| Abstrakt: |
Dyslipidemia is universal but hypercholesterolemia per se is present in around 50% of dialysis patients. Although dietary therapy is of benefit in some, the majority require drug therapy. We compared the efficacy and safety of simvastatin plus an optimized lipid-lowering dialysis diet with placebo plus diet in a randomized, double-blind trial stratified for dialysis modality. Patients treated with hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) for at least 9 months and with serum non-high-density lipoprotein (HDL) cholesterol greater than 135 mg/dL, low-density lipoprotein (LDL) greater than 116 mg/dL, and triglyceride less than 600 mg/dL after a 6-week dietary treatment phase and an 8-week diet plus placebo run-in phase, were enrolled in the 24-week double-blind treatment phase. Fifty-seven patients (16 men, 41 women, median age 63 years, range 22-75 yr) were randomized 2:1 to diet plus 5 mg/day simvastatin (n = 38: 22 HD, 16 CAPD) or diet plus placebo (n = 19: 12 HD, 7 CAPD) for 24 weeks. Dose was doubled bimonthly (maximum 20 mg/day) if non-HDL cholesterol was greater than 135 mg/dL. Forty-two patients (73.7%) completed the trial. Comparing baseline and 24 weeks, simvastatin (median 10 mg/day) was significantly more effective than placebo in reducing serum non-HDL cholesterol concentrations. For HD, the median percentage changes for total cholesterol (TC) (simvastatin versus placebo) were −21.4% and −12.1% (P= 0.011), respectively; for LDL cholesterol, −33.0% and −8.8% (P= 0.023); for non-HDL cholesterol, −25.2% and −14.0% (P= 0.008); and for TC:HDL, −17.65% and −1.67% (P= 0.008). For CAPD, changes for TC were −22.1% and −1.5% (P= 0.003), respectively; for LDL, −36.4% and 0.0% (P= 0.001); for non-HDL cholesterol, −24.9% and −3.6% (P= 0.002); and for TC:HDL ratio, −21.49% and +9.74% (P= 0.045). Changes with CAPD in apolipoprotein (Apo) A1 were −4.7% and +4.0% (P= 0.031); and for ApoB, −19.9% and +2.6%, respectively (P= 0.031). There were no significant changes in ApoA1 or ApoB with HD. Compared with placebo, triglyceride levels fell 10.2% with HD and 6.2% with CAPD. HDL cholesterol was unchanged with HD but rose 8.5% with CAPD. These trends, however, did not reach statistical significance (P0.05). There was no effect on Lp (a). The incidence of clinical and laboratory adverse experiences were not increased in the simvastatin-treated patients compared with placebo. Simvastatin appears to be a safe and effective treatment for the reduction of serum non-HDL cholesterol levels in both HD and, particularly, CAPD patients. © 2002 by the National Kidney Foundation, Inc. |
