Much for little: great benefits of the cardiovascular polypill in coronary heart disease

In Spain, cardiovascular diseases are the leading cause of death. In 2022, 120,572 people died due to this reason, which is 26.03% of the total deaths in the country. In this context, doctors with great experience and international recognition, such as Valentin Fuster, have been defending the role of innovation in diagnosis as well as treatment for years. Fuster, who combines his duties as General Director of the Carlos III National Cardiovascular Research Center (CNIC) in Madrid and Director of the Cardiovascular Institute and “Physician-in-Chief” of the Mount Sinai Fuster Medical Center in New York, explains this. The interview is based in particular on the promising future of the cardiovascular polypill developed by CNIC and the pharmaceutical company Ferrer, which has managed to incorporate acetylsalicylic acid, a statin (atorvastatin) and an ACE inhibitor (ramipril) in a single capsule. Together, they have been demonstrated by the results of the SECURE study to be an effective strategy in reducing cardiovascular events and cardiovascular mortality. For his part, Dr. José Ramón González-Junate, Head of the Cardiology and CCU Service at the University Clinical Hospital and Professor of Cardiology at the University of Santiago de Compostela, commends the reduction in cardiovascular morbidity and mortality thanks to this innovative drug.

Dr. Valentin Fuster
Dr. Valentin Fuster

Why does heart disease remain the leading cause of death in the world, despite the fact that more and more new treatments are available?

Valentin Fuster (VF): Heart disease is a silent epidemic. This means that, despite all efforts, it is still the leading cause of death globally.1 We know that control of risk factors, along with promotion of healthy lifestyle habits, has a clear impact on cardiovascular mortality., For a long time we are Working to change the lifestyle of the population. And we have seen that these healthy habits should be promoted at an early age.

At CNIC we have projects for children aged 3 to 5 years, where we have really seen that interventions to make them better aware about heart health have an impact on growth and reduction in risk factors, such as Obesity and diabetes or prediabetes, etc. We also have some programs dedicated to changing lifestyle habits in the adult population. These changes are much more difficult because modifying lifestyle habits in adults is very complex, but can still be achieved if sustained changes in their lifestyle can contribute to lower incidence and lower cardiovascular risk factors. Can do. It is not only about treating or preventing heart disease, but also about promoting a healthy lifestyle from the first years of life. Only in this way can we face this pandemic.

Around 2007, the idea of ​​developing a polypill came to his mind. What challenges were faced and what was achieved during all these years?

V.F. Today we know that controlling risk factors such as smoking, high blood pressure, diabetes, high cholesterol or lack of exercise reduces the chance of suffering from the disease. But what happens when it has already happened? The studies make it very clear: Even if a myocardial infarction has already occurred, healthy lifestyle habits improve the prognosis, but they do not do so alone. It is necessary for the patient to take preventive medicine.2,3,4

Although these are very conscious patients, we know that 50% of patients with chronic diseases do not take their medications properly.5 This lack of adherence to treatment determines that safety is reduced and complications increase. Adherence to treatment is influenced by many different factors, but one of the most important factors is the complexity of the therapy the patient is receiving. The greater the number of medications or the greater the complexity, the lower will be adherence.

So when in 2006, after personally confirming that cardiovascular prevention was very poor in some emerging countries due to cost and shortage of drugs, I came up with the idea to start developing a polypill. The aim was not only to simplify treatment but also to make it more affordable and accessible in these emerging countries.

And that’s what we’ve achieved with Polypill. Three medicines in one that simplifies treatment. As shown in the SECURE study published in NEJM, the drug is effective in preventing cardiovascular events after a heart attack, reducing real-world mortality from cardiovascular causes by 33%. But it also improves treatment compliance, which is a big problem in these patients.6.7 Due to all this, WHO has included it in the list of essential medicines.8 And it will be included in the ESC ACS 2023 guide9,

what effect Must be on the WHO list of essential medicines,

JR Gonzalez-Junate (JRGJ): This is due to the strong clinical evidence of the polypill’s benefits. It improves the cardiovascular prognosis of patients who suffer from an atherothrombotic event, especially in patients with recent acute coronary syndrome. The magnitude of benefit in terms of reduction in new serious events and cardiovascular mortality is greater than that of new drugs recently introduced for the treatment of cardiovascular disease. Clinicians involved in the treatment of patients with cardiovascular disease, and particularly ischemic heart disease, should consider how to extend these benefits to our patients. We cannot deprive them of such a huge impact in terms of heart health.

