The CNIC polypill reduces the risk of major cardiovascular events compared to monocomponents alone

Barcelona, November 30, 2021 – The results of the NEPTUNO study , the first real-life clinical study (RWD), with patients treated with the CNIC polypill, are announced today. This single polypill, composed of three class A drugs recommended in cardiovascular prevention guidelines1, is indicated to treat patients who have previously suffered a cardiovascular event, such as a myocardial infarction or ischemic stroke.

 

The NEPTUNO clinical study was carried out in 6,456 patients in secondary cardiovascular prevention in Spain. Most had suffered a previous cardiovascular event; about ten percent had had two. The objective of the study was to determine the effectiveness of the CNIC cardiovascular polypill in the incidence of Major Adverse Cardiovascular Events (MACEs) in patients in secondary prevention, in the context of routine clinical practice. Additionally, the effectiveness on  Cardiovascular Risk Factors (CVRF) such as blood pressure and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) was evaluated. We also investigated the persistence of therapy, as well as the use and costs of healthcare resources.

 

Meaningful  Real-Life Data (RWD) Results

 

The results of the NEPTUNE study demonstrate a decreased risk of major cardiovascular events  in patients treated with the CNIC polypill, compared to those receiving identical or equipotent drugs separately. Patients treated with the CNIC polypill also showed better control of cardiovascular risk factors (CVRF), such as blood pressure and lipid profile, along with greater persistence to therapy, compared to patients taking identical or equipotent medications separately2. The study shows that the use of the CNIC polypill significantly reduces the demand on healthcare resources, compared to control groups. This reduction in use and associated costs is significant in terms of patient days of hospitalization, being a consequence of the  lower incidence of  CV events and the lower number of medical visits required in patients treated with the CNIC3 polypill. The results of the NEPTUNO study were presented at the European Society of Cardiology (ESC) 2021 Congress at the end of August2,3.

 

According to Rodrigo Palma dos Reis, Ferrer's medical director, "with these results, Ferrer continues to show a strong commitment to improving the lives of patients in the cardiovascular area, reducing recurrent major cardiovascular adverse events. Our goal is to provide a baseline treatment to avoid recurrent events in patients who have suffered heart attacks and/or strokes, hence the importance of these results."

 

This study is the first direct observation of the real-life impact and outcomes in  patients on secondary prevention of the CNIC polypill in different healthcare settings. The CNIC polypill is the result of a co-development and collaboration between the CNIC (National Center for Cardiovascular Research) and Ferrer.

 

To confirm these results, a randomized clinical trial is underway: SEcondary prevention of Cardiovascular disease in the Elderly (SECURE)4. The results of the analysis of 2,500 patients are expected to be presented at the ESC Congress 2022 in Barcelona. These results will have prognostic value, since the study will compare the CNIC polypill with standard therapy in the incidence of MACEs. They will be presented by Dr. Valentí Fuster, Director General of the CNIC and Dr. José Maria Castellano, Clinical Trials Coordinator of the CNIC.

 

The SECURE study could confirm that the CNIC polypill is a useful clinical strategy, as a background therapy, to reduce the incidence of new cardiovascular events and improve the control of CVRF in patients, in secondary cardiovascular prevention settings.

 

About cardiovascular disease:

According to the World Health Organization, cardiovascular disease (CVD) causes more than half of all deaths in Europe, 46 times the number of deaths and 11 times the burden of disease attributable to AIDS, tuberculosis and malaria combined. 80% of premature heart disease and stroke are preventable5.

 

According to the European Society of Cardiology, nearly 49 million people are living with the disease in Europe. Every year, cardiovascular disease causes 3.9 million deaths in Europe6.

It has been estimated that up to 50-75% of patients with previous myocardial infarction will have a recurrent cardiovascular event in the same or different vascular beds in the first 3 years after an acute cardiac event7-9. In addition, patients with previous myocardial infarction have a 5-6 times higher risk of cardiovascular death during the first year10.

 

Additional Information:

• The pharmaceutical form is a hard capsule containing six different possible formulations, depending on the dosage of the three components of the polytablet, which are acetylsalicylic acid (AAS), atorvastatin (A) and ramipril (R).
• The NEPTUNO study is a retrospective epidemiological analysis of an anonymized dataset of electronic medical records contained in the BIG-PAC administrative database during the years 2015-2018. The BIG-PAC database contains anonymised data from 1.8 million patient records from seven primary care areas and hospitals in Spain

 

Download here the main results of the Neptune Study

 

References:

1. Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Bäck M et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Aug 30:ehab484. doi: 10.1093/eurheartj/ehab484.
2. J R Gonzalez Juanatey, A Cordero, J M Castellano, L Masana, R Dalmau, J E Ruiz, V Fuster, NEPTUNO study, Reduction of cardiovascular events in patients with cardiovascular disease with the CV-polypill: a retrospective and propensity score matching study, European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.2548, https://doi.org/10.1093/eurheartj/ehab724.2548
3. A Cordero, J R Gonzalez-Juanatey, J M Castellano, L Masana, R Dalmau, J E Ruiz Olivar, V Fuster, NEPTUNO study, The real-world cost and health resource utilization associated to the La polipill cardiovascular CNIC  compared to usual care, European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.2545, https://doi.org/10.1093/eurheartj/ehab724.2545
4. Secondary Prevention of Cardiovascular Disease in the Elderly Trial (SECURE). ClinicalTrials.gov Identifier: NCT02596126. Available at: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02596126&cntry=&state=&city=&dist= Last access  October 2021
5. World Health Organization. Cardiovascular diseases. Fact sheet 2021. Available at https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds). Last access October 2021
6. Adam Timmis, Nick Townsend, Chris P Gale, Aleksandra Torbica, Maddalena Lettino, Steffen E Petersen, Elias A Mossialos, Aldo P Maggioni, Dzianis Kazakiewicz, Heidi T May et al. European Society of Cardiology: Cardiovascular Disease Statistics 2019, European Heart Journal, Volume 41, Issue 1, 1 January 2020, Pages 12–85, https://doi.org/10.1093/eurheartj/ehz859
7. Andrés E, Cordero A, Magán P, Alegría E, León M, Luengo E, et al.

Longterm mortality and hospital readmission after acute myocardial infarction: an eight-year follow-up study. Rev Esp Cardiol. 2012;65:414-20.

• Soldati S, Di Martino M, Castagno D, Davoli M, Fusco D. In-hospital myocardial infarction and adherence to evidence-based drug therapies: a real-world evaluation. BMJ Open. 2021; 11:e042878.
• Zabawa C, Cottenet J, Zeller M, Mercier G, Rodwin VG, Cottin Y, et al. Thirty-day rehospitalizations among elderly patients with acute myocardial infarction: Impact of postdischarge ambulatory care. Medicine (Baltimore). 2018; 97:e11085. 
• Mendis S, Abegunde D, Yusuf S, Ebrahim S, Shaper G, Ghannem H, et al. WHO study on Prevention of REcurrences of Myocardial Infarction and StrokE (WHO-PREMISE). Bull World Health Organ. 2005; 83:820–9.