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
| Autor: | Mostaza, José M, Suárez-Fernández, Carmen, Cosín-Sales, Juan, Gómez-Huelgas, Ricardo, Brotons, Carlos, Araujo, Francisco Pestana, Borrayo, Gabriela, Ruiz, Emilio, VULCANO investigators |
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| Přispěvatelé: | UCH. Departamento de Medicina y Cirugía, Producción Científica UCH 2022 |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Cardiovascular system - Diseases - Risk factors
Primary prevention Tablets (Medicine) Polypill Enfermedades cardiovasculares - Factores de riesgo Fixed-dose combination Medicamentos - Dosificación - Formas Cholesterol LDL Cardiovascular disease Drug Combinations Cardiovascular system - Diseases - Prevention Cholesterol Cardiovascular Diseases Drugs - Dosage forms Humans Enfermedades cardiovasculares - Prevención Hydroxymethylglutaryl-CoA Reductase Inhibitors Cardiology and Cardiovascular Medicine Pastillas (Farmacia) Non-inferiority trial Cardiovascular risk factors Antihypertensive Agents |
| DOI: | 10.1186/s12872-022-03013-w |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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