title: The effect of basal insulin glargine on the fibrinolytic system and von Willebrand factor in people with dysglycaemia and high risk for cardiovascular events: Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial.
abstract: Fibrinolytic factors, plasminogen activator inhibitor-1, tissue plasminogen activator, tissue plasminogen activator/plasminogen activator-complex and the haemostatic factor von Willebrand factor are known markers of cardiovascular disease. Their plasma levels are adversely affected in patients with dysglycaemia, and glucose normalization with insulin glargine might improve the levels of these factors.
  
  
  
  Prespecified Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial (ClinicalTrials.gov number, NCT00069784). Tissue plasminogen activator activity, tissue plasminogen activator antigen, plasminogen activator inhibitor-1 antigen, tissue plasminogen activator/plasminogen activator inhibitor-1 complex and von Willebrand factor were analysed at study start, after 2 years and at the end of the study (median follow-up of 6.2 years).
  
  
  
  Of 129 patients (mean age of 64 ± 7 years, females: 19%), 68 (53%) and 61 (47%) were randomized to the insulin glargine and standard care group, respectively. Allocation to insulin glargine did not significantly affect the studied fibrinolytic markers or von Willebrand factor compared to standard care. Likewise, there were no significant differences in plasminogen activator inhibitor-1, tissue plasminogen activator antigen and von Willebrand factor. During the whole study period, the within-group analysis revealed a curvilinear pattern and significant changes for tissue plasminogen activator/plasminogen activator inhibitor-1 complex, tissue plasminogen activator antigen and von Willebrand factor in the insulin glargine but not in the standard care group.
  
  
  
  In people with dysglycaemia and other cardiovascular risk factors, basal insulin does not improve the levels of markers of fibrinolysis or von Willebrand factor compared to standard glucose-lowering treatments.
authors.affiliation: 1 Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.|2 Department of Medicine, Sunderby Hospital, Luleå, Sweden.
authors.forename: Aslak
authors.initials: A
authors.lastname: Rautio
authors.affiliation: 1 Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.|3 Research Unit, Skellefteå Hospital, Skellefteå, Sweden.
authors.forename: Kurt
authors.initials: K
authors.lastname: Boman
authors.affiliation: 4 Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.
authors.forename: Hertzel C
authors.initials: HC
authors.lastname: Gerstein
authors.affiliation: 1 Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.|3 Research Unit, Skellefteå Hospital, Skellefteå, Sweden.
authors.forename: Jenny
authors.initials: J
authors.lastname: Hernestål-Boman
authors.affiliation: 4 Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.
authors.forename: Shun Fu
authors.initials: SF
authors.lastname: Lee
authors.affiliation: 1 Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.|3 Research Unit, Skellefteå Hospital, Skellefteå, Sweden.
authors.forename: Mona
authors.initials: M
authors.lastname: Olofsson
authors.affiliation: 5 Unit of Cardiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Linda Garcia
authors.initials: LG
authors.lastname: Mellbin
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects*; D018149:Glucose Intolerance / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017395:Plasminogen Activator Inhibitor 1 / Q000097:blood; D012307:Risk Factors; D013548:Sweden; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000097:blood; D016896:Treatment Outcome; D014841:von Willebrand Factor / Q000378:metabolism*
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D017395:Plasminogen Activator Inhibitor 1; C051321:SERPINE1 protein, human; D014841:von Willebrand Factor; D000069036:Insulin Glargine; C067262:PLAT protein, human; D010959:Tissue Plasminogen Activator
keywords: Diabetes; fibrinolysis; glucose-lowering treatment; insulin glargine