In a new study, researchers found that omecamtiv mecarbil, a new, investigational heart drug, reduced the risk of heart failure-related events in patients with heart failure with reduced ejection fraction.
The research was conducted by a team at the University of California San Francisco.
Ejection fraction is a measurement of the proportion of blood the heart pumps out with each contraction.
Heart failure with reduced ejection fraction, or HFrEF, occurs when the left ventricle, the heart’s largest pumping chamber, loses its ability to contract normally.
The heart can’t pump with enough force to push blood into circulation. An ejection fraction of 40% or less is used to define HFrEF.
In the study, the team assessed omecamtiv mecarbil, an investigational drug that was granted “fast track” designation as a new heart failure treatment option by the U.S. Food and Drug Administration in May 2020.
Omecamtiv mecarbil binds to cardiac myosin, the protein in the heart that transforms chemical energy into mechanical work, thus powering muscle contraction.
According to the team, omecamtiv mecarbil is the first in a class of heart medicines called myotropes that selectively target cardiac muscle to improve cardiac performance.
In previous studies, it was found to improve cardiac function by increasing the effectiveness by which myosin interacts with actin, another protein involved in heart muscle contraction.
The current study focused on evaluating the effect of this potential medication on outcomes in patients with chronic heart failure.
The study enrolled more than 8,000 patients in 35 countries with chronic heart failure who were either currently hospitalized for heart failure or with a recent history of hospitalization or emergency department visit for heart failure within one year prior to screening.
Participants were predominantly male with an average age of 66 years and an average ejection fraction of 27%.
In addition: 62% had coronary artery disease; 40% had Type 2 diabetes; 70% had high blood pressure; 36% had chronic kidney disease, and 25% were hospitalized at the time of enrollment.
The team found that patients receiving omecamtiv mecarbil had less risk of experiencing a heart failure event or cardiovascular death.
The medicine had a greater effect on patients with lower ejection fraction (an indicator of more advanced heart failure).
In addition, the concentration in the blood of N-terminal B-type natriuretic peptide, a hormone that is increased with worsening heart failure, was reduced in patients treated with omecamtiv mecarbil.
There was no big difference in adverse events between patients randomized to treatment or placebo.
In addition, side effects that typically in the use of current heart failure therapies, such as adverse effects on blood pressure, heart rate, potassium levels or kidney function, were not observed.
The team says this study provides strong evidence about the efficacy and safety of this novel therapy. It will inform potential future implementation of omecamtiv mecarbil to treat chronic heart failure.
One author of the study is John R. Teerlink, M.D.
The study is published in The New England Journal of Medicine.
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