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Polypill Is an Important Strategy for the Prevention of Cardiovasacular Disease Risk

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Polypill Is an Important Strategy for the Prevention of Cardiovasacular Disease Risk Debate Polypill Is an Important Strategy for the Prevention of Cardiovasacular Disease Risk Denis Xavier, MD, Alben Sigamani, MD, Deepak Y. Kamath, MD, Prem Pais, MD, Bangalore, India Cardiovascular disease burden for the population at large. This strategy is less likely to and polypill be successful in the long run, as “at risk” individuals need to change their behavior in contrast to those around While the cardiovascular disease (CVD) burden has them. decreased in developed countries, it has exponentially increased in low- and middle-income countries (LMICs). The population level approach involves the shift of the It is estimated that by 2020, 80% of the burden of CVD mean levels of risk factors exposure of entire populations will occur in LMICs (1). The decrease in developed in a favorable direction. This radical strategy has large countries has been attributed to reduction in risk factors, potential for change in the population and is considered early detection and effective care. The increase in LMICs behaviorally appropriate. A good example is the change is largely due to rapid urbanization and poor health care effected in the diet in North Karelia in the 1970s in systems. Finland (6). This strategy, although radical, is acceptable to all and does not exert pressure on individuals to The polypill, a multiconstituent combination pill change. containing blood pressure lowering agents, a statin, antiplatelet agent, and folic acid, was hypothesized to prevent 80% of cardiovascular events (2). Nine The Impact of CVD Risk Factor Modification modifiable risk factors accounted globally for over 90% There is a clear graded relationship between blood of the total population attributable risk (PAR) for an pressure (BP) and serum cholesterol with CVD. acute myocardial infarction (3) or stroke (4). Importantly, Therefore reducing BP and serum cholesterol from any CVD risk factors are ubiquitous. In the INTERHEART level has potential benefits, which is more pronounced study (3) conducted in 52 countries in all regions of the in those at higher risk (advancing age or in individuals world, 99% of the controls had at least one CVD risk with multiple risk factors) (7). factor. To contain this global pandemic, a revolutionary strategy is called for. The currently accepted strategy is to start treatments [lifestyle modification (LSM) or drugs] only over a Approaches to Prevention predetermined threshold for a risk factor. The average There are two approaches to prevention: at the individual “normal” BP and serum cholesterol have shifted and at the population levels (5). In the individual level considerably compared to known values in the past (7). approach, individuals at risk are screened and if needed This shift is clearly due to the environments people are treated. The advantage is a favorable benefit–risk ratio, living in and the prevalent lifestyle. Mortality from IHD but involves costs for screening, and has limited potential and strokes doubles with every 8 years of increasing age. There is a strong case to reduce risk factor levels well below the “normal values.” Preventive strategies must From: St. John’s Research Institute, Bangalore, India (D.X., A.S., D.Y.K., P.P.) therefore be implemented at an early age irrespective of risk factor threshold or presence of disease. Corresponding Author: Denis Xavier Professor and Head, Department of Pharmacology, St. John’s Medical College, and Division of Clinical Trials, St. John’s Research Institute, Koramangala, Bangalore 560034, India. [ 74 ] Polypill Is an Important Strategy for the Prevention of CVD Risk Debate CVD Risk Factor Modification with Lifestyle Combining drugs that act by different mechanisms to Intervention modify the same physiological parameter is an attractive option. This is because lower doses of multiple drugs that Present approaches to LSM even among motivated act through different mechanisms will have greater effect people are unlikely to bring about the required reductions with lower rates of adverse events as seen with for BP- in risk factors at the population level (8). Moreover lowering drugs (2). A systematic review demonstrated physician’s knowledge and skills on how to implement that FDCs improved adherence that in turn improved sustained changes in lifestyle are inadequate, even in outcomes in a range of settings (15). Thus it is clear that developed countries (9). taking all proven therapies in appropriate patients can result in greater reduction in CVD events and death than Do lifestyle interventions work? utilizing only some of these agents. In the Nurses’ Health Study (8) at the end of follow- up, only 3% of the 84,129 women were in the low- The polypill concept for CVD prevention risk category. A systematic review and meta-analysis For secondary prevention, Yusuf proposed a four-drug (10) evaluated