K/DOQI Clinical Practice Guidelines for
Managing Dyslipidemias in Chronic Kidney Disease
IV. Research
Recommendations
THERE ARE REASONABLE doubts as to whether trial results from the general
population are applicable to all patients with CKD. It is beyond the scope of
these guidelines to recommend all research that should be conducted in patients
with dyslipidemia and CKD, or to design clinical trials. However, it is apparent
that some questions are particularly well suited for study (Table
42), although
these recommendations are not meant to be endorsements for specific protocols.
For children with CKD and/or a functioning kidney transplant, prospective cohort
studies with long-term follow-up are recommended to determine:
-
The prevalence of dyslipidemias at all stages of CKD over time
-
The associations between dyslipidemias and subsequent ACVD
For children with CKD and/or a functioning kidney transplant, phase I and phase
II trials, and pharmacokinetic dosing studies are recommended to establish the
safety and lipid-lowering efficacy of agents (including, but not limited to):
-
Bile acid sequestrants, eg, colesevelam
-
Cholesterol uptake inhibitors, eg, ezetibmide
-
Statins
-
Fibrates
-
Nicotinic acid
-
Sevelamer hydrochloride
-
Appropriate lipid-lowering drug combinations
For adults with CKD and/or a functioning kidney transplant, phase I and phase II
trials and pharmacokinetic dosing studies are recommended to establish the
safety and lipid-lowering efficacy of new agents (including, but not limited
to):
-
Colesevelam
-
Cholesterol uptake inhibitors, eg, ezetimibe
-
Appropriate lipid-lowering drug combinations
For patients with Stages 1-4 CKD, these and other appropriate studies are
recommended to determine whether:
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with any lipid profile.
-
A statin safely reduces the rate of decline in GFR in patients with any
lipid profile.
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with LDL
100
mg/dL (
2.59 mmol/L).
-
A statin safely reduces the rate of decline in GFR in patients with LDL
100
mg/dL (
2.59 mmol/L).
-
A fibrate safely reduces the incidence of ACVD and all-cause mortality in
patients with triglycerides
200
mg/dL (
2.26 mmol/L)
and non-HDL cholesterol
130
mg/dL (
3.36 mmol/L).
-
A fibrate safely reduces the rate of decline in GFR in patients with
triglycerides
200
mg/dL (
2.26 mmol/L)
and non-HDL cholesterol
130
mg/dL (
3.36 mmol/L).
For chronic hemodialysis patients, these and other appropriate studies are
recommended to determine whether:
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with any lipid profile.
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with triglycerides
200
mg/dL (
2.26 mmol/L)
and non-HDL cholesterol
130
mg/dL (
3.36 mmol/L).
-
A fibrate safely reduces the incidence of ACVD and all-cause mortality in
patients with triglycerides
200
mg/dL (
2.26 mmol/L)
and non-HDL cholesterol
130
mg/dL (
3.36 mmol/L).
-
Sevelamer hydrochloride safely reduces the incidence of ACVD and all-cause
mortality in patients with triglycerides
200
mg/dL (
2.26 mmol/L)
and non-HDL cholesterol
130
mg/dL (
3.36 mmol/L).
|

|
|
Click on Image to view full size |
For chronic peritoneal dialysis patients, these and other appropriate studies
are recommended to determine whether:
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with any lipid profile.
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with LDL
100
mg/dL (
2.59 mmol/L).
For kidney transplant recipients, these and other appropriate studies are
recommended to determine whether:
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with any lipid profile.
-
A statin safely reduces the rate of decline in GFR in patients with any
lipid profile.
-
A statin safely reduces the incidence of ACVD and all-cause mortality in
patients with LDL
100
mg/dL (
2.59 mmol/L).
-
A statin safely reduces the rate of decline in GFR in patients with LDL
100
mg/dL (
2.59 mmol/L).
| © 2003 National Kidney Foundation, Inc. |