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ACSM'S Health & Fitness Journal:
doi: 10.1249/FIT.0b013e3181bcd79d
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Cardiovascular Disease: Using a Polypill, Lifestyle Modification, or a Combined Approach to Reducing Overall Risk

deJong, Adam M.A., FACSM

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Adam deJong, M.A., FACSM, is the assistant director of Preventive Cardiology and Rehabilitation at William Beaumont Hospital in Royal Oak, MI. He is also a faculty lecturer in the School of Health Sciences at Oakland University in Rochester, MI.

Cardiovascular disease continues to be a significant health issue, contributing to more deaths than any other disease in developed countries while becoming the leading cause of death in developing countries worldwide (26). Although the risk factors for cardiovascular disease are well known, they remain poorly controlled in the United States (14), leading to increased costs for treatment (1). It has been estimated that nine risk factors, including smoking, hypertension, diabetes mellitus, obesity, poor dietary patterns, physical inactivity, alcohol consumption, elevated blood apolipoprotein levels, and psychosocial factors, account for approximately 90% of population-attributed risk for cardiovascular disease (27). These associations are even more striking in young people, further highlighting the preventability of cardiovascular disease (27). In fact, Chiuve and associates (7) estimated that 62% of all coronary events could be avoided if all men adhered to a low-risk lifestyle that included smoking abstinence, regular exercise, healthy diet, moderate alcohol intake, and the maintenance of a healthy weight.

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USE OF A PROPOSED POLYPILL FOR REDUCING CARDIOVASCULAR DISEASE

In 2003, Wald and Law (24) proposed a strategy to reduce the incidence of cardiovascular disease events by 80%. This strategy used combination pharmacotherapy, or a polypill, aimed at simultaneously lowering three cardiovascular risk factors (low-density lipoprotein cholesterol, hypertension, and platelet function). This polypill, which included a statin (to lower cholesterol), three blood pressure-lowering drugs (a thiazide, a β-blocker, and an angiotensin-converting enzyme inhibitor), folic acid (to reduce homocysteine), and low-dose aspirin, was theorized to be safe for widespread use and would have a greater impact on disease prevention than any other single intervention in the western world (24).

In previous studies, all components of the polypill, with the exception of folic acid, have been individually shown to decrease cardiovascular events by 20% to 35% in both primary and secondary prevention programs (8). In fact, half of the reduction in cardiovascular mortality seen during the past 30 years in developed countries can be attributed to medical therapy (9). However, current medical therapy, which includes individualized medications aimed at specific risk factors, is associated with significant levels of medication discontinuation rates and adherence problems (3,5,16). It is felt that by combining all of the necessary ingredients to reduce cardiovascular risk into one pill, an improvement in compliance and adherence to the medication would be noted (20).

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A randomized controlled trial, The Indian Polycap Study, evaluated the effectiveness of a polypill on simultaneously lowering cardiovascular risk factors (22). The authors concluded that the Polycap therapy decreased cardiovascular risk by 27% and stroke risk by 8%. Although these improvements are significant, they represent changes that are slightly less than those achieved by using statin or aspirin therapy alone (22). In addition, these proposed benefits are significantly less than those projected by Wald and Law (24). However, regardless of the comparative improvements, the reduction of risk found by using a polypill in apparently healthy individuals or diseased populations would still provide a dramatic step in reducing deaths associated with cardiovascular disease.

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LIFESTYLE MODIFICATION AS AN ANSWER TO THE POLYPILL

Opponents to the polypill concept have some concerns regarding the preventive strategy. In particular, they cite a lack of randomized trials, the lack of attention to other major risk factors (cigarette smoking, obesity, physical inactivity), its reliance on drugs over a healthy lifestyle, and the potential cost (11). There also are concerns that various populations could be either overtreated or undertreated, depending on their initial starting risk (13), and that the use of aspirin, even at low doses, could adversely affect many to whom the drug was prescribed (13). However, the primary limitation of the polypill is its use as a first-line therapy to stabilize cardiovascular disease, which in turn diminishes the use of comprehensive lifestyle management and provides individuals with a perceived quick fix to reducing cardiovascular risk (13).

