Adding aliskiren to enalapril in treating heart failure patients resulted in more adverse events but no benefit, a UK team reported.
Adding aliskiren to enalapril in drug regimens for heart failure patients resulted in more adverse events but no benefit, a UK team reported at the American College of Cardiology’s 65th Scientific Session & Expo in Chicago, IL.
Aliskiren (Tekturna/Novartis) is a renin inhibitor.
“Noninferiority was not shown for aliskiren as compared to enalapril,” John J.V McMurray, MD of the of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow said in a study presented April 4 and simultaneously published in the New England Journal of Medicine.
The study, known as ATMOSPHERE, was designed to see if patients who got the drug combo would do better than those who got only the ACE inhibitor enalapril.
There were 2,336 patients who got enalapril, 2340 who got aliskiren, and 2,340 who got both drugs.
All had an ejection fraction of 35% or less.
Overall there were 770 patients (32.9%) who got both drugs and who either died from cardiovascular disease or were hospitalized with an acute event.
There were 791 patients (33.8%) who either died or had serious events in the aliskiren group. In the enalapril group there were 808 (34.6%) patients who died or had serious events.
But at a three-year followup point, hypotension, renal dysfunction, and hyperkalemia were found to have occurred more commonly with the combination therapy than with enalapril.
In the combo drug croup, 15% of patients had hyperkalemia vs. 8.2% for aliskiren alone and 10.4% for enalapril alone.
Renal impairment was also higher (16.6% of patients) in the combo group compared to 11.9% for aliskiren and 13.1% for enalapril.
“Our findings do not support the use of a renin inhibitor as an alternative therapy to an ACE inhibitor because the pre-specified criterion for noninferiority was not met,” the team concluded.