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Vol. 74. Issue 1.
Pages 51-58 (January 2021)
Original article
DOI: 10.1016/j.rec.2019.11.008
Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?
Estudio farmacodinámico del policomprimido cardiovascular: ¿existe algún tipo de interacción entre los monocomponentes?
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José R. González-Juanateya, Juan Tamargob, Ferran Torresc, Burkhard Weisserd, Natalia Oudovenkoe,
Corresponding author
noudovenko@ferrer.com

Corresponding author: Departamento Médico, Ferrer Internacional, Avda. Diagonal 549, 08029 Barcelona, Spain.
a Servicio de Cardiología, Hospital Clínico Universitario de Santiago de Compostela, CIBERCV; IDIS, Santiago de Compostela, A Coruña, Spain
b Departamento de Farmacología, Escuela de Medicina, Universidad Complutense, Fundación Gregorio Marañón, CIBERCV, Madrid, Spain
c Unidad de Bioestadística, IDIBAPS, Hospital Clínic de Barcelona, Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
d Institut für Sportwissenschaft, Christian-Albrechts-Universität zu Kiel, Kiel, Germany
e Departamento Médico, Ferrer Internacional, Barcelona, Spain
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Tables (4)
Table 1. Baseline clinical characteristics of the study population (safety population)
Table 2. Changes in blood pressure
Table 3. Changes in lipid parameters
Table 4. Overall adverse events during the randomization phase in the safety population
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Abstract
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.

Keywords:
Atorvastatin
LDL-C
Pharmacodynamics
Polypill
Ramipril
Systolic blood pressure
Abbreviations:
BP
DBP
LDL
SBP
Resumen
Introducción y objetivos

Comparar la farmacodinámica del policomprimido CNIC (atorvastatina 40mg, ramipril 10mg, ácido acetilsalicílico 100mg) sobre el colesterol unido a lipoproteínas de baja densidad (c-LDL) y presión arterial sistólica (PAS) con los productos de referencia, atorvastatina y ramipril.

Métodos

Estudio multicéntrico, aleatorizado, abierto, de 3 grupos paralelos, que comparó el efecto del policomprimido CNIC frente a ramipril 10mg y atorvastatina 40mg sobre la PAS y c-LDL. Los objetivos coprimarios fueron las diferencias en las medias ajustadas de PAS 24h (mediante monitorización ambulatoria de PA) y el c-LDL durante el estudio, mediante un modelo ANCOVA.

Resultados

De los 241 pacientes en la población por protocolo, 84 recibieron policomprimido CNIC (grupo A), 84 atorvastatina (grupo B), y 73 ramipril (grupo C). La PAS se redujo de 139,3 (12,5) a 133,2 (12,9) mmHg en el grupo A y de 138,1 (11,9) a 134,0 (12,8) mmHg en el grupo C (diferencia media ajustada de PAS desde niveles basales 1,77mmHg (IC90%, −0,5–4,0) a favor del grupo A, sin alcanzar diferencias significativas. El c-LDL se redujo en 33,9 (21,6) y 29,2 (25,8) mg/dl en los grupos A y B, respectivamente (diferencia media ajustada desde niveles basales para el descenso del c-LDL del 7,0% (IC90%, 1,5–12,4), significativamente a favor del policomprimido). Los 3 tratamientos fueron bien tolerados.

Conclusiones

Los resultados de este estudio descartan un efecto negativo de la interacción entre los componentes del policomprimido-CNIC sobre la PA. La reducción del c-LDL fue mayor con el policomprimido-CNIC, sugiriendo un efecto sinérgico de los componentes.

Palabras clave:
Atorvastatina
c-LDL
Farmacodinámica
Policomprimido
Ramipril
Presión arterial sistólica

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