Effects of combined prednisone + fluvastatin on cholesterol and bilirubin in pediatric patients with minimal change nephropathy.

BACKGROUND

Nephrotic syndrome is associated with hyperlipidemia and low serum bilirubin. Corticosteroids and statins are routinely administered to patients with this syndrome. However, knowledge of the mechanisms that underlie hyperlipidemia is incomplete.

OBJECTIVES

The aim of this study was to compare the effects of prednisone monotherapy with those of prednisone + fluvastatin on lipid, albumin, and bilirubin levels in patients with nephrotic syndrome.

METHODS

Pediatric patients (4-12 years of age) with minimal change nephropathy were consecutively assigned to receive prednisone monotherapy (1-2 mg/kg/d; maximal total dose, ≤60 mg) or prednisone at the same dosage plus fluvastatin (5 mg/d if aged <5 years; 10 mg/d if aged ≥5 years), for 6 weeks. A control group comprised healthy children without evidence of renal, hepatobiliary, cardiovascular, or hematologic disease. Total and direct bilirubin, albumin, triglycerides (TG), total cholesterol (TC), and 24-hour urinary protein (Upr) were determined at baseline (week 0) and at weeks 4 and 6 after the start of therapy.

RESULTS

Sixty evaluable patients were assigned active treatment (monotherapy: 16 male, 14 female; mean age, 7.6 [3.6] years [range, 6-12 years]; combination therapy: 15 male, 15 female; mean age, 7.1 [4.9] years [range, 4-12 years]); the control group comprised 50 healthy children (26 male, 24 female). With both prednisone monotherapy and prednisone + fluvastatin, total and direct bilirubin, and albumin were significantly increased from baseline, and TG, TC, and Upr were significantly decreased (all, P < 0.01). There was no significant difference in treatment effect between the 2 treatment groups. Pretreatment total and direct bilirubin levels were significantly lower in the active-treatment groups than in the control group (n = 50) (all, P < 0.01); after treatment, total and direct bilirubin concentrations were increased to levels reported in the control group. Pre- and posttreatment levels of total bilirubin were positively correlated with albumin but negatively correlated with TC.

CONCLUSIONS

Low blood bilirubin levels appeared to have reduced resistance to oxidative stress and to have contributed to disturbances in lipid metabolism in these pediatric patients with nephrotic syndrome. Prednisone with or without fluvastatin apparently corrected bilirubin levels and reduced blood lipids. There was no apparent additive effect of fluvastatin on lipids.

CLINICAL TRIAL REGISTRATION

ChiCTR-TQR-12002602.

Copyright © 2013. Published by EM Inc USA.