Clinical Effectiveness of the Cardiovascular Polypill in a Real-Life Setting in Patients with Cardiovascular Risk: The SORS Study.
Adrenergic beta-Antagonists
/ therapeutic use
Angiotensin-Converting Enzyme Inhibitors
/ therapeutic use
Antihypertensive Agents
/ therapeutic use
Blood Pressure
/ drug effects
Cardiovascular Diseases
/ prevention & control
Cholesterol
/ blood
Drug Combinations
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
/ therapeutic use
Male
Medication Adherence
Mexico
Middle Aged
Prospective Studies
Risk Factors
Treatment Outcome
Adherence
Cardiovascular polypill
Cardiovascular risk factors
Global cardiovascular risk
High-risk primary prevention
Secondary prevention
Journal
Archives of medical research
ISSN: 1873-5487
Titre abrégé: Arch Med Res
Pays: United States
ID NLM: 9312706
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
31
10
2018
revised:
12
03
2019
accepted:
02
04
2019
entrez:
19
5
2019
pubmed:
19
5
2019
medline:
31
1
2020
Statut:
ppublish
Résumé
The cardiovascular disease pandemic has promoted the cardiovascular polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available. We conducted a multicentre, observational and prospective registry of a polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer polypill. At one year with the polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p <0.001), and from 89.1 mmHg to 80.4 mmHg (p <0.001) respectively. LDLc levels were significantly reduced 132.5-107.6 mg/dL (p <0.001). The 10 year Framingham cardiovascular disease risk was also reduced in the high-risk group (33.7 + 22.0 vs. 21.2 + 14.8; p <0.001) and in the intermediate risk group (23.7 + 14.8 vs. 12.7 + 11.4; p <0.001). To our knowledge, the results of the current study constitute the first real life data on the impact of a polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.
Sections du résumé
BACKGROUND
The cardiovascular disease pandemic has promoted the cardiovascular polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available.
METHODS
We conducted a multicentre, observational and prospective registry of a polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer polypill.
RESULTS
At one year with the polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p <0.001), and from 89.1 mmHg to 80.4 mmHg (p <0.001) respectively. LDLc levels were significantly reduced 132.5-107.6 mg/dL (p <0.001). The 10 year Framingham cardiovascular disease risk was also reduced in the high-risk group (33.7 + 22.0 vs. 21.2 + 14.8; p <0.001) and in the intermediate risk group (23.7 + 14.8 vs. 12.7 + 11.4; p <0.001).
CONCLUSIONS
To our knowledge, the results of the current study constitute the first real life data on the impact of a polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.
Identifiants
pubmed: 31101241
pii: S0188-4409(18)30717-3
doi: 10.1016/j.arcmed.2019.04.001
pii:
doi:
Substances chimiques
Adrenergic beta-Antagonists
0
Angiotensin-Converting Enzyme Inhibitors
0
Antihypertensive Agents
0
Drug Combinations
0
