TY - JOUR
T1 - Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: 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 - Prabhakaran, D
AU - Reddy, Kolli
AU - Field, Jane
AU - Bullen, Chris
AU - Elley, Carolyn
AU - Selak, Vanessa
AU - Rafter, Natasha
AU - Wadham, Angela
AU - Berwanger, Otavio
AU - Rodgers, A
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 - Cardiovascular disease
KW - Meta-analysis
KW - Polypill
KW - Prospective
UR - http://www.scopus.com/inward/record.url?scp=84888003452&partnerID=8YFLogxK
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 -