Jose Ramon Gonzalez Juanate
Jose Ramon Gonzalez Juanate
Jose Ramon Gonzalez-Juante

Bearing in mind that therapeutic objectives are increasingly becoming more invasive, how is the cardiovascular polypill implemented in clinical practice?

JRGJ: Cardiovascular polypill should be included in the care process of patients who suffer from an atherothrombotic event. Following the results of the SECURE study7 This should be protocolized at discharge of patients hospitalized for acute coronary syndrome. In both patients with ischemic heart disease and those who have suffered atherothrombotic stroke or have been diagnosed with peripheral artery disease, the cardiovascular polypill should be the “core” of their therapeutic strategy that needs to be personalized in a complementary manner with other medications. Will happen. Achieving therapeutic objectives is always based on the concomitant diseases and needs of the patients.

On the other hand, the use of the polypill may become a good indicator of therapeutic adaptation in these groups of patients. In short, the scientific evidence in terms of reduction in cardiovascular morbidity and mortality available with the Polypill can be summarized as “so much for so little”.10.11,

What is the role of AS-containing polypill + atorvastatin + ramipril for secondary prevention of myocardial infarction at present? And in the future?

JRGJ: From my perspective, this is the strategy that has shown some of the greatest benefits in treatment. In the future, treatment with Polypidora will have to be implemented as early as possible and the rest of the complementary treatment individualized based on the control needs of blood pressure, cholesterol, gluco-metabolic, antiplatelet, etc. From patients. There is no doubt that this is the best strategy to optimize therapeutics based on patients’ characteristics.

Bibliographic references

1. World Heart Report 2023: Confronting the world’s number one killer. Geneva, Switzerland. World Heart Federation. 2023. Available at: https://world-heart-federation.org/wp-content/uploads/World-Heart-Report-2023.pdf. Last accessed 4 September 2023.

2. Bansilal S, Castellano JM, Garrido E, Wei HG, Freeman A, Spatel C, Garcia-Alonso F, Lizano I, Arnold RJ, Rajda J, Steinberg G, Fuster V. Assessing the impact of medication adherence on long-term cardiovascular outcomes. J Am Coll Cardiol. 2016 Aug 23;68(8):789-801. doi:10.1016/j.jacc.2016.06.005

3. Antithrombotic Trialists (ATT) Collaboration, Begent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J et al. Aspirin in primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomized trials. Lancet. 2009 May 30;373(9678):1849-60. DOI: 10.1016/S0140-6736(09)60503-1

4. Cardiovascular Outcomes Prevention Evaluation Study Investigators, Youssef S, Sleight P, Pogue J, Bosch J, Davis R, Dagenais G. Effect of the angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi:10.1056/NEJM200001203420301.

5. Bitton A, Chaudhary NK, Matlin OS, Swanton K, Schrank WH. Impact of medication adherence on costs and outcomes of coronary artery disease: a systematic review. Am J Med. 2013 Apr;126(4):357.e7-357.e27. doi:10.1016/j.amjmed.2012.09.004. PMID: 23507208.

6. Castellano JM, Sanz G, Penalvo JL, Bansilal S, Fernandez-Ortiz A, Alvarez L et al. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82. doi:10.1016/j.jacc.2014.08.021.

7. Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A et al. Polypill strategy in secondary cardiovascular prevention. N Engl J Med. 2022;387(11):967-977. doi:10.1056/NEJMoa2208275

8. Selection and use of essential medicines 2023: Executive summary of the report of the 24th WHO Expert Committee on Selection and Use of Essential Medicines, 24 – 28 April 2023. Available at: https://www.who.int/publications/i/items/WHO-MHP-HPS-EML-2023.01

9. Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A et al. 2023 ESC guidelines for the management of acute coronary syndrome. Euro Heart J. 2023 Aug 25:ehad191. doi:10.1093/eurheartj/ehad191.

10. Hopmans M, Castellano Vazquez JM, Gaziano T, Dymond A, Luby A et al. Cost-effectiveness analysis of the CNIC-polypill strategy compared to usual care in secondary cardiovascular prevention from a Spanish perspective using data from the SAFE trial. Presented at the 2023 ISPOR Europe Congress, Copenhagen, 12–15 November. Available at: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2023-3788/131804

11. Cordero A, Dalmau Gonzalez-Galarza R, Massana L, Fuster V, Castellano JM, Ruiz Oliver JE et al. Economic burden associated with treatment with cardiovascular polypill in secondary prevention in Spain: cost-effectiveness results of the NEPTUNO study. Clinicocon Result Res. 2023 Jul 19;15:559-571. doi:10.2147/ceor.s396290.

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