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, José M. ![Identificador ORCID](/img/uab/orcid.ico)
(Hospital Carlos III (Madrid))
Suárez-Fernández, Carmen (Universidad Autónoma de Madrid)
Cosín-Sales, Juan (Universidad UCH-CEU)
Gomez Huelgas, Ricardo (Universidad de Málaga)
Brotons, Carlos ![Identificador ORCID](/img/uab/orcid.ico)
(Institut d'Investigació Biomèdica Sant Pau)
Araujo, Francisco Pestana (Hospital dos Lusíadas)
Borrayo, Gabriela (Instituto Mexicano del Seguro Social (IMSS))
Ruiz, Emilio (Ferrer Internacional)
Universitat Autònoma de Barcelona
Fecha: |
2022 |
Resumen: |
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. 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. 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. 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; ). The online version contains supplementary material available at 10. 1186/s12872-022-03013-w. |
Derechos: |
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Lengua: |
Anglès |
Documento: |
Article ; recerca ; Versió publicada |
Materia: |
Cardiovascular disease ;
Cardiovascular risk factors ;
Fixed-dose combination ;
Non-inferiority trial ;
Primary prevention ;
Polypill |
Publicado en: |
BMC Cardiovascular disorders, Vol. 22 (december 2022) , ISSN 1471-2261 |
DOI: 10.1186/s12872-022-03013-w
PMID: 36550424
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Registro creado el 2023-08-03, última modificación el 2023-09-01