The efficacy and safety of valsartan in obese and non-obese pediatric hypertensive patients

Abstract

This post hoc analysis assessed the efficacy and tolerability of valsartan for the treatment of hypertension in obese vs non-obese children and adolescents. After a 1-week antihypertensive washout period, 142 obese and 119 non-obese hypertensive children and adolescents aged 6 to 16 years were randomized to 2 weeks of once-daily treatment with valsartan 10 to 20 mg, 40 to 80 mg, or 80 to 160 mg, followed by re-randomization to either valsartan or placebo for an additional 2 weeks. Patients could continue to receive valsartan during an optional 52-week, open-label extension. Valsartan resulted in statistically significant (P<.05) and clinically relevant reductions in mean sitting blood pressure (BP), ranging from approximately 7/4 mm Hg (valsartan 10-20 mg) to 13/9 mm Hg (valsartan 80-160 mg) in both obese and non-obese patients. BP control was achieved in 44% of obese and 56% of non-obese patients. Following re-randomization, non-obese patients experienced an increase in BP during placebo treatment, albeit levels remained below baseline, whereas BP reductions were maintained in valsartan recipients (P<.05). The most frequent adverse events during the open-label phase were headache and fever. Valsartan provides similar antihypertensive efficacy in obese and non-obese hypertensive children and adolescents, with good tolerability in both patient populations.

Figure 1

Patient disposition.

Figure 2

Mean change (95% confidence intervals) from baseline to the end of phase 1 in (A) mean sitting systolic blood pressure (MSSBP) and (B) mean sitting diastolic blood pressure (MSDBP). *P<.0001 vs baseline; ^† P<.01 vs baseline; ^‡ P<.05 vs baseline.

Figure 3

Mean change (95% confidence intervals) from the end of phase 1 to the end of phase 2 in (A) mean sitting systolic blood pressure (MSSBP) and (B) mean sitting diastolic blood pressure (MSDBP). *P<.0001 vs the end of phase 1; ^‡ P<.05 vs the end of phase 1.