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The proposed topic for this review is the effectiveness of a fixed-dose combination therapy, also known as the polypill, for secondary prevention of cardiovascular disease. The specific therapy combination of interest includes aspirin,…

NOMINATED TOPIC | October 31, 2016
Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

The proposed topic for this review is the effectiveness of a fixed-dose combination therapy, also known as the polypill, for secondary prevention of cardiovascular disease. The specific therapy combination of interest includes aspirin, cholesterol management, and blood pressure-lowering medications, in a single pill. This proposed assessment of the polypill should focus on the polypill s effectiveness for increasing medication adherence among patients with cardiovascular disease; improving clinical outcomes, which would include decreases in blood pressure and cholesterol and cardiovascular events; and reducing medication costs for patients.

While the Food and Drug Administration has not yet regulated polypills, they recognize a fixed-dose combination as a formulation comprising of at least two active pharmaceutical ingredients (APIs) available on the market as single entity products.1 While there remains no uniform definition of a polypill, the combination of aspirin, cholesterol management, and blood pressure-lowering medications into a single fixed-dose combination pill has been proposed as a complementary care strategy in the prevention of cardiovascular disease.2

Individuals living with cardiovascular disease or those who had a cardiac event would greatly benefit from a fixed-dose combination of aspirin, blood pressure lowering and cholesterol management treatments in a single pill. Among this patient population, the specific health-related benefits of interest include improving medication adherence, lowering the cost of medications for patients by using a single pill, improving blood pressure and cholesterol levels and ultimately, a reduction in cardiovascular events.

  1. Mogielnicki M, Swieczkowski D, Bachorski W, Zuk G, Gilis-Malinowska N, Zarzeka A, et al.; The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) perspective on cardiovascular Polypill: A multidimensional concept. Cardiol J. 2016;23(5):515-17.
  2. Lafeber M, Spiering W, Visseren FL, Grobbee DE. Multifactorial Prevention of Cardiovascular Disease in Patients with Hypertension: the Cardiovascular Polypill. Curr Hypertens Rep. 2016;18(5):40.
Describe why this topic is important.

Cardiovascular disease is one of the leading causes of death in the United States. Heart attacks and strokes are responsible for 1 of every 3 deaths in the country. Thus, managing the risk factors for cardiovascular disease is important, especially in secondary prevention because about 30% of all events are recurrent.3,4 Patients living with cardiovascular disease are often on several medications, including aspirin, cholesterol management, and blood pressure-lowering agents, all of which have been shown to reduce cardiovascular events.4,5,6 Yet, evidence has shown a decreased effectiveness of secondary prevention of cardiovascular disease, which may be due to inadequate prescription of medication, poor adherence to treatment, limited availability of medications, and unaffordable costs of treatment.7 Thus, it is important to understand different approaches for optimizing cardiovascular risk factor management for secondary prevention. The polypill is a proposed approach for addressing the issues in secondary prevention of cardiovascular disease and could prove effective to improving cardiovascular disease outcomes, warranting additional evidence such as this review. 3. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, et al.; Heart disease and stroke statistics

2014 update. a report from the American Heart Association. Circulation. 2014;29(3):e28 292. 4. Hedner T, Kjeldsen SE, Narkiewicz K, Oparil S. The polypill: an emerging treatment alternative for secondary prevention of cardiovascular disease. Blood Press. 2016;25(5):276-9. 5. Task Force for the management of arterial hypertension of the European Society of Hypertension; Task Force for the management of arterial hypertension of the European Society of Cardiology. 2013 ESH/ESC Guidelines for the Management of Arterial Hypertension. Blood Press. 2013;22(4):193 278. 6. Kjeldsen SE, Narkiewicz K, Oparil S, Hedner T. 2013 European Society of Hypertension/European Society of Cardiology Hypertension Guidelines. Blood Press. 2013;22(4):191 2. 7. Kolte D, Aronow WS, Banach M. Polypills for the prevention of Cardiovascular diseases. Expert Opin Investig Drugs. 2016;25(11):1255-64.

How will an answer to your research question be used or help inform decisions for you or your group?

Million Hearts is a US Department of Health and Human Services initiative co-led by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, with the goal of preventing one million heart attacks and strokes within 5 years. To achieve this goal, Million Hearts has worked to improve access to effective care, focus clinical attention to the prevention of heart attack and stroke, and improve the prescription and adherence to appropriate medications. Additionally, Million Hearts aims to improve care for people who need treatment by encouraging a targeted focus on the the ABCS of heart health- Aspirin when appropriate, Blood pressure control, Cholesterol management, and Smoking cessation. A polypill which includes a combination of aspirin, cholesterol management, and blood pressure-lowering medications would help address some of the key tenants of Million Hearts . The polypill is an emerging area in medicine that requires additional research and scientific evidence, but could prove to be an effective strategy for secondary prevention of cardiovascular disease and be more cost-effective compared to taking many medications to address cardiovascular disease risk factors. The results of a comparative effectiveness review on the clinical and economic effectiveness of the polypill will help Million Hearts , clinicians, and health care purchasers understand if this treatment method is useful in reducing cardiovascular events and controlling risk factors such as high blood pressure and high cholesterol.

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Page last reviewed November 2017
Page originally created October 2016

Internet Citation: The proposed topic for this review is the effectiveness of a fixed-dose combination therapy, also known as the polypill, for secondary prevention of cardiovascular disease. The specific therapy combination of interest includes aspirin,…. Content last reviewed November 2017. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.
https://effectivehealthcare.ahrq.gov/get-involved/nominated-topics/the-proposed-topic-for-this-review-is-the-effectiveness-of-a-fixed-dose-combination-therapy-also-known-as-the-polypill-for-secondary-prevention-of-cardiovascular-disease-the-specific-therapy-combination-of-interest-includes-

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