Impact of treatment strategies incorporating sacubitril/valsartan on achievement of guideline-recommended blood pressure targets and representative safety outcomes

This real-world, non-interventional, retrospective cohort study evaluated the achievement rate of guideline-recommended target blood pressure (BP) and representative safety profile of the treatment incorporating sacubitril/valsartan (Sac/Val) in Japanese patients with essential hypertension. Data were collected from electronic health records from ~4700 clinics across Japan, covering ~11.4% of the nationwide population. Of the 1405 eligible patients, 1247 were included in the effectiveness analysis. The primary endpoint investigated the proportion of patients achieving the Japanese Society of Hypertension 2019-recommended antihypertensive goals within 8 weeks of initial Sac/Val administration (index date). Secondary endpoints included description of baseline characteristics and their relative contribution to BP goal attainment, description of prescription patterns, and safety. A total of 29.8% of patients achieved individual estimated BP goals, with significant mean reductions in systolic and diastolic BPs (-15.6 mmHg and -6.1 mmHg, respectively, p < 0.0001). Patients aged ≥75 years, those with cerebrovascular disease, and those classified as Grade I hypertension were more likely to meet BP goals. Among patients with BP reduction of ≥10 mmHg, the most common prescription pattern at index date was a combination of calcium channel blocker (CCB) and Sac/Val, and a majority switched from CCB and angiotensin receptor blocker combination or were on CCB monotherapy. The most common signs of adverse events were hypotension and diuresis-related events, particularly during summer. The discontinuation rates following these signs were 1.0% and 0.8%. This real-world study demonstrated the clinical utility and representative safety profile of treatments involving Sac/Val in Japanese patients with essential hypertension.