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Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?

Authors
  • González-Juanatey, José R1
  • Tamargo, Juan2
  • Torres, Ferran3
  • Weisser, Burkhard4
  • Oudovenko, Natalia5
  • 1 Servicio de Cardiología, Hospital Clínico Universitario de Santiago de Compostela, CIBERCV; IDIS, Santiago de Compostela, A Coruña, Spain. , (Spain)
  • 2 Departamento de Farmacología, Escuela de Medicina, Universidad Complutense, Fundación Gregorio Marañón, CIBERCV, Madrid, Spain. , (Spain)
  • 3 Unidad de Bioestadística, IDIBAPS, Hospital Clínic de Barcelona, Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain. , (Spain)
  • 4 Institut für Sportwissenschaft, Christian-Albrechts-Universität zu Kiel, Kiel, Germany. , (Germany)
  • 5 Departamento Médico, Ferrer Internacional, Barcelona, Spain. Electronic address: [email protected] , (Spain)
Type
Published Article
Journal
Revista espanola de cardiologia (English ed.)
Publication Date
Jan 01, 2021
Volume
74
Issue
1
Pages
51–58
Identifiers
DOI: 10.1016/j.rec.2019.11.008
PMID: 31983653
Source
Medline
Keywords
Language
Spanish
License
Unknown

Abstract

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). 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. 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. 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. Copyright © 2019 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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