Prototyping and Manufacturing of Customized Over-Encapsulated Polypills for Heart Failure With Reduced Ejection Fraction in a Safety-Net Health Care System

Colette Dejong¹, Matthew S Durstenfeld², Jonathan D Davis², Christina S Wang³, Justin C Chen⁴, Dhruv S Kazi⁵, Matthew D Hickey⁶, Janet Grochowski⁶, Wayne T Steward⁷, Elise D Riley⁷, Lucas S Zier⁸, Niloufar Moreau³, Mark D Huffman⁹, Alexander T Sandhu¹⁰, Paul A Heidenreich¹⁰, Anubha Agarwal¹¹, Priscilla Y Hsue¹²

Affiliations

¹ VA Palo Alto Health Care System, Palo Alto, CA; Division of Cardiology, Stanford University School of Medicine, Palo Alto, CA. Electronic address: cdejong@stanford.edu.
² Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA.
³ Division of Pharmacy, Zuckerberg San Francisco General Hospital, San Francisco, San Francisco, CA.
⁴ Division of Cardiology, Washington University School of Medicine in St. Louis, St. Louis, MO.
⁵ Richard A. and Susan F. Smith Center for Outcomes Research, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.
⁶ Division of HIV, Infectious Disease, and Global Medicine, University of California, San Francisco, San Francisco, CA.
⁷ Division of Prevention Science, Department of Medicine, University of California, San Francisco, CA.
⁸ Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA; Division of Clinical Informatics and Digital Transformation, University of California, San Francisco, San Francisco, CA.
⁹ Cardiovascular Division and Global Health Center, Washington University School of Medicine in St. Louis, St. Louis, MO; The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
¹⁰ VA Palo Alto Health Care System, Palo Alto, CA; Division of Cardiology, Stanford University School of Medicine, Palo Alto, CA.
¹¹ Cardiovascular Division and Global Health Center, Washington University School of Medicine in St. Louis, St. Louis, MO.
¹² Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.

PMID: 40169092
PMCID: PMC12516335
DOI: 10.1016/j.cardfail.2025.01.030

Prototyping and Manufacturing of Customized Over-Encapsulated Polypills for Heart Failure With Reduced Ejection Fraction in a Safety-Net Health Care System

Colette Dejong et al. J Card Fail. 2025 May.

. 2025 May;31(5):868-871.

doi: 10.1016/j.cardfail.2025.01.030. Epub 2025 Mar 30.

Authors

Affiliations

¹ VA Palo Alto Health Care System, Palo Alto, CA; Division of Cardiology, Stanford University School of Medicine, Palo Alto, CA. Electronic address: cdejong@stanford.edu.
² Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA.
³ Division of Pharmacy, Zuckerberg San Francisco General Hospital, San Francisco, San Francisco, CA.
⁴ Division of Cardiology, Washington University School of Medicine in St. Louis, St. Louis, MO.
⁵ Richard A. and Susan F. Smith Center for Outcomes Research, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.
⁶ Division of HIV, Infectious Disease, and Global Medicine, University of California, San Francisco, San Francisco, CA.
⁷ Division of Prevention Science, Department of Medicine, University of California, San Francisco, CA.
⁸ Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA; Division of Clinical Informatics and Digital Transformation, University of California, San Francisco, San Francisco, CA.
⁹ Cardiovascular Division and Global Health Center, Washington University School of Medicine in St. Louis, St. Louis, MO; The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
¹⁰ VA Palo Alto Health Care System, Palo Alto, CA; Division of Cardiology, Stanford University School of Medicine, Palo Alto, CA.
¹¹ Cardiovascular Division and Global Health Center, Washington University School of Medicine in St. Louis, St. Louis, MO.
¹² Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.

PMID: 40169092
PMCID: PMC12516335
DOI: 10.1016/j.cardfail.2025.01.030

No abstract available

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Conflict of interest statement

Disclosures CD's spouse is employed by and holds stock in iRhythm Technologies. MDH (Huffman) has received travel support from the World Heart Federation and has an appointment at The George Institute for Global Health, which has a patent and license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH (Huffman) and AA plan to submit patents for heart failure with reduced ejection fraction polypills. PYH has received honoraria from Gilead, Merck and Pfizer, unrelated to this study. ATS has consulted for Lexicon Pharmaceuticals and has research funding from Novartis Pharmaceuticals and Reprieve Cardiovascular unrelated to this study.

Figures

**Fig. 1.**
Prototypes of customized polypills for heart failure with reduced ejection fraction. ACEi, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor-neprilysin inhibitor; BB, beta-blocker; DOAC, direct oral anticoagulant; GDMT, guideline-directed medical therapy; HFrEF, heart failure with reduced ejection fraction; metoprolol XL, metoprolol succinate; MRA, mineralocorticoid receptor antagonist; SGLT2, sodium-glucose cotransporter-2. *Doses are listed from left to right. For generic medications, sample tablets are shown; size varies by manufacturer. **Half-tablets of sacubitril/valsartan 49/51mg and 97/103 mg were substituted for doses of 24/26 mg and 49/51 mg, respectively.

See this image and copyright information in PMC

References

1. Mastromarino V, Casenghi M, Testa M, Gabriele E, Coluccia R, Rubattu S, et al. Polypharmacy in heart failure patients. Curr Heart Fail Rep 2014;11(2):212–9. 10.1007/s11897-014-0186-8. - DOI - PubMed
1. Agarwal A, Yancy CW, Huffman MD. Improving care for heart failure with reduced ejection fraction—a potential polypill-based strategy. JAMA 2020;324(22):2259–60. 10.1001/jama.2020.21395. - DOI - PubMed
1. Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, et al. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): rationale and design for a randomized controlled trial. Am Heart J 2022;254:183–93. 10.1016/j.ahj.2022.09.004. - DOI - PMC - PubMed
1. Muñoz D, Uzoije P, Reynolds C, Miller R, Walkley D, Pappalardo S, et al. Polypill for cardiovascular disease prevention in an underserved population. NEJM 2019;381(12):1114–23. 10.1056/NEJMoa1815359. - DOI - PMC - PubMed
1. Chen JC, DeJong C, Agarwal M, Hairston AM, Durstenfeld MS, McKay V, et al. Stakeholder perspectives on a heart failure with reduced ejection fraction polypill: a multicenter mixed methods study. Circ: Cardiovasc Qual Outcomes 2024. Nov;17(11):e011121. - PMC - PubMed

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Prototyping and Manufacturing of Customized Over-Encapsulated Polypills for Heart Failure With Reduced Ejection Fraction in a Safety-Net Health Care System

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Prototyping and Manufacturing of Customized Over-Encapsulated Polypills for Heart Failure With Reduced Ejection Fraction in a Safety-Net Health Care System

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Conflict of interest statement

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