TOPLINE

Patients with heart failure with reduced ejection fraction (HFrEF) who used a customized polypill for quadruple guideline-directed medical therapy had higher adherence to medication, took fewer pills, and found the therapy acceptable and feasible compared with those who used separate tablets, according to a brief report published in JACC: Heart Failure.

METHODOLOGY

• Researchers conducted an open‑label randomized pilot trial (COMBO-HF-X) to assess whether a customizable over‑encapsulated polypill improved adherence compared with individual tablets in patients with HFrEF.
• Thirty-five adults with HF and EF less than 50% were enrolled at a San Francisco hospital between February and July of 2024. The median age was 54 years, and 71% were men.
• Patients were randomly assigned to receive quadruple guideline-directed medical therapy either as separate tablets or as a customized polypill for 1 month and were then switched to the alternate format for another month.
• A community pharmacy partner over-encapsulated each polypill with personalized doses of four core HF drugs — a beta‑blocker, a mineralocorticoid receptor antagonist, an SGLT2 inhibitor, and an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor — and added other heart medicines if the capsule size allowed.
• The primary outcome was overall adherence at 1 month, estimated by counting pills and calculating the mean proportion taken for each drug class. Other endpoints included feasibility, acceptability, safety events, and exploratory clinical outcomes.

TAKEAWAY

• Twenty-seven patients completed the study. The overall rate of adherence was higher for the polypill than for separate tablets (83.3% vs 74.6%), corresponding to a difference of 8.7% (P < .001).
• Use of the polypill reduced total daily pill burden by 3.4 and improved the treatment satisfaction convenience score by 20.1 points compared with use of individual tablets (P < .001 for both).
• The polypill was highly acceptable to patients, with 93% wanting to continue using it long term. The pharmacy took an average of 27 minutes to prepare a 1-month supply at a cost of $60.
• Rates of serious adverse events and overall adverse events did not differ significantly between the two arms.

IN PRACTICE

“Recent advances, such as automated over-encapsulation and pharmaceutical 3D printing, could increase the potential of this strategy to be brought to scale,” the researchers wrote.

SOURCE

The study was led by Colette DeJong, MD, VA Palo Alto Health Care System in Palo Alto, California, and Matthew S. Durstenfeld, MD, MAS, Los Angeles David Geffen School of Medicine in Los Angeles. It was published online on July 10 as a brief report in JACC: Heart Failure.

LIMITATIONS

The trial had a short duration and a small sample size. Researchers relied on pill counts to assess adherence.

DISCLOSURES

The study received support from a University of California San Francisco (UCSF) CAPS-HIV innovative grant, the UCSF Center for AIDS Research, a UCSF award, and the National Center for Advancing Translational Sciences, National Institutes of Health (NIH). Several authors reported receiving grants from NIH, and receiving consulting fees, research funding, travel support, and honoraria from pharmaceutical or device companies. Two authors reported plans to file patents for a HF polypill. One author reported their spouse’s employment and stock ownership in a cardiac monitoring device firm. Detailed information is available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.