One proposed alternative to the polypill is the polymeal. The polymeal has been described as "a safer, more natural, and tastier option to the polypill, with the potential to reduce cardiovascular disease by more than 75%" (12). The polymeal includes wine, fish, dark chocolate, fruit, vegetables, garlic, and almonds, which have each been independently reported as having cardioprotective effects (12). It is proposed that regular consumption of these ingredients provides similar cardioprotective effects to the polypill, without the potential for adverse effects. Potential limiting factors to use of the polymeal are allergies to the specific food ingredients, as well as the potential for it to have a cost that is similar to or slightly higher than that of the polypill (12).

A downfall to the polypill and the polymeal is that each fails to address physical inactivity, which is a major risk factor for cardiovascular disease. Physical inactivity has been linked to more than 17 unhealthy conditions that result in approximately 250,000 premature deaths per year (6) and increases the relative risk for the development of cardiovascular disease by 1.5 to 2.4 times that found in active individuals (18). Physical activity also includes similar cardioprotective effects to those found in the polypill, including antiatheroschlerotic, psychological, antithrombotic, antiischemic, and antiarrhythmic properties (13) (see Figure). Even more encouraging is that physical inactivity does not have to be addressed through a standardized exercise program, but rather benefits can be obtained through lifestyle approaches to physical activity (i.e., walking the dog, gardening) (2,10).

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Figure. Benefits rec...
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It would seem, however, that significant benefits for reducing cardiovascular risk could result from a combined program of physical activity and dietary changes. This concept was emphasized in the PREMIER trial, which demonstrated a significant reduction in cardiovascular risk, including improvements in physical fitness, body weight, and blood pressure, from a combined dietary and exercise intervention (25). These same lifestyle interventions can have significant impact on diabetes mellitus, resulting in enhanced glucose control and weight reduction, further reducing cardiovascular risk (23).

It also has been shown that lifestyle modification and pharmacotherapy have benefits that are both independent and additive (4,15,21), indicating that perhaps the greatest benefit may be achieved through a "poly-portfolio" (19). It has been proposed that this approach could yield up to a 97% reduction in risk of dying from coronary heart disease (19). This proposal is additionally supported by data from the Lifestyle Heart Trial (17) and from a study by Barnard and colleagues (4) that found programs that include multifactorial risk reduction services using pharmacotherapy and resulted in significantly greater reductions in total cholesterol, low-density lipoprotein cholesterol, and triglycerides beyond those seen with cholesterol-lowering drugs alone. Thus, in certain populations, intensive therapy to modify risk factors using weight reduction, regular exercise, a very-low-fat diet, and lipid-lowering medication may be more beneficial in modifying cardiovascular risk than drug therapy alone, resulting in fewer deaths and revascularization procedures (21).

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FUTURE DIRECTIONS

It is apparent that lifestyle modification plays a large role in reducing cardiovascular risk. As professionals who commonly work in primary and secondary prevention roles, allied health professionals will need to work closely with referring physicians to identify those individuals who are candidates for more intensive lifestyle interventions. In addition, the educational components necessary for successful lifestyle modification and the implementation of the risk-reduction programs will fall outside of traditional medical communities and onto the responsibilities of these professionals. By implementing safe and effective exercise and educational programs aimed at reducing cardiovascular risk, the role of pharmacology may be able to be reduced, with subsequent lifestyle changes taking the forefront for improved cardiovascular health. Although the polypill may have its benefits, Franklin and associates (13) recommend a profound statement to be included with any treatment using medications, whether singly or in a polypill form. They state: "Take medication each day in the prescribed dosage, followed or preceded by 30 minutes or longer of moderate-to-vigorous physical activity, in combination with a low-fat low-cholesterol diet, weight management, and the avoidance or cessation of cigarette smoking (13)."

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References

1. American Heart Association. Heart Disease and Stroke Statistics - 2005 Update. Dallas (TX): American Heart Association; 2005.

2. Andersen RE, Wadden TA, Bartlett SJ, et al. Effects of lifestyle activity versus structured aerobic exercise in obese women: A randomized trial. JAMA. 1999:335-40.

3. Avorn J, Monette J, Lacour A, et al. Persistence of use of lipid-lowering medications: A cross-national study. JAMA. 1998;279:1458-62.

