EFFICACY AND SIDE-EFFECTS OF CYCLOSPORINE DOSE MONITORING WITH LEVELS-6-H AFTER THE MORNING DOSE IN HEART-TRANSPLANT PATIENTS

The purpose of this study was to compare CsA dose monitoring with trou gh levels (T-0) vs, levels obtained 6 h after the morning dose of CsA (T-6), with respect to the incidence of acute rejection and renal dysf unction, and the cumulative dose, as well as the cost of CsA after hea rt transplantation. Twenty consecutive adult heart transplant patients receiving quadruple sequential immunosuppression were prospectively r andomized into CsA monitoring with T-0 (Group I) vs. T-6 levels (Group II). Oral CsA was started at a dosage of 2 mg/kg/d, 1-4 d after trans plantation. The target range for either T-0 or T-6 was 150 to 250 ng/m l (enzyme multplied immuno-logic technique), respectively. The CsA dos e was increased or decreased by 0.5-1 mg/kg/d if the measured level wa s outside of the target range. Throughout the follow-up period (Group I, 11+/-2 months; Group II, 10+/-3 months), the incidence of acute rej ection (ISHLT grade greater than or equal to 2) was 50% in each group. The left ventricular ejection fraction and serum creatinine were simi lar in both groups at 1 month and at the end of the follow-up. The max imal dose of CsA (mg/kg/d): 3.8+/-1 vs. 5+/-0.6 (P=0.002), the minima l dose: 2.2+/-0.7 vs. 3.4+/-0.8 (P=0.003), and the current dose: 2.6+/ -0.6 vs. 3.5+/-1 (P=0.02), were lower in Group II, as well as the cumu lative dose of CsA (mg): 61790+/-19754 vs. 88524+/-18082 (P=0.005), an d its cost (CDN$): 3589+/-1116 vs. 5106+/-1045 (P=0.005). In conclusio n, CsA dose monitoring with T-6 was associated with a 30% lower CsA do se and cost compared to T-0, with the same effectiveness in the preven tion of acute rejection, and similar cardiac and renal function.