INTRODUCTION AND OBJECTIVES: To compare the pharmacodynamics of the CNIC 
polypill (atorvastatin 40mg/ramipril 10mg/aspirin 100mg) in terms of low-density 
lipoprotein cholesterol (LDL-C) and systolic blood pressure (SBP), with the 
corresponding reference products (atorvastatin and ramipril).
METHODS: This was a multicenter, randomized, open-label, and parallel 3-arm 
study comparing the effect of the CNIC polypill vs ramipril 10mg and 
atorvastatin 40mg on SBP and LDL-C. The coprimary endpoints were differences in 
the adjusted mean 24-hour SBP (using ambulatory BP measurement) and LDL-C during 
the study period estimated using an ANCOVA model.
RESULTS: Of the 241 patients included in the per protocol population, 84 
received the CNIC polypill (group A), 84 atorvastatin (group B), and 73 ramipril 
(group C). SBP decreased from 139.3±12.5 to 133.2±12.9mmHg in group A and from 
138.1±11.9 to 134.0±12.8mmHg in group C (baseline adjusted mean difference for 
the decrease in SBP was 1.77mmHg (90%CI, -0.5 to 4.0) in favor of group A, 
without reaching statistical significance. LDL-C was reduced by 33.9±21.6 and 
29.2±25.8mg/dL in groups A and B, respectively (baseline adjusted mean 
difference for the decrease in LDL-C was 7.0% (90%CI, 1.5-12.4), a significantly 
greater decrease with the polypill). The 3 treatments were well tolerated.
CONCLUSIONS: The results of this study rule out a negative effect on blood 
pressure of the interaction between the components of the CNIC polypill. The 
reduction in LDL-C was greater in the CNIC polypill group, suggesting a 
synergistic effect of the components.