The Food and Drug Administration (FDA) has expanded the approval of Diovan (valsartan) to include patients 1 to 5 years of age for the treatment of hypertension. Previously, the treatment was indicated for patients 6 years of age and older.
The approval was based on data from 3 randomized, double-blind clinical studies that assessed the antihypertensive effect of valsartan in 290 children 1 to less than 6 years of age. In Study 1 (N=90), patients who weighed less than 18kg received 5, 20 or 40mg of valsartan daily, while patients weighing greater than or equal to 18kg received 10, 40, and 80mg of valsartan daily. Results showed that at the end of 2 weeks, the 3 dose levels of valsartan reduced systolic blood pressure from the baseline by 8.4, 8.3, and 8.6 mmHg, respectively, but a dose response could not be demonstrated.
Findings from Study 2 (N=74) showed that higher doses (1mg/kg and 4mg/kg daily) of valsartan were associated with numerically greater blood pressure reductions at week 6 compared with the lowest dose (0.25mg/kg).
In Study 3 (N=126), dose dependent reductions in mean systolic blood pressure were observed with valsartan at week 6 (4.1mmHg with valsartan 0.25mg/kg and 8.5mmHg with valsartan 4mg/kg). Moreover, patients with chronic kidney disease showed reductions in mean systolic blood pressure with valsartan 4mg/kg compared with 0.25mg/kg (9.2mmHg vs 1.2mmHg). No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30mL/min/1.73m2.
The use of Diovan oral suspension, which is prepared using Diovan tablets, is recommended in patients 1 to 5 years of age. The suspension can be stored for either up to 30 days at room temperature or up to 75 days at refrigerated conditions. Diovan tablets and oral suspension are not substitutable on a mg-per-mg basis as the systemic exposure to valsartan is 60% higher with the suspension compared to tablets.
Diovan [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2021.