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Long-term safety and tolerability of valsartan in children aged 6 to 17 years with hypertension
- Source :
- Pediatric Nephrology. March, 2019, Vol. 34 Issue 3, p495, 12 p.
- Publication Year :
- 2019
-
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.<br />Author(s): Randall Lou-Meda [sup.1] , Brigitte Stiller [sup.2] , Zenaida L. Antonio [sup.3] , Ewa Zielinska [sup.4] , Hui-Kim Yap [sup.5] , Hee Gyung Kang [sup.6] , Monique Tan [sup.7] [...]
Details
- Language :
- English
- ISSN :
- 0931041X
- Volume :
- 34
- Issue :
- 3
- Database :
- Gale General OneFile
- Journal :
- Pediatric Nephrology
- Publication Type :
- Academic Journal
- Accession number :
- edsgcl.571548240
- Full Text :
- https://doi.org/10.1007/s00467-018-4114-0