Estimating the impact of single pill combination therapy for hypertension: projections of patient outcomes in Italy

Introduction: Hypertension affects almost a third of the Italian population and is a major risk factor for cardiovascular disease. Management of hypertension is often hindered by poor adherence to complex treatment regimens. This analysis aimed to estimate the 10-year clinical outcomes associated with single pill combination (SPC) therapies compared with other treatment pathways for the management of hypertension in Italy. Methods: A microsimulation modeling approach was used to project health outcomes over a 10-year period for people with hypertension. Input data for four treatment pathways [current treatment practices (CTP), single drug with dosage titration then sequential addition of other agents (start low and go slow, SLGS), free choice combination with multiple pills (FCC) and SPC] were sourced from the Global Burden of Disease 2017 data set. The model simulated clinical outcomes for 1 000 000 individuals in each treatment pathway, including mortality, chronic kidney disease (CKD), stroke, ischemic heart disease (IHD) and disability-adjusted life years (DALYs). Results: Through improved adherence, SPC was projected to improve clinical outcomes versus CTP, SLGS, and FCC. SPC was associated with reductions in mortality, incidence of clinical events, and DALYs versus CTP of 5.4%, 11.5%, and 5.7%, respectively. SLGS and FCC were associated with improvements in clinical outcomes versus CTP, but smaller improvements than those associated with SPC. Conclusions: Over 10 years, combination therapies (including SPC and FCC) were projected to reduce the burden of hypertension compared with conventional management approaches in Italy. Due to higher adherence, SPC was associated with the greatest overall benefits versus other regimens