The Effects of Lowering Low-density Lipoprotein Cholesterol Levels to New Targets on Cardiovascular Complications in Peritoneal Dialysis Patients
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): LDL-cholesterol
Intervention type(s): Other
Intervention description(s): This is a 2-arm, open label, multi-center, randomized trial comparing aggressive to standard treatment of LDL-cholesterol. After screening, randomization, participants will be seen every 3 months during the follow-up period. An LDL-cholesterol 100 mg/dL is the goal for the standard group and the target for the aggressive group is 70 mg/dL. A lipid lowering algorithm has been developed based on the NCEP-ATP III recommendation which is used as a general guideline, allowing alterations based on the individual participants needs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDL-cholesterol; Prevalent peritoneal dialysis patients with hypercholesterolemia