Anti-inflammatory interventions in end-stage kidney disease: a randomized, double-blinded, controlled and crossover clinical trial on the use of pravastatin in continuous ambulatory peritoneal dialysis.

BACKGROUND AND AIMS: Inflammation is highly prevalent in patients on dialysis. Statins have anti-inflammatory actions but their use has been scarcely studied in continuous ambulatory peritoneal dialysis (CAPD). We undertook this study to compare the effect of pravastatin vs. placebo on the serum concentrations of C-reactive protein (CRP) in patients on CAPD. METHODS: In a double-blind, controlled and crossover clinical trial, 76 CAPD patients were randomized to either pravastatin or placebo for 2 months. After this first period of treatment, patients had a 1-month wash-out period and, finally, they were crossed-over to receive the other drug (or placebo) for 2 more months. Measurement of clinical and biochemical variables and CRP was performed at the beginning and at the end of each treatment period. RESULTS: Median CRP was only significantly decreased in the pravastatin group in both periods of treatment: first period (baseline vs. final, mg/L): pravastatin 7.4 (2-21) vs. 2.6 (1-6), p <0.05; placebo 3.9 (2-10) vs. 6.8 (3-12), pNS; second period: pravastatin 4.3 (2-15) vs. 1.9 (1-7), p <0.05; placebo 4.9 (2-17) vs. 6.8 (2-19), p <0.05. Results were significantly different (p <0.05) between groups only at the end of each treatment period. Additionally, total and LDL-cholesterol significantly decreased in the pravastatin group. CONCLUSIONS: Pravastatin significantly reduced serum levels of CRP and total and LDL-cholesterol compared to placebo. This treatment may be of great help to decrease the inflammatory status and probably the cardiovascular disease of CAPD patients.