Complete Medical Guide and Prevention for Heart Disease Volume XXII; Raynauds
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They should be used with great caution in the presence of grade I AV block and their use is not recommended in combination with other dromotropic negative drugs, like beta-blockers, amiodarone, or digoxin.
Changes in the twentieth century characterized by technological advances combined to increase food availability; this, together with subsequent deteriorations in levels of physical activity, has increased the prevalence of risk factors for CVD [ ]. Consequently, in an increasing number of populations there is a high level of the risk factors for CVD, especially for many of those living in high-income countries [ ]. Although effective therapy for treating CVD is available, due to high costs, low compliance, and poor identification of those at risk many individuals who could benefit from treatment remain untreated or inadequately treated.
It seems evident that new and innovative strategies will be indispensable for controlling the global epidemic of heart disease. With this in mind, Wald and Law [ ] proposed the concept of the polypill as a population CVD prevention strategy based on mass treatment. The concept proposes a radical approach based on the principle that high risk is common and a large preventive effect for CVD would require intervention in everyone at increased risk irrespective of their risk factor levels, modifying several risk factors together and reducing these risk factors by as much as possible. The specific components of the originally proposed polypill included: one statin e.
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The concept also includes the strategy of giving this combination pill to everyone over 55 years of age and all those with existing CVD irrespective of age, hence stopping all efforts focused on the measurement of risk factors and screening for CVD. Since p. The proposed polypill could have multiple advantages [ , ]. Among these, one of the most relevant is facilitating the delivery of effective medications for the prevention and treatment of CVD.
Having multiple medications combined in a single pill could dramatically improve adherence to medication and improved compliance could greatly contribute to a reduction in CVD events. Other strengths of the polypill include: facilitation of prescription and dose titration, reduction of costs by combining generic components, and provision of a platform for other widespread CVD prevention approaches e. This is further supported given that such a combination pill appears to have high levels of tolerability, bioavailability, and no pharmacokinetic drug—drug interactions among the individual components [ ].
Considering these combined strengths, a polypill could in theory provide great gains in terms of prevention of cardiovascular events, even among those free from CVD see Fig. The polypill concept is still under evaluation and these potential advantages require further investigation. Besides the lack of evidence given that this is still a concept in the process of development and testing , adverse effects and the costs of medicalizing large proportions of the population could limit the prospects of a future polypill era in CVD prevention.
Also it is still unclear whether a polypill would be a safe alternative to individual drugs, and the optimal combination to be included in a polypill is still under debate [ ]. Furthermore, after the key medications to be incorporated in a polypill have been identified its registration could also pose a challenge, particularly so for primary prevention as the efficacy of the combination still requires demonstration.
Finally, a major concern remains regarding the effect of the availability of a polypill on the communication and implementation of healthy lifestyles individuals might rely on a polypill to be effective and abandon healthy lifestyle habits. Despite the uncertainties, the prospects are promising. If a polypill was to be given to all US adults aged over 55 and those with a history of CVD it could contribute to the prevention of 4 million coronary heart disease events and more than 2 million stroke events over 10 years of treatment [ ].
Since the original polypill publication, different combination pills have been developed [ ].
A combination of amlodipine 2. This polypill effectively reduced systolic blood pressure by TIPS was a phase II double-blind randomized trial conducted among individuals in India aged 45—80 years and without CVD, in which the efficacy of the polycap a combination of thiazide The two formulations had similar tolerability while the full-dose polycap was more effective in reducing blood pressure and LDL cholesterol [ ].
New evidence and new studies are required to confirm the efficacy and safety of the polypill in preventing hard events MI and stroke for both the primary and secondary prevention of CVD. Although a polypill could be effective, medicalizing a large proportion of the population could have a great impact in terms of costs and side effects.
Side effects of a polypill would depend on the individual components selected, among which aspirin could generate the most serious adverse effects including haemorrhagic stroke, extracranial haemorrhage, upper abdominal discomfort, and gastrointestinal bleeding. The specific probabilities of experiencing adverse effects while taking a polypill remain unknown, and studies with longer periods of polypill treatment will be necessary to obtain a better estimate. The levels of adverse effects would play a key role in the level of adherence to a polypill as well as in the cost-effectiveness of this treatment.
