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V-005 CYCLOSPORINE A CONCENTRATION AND ANTIHYPERTENSIVE EFFECT BETWEEN AMLODIPINE AND VALSRATAN REGIMEN IN POST TRANSPLANT HYPERTENSIVE PATIENTS TREATED WITH CYCLOSPORINE A

Background To evaluate the effect of amlodipine and valsartan on blood pressure control in renal transplant patients and to analyze the correlation between CYP3A5 or MDR1 genotype and the antihypertensive effect of these two regimens. Methods One hundred fifty renal transplant patients with stage 1 or 2 hypertension were enrolled in the trial. Patients wererandomly assigned to amlodipine or valsartan. Metoprolol was added if blood pressure was not under control after four weeks. Blood pressure and plasma levels of cyclosporin A (CsA) were monitored during the 24-week trial. CYP3A5 and MDR1 genotypes were determined using a PCR-RFLP method. Results The demographic features and the baseline blood pressure were similar between these two groups. During the 24-week trial, the reduction of SBPwas similar between the amlodipine and valsartan groups. However, the reduction of DBP was significantly greater in the amlodipine group compared to the valsartan group at 12, 16 and 24 weeks of treatment. The plasma level of CsA at 2 hours of medication (C2) was significantly higher in the amlodipine group than that in the valsartan group after 4 weeks of the trial. The reduction of DBP at 24 weeks was greater in the subjects with CYP3A5 *3/*3 variant than those with CYP3A5*1/*1 variant (−13.5 ± 1.9 mmHg vs. −8.7 ± 1.6 mmHg, P < 0.05). Conclusion The present study demonstrated that amlodipine produced a greater reduction of DBP than valsartan although both amlodipine and valsartan resulted in a satisfactory control of blood pressure in patients with renal transplantation. Administration of amlodipine significantly increased the plasma concentration of CsA, and its effects on blood pressure control and CsA concentration may associated with CYP3A5 genotype in these subjects.