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

Pediatric Nephrology Jan 31, 2019

Lou-Meda R, et al. - In this 18-month, open-label, multicentre, prospective study conducted in 150 patients, researchers evaluated the long-term safety and tolerability of valsartan in hypertensive children aged 6–17 years, with or without chronic kidney disease (CKD). A total of 117 (78%) patients completed the study. Findings revealed general good tolerability of valsartan. It showed an adverse event (AE) profile consistent with angiotensin receptor blockers in the overall population and in patients with underlying CKD. Valsartan offered a maintained long-term efficacy and a beneficial impact on proteinuria. All patients exhibited a clinically and statistically significant reduction in mean sitting systolic and diastolic blood pressures at week 78 (− 14.9 mmHg and − 10.6 mmHg, respectively). CKD patients demonstrated decreased mean urine albumin creatinine ratio within the first 3 months of treatment, which was sustained. At least one AE was experienced by a higher percentage of CKD patients vs non-CKD patients (85.3% vs 73.3%, respectively). The majority of AEs were mild (50.7%) or moderate (18.7%) in severity. Compared to non-CKD patients, patients with underlying CKD more commonly had increases in serum potassium, creatinine and blood urea nitrogen. In 28.4% of CKD patients and 13.5% of non-CKD patients, a > 25% decrease in Schwartz estimated glomerular filtration rate (eGFR) was observed.
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