title: Risk of stroke and cardiovascular events after ischemic stroke or transient ischemic attack in patients with type 2 diabetes or metabolic syndrome: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial.
abstract: OBJECTIVE
  To perform a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, which tested the effect of treatment with atorvastatin in reducing stroke in subjects with a recent stroke or transient ischemic attack, to explore the effects of treatment in subjects with type 2 diabetes mellitus or metabolic syndrome (MetS).
  
  
  METHODS
  The 4731 subjects enrolled in the SPARCL trial were classified as having type 2 diabetes mellitus at enrollment (n = 794), MetS retrospectively (n = 642), or neither diabetes nor MetS (n = 3295, the reference group) based on data collected at baseline. Cox regression models were used to determine whether the effect of treatment on the primary end point (combined risk of nonfatal and fatal stroke) and secondary end points (major coronary events, major cardiovascular events, any coronary heart disease event, and any revascularization procedure) varied based on the presence of type 2 diabetes mellitus or MetS.
  
  
  RESULTS
  Subjects with type 2 diabetes mellitus had increased risks of stroke (hazard ratio [HR] = 1.62; 95% confidence interval [CI], 1.33-1.98; P < .001), major cardiovascular events (HR = 1.66; 95% CI, 1.39-1.97; P < .001), and revascularization procedures (HR = 2.39; 95% CI, 1.78-3.19; P < .001) compared with the reference group. Subjects with MetS were not at increased risk for stroke (P = .78) or major cardiovascular events (P = .38) but more frequently had revascularization procedures (HR = 1.78; 95% CI, 1.26-2.5; P = .001). There were no treatment × subgroup interactions for the SPARCL primary end point (P = .47).
  
  
  CONCLUSIONS
  The SPARCL subjects with type 2 diabetes were at higher risk for recurrent stroke and cardiovascular events. This exploratory analysis found no difference in the effect of statin treatment in reducing these events in subjects with or without type 2 diabetes or MetS. Trial Registration clinicaltrials.gov Identifier: NCT00147602.
authors.affiliation: Vanderbilt University, Nashville, TN, USA. stealthasc@earthlink.net
authors.forename: Alfred
authors.initials: A
authors.lastname: Callahan
authors.forename: Pierre
authors.initials: P
authors.lastname: Amarenco
authors.forename: Larry B
authors.initials: LB
authors.lastname: Goldstein
authors.forename: Henrik
authors.initials: H
authors.lastname: Sillesen
authors.forename: Mike
authors.initials: M
authors.lastname: Messig
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Samsa
authors.forename: Irfan
authors.initials: I
authors.lastname: Altafullah
authors.forename: Lucy Y
authors.initials: LY
authors.lastname: Ledbetter
authors.forename: Mary J
authors.initials: MJ
authors.lastname: MacLeod
authors.forename: Russell
authors.initials: R
authors.lastname: Scott
authors.forename: Michael
authors.initials: M
authors.lastname: Hennerici
authors.forename: Justin A
authors.initials: JA
authors.lastname: Zivin
authors.forename: K Michael A
authors.initials: KM
authors.lastname: Welch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000069059:Atorvastatin; D002320:Cardiovascular Physiological Phenomena / Q000187:drug effects; D002784:Cholesterol / Q000097:blood*; D016001:Confidence Intervals; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D002546:Ischemic Attack, Transient / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D008075:Lipoproteins, HDL / Q000097:blood; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications*; D008875:Middle Aged; D016016:Proportional Hazards Models; D011758:Pyrroles / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors; D020521:Stroke / Q000150:complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D014280:Triglycerides / Q000097:blood; D055815:Young Adult
chemical_list: D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008075:Lipoproteins, HDL; D008077:Lipoproteins, LDL; D011758:Pyrroles; D014280:Triglycerides; D002784:Cholesterol; D000069059:Atorvastatin