B010: Amlodipine versus cilazapril/losartan in renal transplant recipients with hypertension

We conducted a prospective, randomized, double-blind, parallel group trial for a period of 20 weeks, to compare the antihypertensive and cardiac protective effects of Amlodipine and Cilazapril in renal transplant recipients (RTR) with mild to moderate hypertension. Immediately thereafter, patients who experienced side effects were crossed over, in an open-label fashion, to either the other drug, or Losartan. At one-year follow-up, those RTR who remained on Amlodipine were compared with those who remained on Cilazapril or had been crossed over to Losartan. Diastolic blood pressure was measured by conventional methods (CDBP) and an average whole-day diastolic BP (WDDBP) was obtained by ambulatory blood pressure monitoring (ABPM) at baseline (1), 8 weeks (2), and 20 weeks (3) of randomization, and by (CDBP) at 52 weeks (4) of follow-up. Left ventricular mass (LVM) was evaluated by echocardiography at baseline (1), 20 weeks (3), and 52 weeks (4) of follow up. Twenty-three RTR were randomized to Amlodipine (G1) and 25 to Cilazapril (G2). The mean age was 37.4 and 39.6 years respectively (P=NS). Seventy percent of subjects in each group were males, and all but one in each group required a washout period because of other antihypertensive drugs. All subjects were on cyclosporine and prednisone. Average serum creatinine at baseline was 122 and 135 μmol/L in G1 and G2 respectively (P = NS). A repeated measure analysis was conducted on the outcome variables at the four points in time (1, 2, 3, and 4). Data are shown in average values. At 52 weeks of follow up, average CDBP (CDBP4) was 84 and 85mmHg in Amlodipine (n=17) and Cilazapril/Losartan (n=16) groups, respectively (P=NS); and the average LV mass (LVM4) was 156 and 150gm in both groups respectively. (See Table) CDBP1 WDDBP1 LVM1 G1 (n = 23) 99 mmHg 90 mmHg 175 gm G2 (n = 25) 100 mmHg 95 mmHg 164 gm P NS NS NS CDBP2 WDDBP2 *CDBP3 WDDBP3 LVM3 G1 (n=23) 89 mmHg 84 mmHg 86 mmHg 83 mmHg 167 gm G2 (n=25) 89 mmHg 84 mmHg 91 mmHg 85 mmHg 160 gm *p =