That primary outcome occurred in 37.0% of the 4,120 participants randomly assigned to the drug compared to 39.1% of the 4,112 who got a placebo, an 8% reduction.
Despite the absolute difference of just 2.1%, the improvement was statistically significant (P=0.03), according to results unveiled at the American Heart Association (AHA) Scientific Sessions meeting and published in the New England Journal of Medicine.
The research team, led by Dr. John Teerlink of the San Francisco Veterans Affairs Medical Center, in California, characterized the difference as "modest."
Amgen, Cytokinetics and Servier paid for the study. The U.S. Food and Drug Administration gave the drug a Fast Track designation in May.
In addition to having symptomatic chronic heart failure, the participants had an ejection fraction of 35% or less. All were treated with standard heart-failure therapy. A heart-failure event was hospitalization or an urgent visit for heart failure.
The drug did not affect the odds of death from cardiovascular causes alone. The rate was 19.6% for the Amgen drug and 19.4% for placebo after a median follow-up of 21.8 months.
The treatment also seemed to produce no difference in the frequency of cardiac ischemia and ventricular arrhythmia, or in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score.
The rate of death from any cause was an identical 25.9% in both groups.
"The lack of effect on death from either cardiovascular causes or any cause is surprising" in the context of previous research, the researchers write.
The rates for first hospitalization for heart failure were 27.7% with omecamtiv mecarbil and 28.7% with placebo, a non-significant difference.
"There was no difference in the change in systolic blood pressure between baseline and 24 or 48 weeks between the omecamtiv mecarbil group and the placebo group," the researchers say.
Heart failure affects more than 23 million people worldwide and is the leading cause of hospitalization and readmissions in people 65 and older.
GALACTIC-HF was done at 945 sites in 35 countries.
The phase-3 study was undertaken after a smaller study of 448 volunteers, reported at the AHA meeting five years ago, found that omecamtiv mecarbil showed statistically significant improvements such as an increase in the volume and the percentage of blood pumped with each heartbeat, a reduction in heart rate and a decrease in the size of the heart.
By Reuters Staff
SOURCE: https://bit.ly/2UmScuT The New England Journal of Medicine, online November 13, 2020.
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