Dataset Information

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

ABSTRACT:

Objective

The 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).

Methods

This 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.

Results

Of 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.

Conclusions

Valsartan 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.

SUBMITTER: Lou-Meda R

PROVIDER: S-EPMC6349801 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Lou-Meda Randall R Stiller Brigitte B Antonio Zenaida L ZL Zielinska Ewa E Yap Hui-Kim HK Kang Hee Gyung HG Tan Monique M Glazer Robert D RD Valentin Michele A MA Wang Linda L

Pediatric nephrology (Berlin, Germany) 20181105 3

<h4>Objective</h4>The 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).<h4>Methods</h4>This 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), seriou ...[more]

PMID: 30397789

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Dataset Information

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

Objective

Methods

Results

Conclusions

Publications

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

Similar Datasets

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