Effectiveness and Safety of Aliskiren and Aliskiren Hydrochlorothiazide (HCT) in a Multiethnic, Real-World Setting

Abstract

Numerous randomized clinical trials have demonstrated the efficacy and tolerability of aliskiren and aliskiren hydrochlorothiazide (aliskiren HCT) single-pill combination therapy in patients with hypertension. The objective of the present study was to evaluate the effectiveness and safety of aliskiren-based therapy under daily life conditions in a multiethnic population. This observational, multicenter, noninterventional study, conducted at 420 centers in Asia and the Middle East, included adult patients with hypertension who received treatment with aliskiren or aliskiren HCT as single or add-on therapy for a planned treatment period of at least 26 weeks. The main effectiveness assessments included the proportion of patients achieving therapeutic blood pressure (BP) goal (defined as systolic BP [SBP]/diastolic BP [DBP]<140/90 mmHg, or <130/80 mmHg in patients with diabetes) and BP response, and change in mean sitting BP from baseline to study end. Of 4,826 patients (mean age 51.4 years, 65.9% male, 64.5% Asian, 41.5% diabetic) included in the study, 3,473 received aliskiren and 1,353 received aliskiren HCT. Almost half the study population (48.1%) received aliskiren or aliskiren HCT as add-on therapy. The therapeutic BP goal was achieved in 49.5% of patients treated with aliskiren and 48.3% of patients receiving aliskiren HCT; attainment of BP goal increased to more than 70% when a classic BP target of <140/90 mmHg was applied for all patients. Reductions in mean sitting SBP/DBP were significantly lower versus baseline for both aliskiren (24.1/12.2 mmHg) and aliskiren HCT (27.6/14.1 mmHg) and BP response rates were consistently achieved in more than 80% of all patients during the study. Aliskiren treatment was well tolerated with only a small proportion of patients experiencing adverse events (AEs; 2.1%) and serious AEs (0.3%). In this real-world, naturalistic setting, antihypertensive treatment with an aliskiren-based regimen was effective and well-tolerated in this multiethnic population with arterial hypertension.