Ferrer, a Spanish pharmaceutical company and CNIC, the Spanish National Center for Cardiovascular Research, today announce the results of NEPTUNO, the first real-world clinical study on patients treated with the c. This single pill, composed of the three class A medications recommended in the cardiovascular prevention guidelines, is used to treat patients who have previously suffered a CardioVascular (CV) event, such as heart-attack or ischemic stroke.
The NEPTUNO clinical study for secondary cardiovascular prevention was carried out on 6,456 patients in Spain. Most had one previous cardiovascular event; approximately ten per cent had experienced two. The study’s purpose was to determine the effectiveness of the CNIC-Polypill in the incidence of MACE (Major Adverse Cardiovascular Events) in secondary prevention patients, within the context of routine clinical practice. Additionally, the effectiveness on Cardiovascular Risk Factors (CVRF) such as blood pressure and lipidic profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) was assessed. Persistence to therapy was also investigated as well as the utilization of healthcare resources and costs.
Significant real-life data results
The results from the NEPTUNO study demonstrate a decreased risk of MACE in CNIC-Polypill treated patients, when compared to those being administered identical or equipotent drugs separately. Patients treated with the CNIC-Polypill also showed improved control of CVRF, such as blood pressure and lipid profile, together with a longer persistence to therapy, when compared to patients taking the identical or equipotent drugs separately. The study demonstrates that the use of the CNIC-Polypill significantly lowers the demand on healthcare resources, when compared to control cohorts. This reduction in utilization and associated costs is significant in terms of patient hospitalization days, resulting in lower CV events and a reduction in the number of medical visits required in the CNIC-Polypill cohort. The results of the NEPTUNO study were presented at the European Society of Cardiology (ESC) Congress 2021 at the end of August.
According to Rodrigo Palma dos Reis, chief medical officer at Ferrer: “With these results, Ferrer continues to show a strong commitment to improving patients’ lives within the cardiovascular sector, reducing recurrent MACE. We aim to provide a baseline treatment for patients who have suffered heart attacks and/or isquemic strokes – to avoid recurrent CV events, hence the importance of these results.”
This study is the first direct observation of the real-world impact and outcomes of the CNIC-Polypill for secondary prevention patients within healthcare settings. The CNIC-Polypill is the result of a co-development and partnership between CNIC (Centro Nacional de Investigaciones Cardiovasculares, the Spanish National Center for Cardiovascular Research, Madrid) and Ferrer.
To confirm these results, a randomized clinical trial is under way: SEcondary prevention of CardiovascUlaR disease in the Elderly (SECURE). Results of the analysis of 2,500 patients are expected to be presented at the 2022 ESC Congress in Barcelona. These will focus on hard outcomes, when compared to standard therapy. They will be presented by Dr. Valentí Fuster, general director at CNIC and Dr. José Maria Castellano, coordinator of clinical trials.
Going-forward, the CNIC-Polypill could be a useful clinical strategy – as baseline therapy – to reduce the incidence of new CV events and improve the control of CVRF in patients in secondary cardiovascular prevention settings.