The potential costs of a polypill have been estimated to be rather low, given that the combination will include only generic components. However, since a polypill is not yet commercially available actual costs are still unknown and will depend on multiple factors, including levels of adverse effects, the cost of the ingredients to be included in the combination, costs of packaging and commercializing, and the costs of research, development, registration, marketing, and distribution, and profit margins for the manufacturers [ ]. Given that the costs are unknown, the existing calculations on the cost-effectiveness of a polypill are only speculative; however, since all the individual components have proven to be cost-effective in multiple populations no major differences would be expected for a polypill.
The first evaluation of the cost-effectiveness of a polypill calculated how much it should cost in order to be cost-effective for the primary prevention of CVD among men aged 50 years or above [ ]. More recently, using the Dutch primary healthcare setting, different potential polypill combinations were tested and found to be cost-effective compared with usual care [ ]. The best levels of cost-effectiveness were found for polypill combinations without aspirin and with a double dose of statins [ ].
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Although these initial reports indicate that it is very probable that a polypill will be cost-effective for the secondary prevention of CVD, the actual costs of a polypill once it becomes available and its cost-effectiveness for the primary prevention of CVD need further evaluation. Whether a polypill could be a safe and cost-effective alternative to current methods of preventing CVD remains unknown, and is one of the key challenges for its implementation for the prevention of CVD.
The polypill is a promising concept that has the potential to dramatically change and improve current strategies for preventing CVD. Questions remain regarding its long-term efficacy, safety, tolerability, and cost-effectiveness, especially for primary prevention of CVD. Multiple trials aiming to clarify the role that a polypill could have in the treatment and prevention of CVD are currently being conducted.
Once a polypill becomes available, instead of replacing a healthy lifestyle it should be combined with adequate levels of physical activity, smoking cessation, and an optimal diet to further reduce the levels of CVD. It is probably caused by his COPD and current intake of a non-selective beta-blocker. His blood pressure is also still too high.
In this case the non-selective beta-blocker should be replaced by a selective beta-blocker e. If beta-blockers are not tolerated at all, ivabradine may be considered. The combination of an ACEi with an ARB is not recommended in this patient in addition to the treatment with aliskiren. Both the treatment with the ACEi and the beta-blocker should be continued as the patient suffered from a significant MI with left ventricular dysfunction.
Erdmann E. Safety and tolerability of beta-blockers: prejudices and reality.
Eur Heart J ; 11 Suppl. A : A21—A Eur Heart J ; 25 : — ESC guidelines for the diagnosis and treatment of acute and chronic heart failure Eur Heart J ; 33 : — Drugs for the heart , 7th edn, Philadelphia, PA: Saunders Elsevier, pp. The chapter on beta-blockers provides a detailed description on the pharmacology, types of beta-blockers, indications, and contraindications. Lancet ; : — SHIFT investigators. A systematic review: effect of angiotensin converting enzyme inhibition on left ventricular volumes and ejection fraction in patients with a myocardial infarction and in patients with left ventricular dysfunction.
Eur J Heart Fail ; 9 : — Find this resource:. Effect of angiotensin-converting enzyme inhibition on functional class in patients with left ventricular systolic dysfunction—a meta-analysis. Eur J Heart Fail ; 8 : 90—6.
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Proteinuria, chronic kidney disease, and the effect of an angiotensin receptor blocker in addition to an angiotensin-converting enzyme inhibitor in patients with moderate to severe heart failure. Circulation ; : — Eur Heart J ; 30 : — Calhoun DA. Aldosterone and cardiovascular disease. Circulation ; : —4. Desai A. Hyperkalemia associated with inhibitors of the renin-angiotensin-aldosterone system.
Leopold JA. Aldosterone, mineralocorticoid receptor activation, and cardiovascular remodeling.
Circulation ; : e—e Aldosterone receptor antagonists. Circulation ; : —9. Angiotensin-converting enzyme inhibitors reduce mortality in hypertension: a meta-analysis of randomized clinical trials of renin-angiotensin-aldosterone system inhibitors involving patients. J Hypertens ; 29 : — Epstein M.