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dc.contributor.author | Mostaza, José M | |
dc.contributor.author | Suárez-Fernández, Carmen | |
dc.contributor.author | Cosín-Sales, Juan | |
dc.contributor.author | Gómez-Huelgas, Ricardo | |
dc.contributor.author | Brotons, Carlos | |
dc.contributor.author | Araujo, Francisco Pestana | |
dc.contributor.author | Borrayo, Gabriela | |
dc.contributor.author | Ruiz, Emilio | |
dc.contributor.author | VULCANO investigators | |
dc.date.accessioned | 2024-02-27T15:24:41Z | |
dc.date.available | 2024-02-27T15:24:41Z | |
dc.date.issued | 2022-12-22 | |
dc.identifier.other | http://hdl.handle.net/10668/20264 | |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/18859 | |
dc.description.abstract | 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; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ). | |
dc.language.iso | eng | |
dc.type.hasVersion | VoR | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Cardiovascular disease | |
dc.subject | Cardiovascular risk factors | |
dc.subject | Fixed-dose combination | |
dc.subject | Non-inferiority trial | |
dc.subject | Polypill | |
dc.subject | Primary prevention | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Antihypertensive Agents | |
dc.subject.mesh | Cholesterol, LDL | |
dc.subject.mesh | Drug Combinations | |
dc.subject.mesh | Cardiovascular Diseases | |
dc.subject.mesh | Cholesterol | |
dc.subject.mesh | Hydroxymethylglutaryl-CoA Reductase Inhibitors | |
dc.title | 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. | |
dc.type | research article | |
dc.rights.license | Attribution 4.0 International | * |
dc.identifier.pubmedID | 36550424 | es_ES |
dc.format.volume | 22 | es_ES |
dc.format.number | 1 | es_ES |
dc.format.page | 560 | es_ES |
dc.identifier.doi | 10.1186/s12872-022-03013-w | |
dc.identifier.e-issn | 1471-2261 | es_ES |
dc.identifier.journal | BMC cardiovascular disorders | es_ES |
dc.rights.accessRights | open access | es_ES |
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