Abstract-The efficacy and safety of valsartan were studied in 90 children (mean age: 3.2 years; 60% male; 30% black) with systolic blood pressure (SBP) Ն95th percentile. Nineteen percent received valsartan in addition to previous antihypertensive therapy. Subjects were randomly assigned to low-, medium-, or high-dose valsartan for 2 weeks (phase 1) and then reassigned randomly to placebo or to remain on the same valsartan dose for 2 additional weeks (phase 2). After this, subjects were enrolled into a 52-week, open-label phase during which valsartan was dosed to achieve SBP Ͻ95th percentile. Statistically significant reductions in SBP and diastolic blood pressure of Ϸ8.5 mm Hg and 5.7 mm Hg, respectively, were observed at the end of phase 1 in all of the valsartan dose groups. SBP and diastolic blood pressure were also significantly lower during phase 2 in valsartan recipients compared with placebo recipients. SBP Ͻ95th percentile was achieved in 77.3% of subjects during the open-label phase. Adverse events were minor and occurred at similar frequencies in each of the 3 dose groups in phase 1 and at equal frequencies in the valsartan and placebo arms in phase 2. Serious adverse events and drug-related adverse events occurred infrequently during both the double-blind (2.2% and 5.6%, respectively) and open-label (14.8% and 6.8%, respectively) portions of the study.Valsartan treatment had no demonstrable negative effects on growth and development. In this study, the first trial of an antihypertensive agent conducted in children To date, however, all of these studies have been conducted in children Ͼ6 years old, leaving a significant information deficit regarding the treatment of hypertension in younger children, most of whom have underlying kidney disease or other secondary causes of hypertension. [3][4][5] Valsartan is an angiotensin II receptor blocker approved in adults for the treatment of hypertension, heart failure, and left ventricular failure or left ventricular dysfunction postmyocardial infarction. 6 Its effects primarily result from selective blockade of the angiotensin type I receptor in vascular smooth muscle and adrenal gland. 6,7 Valsartan effectively reduces systolic blood pressure (BP; SBP) and diastolic BP (DBP) in adults, both as monotherapy and in combination with other antihypertensive agents, displaying similar antihypertensive efficacy to other antihypertensive drug classes. [7][8][9][10] Given its effects on angiotensin blockade, valsartan may also reduce proteinuria and have other beneficial effects in patients with underlying kidney disease. 10 For these reasons, valsartan is an attractive drug for use in young children with hypertension.This study was conducted to explore the efficacy of valsartan in reducing BP in children aged 1 to 5 years with hypertension. We also examined the safety and tolerability of both short-and long-term administration of valsartan in this population. MethodsThis was a double-blind, randomized, multicenter study sponsored by Novartis Pharmaceuticals and perfor...

The effectiveness and safety of valsartan have not been assessed in hypertensive children. Therefore, hypertensive patients aged 6 to 16 years (n=261) were randomized to receive weight‐stratified low‐ (10/20 mg), medium‐ (40/80 mg), or high‐dose (80/160 mg) valsartan for 2 weeks. After 2 weeks, patients were randomized to a 2‐week placebo‐controlled withdrawal phase. Dose‐dependent reductions in sitting systolic blood pressure (SSBP) and sitting diastolic blood pressure (SDBP) were observed after 2 weeks (low dose, −7.9/−4.6 mm Hg; medium dose, −9.6/−5.8 mm Hg; high dose, −11.5/−7.4 mm Hg [P<.0001 for all groups]). During the withdrawal phase, SSBP and SDBP were both lower in the pooled valsartan group than in the pooled placebo group (SSBP, −2.7 mm Hg [P=.0368]; SDBP, −3.0 mm Hg [P=.0047]). Similar efficacy was observed in all subgroups. Valsartan was well tolerated and headache was the most commonly observed adverse event during both the double‐blind and 52‐week open‐label phases. J Clin Hypertens (Greenwich). 2011;13:357–365. ©2011 Wiley Periodicals, Inc.

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Objective: to analyze the clinical history and evolution of children and adolescents with IH, emphasizing some of their peculiar features. Methods: we followed 471 patients with IH at an outpatient clinic. Patients were submitted to the following protocol: abdominal X-ray, kidney and urinary tract ultrasonography; urinary ionogram, blood gas and biochemical analyses; 24-hour urine for measurement of calcium and other electrolytes and creatinine; urinalysis, urine culture and phase-contrast microscopy; second morning urine collected after fasting for measurement of calcium and creatinine. Results: at the time of diagnosis, 6% of the patients were infants, 15% preschool children, 55% school children, and 24% adolescents ; 56% of them were boys. Clinical and laboratory findings were: 47% had hematuria and abdominal pain, 31% had isolated hema-turia, 14% isolated abdominal pain, and 8% had urinary tract infection, nocturnal enuresis, suprapubic pain or urethralgia, or the frequency/urgency syndrome with urinary incontinence. Hypercalciuria was associated with urolithiasis in 56% of patients. There was association with hyperuricosuria in 18.5% of the cases, and hypocitraturia in 8.5% of the cases. Evolution was poor for 33% of the patients, with recurrence of nephrolithiasis, persistence of hematuria, and abdominal pain. Conclusions: IH must be diagnosed and treated with criteria in order to reduce consequences such as hematuria, abdominal pain, urinary stone formation and possible bone involvement. Signs and symptoms such as urgency and urinary incontinence, suprapubic pain and nocturnal enuresis may result from renal hyperexcretion of calcium. J Pediatr (Rio J) 2001; 77 (2): 101-4: hematuria, enuresis, urinary incontinence. Resumo Objetivo: analisar a história clínica e evolução de crianças e adolescentes com HI, ressaltando peculiaridades próprias destes pacientes. Métodos: 471 pacientes portadores de HI têm sido acompanha-dos em regime ambulatorial, sendo submetidos ao protocolo: Rx de abdome, ultra-sonografia de rins e vias urinárias; ionograma, gaso-metria e bioquímica de sangue; urina de 24 horas para dosagem de cálcio e outros eletrólitos e creatinina; urinálise, urocultura e micros-copia de contraste de fase; urina de segunda micção matinal em jejum para dosagem de cálcio e creatinina. Resultados: 56% masculinos e 44% femininos; 56% brancos, 37% não-brancos e 7% sem relato da cor da pele. Ao diagnóstico 6% eram lactentes, 15% pré-escolares, 55% escolares e 24% adolescen-tes. 47% tinha hematúria associada à dor abdominal, 31% hematúria isolada, 14% dor abdominal isolada, e 8% tinham infecção urinária, enurese noturna, dor suprapúbica ou uretral ou a síndrome miccional com freqüência/urgência e incontinência urinária. A associação de hipercalciúria com litíase do trato urinário foi positiva em 56% dos pacientes. Em 18,5% houve associação com hiperuricosúria e em 8,5% com hipocitratúria. 33% dos pacientes tiveram má evolução com recorrência de nefrolitíase, persistência de hematúria e dor abdominal. Conclusões:...