Despite the proven efficacy of guideline-directed medical therapies for heart failure, and the fact that guideline-recommended quadruple therapy reduces mortality by 50%, real-world use remains suboptimal, particularly in disadvantaged populations, noted Ambarish Pandey from the University of Texas Southwestern Medical Center in Dallas.
This is explained by both physician inertia in uptitrating therapy and the burden of taking multiple pills for patients who are often already poly-medicated, leading to poor adherence, he explained.
A polypill approach, which combines multiple medications in a single pill, has already proven effective in cardiovascular prevention but had not yet been evaluated in heart failure. However, heart failure regimens are complex and individualized, raising the question of the potential efficacy of a fixed-dose combination.
The open-label, randomized POLY-HF trial evaluated a polypill combining metoprolol at 20, 50, 100, or 150 mg, empagliflozin (Jardiance*, Boehringer Ingelheim/Lilly) at 10 mg, and spironolactone at 12.5 mg. The three pills were encapsulated into a single capsule by an external pharmacy. This polypill was compared with the administration of the three separate pills in 212 heart failure patients with an LVEF ≤40% who were not receiving guideline-recommended target doses.
The study focused on a socially disadvantaged population, emphasized Ambarish Pandey in an AHA statement.
At six months, LVEF was significantly improved in the polypill group compared with the standard separate-pill group, reaching 39.9% versus 36.5%, according to the late-breaking science session results.
The relative risk of heart failure-related events or death was also significantly reduced by 59% in the polypill group compared with the control group.
Quality of life improved significantly with the polypill, with an increase of 8.5 points on the KCCQ-OSS compared with standard therapy.
Medication adherence was significantly higher in the polypill group, with 79.3% of patients fully adherent versus 54.3%.
Furthermore, after six months, more patients in the polypill group had undergone uptitration of their therapy and were receiving all four classes of guideline-recommended medications compared with the standard therapy group (71% vs. 42%).
Adverse events such as hyperkalemia and renal dysfunction were less frequent in the polypill group, whereas dizziness was more common. Permanent treatment discontinuation was less frequent in the polypill group.
Further studies are needed to evaluate the long-term effects of such a polypill on mortality and morbidity in heart failure patients, as well as cost-effectiveness and implementation strategies for such therapy.
“Our results provide the first evidence that a polypill can be effective in our heart failure patients,” commented Ambarish Pandey in the AHA statement.
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