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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: The George Institute for Global Health, University of Sydney, Sydney, Australia. Electronic address: rwebster@georgeinstitute.org.au.
authors.forename: Ruth
authors.initials: R
authors.lastname: Webster
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
authors.forename: Laurent
authors.initials: L
authors.lastname: Billot
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.forename: Carol
authors.initials: C
authors.lastname: Burch
authors.forename: Bruce
authors.initials: B
authors.lastname: Neal
authors.forename: Tim
authors.initials: T
authors.lastname: Usherwood
authors.forename: Simon
authors.initials: S
authors.lastname: Thom
authors.forename: Neil
authors.initials: N
authors.lastname: Poulter
authors.forename: Alice
authors.initials: A
authors.lastname: Stanton
authors.forename: Michiel L
authors.initials: ML
authors.lastname: Bots
authors.forename: Diederick E
authors.initials: DE
authors.lastname: Grobbee
authors.forename: Dorairaj
authors.initials: D
authors.lastname: Prabhakaran
authors.forename: K Srinath
authors.initials: KS
authors.lastname: Reddy
authors.forename: Jane
authors.initials: J
authors.lastname: Field
authors.forename: Chris
authors.initials: C
authors.lastname: Bullen
authors.forename: C Raina
authors.initials: CR
authors.lastname: Elley
authors.forename: Vanessa
authors.initials: V
authors.lastname: Selak
authors.forename: Natasha
authors.initials: N
authors.lastname: Rafter
authors.forename: Angela
authors.initials: A
authors.lastname: Wadham
authors.forename: Otavio
authors.initials: O
authors.lastname: Berwanger
authors.forename: Anthony
authors.initials: A
authors.lastname: Rodgers
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D003299:Cooperative Behavior; D004338:Drug Combinations; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012307:Risk Factors
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D001241:Aspirin
keywords: Cardiovascular disease; Meta-analysis; Polypill; Prospective