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. (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 (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:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
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

15 p, 2.0 MB

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