Abstract 474: Efficacy and Safety of LCZ696 Compared with Olmesartan in Japanese Patients with Systolic Hypertension

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Objective: To evaluate the efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI) vs olmesartan in Japanese patients with systolic hypertension (SH). Methods: Patients aged ≥20 yrs with mean sitting (ms) SBP ≥150-<180 mmHg were randomized to once-daily LCZ696 200 mg or 400 mg (forced-titrated from 1-week LCZ696 200 mg), or olmesartan 20 mg for 8 weeks. The primary objective of this study was to test if LCZ696 200 mg is superior over olmesartan in msSBP reductions from baseline at week 8. Secondary endpoints were reductions in msSBP with LCZ696 400 mg, reductions in msDBP and ms pulse pressure (PP), BP control rate, and safety for all treatment groups at week 8. Efficacy and safety was also assessed by age (<65 and ≥65 years). Results: A total of 1161 patients (LCZ696 200 mg, n=387; LCZ696 400 mg, n=385; olmesartan, n=389) were randomized. Demographic and baseline characteristics were generally comparable across the treatment groups with mean age of 58.7 yrs (<65 yrs, 771 [67.1%]; ≥65 yrs, 382[32.9%]). The msSBP reductions at week 8 with LCZ696 200 mg were statistically significantly superior to olmesartan and significantly greater with LCZ696 400 mg than olmesartan (Table). Reductions in msDBP and msPP were significantly greater and BP control rates were significantly higher with LCZ696 vs olmesartan. Greater BP and PP lowering with LCZ696 vs olmesartan was independent of age. The incidence of AEs was similar across the treatment and age groups. Conclusion: Treatment with LCZ696 is effective and generally well-tolerated in Japanese patients with SH regardless of age and LCZ696 200 mg showed superior BP lowering effect than olmesartan 20 mg.