This study compares efficacy and safety of valsartan with enalapril in hypertensive children aged 6-17 years. This was a 12-week, randomized, double-blind, parallel-group, active-controlled study. After a single-blind placebo run-in period (4-28 days), patients with mean sitting systolic blood pressure (BP) (MSSBP) at least 95th percentile for age, gender, and height were randomized to receive half the assigned dose for first week, and force-titrated to full dose for 11 weeks (≥18 to <35 kg - valsartan: 80 mg, enalapril: 10 mg; ≥35 to <80 kg - valsartan: 160 mg, enalapril: 20 mg; ≥80 to ≤160 kg - valsartan: 320 mg, enalapril: 40 mg). The primary efficacy variable was changed from baseline in MSSBP to show noninferiority of valsartan to enalapril. Other efficacy variables were changed from baseline in MSDBP, SBP control rate, and 24-h ambulatory BP parameters. Of 300 randomized patients, 281 (94%) completed the study. At week 12, MSSBP reductions were similar for valsartan and enalapril (primary endpoint of noninferiority, P < 0.0001). Least square mean BP reductions from baseline of -15.4/-9.4 mmHg were observed for valsartan compared with -14.1/-8.5 mmHg for enalapril. A similar proportion of patients achieved SBP control (valsartan: 67%; enalapril: 70%). In the subset of patients who underwent ambulatory BP assessments, valsartan provided greater reductions than enalapril in mean 24-h SBP (valsartan: -9.8 mmHg, enalapril: -7.2 mmHg: P = 0.03). The overall incidence of AEs was similar (valsartan 60%, enalapril 58%) with headache, cough, and nasopharyngitis reported most frequently. Valsartan and enalapril provided comparable BP reductions and effective BP control and were well tolerated in hypertensive children aged 6-17 years.
Background Regional citrate anticoagulation (RCA) is one of the methods used to prevent clotting in continuous renal replacement therapy (CRRT). The aim of this study was to describe the outcomes and complications of RCA-CRRT in comparison to heparin anticoagulation (HA)-CRRT in critically ill children. Methods This study was a retrospective review of 30 critically ill children (16 on RCA- and 14 on HA-CRRT) who underwent at least 24 h of CRRT. The mean body weight of the children was 8.69 ± 5.63 kg. RCA-CRRT was performed with a commercially available pre-dilution citrate solution (Prismocitrate 18/0). Results The mean time on RCA-CRRT and HA-CRRT was 148.73 ± 131.58 and 110.24 ± 105.38 h, respectively. Circuit lifetime was significantly higher in RCA-CRRT than in HA-CRRT (58.04 ± 51.18 h vs. 37.64 ± 32.51 h, respectively; p = 0.030). Circuit clotting was observed in 11.63 % of children receiving RCA-CRRT and 34.15 % of those receiving HA-CRRT. Episodic electrolyte and metabolic disturbances were more common in children receiving RCA-CRRT. The survival at discharge from the hospital was 37.5 and 14.3 % among children receiving RCA-CRRT and HA-CRRT, respectively. Conclusions In critically ill children with a low body weight, RCA appeared to be safe and easy to used. Among our patient cohort, RCA was more effective in preventing circuit clotting and provided a better circuit lifetime than HA.
22 November 2005 in Nephrology Dialysis Transplantation
Background. The aim of this nationwide analysis was to assess the incidence and current treatment profile of arterial hypertension in children undergoing chronic haemodialysis or peritoneal dialysis and attitudes of paediatric nephrologists towards the choice of antihypertensive drugs in their patients. Methods. The study group consisted of 134 children (89 males, 45 females, mean age 10.7±5 years) from all 13 paediatric dialysis centres in Poland. The data were gathered through a questionnaire for each patient dialysed in November 2004. Results. The overall incidence of hypertension in the study group was 55% (74 of 134 patients; 47 males, 27 females). The incidence rate was similar in boys and girls (53 vs 60%) and in those on haemodialysis and peritoneal dialysis (56 vs 54%). Chronic glomerulonephritis as an underlying renal disease was significantly more frequent in the hypertensive than in the normotensive subjects (37 vs 10%, P = 0.004). Residual urine output was higher in normotensives (41 vs 10 ml/kg body weight; P <0.001). Among those treated with antihypertensives: 32% were treated by monotherapy, 36% received two drugs, 22% received three drugs, while 7% received ≥4 drugs. The therapy was effective in only 57% of subjects. We observed no differences in biochemical and clinical parameters between those who responded to the therapy and those who failed to do so. Calcium channel blockers constituted the most frequently administered class of drugs [73% of children; in 43 out of 48 (90%) combined with other drugs, but in 11 out of 24 (46%) as a monotherapy]. In monotherapy, angiotensin-converting enzyme inhibitors and calcium channel blockers were administered most frequently. Conclusion. We conclude that the incidence of hypertension in dialysis children in Poland is high (55%). The effectiveness of antihypertensive treatment is rather low (58%) and the choice of drugs is limited.