Hypercholesterolemia Clinical Trial
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis
patients. Although significant improvements have been made in the management of CVD in the
general population, it is not known whether these interventions would result in similar
benefits in end stage renal disease patients.
Clinical studies conducted in the general population and in patients with established
cardiovascular disease have found a strong independent association between lipid lowering,
primarily LDL-cholesterol, and the risk of all-cause and cardiovascular mortality.
Therefore the National Cholesterol Education Panel (NCEP) has provided guidelines to lower
LDL cholesterol levels to a goal of ≤100 mg/dl in patients with major risk factors of
coronary heart disease. Moreover, the recent Adult Treatment Panel III (ATP III) guidelines
provide an option to lower LDL cholesterol levels to a goal of <70 mg/dl in patients with
very high risks for coronary heart disease.
The National Kidney Foundation K/DOQI guideline regards dialysis patients as having high
risks for coronary heart disease and consequently recommends the LDL cholesterol level to be
maintained under 100 mg/dl. This recommendation is in parallel to the NCEP ATP III guideline
which has been proposed for the general population. However, data regarding cholesterol
levels in dialysis patients have been conflicting, with some observational studies
demonstrating and some not demonstrating a clear, relationship between LDL and
cardiovascular end-points. In addition few randomized studies have been conducted in CKD
patients.
An observational retrospective analysis of patients receiving hemodialysis, the U.S. Renal
Data System Morbidity and Mortality Study, showed that the risk for cardiovascular mortality
was decreased by 36 percent among patients receiving statins, compared to those who did not.
Whereas, a most recent large prospective study in diabetic hemodialysis patients failed to
demonstrate a significant reduction in cardiovascular endpoints with statin therapy.
Moreover, although HD and PD patients both develop chronic hypervolemia and inflammation as
common findings, the relationship between risk factors and outcome may differ between these
two treatment methods. The likely role of glucose from the dialysate in causing dyslipidemia
in PD patients inherits a different strength of association between cholesterol level and
outcome in HD and PD patients.
Therefore, this study aims to examine the clinical outcomes of treating chronic peritoneal
dialysis patients with dyslipidemia to lower cholesterol levels, randomly assigning patients
to either aggressive targets of LDL cholesterol of 70 mg/dl or current standard targets of
LDLD cholesterol of 100 mg/dl.
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