Reconsidering the Polypill for Management of Cardiovascular Risk Factors in Underserved Patients

Abstract

Purpose of Review

The recent publication of “Polypill for Cardiovascular Disease Prevention in an Underserved Population” study prompts a thoughtful review of known care disparities in cardiovascular disease management in underserved patients. A polypill approach as a population health solution to this complex problem should also be reviewed.

Recent Findings

Muñoz and colleagues open-label, randomized controlled trial of polypill vs. usual care was undertaken in minority patients at a federally qualified health center. The polypill, containing atorvastatin, amlodipine, losartan, and hydrochlorothiazide resulted in statistically significant improvements in systolic blood pressure and low-density lipoprotein levels (p = 0.003 and p < 0.001, respectively).

Summary

The significant results of this study demonstrate the ability of a polypill approach to safely lower blood pressure, lipids, and thus estimated 10-year risk of CVD and are consistent with findings observed in previous literature. Uniquely, findings in a largely non-Hispanic Black patient population, offer an opportunity to examine this approach to combat important disparities in care in an underserved U.S. community. Further outcomes-based studies are warranted to explore the validity of these results and long-term safety of polypill treatment and are likely necessary prior to FDA approval and availability of a polypill product.

This is a preview of subscription content, access via your institution.

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. 1.•

    Munoz, D., et al., Polypill for Cardiovascular Disease Prevention in an Underserved Population. N Engl J Med, 2019. 381(12): p. 1114–1123. This randomized, open-label study offered a population health approach to lowering cardiovascular risk in an underserved U.S. Cohort. Utilizing a polypill is a novel, but not new strategy now proven to improve adherence, blood pressure, and cholesterol as a means of tackling this important care disparity.

  2. 2.

    Mouton CP, Hayden M, Southerland JH. Cardiovascular health disparities in underserved populations. Prim Care. 2017;44(1):e37–71.

    Article  Google Scholar 

  3. 3.

    Mensah GA, Wei GS, Sorlie PD, Fine LJ, Rosenberg Y, Kaufmann PG, et al. Decline in cardiovascular mortality: possible causes and implications. Circ Res. 2017;120(2):366–80.

    CAS  Article  Google Scholar 

  4. 4.

    Mensah GA, Cooper RS, Siega-Riz AM, Cooper LA, Smith JD, Brown CH, et al. Reducing cardiovascular disparities through community-engaged implementation research: a National Heart, Lung, and Blood Institute workshop report. Circ Res. 2018;122(2):213–30.

    CAS  Article  Google Scholar 

  5. 5.

    Wall HK, Ritchey MD, Gillespie C, Omura JD, Jamal A, George MG. Vital signs: prevalence of key cardiovascular disease risk factors for million hearts 2022 - United States, 2011-2016. MMWR Morb Mortal Wkly Rep. 2018;67(35):983–91.

    Article  Google Scholar 

  6. 6.••

    Carnethon, M.R., et al., Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association. Circulation, 2017. 136(21): p. e393-e423. This important statement highlights how population-wide improvements in cardiovascular outcomes has not been seen in African Americans. Authors call for researchers, clinicians and all stakeholders to develop population-health strategies to address this care disparity.

  7. 7.

    Jacobson TA, Maki KC, Orringer CE, Jones PH, Kris-Etherton P, Sikand G, et al. National Lipid Association Recommendations for patient-centered Management of Dyslipidemia: part 2. J Clin Lipidol. 2015;9(6 Suppl):S1–122 e1.

    Article  Google Scholar 

  8. 8.

    in Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. 2016: Hyattsville (MD).

  9. 9.

    Sulaica EM, Wollen JT, Kotter J, Macaulay TE. A review of hypertension management in black male patients. Mayo Clin Proc. 2020;95:1955–63.

    Article  Google Scholar 

  10. 10.

    Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6–e245.

    PubMed  Google Scholar 

  11. 11.

    Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381–98.

    Article  Google Scholar 

  12. 12.

    Schultz WM, Kelli HM, Lisko JC, Varghese T, Shen J, Sandesara P, et al. Socioeconomic status and cardiovascular outcomes: challenges and interventions. Circulation. 2018;137(20):2166–78.

    Article  Google Scholar 

  13. 13.

    Arnett MJ, Thorpe RJ Jr, Gaskin DJ, Bowie JV, LaVeist TA. Race, medical mistrust, and segregation in primary care as usual source of care: findings from the exploring health disparities in integrated communities study. J Urban Health. 2016;93(3):456–67.

    CAS  Article  Google Scholar 

  14. 14.

    Naderi SH, Bestwick JP, Wald DS. Adherence to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients. Am J Med. 2012;125(9):882–7 e1.

    Article  Google Scholar 

  15. 15.

    Magnani JW, Mujahid MS, Aronow HD, Cené CW, Dickson VV, Havranek E, et al. Health literacy and cardiovascular disease: fundamental relevance to primary and secondary prevention: a scientific statement from the American Heart Association. Circulation. 2018;138(2):e48–74.

