TAREG

• Key points  

Favourable opinion for reimbursement in the treatment of hypertension in children aged 1 to 5 years.  

• What therapeutic improvement? 

No clinical added value in the therapeutic strategy for hypertension in children aged 1 to 5 years.  

• Role in the care pathway? 

The treatment of hypertension in children is based on lifestyle and dietary measures as a first-line approach, irrespective of blood pressure level, with or without associated pharmacological treatment.  

Pharmacological treatment is recommended from the outset in the event of symptomatic hypertension, hypertension associated with damage to a target organ (in particular, the brain, eyes, heart, kidneys), hypertension combined with diabetes (type 1 or 2) or secondary hypertension. 

When medicinal treatment is deemed necessary, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, beta-blockers or diuretics may be used as first-line therapy. In the absence of absolute contraindications, the choice of medicinal product must target the underlying pathophysiology of the child’s hypertensive disease and the presence of concomitant diseases.  

Among the medicinal alternatives, the antihypertensives in oral solution form with an MA are: SECTRAL (acebutolol), NOYADA (captopril) and LASILIX (furosemide). It should be noted that the proprietary medicinal product HEMANGIOL (propranolol) has received a favourable opinion for a temporary recommendation for use (RTU) in this indication1. 

Role of the medicinal product in the care pathway 

TAREG 3 mg/ml oral solution (valsartan) is a first-line treatment in the management of hypertension in children aged 1 to 5 years. 

To date, TAREG oral solution (valsartan) is the only medicinal product belonging to the angiotensin II antagonist group to have been awarded an MA in the treatment of hypertension in children less than 6 years of age and for which the delivery form is suitable for the paediatric population. 

The Committee highlights the practical value of this oral solution formulation of valsartan for use in very young children.  

• Special recommendations 

The Committee warns that the multi-dose vial packaging with a dosing device graduated in ml, requiring conversion from mg into ml, is not appropriate. Depending on the dose prescribed, multiple handling operations are required, since the total quantity of solution that can be measured into the syringe is 5 ml. In addition, the packaging includes a dosing cup, which is not intended to be used to measure the valsartan dose but to collect successive quantities of solution drawn using the syringe. All these elements promote the risk of medication errors and overdose. To reduce this risk, the Committee would like a dosing device better suited to the MA dosages, with graduation in mg, to be provided. It would also like only one dosing device to be provided.