few specific recommendations for
the evaluation and treatment of dyslipidemias in CKD patients in these
reports. Besides, the NCEP guidelines are applicable to patients with
stages 14 CKD and not specifically
concerned with stage 5 CKD and kidney transplant recipients. It is also
evident that when these guidelines
were published, there were no large
randomized controlled trials evaluating the effects of lipid-lowering therapy in this patient group. Given the
fact that patients with CKD should be
considered in the highest risk group
for cardiovascular disease, it was decided that specific recommendations
regarding dyslipidemia should be applied to patients with CKD. Thus from
the outset of Kidney Disease Outcomes Quality Initiative (K/DOQI),
it was strongly agreed that the management of dyslipidemias in patients
with kidney disease would be one of
the most important issues. However,
recent randomized controlled trials
* Corresponding author
Email: afsarbrs@yahoo.com

Associate Professor of Nephrology, Konya Numune State Hospital, Department of Nephrology, Numune Hastanesi, Yazr Mahallesi, 42250
Seluklu/Konya

showed that dyslipidemia treatment

in these patients had shown modest
benefit at best with regard to cardiovascular mortality. The specific recommendations about dyslipidemias
in CKD patients are reviewed along
with the new studies and future perspectives.
Conclusion
While preparing the dyslipidemia
guidelines for CKD patients, the K/
DOQI working group anticipated
from the beginning that all the guidelines should be updated whenever
new information becomes available.
We do not know whether trial results
from the general population are applicable to all patients with CKD. A
new guideline incorporating the data
of a recent research is necessary.

Introduction

The number of patients with chronic

kidney disease (CKD) is increasing. Unfortunately, the survival of
CKD patients remains poor. Among
other factors, cardiovascular disease (CVD) is the leading cause of
death in CKD patients. Both traditional and non-traditional factors
play a role for increased cardiovascular mortality. Among traditional
risk factors, diabetes, hypertension
and dyslipidemia are the leading
causes. Anaemia, inflammation, oxidative stress,
disorders of calcium
phosphorus metabolism, arterial
stiffness and malnutrition can be
stated as
non-traditional risk factors13. Thus, it is of no question that
CKD patients can be considered as
high-risk patients. In previous reports such as Adult Treatment Panel
(ATP) III, there was no specific interest regarding the dyslipidemia in
CKD patients. Thus in response to
the recommendations of the National

Kidney Foundation (NKF) Task Force

on CVD, the NKF Kidney Disease Outcomes Quality Initiative (K/DOQI)
convened a work group to develop
guidelines for the management of
dyslipidemias, one of the risk factors
for CVD in CKD. This critical review
gives brief information about these
guidelines first and the interpretation of these guidelines based on the
recently conducted randomized prospective studies thereafter.

Discussion

The author has referenced some of

its own studies in this review. These
referenced studies have been
conducted in accordance with the
Declaration of Helsinki (1964) and
the protocols of these studies have
been approved by the relevant
ethics committees related to the
institution in which they were
performed. All human subjects, in
these referenced studies, gave
informed consent to participate in
these studies.
Adult Treatment Panel III guidelines
According to the Executive Summary of the Third Report of the National Cholesterol Education Program
(NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High
Blood Cholesterol in Adults (ATP III)
guidelines, management of all lipid
disorders begin with therapeutic
lifestyle changes (TLCs). The fact
that TLC has the potential to reduce
cardiovascular risk through several
mechanisms beyond low-density lipoprotein cholesterol (LDL-C) lowering. Along with TLC, diet (saturated
fat <7% of calories, cholesterol <200
mg/day, increased viscous fibre

Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Afsar B. Dyslipidemias in chronic kidney disease: Current guidelines and future perspectives. OA
Nephrology 2013 Apr 01;1(1):2.

Competing interests: none declared. Conflict of interests: none declared.

