Polypill Population-based Theory

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PolyPill: Population-based Therapy

Population-based therapy for heart attack prevention

Since the concepts of CVD risk factors and "the sick individual versus the sick population" were put forward by pioneering epidemiologists, considerable efforts and major investments have been made to promote and implement population based strategies for the prevention of cardiovascular events. These include issuing dietary guidelines and regulating food industries to lower cholesterol and salt intake, and also national policies to promote increased physical activity and reduce smoking. Similarly, guidelines for screening and treatment of major modifiable risk factors such as hypercholesterolemia and hypertension have been part of the original strategy for prevention of CVD. However, despite early success, risk factors for atherosclerosis have become increasingly prevalent. For example, in the US more than half of the middle age population has one or more risk factors. Atherosclerotic cardiovascular disease - led by heart attack and stroke - remains the number one killer in most developing countries and presents a major threat to developing societies. Therefore, newer and more effective strategies are urgently needed.

The discovery of "vulnerable plaque" and its evolution to the broader concept of "the vulnerable patient" have opened new avenues in the field of preventive cardiology. The Screening for Heart Attack Prevention and Education (SHAPE) Task Force organized by the Association for Eradication of Heart Attack (AEHA) has recently issued the SHAPE guideline introducing a new paradigm for the prevention of acute cardiovascular events. The SHAPE guideline focuses primarily on the detection and aggressive treatment of vulnerable patients - i.e. those individuals with a very high level of risk for a near term event.

The AEHA organization has also envisioned a future era of "Polypill" ( see footnote) therapy as an "unconditional" population-based strategy for prophylactic therapy of high risk populations without screening. But AEHA noted the time for undertaking such a public initiative has not arrived. In anticipation of such a foreseeable future, we discuss here the challenges and promises of multi-constituent cardiovascular pills (MCCP), including "Polypill."

Hypertension, lipid disorders and other risk factors for cardiovascular events are highly co-prevalent . 30 million US adults have concomitant hypertension and lipid disorders. Even when cardiovascular risk factors are identified they are infrequently treated to accepted goals. Fewer than 10% with hypertension and lipid disorders are treated to goal for both disorders. That medicines have therapeutic benefits beyond their primary targets is now generally accepted (e.g. the 'pleiotropic' benefits of statins beyond cholesterol reduction). The concept of a single, multi-mechanistic, safe, effective and inexpensive cardiovascular prophylactic that can be taken routinely with minimal professional supervision is certainly attractive and - if realized - has the potential to impact public health benefit profoundly.

Risk factors for atherosclerotic cardiovascular disease (CVD) are highly co-prevalent but poorly identified and treated. The Screening for Heart Attack Prevention and Education (SHAPE) Task Force from the Association for Eradication of Heart Attack (AEHA) has recently proposed a new strategy that recommends screening for subclinical atherosclerosis and implementing aggressive treatment of "vulnerable patients". The Task Force has also envisioned future developments that may shift mass screening strategies to mass prophylactic therapy. The "Polypill" concept, introduced by Wald and Law suggests a combination of statin, low-dose anti-hypertensives, aspirin and folic acid, in a single pill, taken prophylactically by high risk population can cut CVD event rates by as much as 80%. In this communication, we review the challenges and promises of such a strategy. "Polypill" is but one of an astronomical number of possible multi-constituent pills (MCCP). Attractive as the MCCP concept is, it lacks evidence from randomized controlled trials, and begs numerous questions about the credibility of the concept, the design and synthesis of such complex pills, pharmacokinetics, pharmacodynamics, bioequivalence, "class" vs. unique properties, interactions, evidence of clinical efficacy and safety, regulatory approval, post-marketing surveillance, prescription vs. over-the- counter use, responsibility for initiating and monitoring therapy, patient education, counterfeiting and importation, reimbursement, advertisement, patent protection, commercial viability, etc. If these issues are favorably addressed, MCCP stand to dramatically change the manner in which CVD is prevented particularly in developing societies. Notwithstanding, assuming low commercial interests, realizing the promises of MCCP will demand serious attention from national public health policymakers.

1 "Polypill" is a proprietary name and should be differentiated from the main body of text, as "Polypill" or as "Polypill" (in italics, as used in this article). It should not be used in generic fashion as an ordinary word (for example it should not be preceded by the indefinite article nor used in the plural form). A trademark application has been submitted by Professors Wald and Law [US trademark application # 76489257 February 11, 2003. http://www.uspto.gov/; http://tarr.uspto.gov/servlet/tarr?regser=serial&entry=76489257].

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