1 research outputs found
Aliskiren, enalapril, or aliskiren and enalapril in heart failure
BACKGROUND
Among patients with chronic heart failure, angiotensin-converting–enzyme (ACE)
inhibitors reduce mortality and hospitalization, but the role of a renin inhibitor in
such patients is unknown. We compared the ACE inhibitor enalapril with the renin
inhibitor aliskiren (to test superiority or at least noninferiority) and with the combination
of the two treatments (to test superiority) in patients with heart failure
and a reduced ejection fraction.
METHODS
After a single-blind run-in period, we assigned patients, in a double-blind fashion,
to one of three groups: 2336 patients were assigned to receive enalapril at a dose
of 5 or 10 mg twice daily, 2340 to receive aliskiren at a dose of 300 mg once
daily, and 2340 to receive both treatments (combination therapy). The primary
composite outcome was death from cardiovascular causes or hospitalization for
heart failure.
RESULTS
After a median follow-up of 36.6 months, the primary outcome occurred in 770
patients (32.9%) in the combination-therapy group and in 808 (34.6%) in the
enalapril group (hazard ratio, 0.93; 95% confidence interval [CI], 0.85 to 1.03). The
primary outcome occurred in 791 patients (33.8%) in the aliskiren group (hazard
ratio vs. enalapril, 0.99; 95% CI, 0.90 to 1.10); the prespecified test for noninferiority
was not met. There was a higher risk of hypotensive symptoms in the combination-therapy
group than in the enalapril group (13.8% vs. 11.0%, P=0.005), as
well as higher risks of an elevated serum creatinine level (4.1% vs. 2.7%, P=0.009)
and an elevated potassium level (17.1% vs. 12.5%, P<0.001).
CONCLUSIONS
In patients with chronic heart failure, the addition of aliskiren to enalapril led to
more adverse events without an increase in benefit. Noninferiority was not shown
for aliskiren as compared with enalapri