the effects of LSMs through individual combination of aspirin, beta-blocker, statin, and ACEI counseling and education. The absolute reductions (95% and estimated that their use would result in a cumulative confidence interval) in systolic and diastolic BP and risk reduction of 75% in CVD events (16). Wald and Law blood cholesterol were -3.6 mmHg (-3.9, -3.3 mmHg), in 2003, after a more extensive analysis (2), proposed -2.8 mmHg (-2.9, -2.6 mmHg), and 0.07 mmol/L (-0.8, a polypill involving a six-drug combination that could 0.06 mmol/L), respectively. The pooled odds ratio for potentially reduce IHD events by 88% and stroke by risk reduction of total mortality was 0.96 (0.92, 1.01) 80%. The six-drug combination contained three BP- and that for CHD mortality was 0.96 (0.89, 1.04). This lowering drugs at half doses (thiazide, beta-blocker, and review suggests that lifestyle interventions through ACEI), aspirin, a statin, and folic acid. They argued that counseling or education produces only modest changes this pill could be given to anyone over 55 years without in risk factors and has a limited effect on mortality. measurement or monitoring of risk factors as well as to We therefore need to explore more effective strategies to all individuals with a CVD event. They estimated that implement LSM. On a more urgent basis, to contain the adverse effects with this polypill would occur only in burgeoning epidemic of CVD, especially in developing about 8% of treated subjects, with most due to aspirin. countries, we must explore more effective alternative Importantly all the drugs used in the proposed polypill approaches (i.e., drug therapy) for primary and secondary have been in use for over a decade with acceptable rates prevention. of adverse effects at standard doses. International health authorities and funding agencies Drugs for CVD prevention such as the World Health Organization, Centers for Disease Control, the Wellcome Trust, and the National Three categories of drugs namely BP-lowering, lipid- Institutes of Health have encouraged the testing of the lowering, and anti-platelet drugs have been well proven polypill. In response, several groups around the world in reducing CVD events in secondary prevention are in different stages of research (17). while the former two demonstrate benefits in primary prevention as well. In spite of strong evidence for a few decades now, the use of these therapies is suboptimal Secondary prevention even in high-income countries (11–13) and even lower rates in LMICs (14). The Prospective Urban Rural Epidemiologic (PURE) cohort study (14) included over 150,000 subjects from For primary and secondary prevention of CVD, 17 countries of whom 5650 had coronary heart disease individuals must take several drugs lifelong. Adherence event and 2292 had stroke. Overall, few individuals with is a significant problem especially in LMICs and for CVD took antiplatelet drugs (25.3%), beta-blockers those without universal health insurance coverage. A (17.4%), ACE inhibitors or ARBs (19.5%), or statins fixed dose combination (FDC) is a strategy that could (14.6%). Use in high-income countries was as follows: improve adherence by reducing costs and the pill burden. antiplatelet drugs 62.0%, beta-blockers 40.0%, ACE [ 75 ] Journal of Clinical and Preventive Cardiology April 2012 | Number 2 Xavier et al inhibitors or ARBs 49.8% and statins 66.5%. The use in especially in developing countries, what should be our low-income countries was abysmally low at 8.8%, 9.7%, approach to the use of a polypill in primary prevention? 5.2% and 3.3%, respectively. Other studies (18,19) also With the evidence already available, a polypill must recorded less than optimal use of EBMs in different be used in a high-risk primary prevention population. regions of the world. The reduction in the burden of On the other hand, in low- to moderate-risk primary CVD in developed countries is largely attributed to the prevention, it must be more carefully considered and use of EBMs. The polypill is certainly a clear strategy to not as yet widely used until clinical trial evidence is improve the use of EBMs in secondary prevention. available. We can consider it for those who are unlikely to be adherent to multiple drugs (forgetfulness), without Primary prevention support for regular doctor visits and prescription refills and for whom cost for multiple drugs is a constraint. The use of the polypill for primary prevention is presently arguable. Let us consider primary prevention More importantly, use of the polypill must be an integral from two perspectives: high-risk primary prevention part of an overall strategy for CVD prevention. From and moderate- to low-risk primary prevention. Wald the patients’ perspective, education on LSM and the and Law argued against stratifying people by risk factor need for regular medications is essential. From a larger levels and recommended using just age (above 55years) perspective that should involve caregivers and the as sufficient indication for life-long use of a polypill (2).
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