Long-term safety and tolerability of valsartan in children aged 6 to 17 years with hypertension

Abstract

ObjectiveThe present study aimed to assess the long-term safety and tolerability of valsartan in hypertensive children aged 6–17 years, with or without chronic kidney disease (CKD).MethodsThis was an 18-month, open-label, multicentre, prospective study conducted in 150 patients with history of hypertension with or without CKD. The primary endpoint was long-term safety and tolerability of valsartan and valsartan-based treatments, assessed in terms of adverse events (AEs), serious AEs, laboratory measurements, estimated glomerular filtration rate (eGFR), urinalysis and electrocardiogram.ResultsOf 150 enrolled patients, 117 (78%) completed the study. At week 78, a clinically and statistically significant reduction in mean sitting systolic and diastolic blood pressures was observed in all patients (− 14.9 mmHg and − 10.6 mmHg, respectively). Within the first 3 months of treatment, mean urine albumin creatinine ratio decreased in CKD population, which was sustained. A higher percentage of CKD patients had at least one AE compared to non-CKD patients (85.3% vs. 73.3%, respectively). The majority of AEs were mild (50.7%) or moderate (18.7%) in severity. As expected, in patients with underlying CKD, increases in serum potassium, creatinine and blood urea nitrogen were more commonly reported compared to non-CKD patients. A > 25% decrease in Schwartz eGFR was observed in 28.4% of CKD patients and 13.5% of non-CKD patients.ConclusionsValsartan was generally well tolerated, with an AE profile consistent with angiotensin receptor blockers in the overall population and in patients with underlying CKD. Long-term efficacy was maintained and a beneficial effect on proteinuria was observed.

Hypertension in Children and Adolescents: A Position Statement From a Panel of Multidisciplinary Experts Coordinated by the French Society of Hypertension

“…Several randomised controlled trials of ACE inhibitors (among them enalapril, lisinopril) and of ARBs (losartan, valsartan, candesartan) in children with HTN have shown a good BP response to the medication ( 57 – 62 ). Safety and tolerability of valsartan in children 6 to 17 years of age with HTN have been recently evaluated by EMA and by the French Haute Autorité de Santé (HAS) ( 63 , 64 ). In children with HTN and renal failure, proteinuria, or diabetes mellitus, an ACE inhibitor or ARB is recommended as the initial antihypertensive agent unless there is an absolute contraindication ( 9 ).…”

Narrative update of clinical trials with antihypertensive drugs in children and adolescents

“…A total of 31 ( 25 – 55 ) CTs have been summarized in the present review, the majority ( n = 20), ( 26 , 29 – 38 , 40 , 41 , 45 , 47 – 53 ) ( Table 3 ) including children with both primary and secondary HTN. Fewer CTs investigated antihypertensive drugs focusing only on children with primary HTN and taking into account concomitant obesity ( 48 ) or race ( 46 ).…”

“…The majority children participating in CTs on secondary HTN had renal disease as the first cause of HTN ( 27 , 31 , 34 – 40 , 42 , 43 , 47 , 49 – 55 ). Some of the CTs in renal disease assessed changes in albuminuria or proteinuria ( 35 , 36 , 52 , 53 ).…”

CKD Care and Research in Guatemala: Overview and Meeting Report

“…The first relates the experiences of clinicians caring for CKD through case series or single-center surveys. 34 Reports have included descriptions of the barriers and facilitators to delivering peritoneal dialysis in rural areas 35 ; case mix, treatment protocols, and barriers and facilitators for treatment adherence in pediatric CKD 28 , 32 , 33 , 36 ; and the burden of proteinuria and CKD in a type 2 diabetes rural cohort. 37 …”