Prabhakaran, personal communication. This study aims to collect important efficacy and acceptability data from a variety of countries and may facilitate consideration of drug registration. In the absence of results from large clinical trials with built-in cost-effectiveness evaluations, data regarding the cost-effectiveness of a poly-pill are limited to estimates from modeling e.
Prospects for a Cardiovascular Disease Prevention Polypill | Annual Review of Public Health
More data are required from actual trials that specifically evaluate cost-effectiveness of such a polypill in primary as well as secondary CVD prevention. Gaziano et al. Thus, modeled data suggest that such regimens could prove to be cost-effective for primary as well as secondary CVD prevention.
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According to UMPIRE study investigators' estimates, the polypill, which is composed wholly of generic components, will have three-tiered pricing to ensure equitable access. The profits from higher realizations from the developed countries will help sustain the pricing in developing countries. Thus, in looking at the models, a polypill may be cost-effective in populations at high risk for CVD. However, its effectiveness in low-risk populations remains to be evaluated.
The polypill idea is a controversial topic and has continued to generate many critical reviews, editorials, and correspondence publications in several journals 40 , 50 , 60 , ProCor, a Boston-based nonprofit network linking health professionals worldwide, invited comments about the polypill in Selected comments from some of the world's leading CVD experts, which originally appeared in ProCor's news and discussion forum, are presented in Table 4. Concerns have also been expressed that a polypill might negatively influence attitudes and health-promotion efforts advocating for improvements in diet and physical activity among policy makers and individuals.
Those opposing the polypill argue that it promotes a pharmaceutical solution to a problem that is largely related to lifestyle factors and that modification of diet and physical activity patterns reduce long-term risk just as effectively The pill has also been viewed as a shotgun approach to treating patients in lieu of risk estimation and personalized care.
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Using population risk-factor levels to treat a patient seems unnecessary when individual risks can be estimated using simple tools e. A more refined solution might be to improve and adapt available risk-estimation tools to guide therapy. This method would prevent unnecessary medicalization in a group who can be otherwise managed with lifestyle interventions alone. Adapting a healthy lifestyle has beneficial effects beyond prevention of CVDs.
Practical Applications for Single Pill Combinations in the Cardiovascular Continuum
It gives a sense of well-being and better ability to cope with stress; there is also sufficient evidence that physical activity can delay development of type 2 diabetes 2 , Thus serious efforts to modify lifestyle habits are warranted before trying risk-factor-lowering drugs A polypill should therefore not be viewed as an alternative to lifestyle modification, but rather as complimentary.
The recently published polypill study from Iran has further validated concerns regarding adherence to therapy because BP and lipid reductions were lower than anticipated. Hence, strategies to incentivize adherence need to be developed and tested in parallel with other testing and definitely before extensive rollout of the polypill for common use Some researchers have considered a polypill practicable in developing countries where access to resources is limited. However, the feasibility of the polypill will vary depending on risk-factor prevalence, availability of resources, age distribution of the population, and burden of CVD in comparison with other health problems.
Besides this, the benefits of chronic disease prevention strategies are realized over a long term. Hence, it should not be surprising that most developing countries have directed their resources to mitigate acute infectious diseases, for which achievable benefits are more rapid.
Other questions that remain unanswered include the generalizability of risk-factor control using a fixed-dose combination, given heterogeneity in responses among patients; whether safety and cost projections will be realized, as the authors of meta-analyses have suggested; and last, whether a one-size-fits-all approach is medically, scientifically, and ethically sound.
The polypill is a controversial and potentially novel approach for CVD prevention. It attempts to combine clinical and public health approaches to reduce the absolute risk of CVD by concurrently controlling multiple risk factors. Besides reducing global CVD risk, risk-factor control itself may be associated with less morbidity, better quality of life 32 , and lower long-term health care costs Hence, the cumulative benefits of improving an individual's CVD risk-factor profile may extend beyond increasing CVD-free life years.
The balance of evidence and expert sentiments cautions, however, that the polypill not be viewed in isolation, but as one of several strategies within a broader policy and practice framework for preventing CVD Furthermore, greater external validation is required regarding the benefits, risks, costs, convenience, and acceptability of the polypill; these should be rigorously and empirically evaluated because these are key practical components in implementing and sustaining any intervention.
Since the concept first drew major attention in , a few trials to date have contributed independent increments toward establishing an eventual and more exact role for this intervention. A large-scale observational study by Kaiser Permanente provided evidence of effectiveness of bundling statins and angiotensin-converting enzyme inhibitors ACEI in reducing CVD-related hospitalization in patients with diabetes or CHD or both The TIPS trial further strengthened the evidence base by demonstrating noninferiority of the polypill compared with individual medications, while alleviating concerns regarding increased incidence of adverse reactions when compared with single drugs over the duration of this trial.
The bioequivalence study conducted in India also allayed fears regarding negative interactions between polypill components, and Markov models suggest that combination therapies may reduce patient and health system costs when used in high-CVD-risk patients. However, the aggregate balance of risks, benefits, and costs associated with using a polypill in low-to-medium-risk populations requires further consideration.
The Prevention Of Cardiovascular Disease: Have We Really Made Progress?
As such, the Combination Pharmacotherapy and Public Health Research Working Group convened by the CDC corroborated that the polypill may contribute to improving access to preventive therapies in underserved populations 13 , including uninsured and low socioeconomic population groups in developed countries. However, given that the greater proportion of CVD burdens are experienced in low- and middle-income countries, it is heartening that efforts to test CPs thus far have largely been carried out in developing nations; however, it is also disconcerting that the major pharmaceutical industries have been reluctant to invest in this polypill venture.
