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

R. Webster; A. Patel; L. Billot; A. Cass; C burch; B. Neal; T usherwood; S Thom; N. Poulter; A Stanton; M.L. Bots; D.E. Grobbee; D. Prabhakaran; K.S. Reddy; J. Field; C Bullen; C.R. Elley; V Selak; N Rafter; A Wadham; O. Berwanger; A. Rodgers; Collaboration SPACE

doi: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

R. Webster, A. Patel, L. Billot, A. Cass, C burch, B. Neal, T usherwood, S Thom, N. Poulter, A Stanton, M.L. Bots, D.E. Grobbee, D. Prabhakaran, K.S. Reddy, J. Field, C Bullen, C.R. Elley, V Selak, N Rafter, A WadhamO. Berwanger, A. Rodgers, Collaboration SPACE

Research output: Contribution to journal › Article › Academic › peer-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 language	English
Pages (from-to)	30-35
Number of pages	6
Journal	International Journal of Cardiology
Volume	170
Issue number	1
DOIs	https://doi.org/10.1016/j.ijcard.2013.10.007
Publication status	Published - 5 Dec 2013

Keywords

Antihypertensive Agents
Aspirin
Cardiovascular Diseases
Cooperative Behavior
Drug Combinations
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Prospective Studies
Randomized Controlled Trials as Topic
Risk Factors
Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

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10.1016/j.ijcard.2013.10.007

http://www.ncbi.nlm.nih.gov/pubmed/24144927

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Webster, R., Patel, A., Billot, L., Cass, A., burch, C., Neal, B., usherwood, T., Thom, S., Poulter, N., Stanton, A., Bots, M. L., Grobbee, D. E., Prabhakaran, D., Reddy, K. S., Field, J., Bullen, C., Elley, C. R., Selak, V., Rafter, N., ... SPACE, C. (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, 170(1), 30-35. https://doi.org/10.1016/j.ijcard.2013.10.007

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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 = "Antihypertensive Agents, Aspirin, Cardiovascular Diseases, Cooperative Behavior, Drug Combinations, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Comparative Study, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't",

author = "R. Webster and A. Patel and L. Billot and A. Cass and C burch and B. Neal and T usherwood and S Thom and N. Poulter and A Stanton and M.L. Bots and D.E. Grobbee and D. Prabhakaran and K.S. Reddy and J. Field and C Bullen and C.R. Elley and V Selak and N Rafter and A Wadham and O. Berwanger and A. Rodgers and Collaboration SPACE",

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Webster, R, Patel, A, Billot, L, Cass, A, burch, C, Neal, B, usherwood, T, Thom, S, Poulter, N, Stanton, A, Bots, ML , Grobbee, DE, Prabhakaran, D, Reddy, KS, Field, J, Bullen, C, Elley, CR, Selak, V, Rafter, N, Wadham, A, Berwanger, O, Rodgers, A & SPACE, C 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

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, R.

AU - Patel, A.

AU - Billot, L.

AU - Cass, A.

AU - burch, C

AU - Neal, B.

AU - usherwood, T

AU - Thom, S

AU - Poulter, N.

AU - Stanton, A

AU - Bots, M.L.

AU - Grobbee, D.E.

AU - Prabhakaran, D.

AU - Reddy, K.S.

AU - Field, J.

AU - Bullen, C

AU - Elley, C.R.

AU - Selak, V

AU - Rafter, N

AU - Wadham, A

AU - Berwanger, O.

AU - Rodgers, A.

AU - SPACE, Collaboration

PY - 2013/12/5

Y1 - 2013/12/5

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 - 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

KW - Comparative Study

KW - Journal Article

KW - Meta-Analysis

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.ijcard.2013.10.007

DO - 10.1016/j.ijcard.2013.10.007

M3 - Article

C2 - 24144927

SN - 0167-5273

VL - 170

SP - 30

EP - 35

JO - International Journal of Cardiology

JF - International Journal of Cardiology

IS - 1

ER -

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

Abstract

Keywords

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