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

Abstract

BackgroundCardiovascular (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 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. MethodsThe VULCANO was an open-label trial involving 492 participants randomised to the CNIC-polypill or usual care. The primary outcome was the mean change in LDL-c and SBP values after 16 weeks of treatment. ResultsThe upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin of 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.ConclusionThe switch from conventional treatment to the CNIC-polypill approach in patients at high CV risk without a previous event was safe and appears a reasonable strategy to control risk factors and prevent CVD.