These companies may be deterred by expectations of lower profit margins, especially if the largest consumer populations are the global poor in developing countries and if ethical expectations demand tiered or affordable pricing. Generic manufacturers without large research and development budgets also do not find an acceptable rate of return for their investments in developing and marketing these drugs. However, if a U. On the other hand, physician preferences have not been widely assessed, and predilection to prescribing individual drugs and titrating doses according to measured risk-factor levels cannot be overlooked In addition, the composition of the ideal polypill remains elusive.
The role of aspirin in patients who are not at high risk for cardiovascular events is yet to be established, given the risks of increased bleeding 4. The American Diabetes Association and U. Preventive Services Task Force recommend the use of aspirin in cases where the benefit is expected to outweigh risk of gastrointestinal bleeding 7 , 46 , Furthermore, different compounds belonging to the same class of drugs are known to vary in efficacy and side-effect profile.
For example, atorvastatin used in the Iranian study has been more efficacious than simvastatin in reducing total and low-density cholesterol levels LDL-c Economic factors and issues of delivery, patient acceptability, and prescriber acceptability will all play important roles in further configuring the best combination of pill components. It might take several years before sufficient clinical data are available and a consensus polypill recommendation is achieved and before widespread implementation is attempted.
New formulations of polypills may also be developed and tested in the future and may play an increasing role in primary prevention of CVD. A wider selection of distinctive formulations may also be developed, which could be aligned to individuals' risk profiles and CVD status. At the same time, reduced adverse drug reactions due to smaller doses of pill components could improve long-term tolerance.
The polypill is not meant to be the fountain of youth or the magic bullet to cure all ails, as it has been referred to in the past Prudent use would be to supplement lifestyle interventions in further reducing CVD risk in those who meet eligibility criteria. To assess the incremental efficacies, we recommend factorial RCTs that compare polypill, lifestyle interventions, and the combination of these.
We also encourage all future trial groups to include cost-effectiveness components in their study designs. Trials that are currently planned or under way will provide data regarding polypill interactions, impact s on intermediate biochemical outcomes, tolerance, adherence, acceptability, and cost-effectiveness.
These are crucial elements in evaluating the practical translatability and sustainability of such an intervention. Trials should also include measurements of diet and activity at baseline and follow-up to examine efficiently whether provision of a polypill might adversely impact or enhance uptake of lifestyle changes.
In summary, it is not clear from the evidence that is currently available whether widespread use of a polypill for CVD prevention, especially for primary prevention, is a threat to or an opportunity in public health. A comprehensive answer to this question will emerge only with more direct data from ongoing and planned studies to guide where an intervention of this sort could fit into individual and societal health-related behavioral and policy decisions.
Cardiovascular diseases CVDs account for a large proportion of global health and socioeconomic burdens. Increases in CVDs and their consequences are more prominent in developing regions of the world. A polypill that would control the important modifiable risk factors simultaneously, thus augmenting cumulative CVD risk reduction, has been proposed and debated for some time. Results from initial trials have suggested that a polypill consisting of a statin, three blood-pressure-lowering drugs, and aspirin is safe as well as efficacious in reducing CVD risks in people at a low risk of CVD.
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Evidence from trials of a polypill on CVD outcomes is still lacking. Concerns regarding cost-effectiveness, acceptability, the optimal combination of components, and ethics of using such a pill in people who are at low risk of CVD are yet to be addressed. Additional evidence is required to delineate the exact role of such a pill in primary as well as secondary CVD prevention. The authors are not aware of any affiliations, memberships, funding, or financial holdings that might be perceived as affecting the objectivity of this review.
The authors thank E. Soliman, S. Yusuf, V. Fuster, G. Sanz, D. Prabhakaran, R. Malekzadeh, O. Johansen, and D. Xavier for sharing details about ongoing trials. Depta and Deepak L. A meta-analysis of six primary prevention trials demonstrated that the reduction in ischemic events with aspirin use was offset by an increase in major bleeding 6. Many of the same factors also increase the risk of bleeding complications 9, It is interesting to compare the effects of low-dose aspirin in primary prevention with the well-known benefits in secondary prevention Although a subgroup analysis of the six primary-prevention trials is consistent with some net benefit of aspirin in adults with diabetes but no known vascular disease 10 , The Treatment of Hyperhomocysteinemia Bradley A.
The benefits of these dietary and lifestyle interventions have been sufficiently impressive so that they have been incorporated into the recommendations for the prevention and treatment of hypertension by many national advisory groups and are included in the Therapeutic Lifestyle Changes of the JNC These groups now commonly recommend a DASH low-sodium type of diet along with lifestyle changes similar to those of EST, as described above 8, 40, , A multidisciplinary public health research working group considered the strengths and concerns of combination pharmacotherapy proposals Stang, 2,3 Jesse A.
Berlin, 4 Martijn Schuemie, 2,3 J. Marc Overhage, 2,5 Marc A. Suchard, 2,6,7,8 Bill Dumouchel, 2,9 Abraham G.
Hartzema, 2,10 and Patrick B. Several studies have shown how IV analysis can reduce bias Dudl et al. More frequent contact and ongoing support enhance both initial weight loss and maintenance 6.
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