4. Barnard RJ, DiLauro SC, Inkeles SB. Effects of intensive diet and exercise intervention in patients taking cholesterol-lowering drugs. Am J Cardiol. 1997;79:1112-4.

5. Berg JS, Dischler J, Wagner DJ, Raia JJ, Palmer-Shevlin N. Medication compliance: A healthcare problem. Ann Pharmacother. 1993;27:S1-S4.

6. Booth FW, Gordon SE, Carlson CJ, Hamilton MT. Waging war on modern chronic diseases: Primary prevention through exercise biology. J Appl Physiol. 2000;88:774-87.

7. Chiuve SE, McCullough ML, Sacks FM, Rimm EB. Healthy lifestyle factors in the primary prevention of coronary heart disease among men: Benefits among users and nonusers of lipid-lowering and antihypertensive medications. Circulation. 2006;114:160-7.

8. Combination Pharmacotherapy and Public Health Research Working Group. Combination pharmacotherapy for cardiovascular disease. Ann Intern Med. 2005;143:593-9.

9. Davies AR, Smeeth L, Grundy EM. Contribution of changes in incidence and mortality to trends in the prevalence of coronary heart disease in the UK: 1996-2005. Eur Heart J. 2007;28:2142-7.

10. Dunn AL, Marcus BH, Kampert JB, et al. Comparison of lifestyle and structured interventions to increase physical activity and cardiorespiratory fitness: A randomized trial. JAMA. 1999;281:327-34.

11. Findlay S. Pill-popping replaces healthy habits. USA Today. 2004;A15.

12. Franco OH, Bonneux L, de Laet C, et al. The polymeal: A more natural, safer, and probably tastier (than the polypill) strategy to reduce cardiovascular disease by more than 75%. BMJ. 2004;329:1447-50.

13. Franklin BA, Kahn JK, Gordon NF, Bonow RO. A cardioprotective "polypill?" Independent and additive benefits of lifestyle modification. Am J Cardiol. 2004;94:162-6.

14. Glover MJ, Grerenlund KJ, Ayala C, Croft JB. Racial/ethnic disparities in prevalence, treatment, and control of hypertension - United States, 1999-2002. MMWR. 2005;54:7-9.

15. Hunninghake DB, Stein EA, Dujovne CA, et al. The efficacy of intensive dietary therapy alone or combined with lovastatin in outpatients with hypercholesterolemia. N Engl J Med. 1993;328:1213-9.

16. Monane M, Bohn RL, Gurwitz Jh, et al. The effects of initial drug choice and comorbidity on antihypertensive therapy compliance: Results from a population-based study in the elderly. Am J Hypertens. 1997;10:697-704.

17. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse heart disease? The Lifestyle Heart Trial. Lancet. 1990;336:129-33.

18. Powell KE, Thompson PD, Caspersen CJ, Kendrick JS. Physical activity and the incidence of coronary heart disease. Annu Rev Public Health. 1987;8:253-87.

19. Robinson JG, Maheshwari N. A "poly-portfolio" for secondary prevention: A strategy to reduce subsequent events by up to 97% over five years. Am J Cardiol. 2005;95:373-8.

20. Sanz G, Fuster V. Fixed-dose combination therapy and secondary cardiovascular prevention: Rationale, selection of drugs and target population. Nat Clin Pract Cardiovasc Med. 2009;6:101-10.

21. Sdringola S, Nakagawa K, Nakagawa Y, et al. Combined intense lifestyle and pharmacologic lipid treatment further reduce coronary events and myocardial perfusion abnormalities compared with usual-care cholesterol-lowering drugs in coronary artery disease. J Am Coll Cardiol. 2003;41:263-72.

22. The Indian Polycap Study Investigators. Effects of polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): A phase II, double-blind randomized trial. Lancet. 2009;373:1341-51.

23. Tuomilehto J, Lindstrom J, Eriksson JG, et al. for the Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344:1343-50.

24. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003;326:1491-6.

25. Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control. JAMA. 2003;289:2083-93.

26. Yach D, Leeder SR, Bell J, Kistnasamy B. Global chronic diseases [Editorial]. Science. 2005;307-17.

27. Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): Case control study. Lancet. 2004;364:937-52.

© 2009 American College of Sports Medicine

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