The Effect of Simvastatin on Lowering Panel Reactive Antibody Titer in Sensitized Dialysis Patients: A Randomized Placebo Controlled Clinical Trial

Abstract

Background: Patients with panel reactive antibodies (PRA) have many difficulties to find a crossmatch-negative kidney for transplantation and are at a higher risk of post-transplantation rejection.

Objective: To evaluate the effect of simvastatin on PRA and post-transplant outcome of these sensitized patients.

Methods: 82 patients with end-stage renal disease (ESRD) with a PRA ≥25% were evaluated. In a one-year follow-up, the patients were treated with simvastatin. These patients were compared with 82 matched controls receiving placebo tablets. At the end of the second and 12^th month, PRA was rechecked in all patients. Those patients who underwent transplantation continued to take simvastatin six months after transplantation. Serum creatinine levels were checked at monthly intervals post-operation.

Results: The mean±SD PRA level at the end of the second month was 36.63%±31.14% and 45.34%±24.36% in cases and controls, respectively (P=0.012). Seven patients in the case group and 10 in the control group were lost to follow-up. The remaining patients continued to take simvastatin for 12 month.The mean±SD PRA level at the end of the 12^th month was 24.02%±31.04% in cases and 43.15%±26.56% in controls (P=0.001). 25 patients underwent renal transplantation and continued to receive simvastatin 6 months after transplantation. These patients were matched with 25 controls treating with placebo. The mean±SD creatinine level 6 months after kidney transplantation was 2.05±1.14 mg/dL and 3.15±1.09 mg/dL in cases and controls consecutively (P=0.02).

Conclusion: Simvastatin can be safely used to lower PRA and improve post-transplantation outcomes.