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dc.contributor.otherUCH. Departamento de Medicina y Cirugía-
dc.contributor.otherProducción Científica UCH 2022-
dc.creatorMostaza Prieto, José María-
dc.creatorSuárez Fernández, Carmen-
dc.creatorCosín Sales, Juan-
dc.creatorGómez Huelgas, Ricardo-
dc.creatorBrotons Cuixart, Carlos-
dc.creatorPestana Araujo, Francisco-
dc.date2022-
dc.date.accessioned2023-05-30T04:00:28Z-
dc.date.available2023-05-30T04:00:28Z-
dc.date.issued2022-12-22-
dc.identifier.citationMostaza, 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-w-
dc.identifier.issn1471-2261 (Electrónico)-
dc.identifier.urihttp://hdl.handle.net/10637/14366-
dc.descriptionEste artículo se encuentra disponible en la siguiente URL: https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-022-03013-w-
dc.descriptionEn este artículo de investigación también participan: Gabriela Borrayo y Emilio Ruiz en representación del grupo de investigadores VULCANO.-
dc.description.abstractBackground: 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.-
dc.formatapplication/pdf-
dc.languagees-
dc.language.isoen-
dc.publisherSpringer Nature-
dc.relationEste artículo de investigación ha sido financiado por el Grupo Ferrer Internacional SA.-
dc.relation.ispartofBMC Cardiovascular Disorders, vol. 22 (22 dec. 2022)-
dc.rightshttp://creativecommons.org/licenses/by/4.0/deed.es-
dc.subjectEnfermedades cardiovasculares - Prevención.-
dc.subjectCardiovascular system - Diseases - Prevention.-
dc.subjectEnfermedades cardiovasculares - Factores de riesgo.-
dc.subjectTablets (Medicine)-
dc.subjectMedicamentos - Dosificación - Formas.-
dc.subjectDrugs - Dosage forms.-
dc.subjectCardiovascular system - Diseases - Risk factors.-
dc.subjectPastillas (Farmacia)-
dc.titleSafety 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-
dc.typeArtículo-
dc.identifier.doihttps://doi.org/10.1186/s12872-022-03013-w-
dc.centroUniversidad Cardenal Herrera-CEU-
Aparece en las colecciones: Dpto. Medicina y Cirugía




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