Combination therapy and formulation challenges in paediatric hypertension: an unmet need.

Hypertension is an increasingly prevalent condition in both adults and children and is associated with significant long-term cardiovascular and renal morbidity. Current paediatric guidelines recommend a stepwise pharmacological approach, initiating treatment with a single antihypertensive agent at a low dose, followed by gradual titration up to the maximum tolerated dose and the addition of a second agent only if blood pressure control is not achieved. In contrast, adult hypertension guidelines increasingly support early combination therapy, particularly in patients with stage 2 hypertension, to achieve faster and more consistent blood pressure control and improve medication adherence. Given that blood pressure regulation involves multiple physiological systems, combining agents with complementary mechanisms of action may enhance antihypertensive efficacy while reducing dose-dependent adverse effects. Although the use of fixed-dose combination therapies is well established in adults, their application in paediatric populations remains limited due to regulatory-, clinical-, and formulation-related challenges. We propose that, in selected paediatric patients with an anticipated inadequate response to monotherapy, early combination therapy may be considered as an alternative to strict stepwise escalation. Expanding paediatric clinical research and developing age-appropriate formulations are essential to optimise hypertension management and improve long-term outcomes in this population.