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

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

Blog Article

Abstract 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 swish supreme glide track white 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 here Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).