Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event the international VULCANO randomised clinical trial

Mostaza Prieto, José MaríaCosín Sales, JuanSuárez Fernández, CarmenGómez Huelgas, RicardoBrotons Cuixart, CarlosPestana Araujo, FranciscoUCH. Departamento de Medicina y CirugíaProducción Científica UCH 20222023-05-302023-05-302022-12-22Mostaza, J. M., Suárez-Fernández, C., Cosín-Sales, J., Gómez-Huelgas, R., Brotons, C., Araujo, F. P., Borrayo, G., Ruiz, E. & VULCANO investigators (2022). Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial. BMC Cardiovascular Disorders, vol. 22, i. 1 (22 dec.), art. 560. DOI: https://doi.org/10.1186/s12872-022-03013-w1471-2261 (Electrónico)http://hdl.handle.net/10637/14366Este artículo se encuentra disponible en la siguiente URL: https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-022-03013-wEn este artículo de investigación también participan: Gabriela Borrayo y Emilio Ruiz en representación del grupo de investigadores VULCANO.Background: Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. Methods: The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. Results: The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNICpolypill arm. Conclusion: The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD.application/pdfenopen accessEnfermedades cardiovasculares - Prevención.Cardiovascular system - Diseases - Prevention.Enfermedades cardiovasculares - Factores de riesgo.Tablets (Medicine)Medicamentos - Dosificación - Formas.Drugs - Dosage forms.Cardiovascular system - Diseases - Risk factors.Pastillas (Farmacia)Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event the international VULCANO randomised clinical trialArtículohttps://doi.org/10.1186/s12872-022-03013-whttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es