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

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...

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Autores: Mostaza J.M., Suárez-Fernández C., Cosín-Sales J., Gómez-Huelgas R., Brotons C., Araujo F.P., Borrayo G., Ruiz E., Pérez P., Espinosa J., Sobrino J., Posé A., Arroyo Díaz J.A., García Vallejo O., Cubo Romano M.P., Jansen Chaparro S., Cabezón Mariscal J., Rico Corral M.A., Abellán Alemán J., Orozco Beltrán D., Escobar Jimenez L., Valdivieso Felices P., Pedro-Botet Montoya J.C., Masana Marín L., Guijarro C., Díaz Rodríguez Á., Díaz Díaz J.L., De la Peña Fernández A., Coloma Bazán E., Cuenca Acevedo R., Suárez Fernández C., Civeira F., Castellano Vázquez J.M., Mostaza Prieto J.M., Suárez Tembra M., Alfonso Megido J., Castiella Herrero J., Tamarit J.J., Martínez-Hervás Alonso M.Á., Carrasco Franco F.J., Álvarez Sala L., Calderón Sandubete E., Rovira Daudi E., Bonilla Rovira F., Murcia Zaragoza J.M., Cuixart Costa L., Bianchi Llave J.L., Álvarez Sánchez C., Marqués Da Silva P., Cunha V., Santos C., Araujo F., Moura J., Rosas Peralta M.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p15961
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=15961
Access Level:acceso abierto
Palabra clave:antihypertensive agent
cholesterol
hydroxymethylglutaryl coenzyme A reductase inhibitor
low density lipoprotein cholesterol
cardiovascular disease
controlled study
drug combination
human
randomized controlled trial
Antihypertensive Agents
Cardiovascular Diseases
Cholesterol
Cholesterol, LDL
Drug Combinations
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Descripción
Sumario: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 CNIC-polypill 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. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13). © 2022, The Author(s).

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