Polypill Shows Promising Results in Risk Control & Prevention of CVD: VULCANO

In a recent study, researchers reported that the CNIC (Centro Nacional de Investigaciones Cardiovasculares, Instituto de Salud Carlos III, Madrid)-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.

The CNIC polypill contains 100 mg of acetylsalicylic acid, two possible doses of atorvastatin (20 mg or 40 mg), and three possible doses of ramipril (2.5 mg, 5 mg)mg, or 10 mg), is the only CV polypill currently marketed in European countries. Studies have found that the risk factor control among patients at high risk of CVD is inadequate, with only 28-35% and 28-37% of patients at or below the recommended blood pressure (BP) and low-density lipoprotein cholesterol (LDL-c) target, respectively. Therefore, Dr Jose María Mostaza and his team conducted a study to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of LDL-c and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event.

The VULCANO study was a prospective phase 3, randomized, open-label trial conducted at 47 centres in Mexico, Portugal, and Spain from 2017 and 2019. In this 16 week study, the researchers included 492 patients without clinical CVD but with potent CVD risk factors and randomized them to the CNIC-polypill or usual care. The major outcome assessed was the mean change in LDL-c and SBP values after 16 weeks of treatment.

Key findings of the study:

• Upon analysis, the researchers observed that the upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin of 10 mg/dL and above zero. Thus, they noted that the CNIC-polypill reached both noninferiority and superiority criteria.
  
• They observed no significant differences in SBP between groups.
• However, they noted that the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg.
• They found that the levels of total cholesterol slightly increased (+0.7%) in the usual-care group and decreased (–7.0%) in the polypill group.
• They also found that the non-high-density-lipoprotein-cholesterol levels fell 8.9% in the polypill group and 1.8% in the usual-care group.
• They reported non-serious gastrointestinal disorders with no reports of major bleeding episodes.

The authors concluded, "The results of the VULCANO study showed that switching from conventional treatment to the CNIC-polypill approach in patients at high CV risk without a previous event was safe and it was associated with a significant improvement in LDL-c and other lipid parameters, preserved BP levels throughout the study follow-up, and there was a trend to improve the overall patient's predicted CV risk."

The pre-print of the study is available online at researchsquare.com and has yet to be peer-reviewed.

DOI:10.21203/rs.3.rs-1033954/v1