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.
All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

Abstract

B Afsar*

Page 2 of 5

(1025 g/day) and plant sterols

(2 g/day) as therapeutic options
enhance LDL lowering), weight management and increased physical activity are strongly recommended.
ATP III reports have identified
LDL-C as the primary target of cholesterol-lowering therapy. Lipoprotein levels must be obtained after
912 hours of fasting.
According to the ATP III algorithm,
people are categorized into three risk
categories: (1) established coronary
heart disease (CHD) and CHD risk
equivalents, (2) multiple (2+) risk
factors and (3) zero to one (01)
risk factor.
CHD risk equivalents include
non-coronary forms of clinical atherosclerotic disease and diabetes.
Major risk factors other than LDL-C
include cigarette smoking, hypertension (BP>140/90 mmHg or on
antihypertensive medication), low
high-density lipoprotein cholesterol
(HDL-C) (<40 mg/dl) and a family
history of premature CHD (CHD in
male first-degree relative <55 years;
CHD in female first-degree relative <65 years; age: men>45 years,
women >55 years). Besides, HDL-C
>60 mg/dl counts as a negative risk
factor, and its presence removes one
risk factor from the total count. All
people with CHD or CHD risk equivalents should be accepted as high risk.
However, in ATP III guidelines, no
specific comments were made on
patients with CKD, and CKD patients
were not managed differently from
other patients. The ATP III only notes
that nephrotic syndrome is a cause of
secondary dyslipidemia and suggests
consideration be given to the use of
cholesterol-lowering drugs if hyperlipidemia persists despite specific
treatment for kidney disease. The ATP
III also notes that various dyslipidemias have been reported in patients with
kidney failure. However, the ATP III
suggests that a cautious approach be
taken, since these patients are prone
to drug side effects, for example, they
are at increased risk of myopathy

from both fibrates and statins. Indeed,

fibrates are contraindicated in stage 5
CKD patients in ATP III reports.
K/DOQI guidelines for
dyslipidemia
As suggested above, no specific recommendation was mentioned in the
major guidelines regarding dyslipidemia and CKD. Thus by the recommendations of the NKF Task Force
on CVD, the NKF K/DOQI convened a
work group to develop guidelines for
the management of dyslipidemias5.
The K/DOQI working group suggests that:

All adults and adolescents with
CKD should be evaluated for dyslipidemias (moderate evidence).
For adults and adolescents with
CKD, the assessment of dyslipidemias should include a complete
fasting lipid profile with total cholesterol, LDL-C, HDL-C and triglycerides (moderate evidence).
For adults and adolescents with
stage 5 CKD, dyslipidemias should
be evaluated upon presentation
(when the patient is stable), at 23
months after a change in treatment or other conditions known
to cause dyslipidemias, and at
least annually thereafter (moderate evidence).
For adults and adolescents with
stage 5 CKD, a complete lipid profile should be measured after an
overnight fast whenever possible
(moderate evidence).

Haemodialysis patients should
have lipid profiles measured either before dialysis, or on days
they are not receiving dialysis
(moderate evidence).

Stage 5 CKD patients with dyslipidemias should be evaluated
for remediable, secondary causes
(moderate evidence).
Treating dyslipidemias according
to K/DOQI
The K/DOQI suggests that:
For adults with stage 5 CKD

and fasting triglycerides 500

mg/dl, which cannot be corrected

by removing an underlying cause,
treatment with TLCs and a triglyceride-lowering agent should be
considered (weak evidence).
For adults with stage 5 CKD and
LDL 100 mg/dl (2.59 mmol/l),
treatment should be considered to
reduce LDL to <100 mg/dl (<2.59
mmol/l) (moderate evidence).
For adults with stage 5 CKD and
LDL <100 mg/dl, fasting triglycerides 200 mg/dl and non-HDL
cholesterol (total cholesterol minus HDL) 130 mg/dl, treatment
should be considered to reduce
non-HDL cholesterol to <130mg/
dl (weak evidence).
For
 adolescents with stage 5 CKD
and LDL 130 mg/dl, treatment
should be considered to reduce
LDL to <130 mg/dl (weak evidence).
For
 adolescents with stage 5 CKD
and LDL <130 mg/dl, fasting triglycerides 200 mg/dl and nonHDL cholesterol (total cholesterol
minus HDL) 160 mg/dl, treatment should be considered to reduce non-HDL cholesterol to <160
mg/dl (weak evidence).
Until the guidelines published by
the K/DOQI working group, there
were very scarce randomized controlled studies examining the effect
of lipid-lowering therapy in CKD
patients. However, after the report
of K/DOQI working group, prospective studies were performed regarding the use of lipid-lowering agents
and cardiovascular outcomes in CKD
patients including peritoneal and

haemodialysis patients. Since these

studies are very important in the
field of treatment of dyslipidemias
in CKD patients, they should be mentioned briefly.
Studies of dyslipidemia treatment
in CKD patients not on dialysis
Few studies have been designed
primarily to investigate the effects
of statins (HMG-CoA [3-hydroxy3-methylglutaryl
coenzyme
A]

Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Afsar B. Dyslipidemias in chronic kidney disease: Current guidelines and future perspectives. OA
Nephrology 2013 Apr 01;1(1):2.

