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LDL Lowering Not Found To Slow Progression of Renal Disease


David Lewis, MD, of the Clinical Trial Service Unit at the University of Oxford, presented overall and sub-analyses of the renal results of the Study of Heart and Renal Protection (SHARP) at the European Renal Association – European Dialysis and Transplant Association in Prague in June.

The study found that lowering LDL cholesterol can prevent and reverse atherosclerosis, but it does not do the same for the progression of chronic kidney disease (CKD).  Preclinical and clinical results suggested that elevated LDL is associated with the development and progression of kidney disease and that lowering LDL could impede the loss of kidney function.  The SHARP trial investigators tested whether such an intervention could slow the progression of renal disease in patients with CKD.

The research team randomly assigned CKD patients aged 40 years and older to receive SIM/EZE, SIM 20 mg, or a placebo for one year.  SIM alone was used as a comparison to assess the safety of adding EZE to SIM.  At one year, patients on SIM were randomized to either the SIM/EZE cohort (4,650 patients) or to the placebo (4,620 patients).  The patients were followed for a median of 4.9 years and a minimum of four years.  SIM/EZE was correlated with a mean LDL reduction of 33m/dL at 2.5 years compared with the placebo arm.

In the entire sample of 9,270 patients with a mean age of 63 years, two-thirds were not on dialysis at the beginning of the trial, and the rest were.  Study participants could not have had a myocardial infarction or coronary revascularization.

The researchers observed no significant effect from the administration of the LDL lowering therapy.

Session moderator Johannes Mann, MD, Director of the Department of Nephrology at Munich General Hospitals emphasized the good news.  He stressed that even if the presence of kidney disease is the only cardiovascular risk factor present, doctors should use LDL lowering independent of patients’ baseline LDL cholesterol because many patients who are not receiving this treatment should be receiving it.

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