Autori: Fortunato Petrillo, Luigi Annicchiarico Petruzzelli, Angela Maria Pellegrino, Enrica Emanuela Cascone, Maria Amicone, Cristina Marchetiello, Eleonora Riccio, Antonio Pisani
Affiliazioni: Chair of Nephrology, Department of Nephrology, Federico II University of Naples.
Background: The accumulation of p-cresol, a metabolic product of aromatic amino acids generated by intestinal microbioma, increases the cardiovascular risk in chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer (SEV) sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of SEV on p-cresol levels in non-dialysis CKD patients.
Methods: This was a single-blind, randomized placebo controlled trial carried on 69 CKD patients (stage 3-5, not on dialysis), randomly assigned (1:1) to receive either SEV or placebo for 3 months. Total p-cresol serum levels were evaluated at baseline (T0), and one (T1) and three months (T3) after treatment start. The primary end-point was to evaluate the effect of SEV therapy on p-cresol levels.
Results: Compared to baseline values (T0, 7.4 ± 2.7 mg/mL), p-cresol mean concentration was significantly reduced in SEV patients after one (-2.06 mg/mL, 95% C.I. -2.62 mg/mL to -1.50 mg/mL; p<0.001) and 3 months of treatment (-3.97 mg/mL, 95%C.I. -4.53 mg/mL to -3.41 mg/mL; p<0.001); no changes of plasma p-cresol concentration was recorded in placebo-treated patients. Moreover, P and LDL values were reduced after three months of treatment by SEV but not placebo.
Conclusions: In conclusion, our study represents the first evidence that SEV is effective in reducing p-cresol levels in CKD patients in conservative treatment, and confirms the beneficial effects of the drug on inflammation and on lipid pattern.
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