학술논문
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
Document Type
Report
Author
Mostaza, José M.; Suárez-Fernández, Carmen; Cosín-Sales, Juan; Gómez-Huelgas, Ricardo; Brotons, Carlos; Araujo, Francisco Pestana; Borrayo, Gabriela; Ruiz, Emilio; Pérez, Pablo; Espinosa, Jacinto; Sobrino, Javier; Posé, Antonio; Arroyo Díaz, Juan Antonio; García Vallejo, Olga; Cubo Romano, Maria Pilar; Jansen Chaparro, Sergio; Cabezón Mariscal, Jesús; Rico Corral, Miguel Angel; Abellán Alemán, José; Orozco Beltrán, Domingo; Escobar Jimenez, Luis; Valdivieso Felices, Pedro; Pedro-Botet Montoya, Juan Carlos; Masana Marín, Luis; Guijarro, Carlos; Díaz Rodríguez, Ãngel; Díaz Díaz, José Luis; De la Peéa Fernández, Andrés; Coloma Bazán, Emmanuel; Cuenca Acevedo, Rafael; Suárez Fernández, Carmen; Civeira, Fernando; Castellano Vázquez, José María; Mostaza Prieto, José María; Suárez Tembra, Manuel; Alfonso Megido, Joaquín; Castiella Herrero, Jesús; Tamarit, Juan José; Martínez-Hervás Alonso, Miguel Ãngel; Carrasco Franco, Francisco Javier; Ãlvarez Sala, Luis; Calderón Sandubete, Enrique; Rovira Daudi, Eduardo; Bonilla Rovira, Fernando; Murcia Zaragoza, Juan Manuel; Cuixart Costa, Lluís; Bianchi Llave, José Luis; Ãlvarez Sánchez, Carmen; Marqués Da Silva, Pedro; Cunha, Vitória; Santos, Catarina; Araujo, Francisco; Moura, José; Rosas Peralta, Martín
Source
BMC Cardiovascular Disorders. December 22, 2022, Vol. 22 Issue 1
Subject
Language
English
ISSN
1471-2261
Abstract
Author(s): José M. Mostaza[sup.1] , Carmen Suárez-Fernández[sup.2,3,4] , Juan Cosín-Sales[sup.5,6] , Ricardo Gómez-Huelgas[sup.7,8] , Carlos Brotons[sup.9,10] , Francisco Pestana Araujo[sup.11] , Gabriela Borrayo[sup.12] , Emilio Ruiz[sup.13] , Pablo Pérez[sup.] , [...]
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). Keywords: Cardiovascular disease, Primary prevention, Fixed-dose combination, Polypill, Non-inferiority trial, Cardiovascular risk factors
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). Keywords: Cardiovascular disease, Primary prevention, Fixed-dose combination, Polypill, Non-inferiority trial, Cardiovascular risk factors