Competing interests: none declared. Conflict of interests: none declared.

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.
All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

Critical review

Page 3 of 5

reductase inhibitor) on cardiovascular outcomes in patients with

CKD who are not undergoing dialysis therapy. The pravastatin pooling
project showed that the relative risk
reduction in major cardiovascular
events observed among patients with
an estimated glomerular filtration
rate (GFR) of 30 ml/min/1.73 m2
and <60 ml/min/1.73 m2 was similar
to that observed in patients with a
GFR 60 ml/min/1.73 m2 (23% and
22%, respectively)6. A meta-analysis
of randomized, placebo-controlled
trials that included >6,500 patients
with CKD demonstrated that statins
significantly reduced both serum lipid concentrations and the incidence
of cardiovascular end points, without evidence of increased adverse
effects7. However, since the studies
were primarily designed to assess
cardiovascular outcomes in patients
with cardiac disease or at high risk
of developing cardiac disease and
lacked predefined kidney function
outcomes, consequently, the renal
findings derived from post hoc analyses might be misleading6. Thus to
diminish these drawbacks, various

trials randomly assigned participants

to statin therapy versus control811.
As a cumulative result of these studies, it was concluded that statins did
not decrease all-cause mortality or
stroke in participants with diabetes
and CKD12. However, statin therapy
increased regression of microalbuminuria to normoalbuminuria, but
did not attenuate the decrease in estimated GFR (eGFR) in patients with
baseline albuminuria9.
However, the aforementioned
studies were conducted on diabetic
CKD patients. To be more comprehensive, Navaneethan et al. evaluated
the benefits of statins in patients with
non-dialysis-dependent CKD with
or without cardiovascular comorbidities, including randomized controlled trials and comparing statins
with placebo. The meta-analysis involved more than 18,500 patients,
and showed that statins reduced the

relative risk of all-cause mortality by

19%, the relative risk of cardiovascular mortality by 20% and the relative risk of non-fatal cardiovascular
events by 25%13. Thus it was concluded that statin therapy is effective in reducing CVD especially in the
early stages of CKD1417. Based on the
data, a recent review suggested more
specifically that it is better for CKD
patients with stage 13 to use statins,
whereas the beneficial role of statins
beyond stage 3 CKD is less clear6.
Apart from statins, there are
also studies investigating the effects of fibrates in CKD patients. In
a randomized study, Tonelli et al.
investigated the effects of gemfibrozil in secondary prevention of cardiovascular events. After a median
follow-up of 5.3 years, gemfibrozil
treatment significantly reduced the
risk of the composite outcome of fatal CHD, non-fatal myocardial infarction and stroke compared with placebo18. In another study, Davis et al.
investigated the effect of fenofibrate
therapy on renal functions in 9,795
type 2 diabetic patients. Estimated
GFR had fallen less from baseline
on fenofibrate than on placebo (P <
0.001). Fenofibrate reduced urine
albumin concentrations and hence
albumin/creatinine ratio by 24% versus 11% (P < 0.001; mean difference
14% [95% CI 918]; P < 0.001), with
14% less progression and 18% more
albuminuria regression (P < 0.001)
than in participants on placebo.
End-stage renal event frequency was
similar (n = 21 vs. 26, P = 0.48). The
authors concluded that fenofibrate reduced albuminuria and slowed eGFR
loss over 5 years, and fenofibrate may
delay albuminuria and GFR impairment in type 2 diabetes patients19.

Studies of dyslipidemia treatment

in CKD patients on dialysis
In a 4D study, Wanner et al. recruited
1,255 diabetic patients with endstage renal disease (ESRD). About
619 patients were in the intervention
group (atorvastatin 20mg/dl) and

