Statins, which are well-established drugs in reducing cardiovascular events in high-risk patients, do not reduce cardiovascular risk in patients undergoing hemodialysis. Patients with chronic kidney disease particularly end-stage renal disease are considered high cardiovascular risk patients.

Investigators conducted a manufacturer-sponsored and administered, international, randomized, double-blind trial of rosuvastatin (10 mg/day) versus placebo in patients aged 50 to 80 who had been on dialysis for more than three months.

The 2,173 patients (38% of which are women, with the average of sixty- four) were followed for a mean of 3.2 years. At baseline, mean LDL levels were about lOOmg/dl, and median C-reactive protein (CRP) levels were about 5mg/I. At three months, LDL decreased by 42.9% in the rosuvastatin group, compared with 1.9% in the placebo group. The CRP level in the rosuvastatin group decreased by 11.5% and increased in the placebo group by 0.2%.

The primary endpoint, time to a major cardiovascular event, was similar in the two groups (hazard ratio for rosuvastatin compared with placebo, 0.96%; confidence interval, 0.84-1.11).

This finding was consistent in all subgroups, including patients with elevated LDL levels and those with elevated CRP levels. LDL level was not associated with risk for cardiovascular events.

The study arrived at two conclusions. First, despite presumably salutary effects on LDL and CRP levels, rosuvastatin did not benefit the patients in this trial. Secondly, the lack of benefit with statins in patients undergoing hemodialysis joins recent evidence of a similar lack in patients with advanced heart failure. Other operative mechanisms may be present in these two high-risk types of patients.