    Article  Google Scholar 

  16. 16.

    Ferdinand KC, Yadav K, Nasser SA, Clayton-Jeter HD, Lewin J, Cryer DR, et al. Disparities in hypertension and cardiovascular disease in blacks: the critical role of medication adherence. J Clin Hypertens (Greenwich). 2017;19(10):1015–24.

    Article  Google Scholar 

  17. 17.

    Campbell DJ, et al. Financial barriers and adverse clinical outcomes among patients with cardiovascular-related chronic diseases: a cohort study. BMC Med. 2017;15(1):33.

    Article  Google Scholar 

  18. 18.

    Mukherjee D, Fang J, Chetcuti S, Moscucci M, Kline-Rogers E, Eagle KA. Impact of combination evidence-based medical therapy on mortality in patients with acute coronary syndromes. Circulation. 2004 Feb 17;109(6):745–9.

    Article  Google Scholar 

  19. 19.

    Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003;326(7404):1419–0.

    CAS  Article  Google Scholar 

  20. 20.

    Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2019;140(11):e596–646.

    PubMed  PubMed Central  Google Scholar 

  21. 21.

    Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):1036–46.

    CAS  Article  Google Scholar 

  22. 22.

    Group, A.S.C, et al. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529–39.

    Article  Google Scholar 

  23. 23.

    McNeil JJ, et al. Effect of aspirin on all-cause mortality in the healthy elderly. N Engl J Med. 2018;379(16):1519–28.

    CAS  Article  Google Scholar 

  24. 24.

    Clarke R, Halsey J, Lewington S, Lonn E, Armitage J, Manson JE, et al. Effects of lowering homocysteine levels with B vitamins on cardiovascular disease, cancer, and cause-specific mortality: meta-analysis of 8 randomized trials involving 37 485 individuals. Arch Intern Med. 2010;170(18):1622–31.

    CAS  Article  Google Scholar 

  25. 25.

    Dicpinigaitis PV. Angiotensin-converting enzyme inhibitor-induced cough: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 Suppl):169S–73S.

    CAS  Article  Google Scholar 

  26. 26.

    Roshandel G, Khoshnia M, Poustchi H, Hemming K, Kamangar F, Gharavi A, et al. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet. 2019;394(10199):672–83.

    CAS  Article  Google Scholar 

  27. 27.

    Mendez-Garcia LA, et al. Six month Polypill therapy improves lipid profile in patients with previous acute myocardial infarction: the heart-Mex study. Arch Med Res. 2019;50(4):197–206.

    CAS  Article  Google Scholar 

  28. 28.

    Castellano JM, Verdejo J, Ocampo S, Rios MM, Gómez-Álvarez E, Borrayo G, et al. Clinical effectiveness of the cardiovascular Polypill in a real-life setting in patients with cardiovascular risk: the SORS study. Arch Med Res. 2019;50(1):31–40.

    Article  Google Scholar 

  29. 29.

    Roy A, Naik N, Srinath Reddy K. Strengths and limitations of using the Polypill in cardiovascular prevention. Curr Cardiol Rep. 2017;19(5):45.

    Article  Google Scholar 

  30. 30.

    Webster R, Patel A, Selak V, Billot L, Bots ML, Brown A, et al. Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk: a prospective, individual patient data meta-analysis of 3140 patients in six countries. Int J Cardiol. 2016;205:147–56.

    Article  Google Scholar 

  31. 31.

    DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200–9.

    Article  Google Scholar 

  32. 32.

    Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the Management of Blood Cholesterol: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J Am Coll Cardiol. 2019;73(24):3168–209.

    Article  Google Scholar 

  33. 33.

    Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, et al. A cluster-randomized trial of blood-pressure reduction in black barbershops. N Engl J Med. 2018;378(14):1291–301.

    Article  Google Scholar 

  34. 34.

    Liu H, Massi L, Laba TL, Peiris D, Usherwood T, Patel A, et al. Patients' and providers' perspectives of a polypill strategy to improve cardiovascular prevention in Australian primary health care: a qualitative study set within a pragmatic randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2015;8(3):301–8.

    Article  Google Scholar 

  35. 35.

    Munoz D, Wang TJ. The Polypill revisited: why we still need population-based approaches in the precision medicine era. Circulation. 2019;140(22):1776–8.

    Article  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Tracy E. Macaulay.

Ethics declarations

Conflict of Interest

The authors declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This article is part of the Topical Collection on Ischemic Heart Disease

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Macaulay, T.E., Sheridan, E. & Ward, S. Reconsidering the Polypill for Management of Cardiovascular Risk Factors in Underserved Patients. Curr Cardiol Rep 23, 19 (2021). https://doi.org/10.1007/s11886-021-01448-9

Download citation

Keywords

  • Cardiovascular disease
  • Risk modification
  • Population health
  • Polypill
  • Hypertension
  • Underserved
  • Social determinants of health