Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?
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, o...
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| Veröffentlicht in: | Revista española de cardiología (English ed.) 2021-01, Vol.74 (1), p.51-58 |
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| creator | González-Juanatey, José R. Tamargo, Juan Torres, Ferran Weisser, Burkhard Oudovenko, Natalia |
| description | 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.
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.
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.
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 niv |
| doi_str_mv | 10.1016/j.rec.2019.11.008 |
| format | Article |
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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.
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.
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.
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.
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.</description><identifier>ISSN: 1885-5857</identifier><identifier>EISSN: 1885-5857</identifier><identifier>DOI: 10.1016/j.rec.2019.11.008</identifier><identifier>PMID: 31983653</identifier><language>eng</language><publisher>Spain: Elsevier España, S.L.U</publisher><subject>Aspirin ; Atorvastatin ; Atorvastatina ; c-LDL ; Cardiovascular Diseases - drug therapy ; Cholesterol, LDL ; Drug Combinations ; Farmacodinámica ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; LDL-C ; Pharmacodynamics ; Policomprimido ; Polypill ; Presión arterial sistólica ; Ramipril ; Systolic blood pressure ; Treatment Outcome</subject><ispartof>Revista española de cardiología (English ed.), 2021-01, Vol.74 (1), p.51-58</ispartof><rights>2019 Sociedad Española de Cardiología</rights><rights>Copyright © 2019 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c1983-aba307cd49a85fee8bcde988b03aa73f821692f78a6c04eabf2f3040cd0ac2f23</citedby><cites>FETCH-LOGICAL-c1983-aba307cd49a85fee8bcde988b03aa73f821692f78a6c04eabf2f3040cd0ac2f23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rec.2019.11.008$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31983653$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>González-Juanatey, José R.</creatorcontrib><creatorcontrib>Tamargo, Juan</creatorcontrib><creatorcontrib>Torres, Ferran</creatorcontrib><creatorcontrib>Weisser, Burkhard</creatorcontrib><creatorcontrib>Oudovenko, Natalia</creatorcontrib><title>Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?</title><title>Revista española de cardiología (English ed.)</title><addtitle>Rev Esp Cardiol (Engl Ed)</addtitle><description>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.
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.
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.
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.
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.</description><subject>Aspirin</subject><subject>Atorvastatin</subject><subject>Atorvastatina</subject><subject>c-LDL</subject><subject>Cardiovascular Diseases - drug therapy</subject><subject>Cholesterol, LDL</subject><subject>Drug Combinations</subject><subject>Farmacodinámica</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors</subject><subject>LDL-C</subject><subject>Pharmacodynamics</subject><subject>Policomprimido</subject><subject>Polypill</subject><subject>Presión arterial sistólica</subject><subject>Ramipril</subject><subject>Systolic blood pressure</subject><subject>Treatment Outcome</subject><issn>1885-5857</issn><issn>1885-5857</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtr3TAQhUVpaF79AdkULbu5jh5-yHRRSmgeEEgWyVqMpVGuLrbkSnbA_76-vWnpKqs5MOccZj5CLjgrOOP15a5IaArBeFtwXjCmPpATrlS1qVTVfPxPH5PTnHeMVVI15SdyLHmrZF3JE7J93EIawES7BBi8oXma7UKjo9MWqYFkfXyFbOYeEh1jv4y-7wt6l_f7hBTCQn2YMIGZfAwUhhhe_mRXEU0cxhgwTPn7OTly0Gf8_DbPyPP1z6er2839w83d1Y_7jdnftIEOJGuMLVtQlUNUnbHYKtUxCdBIpwSvW-EaBbVhJULnhJOsZMYyMMIJeUa-HnrHFH_NmCc9-Gyw7yFgnLMWsqxF24qSr1Z-sJoUc07o9Jj8AGnRnOk9YL3TK2C9B6w51yvgNfPlrX7uBrT_En-JroZvBwOuT756TDobj8Gg9WvXpG3079T_BqZ0jig</recordid><startdate>202101</startdate><enddate>202101</enddate><creator>González-Juanatey, José R.</creator><creator>Tamargo, Juan</creator><creator>Torres, Ferran</creator><creator>Weisser, Burkhard</creator><creator>Oudovenko, Natalia</creator><general>Elsevier España, S.L.U</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202101</creationdate><title>Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?</title><author>González-Juanatey, José R. ; Tamargo, Juan ; Torres, Ferran ; Weisser, Burkhard ; Oudovenko, Natalia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1983-aba307cd49a85fee8bcde988b03aa73f821692f78a6c04eabf2f3040cd0ac2f23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aspirin</topic><topic>Atorvastatin</topic><topic>Atorvastatina</topic><topic>c-LDL</topic><topic>Cardiovascular Diseases - drug therapy</topic><topic>Cholesterol, LDL</topic><topic>Drug Combinations</topic><topic>Farmacodinámica</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors</topic><topic>LDL-C</topic><topic>Pharmacodynamics</topic><topic>Policomprimido</topic><topic>Polypill</topic><topic>Presión arterial sistólica</topic><topic>Ramipril</topic><topic>Systolic blood pressure</topic><topic>Treatment Outcome</topic><toplevel>online_resources</toplevel><creatorcontrib>González-Juanatey, José R.</creatorcontrib><creatorcontrib>Tamargo, Juan</creatorcontrib><creatorcontrib>Torres, Ferran</creatorcontrib><creatorcontrib>Weisser, Burkhard</creatorcontrib><creatorcontrib>Oudovenko, Natalia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Revista española de cardiología (English ed.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>González-Juanatey, José R.</au><au>Tamargo, Juan</au><au>Torres, Ferran</au><au>Weisser, Burkhard</au><au>Oudovenko, Natalia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents?</atitle><jtitle>Revista española de cardiología (English ed.)</jtitle><addtitle>Rev Esp Cardiol (Engl Ed)</addtitle><date>2021-01</date><risdate>2021</risdate><volume>74</volume><issue>1</issue><spage>51</spage><epage>58</epage><pages>51-58</pages><issn>1885-5857</issn><eissn>1885-5857</eissn><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.
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.
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.
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.
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.</abstract><cop>Spain</cop><pub>Elsevier España, S.L.U</pub><pmid>31983653</pmid><doi>10.1016/j.rec.2019.11.008</doi><tpages>8</tpages></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Aspirin Atorvastatin Atorvastatina c-LDL Cardiovascular Diseases - drug therapy Cholesterol, LDL Drug Combinations Farmacodinámica Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors LDL-C Pharmacodynamics Policomprimido Polypill Presión arterial sistólica Ramipril Systolic blood pressure Treatment Outcome |
| title | Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents? |
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