Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk

The SPACE Collaboration

Ruth Webster, Anushka Patel, Laurent Billot, Alan Cass, Carol Burch, Bruce Neal, Tim Usherwood, Simon Thom, Neil Poulter, Alice Stanton, Michiel Bots, Diederick Grobbee, Dorairaj Prabhakara, k. Srinath Reddy, J Field, Chris Bullen, C. Raina Elley, Vanessa Selak, Natasha Rafter, Angela Wadham & 2 others Otavio Berwanger, Anthony Rogers

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered.

Methods: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis.

Results: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (? 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified.

Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events).

Conclusion: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.
Original languageEnglish
Pages (from-to)30-35
Number of pages6
JournalInternational Journal of Cardiology
Volume170
Issue number1
DOIs
Publication statusPublished - 2013

Fingerprint

Meta-Analysis
Blood Pressure
LDL Cholesterol
Cardiovascular Diseases
Delivery of Health Care
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Creatinine
Diabetes Mellitus
Heart Failure
Cholesterol
Economics
Quality of Life
Research Personnel
Mortality

Cite this

Webster, Ruth ; Patel, Anushka ; Billot, Laurent ; Cass, Alan ; Burch, Carol ; Neal, Bruce ; Usherwood, Tim ; Thom, Simon ; Poulter, Neil ; Stanton, Alice ; Bots, Michiel ; Grobbee, Diederick ; Prabhakara, Dorairaj ; Reddy, k. Srinath ; Field, J ; Bullen, Chris ; Elley, C. Raina ; Selak, Vanessa ; Rafter, Natasha ; Wadham, Angela ; Berwanger, Otavio ; Rogers, Anthony. / Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk : The SPACE Collaboration. In: International Journal of Cardiology. 2013 ; Vol. 170, No. 1. pp. 30-35.
@article{74a9d8ed801c477f950ac83940e0c382,
title = "Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: The SPACE Collaboration",
abstract = "Background: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. Methods: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. Results: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (? 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). Conclusion: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.",
keywords = "acetylsalicylic acid, antithrombocytic agent, cholesterol, creatinine, hydroxymethylglutaryl coenzyme A reductase inhibitor, low density lipoprotein cholesterol, article, blood pressure measurement, cardiovascular risk, cause of death, clinical effectiveness, cost effectiveness analysis, diabetes mellitus, diastolic blood pressure, disease association, drug use, heart failure, high risk population, human, income, ischemic heart disease, outcome assessment, patient assessment, priority journal, prospective study, quality of life, risk assessment, risk factor, self report, systolic blood pressure, Cardiovascular disease, Meta-analysis, Polypill, Prospective, Antihypertensive Agents, Aspirin, Cardiovascular Diseases, Cooperative Behavior, Drug Combinations, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors",
author = "Ruth Webster and Anushka Patel and Laurent Billot and Alan Cass and Carol Burch and Bruce Neal and Tim Usherwood and Simon Thom and Neil Poulter and Alice Stanton and Michiel Bots and Diederick Grobbee and Dorairaj Prabhakara and Reddy, {k. Srinath} and J Field and Chris Bullen and Elley, {C. Raina} and Vanessa Selak and Natasha Rafter and Angela Wadham and Otavio Berwanger and Anthony Rogers",
year = "2013",
doi = "10.1016/j.ijcard.2013.10.007",
language = "English",
volume = "170",
pages = "30--35",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier",
number = "1",

}

Webster, R, Patel, A, Billot, L, Cass, A, Burch, C, Neal, B, Usherwood, T, Thom, S, Poulter, N, Stanton, A, Bots, M, Grobbee, D, Prabhakara, D, Reddy, KS, Field, J, Bullen, C, Elley, CR, Selak, V, Rafter, N, Wadham, A, Berwanger, O & Rogers, A 2013, 'Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: The SPACE Collaboration', International Journal of Cardiology, vol. 170, no. 1, pp. 30-35. https://doi.org/10.1016/j.ijcard.2013.10.007

Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk : The SPACE Collaboration. / Webster, Ruth; Patel, Anushka; Billot, Laurent; Cass, Alan; Burch, Carol; Neal, Bruce; Usherwood, Tim; Thom, Simon; Poulter, Neil; Stanton, Alice; Bots, Michiel; Grobbee, Diederick; Prabhakara, Dorairaj; Reddy, k. Srinath; Field, J; Bullen, Chris; Elley, C. Raina; Selak, Vanessa; Rafter, Natasha; Wadham, Angela; Berwanger, Otavio; Rogers, Anthony.

In: International Journal of Cardiology, Vol. 170, No. 1, 2013, p. 30-35.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk

T2 - The SPACE Collaboration

AU - Webster, Ruth

AU - Patel, Anushka

AU - Billot, Laurent

AU - Cass, Alan

AU - Burch, Carol

AU - Neal, Bruce

AU - Usherwood, Tim

AU - Thom, Simon

AU - Poulter, Neil

AU - Stanton, Alice

AU - Bots, Michiel

AU - Grobbee, Diederick

AU - Prabhakara, Dorairaj

AU - Reddy, k. Srinath

AU - Field, J

AU - Bullen, Chris

AU - Elley, C. Raina

AU - Selak, Vanessa

AU - Rafter, Natasha

AU - Wadham, Angela

AU - Berwanger, Otavio

AU - Rogers, Anthony

PY - 2013

Y1 - 2013

N2 - Background: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. Methods: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. Results: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (? 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). Conclusion: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.

AB - Background: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. Methods: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. Results: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (? 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). Conclusion: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.

KW - acetylsalicylic acid

KW - antithrombocytic agent

KW - cholesterol

KW - creatinine

KW - hydroxymethylglutaryl coenzyme A reductase inhibitor

KW - low density lipoprotein cholesterol

KW - article

KW - blood pressure measurement

KW - cardiovascular risk

KW - cause of death

KW - clinical effectiveness

KW - cost effectiveness analysis

KW - diabetes mellitus

KW - diastolic blood pressure

KW - disease association

KW - drug use

KW - heart failure

KW - high risk population

KW - human

KW - income

KW - ischemic heart disease

KW - outcome assessment

KW - patient assessment

KW - priority journal

KW - prospective study

KW - quality of life

KW - risk assessment

KW - risk factor

KW - self report

KW - systolic blood pressure

KW - Cardiovascular disease

KW - Meta-analysis

KW - Polypill

KW - Prospective

KW - Antihypertensive Agents

KW - Aspirin

KW - Cardiovascular Diseases

KW - Cooperative Behavior

KW - Drug Combinations

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Prospective Studies

KW - Randomized Controlled Trials as Topic

KW - Risk Factors

U2 - 10.1016/j.ijcard.2013.10.007

DO - 10.1016/j.ijcard.2013.10.007

M3 - Article

VL - 170

SP - 30

EP - 35

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

IS - 1

ER -