• Augustina Jankauskiene, Dorota Drozdz, Anna Wasilewska, Rejane de Paula-Bernardes, Robert Glazer, Michele Valentin, Monique Tan, YannTong Chiang, and Kiran Bapatla.
• Vilnius University, Vilnius University Hospital "Santaros klinikos", Vilnius, Lithuania.
• Curr Med Res Opin. 2021 Dec 1; 37 (12): 2113-2122.

ObjectiveTo assess the dose-response relationship for reduction in mean systolic blood pressure (MSBP) with valsartan solution, in young children with hypertension with or without chronic kidney disease (CKD).MethodsIn this multicenter, randomized, double-blind, double-dummy study, 127 young children aged 1-5 years with hypertension (MSBP ≥95th percentile) were randomized (1:1) to receive valsartan 0.25 or 4 mg/kg/day for 6 weeks, followed by a 20 week open-label phase, where patients received valsartan 1 mg/kg/day for 4 weeks, and then optionally titrated to 2 mg/kg/day or up to 4 mg/kg/day. The primary endpoint was the change in MSBP from baseline at Week 6 during the double-blind phase.ResultsOverall, 120 patients (94.5%) completed the study; 63 had CKD. A clinically and statistically significant reduction in MSBP from baseline to Week 6 was observed with the valsartan 4 mg/kg group compared with the valsartan 0.25 mg/kg group (8.5 vs 4.1 mmHg; p = .0157). A positive dose-response relationship for MSBP reduction was observed between the 0.25 mg/kg and 4 mg/kg groups (p = .0012). In the CKD subgroup, a significant reduction in MSBP was observed with 4 mg/kg (9.2 mmHg) versus 0.25 mg/kg (1.2 mmHg; p = .0096). In the non-CKD subgroup, a numerically greater decrease in MSBP was observed with 4 mg/kg (7.8 mmHg) versus 0.25 mg/kg (6.9 mmHg; p = .6531). Incidence of adverse events was lower with valsartan 4 mg/kg than 0.25 mg/kg (41.9% vs 51.6%) and similar between CKD and non-CKD subgroups (48.4% vs 45.3%) irrespective of dose. Increase in serum potassium (>20% compared to baseline) was observed more frequently in patients with CKD compared to non-CKD patients.ConclusionValsartan was efficacious and well tolerated in children 1 to 5 years of age with hypertension, with or without CKD. Clinical trial registration: The study has been registered at ClinicalTrials.gov (Identifier: NCT01617681).

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