In a new study from Washington University in St. Louis, researchers found that a widely used heart failure drug named sacubitril/valsartan is no better than valsartan alone in patients with severe heart failure.
The study also provides evidence that the treatment with valsartan may be slightly safer for patients with advanced heart failure.
Heart failure is one of the leading causes of hospitalization in the United States, with about two heart failure hospitalizations occurring every minute.
It is often triggered by damage to the heart from, for example, a heart attack or a viral infection. A complex clinical syndrome, heart failure leads to increased retention of salt and water by the kidneys.
This results in a buildup of fluid in the lungs, causing shortness of breath and fatigue. The body’s response to heart damage is to activate hormonal regulatory systems that attempt to restore normal blood flow to vital organs.
Over time, these hormonal systems can lead to secondary damage to the heart and the circulation, resulting in worsening heart failure.
Most drugs used to treat heart failure block the harmful effects of high levels of compensatory hormones.
The study focused on advanced heart failure patients with reduced pumping capacity, referred to as Heart Failure with a Reduced Ejection Fraction (HFrEF).
They tested 335 patients with advanced heart failure with a reduced ejection fraction. On average, these patients’ hearts pumped only one-third of the blood volume they should have been pumping.
Such patients have chronic shortness of breath and fatigue, even at rest while receiving optimal medical therapy.
Half were assigned to receive sacubitril/valsartan along with standard medical therapy for heart failure; the other half received valsartan alone plus standard medical therapy.
The major finding was that there was no strong difference in levels of the biomarker over 24 weeks in the patients taking sacubitril/valsartan, as compared to patients receiving valsartan.
This finding was observed across all of the subgroups that were examined.
Compared with valsartan alone, the sacubitril/valsartan treatment group also did not show any improvement in the total number of days alive, days out of the hospital and days that were free from complications of heart failure.
Sacubitril/valsartan and valsartan also showed no differences in heart failure hospitalizations, deaths from cardiovascular causes or deaths from any cause.
The team says since the results of the trial did not show significant differences in favor of one treatment strategy over the other, they cannot say that valsartan is better than sacubitril/valsartan for patients with advanced heart failure.
For the most severe heart failure patients, sacubitril/valsartan does not appear to provide an advantage over valsartan, which is a generic drug that is far less expensive to use and was not associated with elevated potassium levels and thus is easier to monitor over time.
If you care about heart health, please read studies about one cup of leafy green vegetables a day can lowers your risk of heart disease and findings of this foot test can show heart rhythm disorder in people with diabetes.
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The study is published in JAMA Cardiology. One author of the study is Douglas L. Mann, MD.
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