title: Combined therapy with sitagliptin plus granulocyte-colony stimulating factor in patients with acute myocardial infarction - Long-term results of the SITAGRAMI trial.
abstract: BACKGROUND
  Autologous progenitor cell therapy comprising granulocyte-colony stimulating factor (G-CSF) for mobilization of bone-marrow derived progenitor cells (BMPCs) into peripheral blood and inhibition of dipeptidylpeptidase-IV by sitagliptin for enhanced myocardial recruitment of circulating BMPCs has been shown to improve survival after acute myocardial infarction (MI) in preclinical studies. In the SITAGRAMI trial we found that during short-term follow-up G-CSF plus sitagliptin (GS) failed to show a beneficial effect on cardiac function and clinical events in patients with acute MI that underwent successful PCI. The objective of the present analysis was to assess the impact of GS versus placebo treatment on long-term clinical outcomes of the SITAGRAMI trial patient population.
  
  
  METHODS
  In the randomized, prospective, double-blind, placebo-controlled SITAGRAMI trial, 174 patients with acute MI were assigned to GS or placebo in a 1:1 ratio. The primary outcome for the present long-term analysis was the composite of death, MI or stroke on long-term follow-up.
  
  
  RESULTS
  The median [IQR] follow-up duration was 4.50 [3.56-5.95] years. The primary outcome occurred in 12.8% of patients assigned to placebo and 9.2% assigned to GS (HR 0.69, 95% CI 0.28-1.69; p=0.42). The incidence of the combined cardiovascular outcome was 47.7% in the placebo- and 41.4% in the GS-group (HR 0.75, 95% CI 0.48-1.18; p=0.21). Overall, there was no significant difference in MACCE rates between both treatment groups (p=0.41).
  
  
  CONCLUSIONS
  These long-term follow-up data indicate that GS therapy does not improve clinical outcomes of patients with acute MI.
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Lisa
authors.initials: L
authors.lastname: Gross
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Hans Diogenes
authors.initials: HD
authors.lastname: Theiss
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Grabmaier
authors.affiliation: Institute for Medical Informatics, Biometry und Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Adrion
authors.affiliation: Institute for Medical Informatics, Biometry und Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mansmann
authors.affiliation: Department of Cardiology, Klinikum Innenstadt, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Sohn
authors.affiliation: Department of Cardiology, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Ellen
authors.initials: E
authors.lastname: Hoffmann
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Steinbeck
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany; Department of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Wolfgang-Michael
authors.initials: WM
authors.lastname: Franz
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany; Department of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: mail@med.cbrenner.net.
authors.forename: Christoph
authors.initials: C
authors.lastname: Brenner
mesh_terms: D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy*; D011446:Prospective Studies; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D000068900:Sitagliptin Phosphate
keywords: Acute myocardial infarction; Clinical studies; Dipeptidylpeptidase IV; Granulocyte-colony stimulating factor; Progenitor cell therapy; Sitagliptin