LCZ696 (Japanese adopted name: sucabitril
valsartan sodium hydrate), a first-in-class
angiotensin receptor neprilysin inhibitor, concomitantly inhibits
neprilysin and blocks
angiotensin type 1 receptor. This randomized, double-blind, placebo-controlled study, the first in Asia for this
drug, evaluated the dose-related efficacy and safety of
LCZ696 in patients with
hypertension using 24-hour ambulatory blood pressure (BP) monitoring. Asian patients aged ≥18 years (n=389) with
hypertension were randomized to receive
LCZ696 100 mg (n=100), 200 mg (n=101), 400 mg (n=96), or placebo (n=92) for 8 weeks. The primary end point was mean difference across the 3 single-dose pairwise comparisons of
LCZ696 versus placebo in clinic diastolic BP after 8-week treatment. Key secondary efficacy variables included changes in clinic systolic BP and pulse pressure and changes in 24-hour, daytime, and nighttime ambulatory BPs and pulse pressure. Safety assessments included recording all adverse events and serious adverse events. A total of 362 patients completed the study. Reductions in clinic systolic BP, diastolic BP (P<0.0001), and pulse pressure (P<0.001) were significantly greater with all doses of
LCZ696 than with placebo. There were also significant reductions in 24-hour, daytime, and nighttime ambulatory systolic BP, diastolic BP, and pulse pressure for all doses of
LCZ696 compared with placebo (P<0.0001).
LCZ696 was well tolerated, and no cases of
angioedema were reported. In conclusion,
LCZ696 is effective for the treatment of
hypertension in Asian population and, in general, is safe and well tolerated. Clinical Trial Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01193101.