A novel three-in-one medication known as a “polypill” has been put to the test in a trial of more than 200 heart failure patients, in an effort to find a new way to effectively treat the condition with fewer drugs and better health outcomes. The findings were just what the scientists had hoped for.
In a randomized clinical trial led by UT Southwestern Medical Center researchers, 212 patients with heart failure received either the polypill or the multiple drugs separately and were monitored for six months. The participants had an average age of 54 years and 78% male (54% black, 33% Hispanic).
What’s more, more than two-thirds of the patients were either uninsured or relied on healthcare programs, which can make affording multiple daily medicines for one condition a financial challenge – as well as a logistical one.
In an effort to improve adherence the team combined the guideline medications into a single daily pill.
“Despite the existence of medical therapies for heart failure that significantly reduce hospitalization and mortality, use of these treatments remains low,” says lead author Ambarish Pandey, M.D., Associate Professor at UT Southwestern.
“Adults with heart failure and left ventricular ejection fraction ≤40% were randomized to a once-daily polypill containing metoprolol succinate (25/50/100/150 mg), spironolactone 12.5 mg and empagliflozin 10 mg, or rapid uptitration of individual guideline-directed medical therapy medications (‘enhanced usual care’),” the researchers write. “Participants also continued treatment with a renin-angiotensin system inhibitor or sacubitril/valsartan as a separate pill.”
As they note here, researchers provided the polypill in several different formulations, allowing doctors to vary doses. The non-polypill group took each drug separately.
At the end of the six months, those taking the polypill had a significant improvement in heart function (3.3 percentage points) in left ventricular ejection fraction (LVEF), compared to the cohort of patients on the separate pill regimen. Essentially, LVEF gauges the percentage of blood the left ventricle pumps out of the organ on each beat. A healthy heart ejects 50-70% of its blood content each beat, but it can drop below 35% in heart failure.
The trial also confirmed that taking the one pill a day was easier to adhere to than having to remember multiple medications – at 79% compared to 54% for the group assigned individual drugs.
And, by six months, 97% of polypill takers were receiving the set of four recommended drug classes for the condition, compared to 78% in the other group.
One of the biggest changes was seen in the prevalence of heart failure hospitalizations and emergency visits. Patients taking the polypill experienced a 60% lower rate of hospital admissions and fewer serious side effects than the other cohort.
“Our findings in the POLY-HF trial established that a polypill strategy offers a realistic path to helping patients achieve and maintain optimal therapy for heart failure, a setting where single-pill approaches had not previously been tested,” says Pandey.
Heart failure currently affects more than six million Americans. And nearly half of the patients diagnosed with it succumb to the illness within five years. And among the six million, an estimated 50% suffer from a type of heart failure due to reduced ejection fraction (HFrEF), where the left ventricle doesn’t contract effectively.
However, this study’s results deliver evidence that a polypill may be a promising treatment for those with HFrEF. It offers a simpler and potentially more cost-effective way of adhering to daily medicine intake and, in turn, reduces the risk of serious events.
“For decades we’ve had medications that meaningfully extend and improve the lives of heart failure patients, yet most people never receive them at the right doses,” says senior author Thomas J. Wang, M.D., Dean of the University of Michigan Medical School. “POLY-HF shows that simplifying how these drugs are delivered can close that gap, and the principle could extend to many other conditions that depend on complex daily regimens.”
The study was published in the journal Nature Medicine.
Source: UT Southwestern