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Cholesterol
97C5T2UQ7J
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
31-40Investigateurs
Misael Arroyo
(M)
Maria Teresa Colosia
(MT)
Juan E Becerril
(JE)
Roberto Vázquez
(R)
Elias Rodriguez
(E)
Alejandro Rodriguez
(A)
Rafael Márquez
(R)
Enrique Gomez
(E)
Juan M González
(JM)
Jose L Ubiarco
(JL)
Jose F Barrera
(JF)
Bertha Vitela
(B)
Laura A Aranda
(LA)
Víctor Peña
(V)
Miguel A Guerrero
(MA)
Susana Ibarra
(S)
Maria I Córdoba
(MI)
Gloria Ledesma
(G)
Gustavo Alarcón
(G)
Jose A Campos
(JA)
Jose L Diez
(JL)
Rafael Elias
(R)
Víctor H Báez
(VH)
Mariano D Cervantes
(MD)
Raúl Apresa
(R)
Javier Casian
(J)
Rafael Corral
(R)
David A Delgado
(DA)
Joel E Padrón
(JE)
Víctor M Hernández
(VM)
Maria A Rodriguez
(MA)
Enrique González
(E)
Alejandro Garcia
(A)
Francisco J González
(FJ)
Miguel A González
(MA)
Nadia Álvarez
(N)
Jorge A Rodriguez
(JA)
Francisco Martinez
(F)
Jose A Gaxiola
(JA)
Luis J Garcia
(LJ)
Luis Gonzaga
(L)
Mirtha Valenzuela
(M)
Ezequiel Garcia
(E)
Manuel Sanchez
(M)
Manuel Oropeza
(M)
Simón Areola
(S)
Guillermo A Rodriguez
(GA)
Maria R Zarate
(MR)
Maria R Jaramillo
(MR)
Adriana L Vega
(AL)
Félix González
(F)
Marisela C Parra
(MC)
Rosalba Lara
(R)
Delia Ruiz
(D)
Alejandro Chávez
(A)
Héctor V Ballardo
(HV)
Ezequiel Gomez
(E)
Antonio Corona
(A)
Mario L Rodriguez
(ML)
Ramon Flores
(R)
Jose A Castro
(JA)
Reynaldo J Jiménez
(RJ)
Jesús M Acosta
(JM)
Angel Morales
(A)
Enrique A Velázquez
(EA)
Gerardo Santana
(G)
Juan J Atilano
(JJ)
Maria G Jiménez
(MG)
Fernando González
(F)
Jose J Santos
(JJ)
Maria A Asmida
(MA)
Jose C Flores
(JC)
Raúl Segura
(R)
Isilio N Morales
(IN)
Javier Estrada
(J)
Jorge L Narváez
(JL)
Silvia Rivera
(S)
Jorge L Flores
(JL)
Norma E Cano
(NE)
Miguel A Guerrero
(MA)
Armando Moreno
(A)
Armando G de la Cruz
(AG)
Noé D Monroy
(ND)
Omar Mejía
(O)
Joaquín I Moreno
(JI)
Martin Limas
(M)
Jose A Maldonado
(JA)
Vania Quisbert
(V)
Claudia C Rojas
(CC)
Mario Flores
(M)
Sonia Salgado
(S)
Ana K Villanueva
(AK)
Ulises Romero
(U)
Alejandro Tirado
(A)
Maria C Guadalupe
(MC)
Javier V Villalpando
(JV)
Alejandro Cortes
(A)
Eliceo Gracia
(E)
Karla G Wong
(KG)
Víctor M Salas
(VM)
Jose L Escobar
(JL)
Pedro Hernández
(P)
Nancy Bello
(N)
Rubén O Yza
(RO)
Octavio Beltrán
(O)
Miguel A Águila
(MA)
Francisco Vera
(F)
Pedro Mejía
(P)
Juan M Arellano
(JM)
Enrique Morlet
(E)
Luis E Lopez
(LE)
Marco A Rios
(MA)
Federico Jiménez
(F)
Yolanda P Rodriguez
(YP)
Javier Salinas
(J)
Alejandro Rivas
(A)
Beatriz Mendoza
(B)
Sergio Téllez
(S)
Jose A Magaña
(JA)
Juan A Quintana
(JA)
Lázaro Aguilar
(L)
Jose Sacen
(J)
Edith Mc Vallarta
(EM)
Fernando F Garcia
(FF)
Maria L Ramírez
(ML)
Maria T Olac
(MT)
German R Bautista
(GR)
Juan Martin
(J)
Marcelo Jiménez
(M)
Jorge Cedillo
(J)
Eddie A Favela
(EA)
Jose Pegueros
(J)
Jose J Becerra
(JJ)
Raul Silva
(R)
Armando Zepeda
(A)
Jorge E Hernández
(JE)
Miguel Marvaes
(M)
Hilario Aguilar
(H)
Ana L Lerma
(AL)
Luis M Fuentes
(LM)
Informations de copyright
Copyright © 2019 IMSS. Published by Elsevier Inc. All rights reserved.