Efficacy and safety of valsartan in children aged 1–5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase. (2nd December 2021)

• Record Type: Journal Article
• Authors: Jankauskiene, Augustina; Drozdz, Dorota; Wasilewska, Anna; de Paula-Bernardes, Rejane; Glazer, Robert; Valentin, Michele; Tan, Monique; Chiang, YannTong; Bapatla, Kiran
• Is Part Of: Current medical research and opinion. Volume 37:Number 12(2021)
• Page Start: 2113
• Page End: 2122
• Publication Date: 2021-12-02
• Subjects: Chronic kidney disease -- dose–response -- hypertension -- pediatric -- valsartan; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2021.1982681
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: Objective: To 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). Methods: In 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. Results: Overall, 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. Conclusion: Valsartan 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).