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A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization

BACKGROUND: The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease (CVD), side effects, improvement in adherence and physician/patient "...

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Autores principales: Soliman, Elsayed Z, Mendis, Shanthi, Dissanayake, Wasantha P, Somasundaram, Noel P, Gunaratne, Padma S, Jayasingne, I Kumudini, Furberg, Curt D
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3023675/
https://www.ncbi.nlm.nih.gov/pubmed/21205325
http://dx.doi.org/10.1186/1745-6215-12-3
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author Soliman, Elsayed Z
Mendis, Shanthi
Dissanayake, Wasantha P
Somasundaram, Noel P
Gunaratne, Padma S
Jayasingne, I Kumudini
Furberg, Curt D
author_facet Soliman, Elsayed Z
Mendis, Shanthi
Dissanayake, Wasantha P
Somasundaram, Noel P
Gunaratne, Padma S
Jayasingne, I Kumudini
Furberg, Curt D
author_sort Soliman, Elsayed Z
collection PubMed
description BACKGROUND: The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease (CVD), side effects, improvement in adherence and physician/patient "acceptability" of the Polypill. METHODS: We conducted an open-label, parallel-group, randomized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD. The trial compared a Polypill (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) to Standard Practice. After randomization, patients were followed monthly for three months. Pre-specified primary outcomes included reduction in systolic blood pressure, total cholesterol and estimated 10-year CVD risk. We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients. RESULTS: Patients were recruited in a six-month period as planned. Two hundred three patients (94.0%) completed the treatment program and returned for their three-month follow-up visits. No safety concerns were reported. These findings suggest a high rate of patient acceptability, a finding that is bolstered by the majority of patients completing the trial (90%) indicating that they would take the Polypill "for life" if proven to be effective in reducing CVD risk. Approximately 86% of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93% for secondary prevention of CVD. Both the Polypill and Standard Practice resulted in marked reductions in systolic blood pressure, total cholesterol and 10-year risk of CVD. However, the differences between the treatment groups were not statistically significant. CONCLUSIONS: We successfully completed a Polypill feasibility trial in Sri Lanka. We were able to document high acceptability of the Polypill to patients and physicians. We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs. The Polypill was however simpler and achieved comparable risk factor reductions, highlighting its potential usefulness in the prevention of CVD. TRIAL REGISTRATION NUMBER: ISRCTN: NCT00567307
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spelling pubmed-30236752011-01-20 A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization Soliman, Elsayed Z Mendis, Shanthi Dissanayake, Wasantha P Somasundaram, Noel P Gunaratne, Padma S Jayasingne, I Kumudini Furberg, Curt D Trials Research BACKGROUND: The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease (CVD), side effects, improvement in adherence and physician/patient "acceptability" of the Polypill. METHODS: We conducted an open-label, parallel-group, randomized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD. The trial compared a Polypill (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) to Standard Practice. After randomization, patients were followed monthly for three months. Pre-specified primary outcomes included reduction in systolic blood pressure, total cholesterol and estimated 10-year CVD risk. We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients. RESULTS: Patients were recruited in a six-month period as planned. Two hundred three patients (94.0%) completed the treatment program and returned for their three-month follow-up visits. No safety concerns were reported. These findings suggest a high rate of patient acceptability, a finding that is bolstered by the majority of patients completing the trial (90%) indicating that they would take the Polypill "for life" if proven to be effective in reducing CVD risk. Approximately 86% of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93% for secondary prevention of CVD. Both the Polypill and Standard Practice resulted in marked reductions in systolic blood pressure, total cholesterol and 10-year risk of CVD. However, the differences between the treatment groups were not statistically significant. CONCLUSIONS: We successfully completed a Polypill feasibility trial in Sri Lanka. We were able to document high acceptability of the Polypill to patients and physicians. We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs. The Polypill was however simpler and achieved comparable risk factor reductions, highlighting its potential usefulness in the prevention of CVD. TRIAL REGISTRATION NUMBER: ISRCTN: NCT00567307 BioMed Central 2011-01-05 /pmc/articles/PMC3023675/ /pubmed/21205325 http://dx.doi.org/10.1186/1745-6215-12-3 Text en Copyright ©2011 Soliman et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<url>http://creativecommons.org/licenses/by/2.0</url>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Soliman, Elsayed Z
Mendis, Shanthi
Dissanayake, Wasantha P
Somasundaram, Noel P
Gunaratne, Padma S
Jayasingne, I Kumudini
Furberg, Curt D
A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title_full A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title_fullStr A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title_full_unstemmed A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title_short A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
title_sort polypill for primary prevention of cardiovascular disease: a feasibility study of the world health organization
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3023675/
https://www.ncbi.nlm.nih.gov/pubmed/21205325
http://dx.doi.org/10.1186/1745-6215-12-3
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