636 served as a control. The primary

end point was a composite of death
from cardiac causes, non-fatal myocardial infarction and stroke. Secondary end points included death from
all causes and all cardiac and cerebrovascular events combined. After a
median of a 4-year follow-up, 469 patients (37%) reached the primary end
point, of whom 226 were assigned to
atorvastatin and 243 to placebo (relative risk 0.92; 95% CI 0.771.10; P =
0.37). Atorvastatin had no significant
effect on the individual components
of the primary end point, except
that the relative risk of fatal stroke
among those receiving the drug was
2.03 (95% CI 1.053.93; P = 0.04).
The authors concluded that atorvastatin had no statistically significant
effect on the composite primary end
point of cardiovascular death, nonfatal myocardial infarction and stroke
in
patients with diabetes receiving
haemodialysis20. However, post hoc
analysis of the 4D study demonstrated that atorvastatin significantly reduced the rate of adverse outcomes in
patients with a baseline LDL-C level in
the highest quartile but not in any of
the other three quartiles21.
Another randomized, double-blind
prospective trial with rosuvastatin
in ESRD was recently published. The
AURORA trial (A Study to Evaluate
the Use of Rosuvastatin in Subjects
on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events) involved 2,776 patients,
5080 years of age, who were undergoing maintenance haemodialysis.
Patients were randomly assigned patients to receive rosuvastatin, 10mg
daily, or placebo. The combined primary end point was death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke.
Secondary end points included death
from all causes and individual cardiac and vascular events. During a
median follow-up period of 3.8 years,
rosuvastatin had no effect on individual components of the primary end
point. There was also no significant

Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Afsar B. Dyslipidemias in chronic kidney disease: Current guidelines and future perspectives. OA
Nephrology 2013 Apr 01;1(1):2.

Competing interests: none declared. Conflict of interests: none declared.

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.
All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

Critical review

Page 4 of 5

Critical review
treatment compared with those on
placebo (15% vs. 16.5%, respectively). Consequently, the results of the
SHARP study for patients on dialysis
were similar to those from the AURORA and 4D studies.
Thus it is obvious that by the light
of aforementioned studies, more
studies are needed to determine
whether statins are useful in CKD
and ESRD. Table 1 summarizes the
possible factors related with inefficiency of statin treatments in randomized controlled trials.

Conclusion

While preparing the dyslipidemia

guidelines for CKD patients, the K/
DOQI working group anticipated
from the beginning that all guidelines
should be updated whenever new,
pertinent information becomes available. To anticipate when these guidelines may need to be updated, the
Work Group discussed ongoing clinical trials in the general population and
in patients with CKD, as those results
may be pertinent to some recommendations. They also have reasonable
doubt as to whether trial results from
the general population are applicable
to all patients with CKD. The major
trials (4D, AURORA, SHARP) were
not completed when these guidelines were prepared. Thus from these
findings, a new guideline incorporating the data of a recent research is
necessary. It is of no question that a

new research is strongly warranted

regarding the pathophysiology of dyslipidemias in CKD and ESRD patients,
with newer treatment options, more
patient and extended follow-up.

Abbreviations list

ATP, Adult Treatment Panel; CHD,

coronary heart disease; CKD, chronic
kidney disease; CVD, cardiovascular
disease; eGFR, estimated GFR; ESRD,
end-stage renal disease; HDL-C, highdensity lipoprotein cholesterol; HMGCoA, 3-hydroxy-3-methylglutaryl coenzyme A; K/DOQI, Kidney Disease
Outcomes Quality Initiative; LDL-C,
low-density lipoprotein cholesterol;
NCEP, National Cholesterol Education Program; NKF, National Kidney
Foundation; RR, rate ratio; TLC, therapeutic lifestyle change

References

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Table 1 Possible factors related with inefficiency of statin treatments in

randomized controlled trials
Lack of statistical power
High dropout rate
Low dose of drugs
Advanced stage of disease
Different pathophysiologic mechanisms of dyslipidemia in CKD patients compared with normal population
Predominance of non-traditional cardiovascular risk factors
Ignorance of causes of renal failure and the age of the subjects
Reverse epidemiology

Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Afsar B. Dyslipidemias in chronic kidney disease: Current guidelines and future perspectives. OA
Nephrology 2013 Apr 01;1(1):2.

Competing interests: none declared. Conflict of interests: none declared.

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.
All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

effect on all-cause mortality. Interestingly, an increased incidence of

fatal haemorrhagic stroke was noted
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LDL-C level in patients undergoing
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observe a clinically or statistically
significant reduction in either mortality or the cardiovascular event rate
in the dialysis population given active

Page 5 of 5

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Licensee OA Publishing London 2013. Creative Commons Attribution License (CC-BY)

For citation purposes: Afsar B. Dyslipidemias in chronic kidney disease: Current guidelines and future perspectives. OA
Nephrology 2013 Apr 01;1(1):2.

Competing interests: none declared. Conflict of interests: none declared.

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.
All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

Critical review